Sharon Worcester

The direct oral anticoagulants (DOACs) apixaban and rivaroxaban are now among the options for thromboprophylaxis in high-risk cancer outpatients with low risk for bleeding and drug interactions, according to a practice guideline update from the American Society of Clinical Oncology.

Sebastian Kaulitzki/Thinkstock

Rivaroxaban also has been added as an option for initial anticoagulation for venous thromboembolism (VTE), and both rivaroxaban and edoxaban are now options for long-term anticoagulation, Nigel S. Key, MB ChB, and colleagues wrote in the updated guideline on the prophylaxis and treatment of VTE – including deep vein thrombosis (DVT) and pulmonary embolism (PE) – in cancer patients (J Clin Oncol. 2019 Aug 5. doi: 10.1200/JCO.19.19.01461).

The addition of DOACs as options for VTE prophylaxis and treatment represents the most notable change to the guideline.

“Oral anticoagulants that target thrombin (direct thrombin inhibitor, dabigatran) or activated factor X (antifactor Xa inhibitors, rivaroxaban, apixaban, and edoxaban) are now approved for treatment of DVT or PE as well as for DVT prophylaxis following orthopedic surgery and for reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation,” the guideline panel wrote.

A systematic review of PubMed and the Cochrane Library for randomized controlled trials (RCTs) and meta-analyses of RCTs published from Aug. 1, 2014, through Dec. 4, 2018, identified 35 publications on VTE prophylaxis and treatment, including 2 RCTs of DOACs for prophylaxis and 2 others of DOAC treatment, as well as 8 publications on VTE risk assessment. A multidisciplinary expert panel appointed by ASCO and cochaired by Dr. Key of the University of North Carolina, Chapel Hill, used this evidence to develop the updated guideline.

The work was guided by “the ‘signals’ approach that is designed to identify only new, potentially practice-changing data – signals – that might translate into revised practice recommendations,” the authors explained.

DOAC-related updates

VTE prophylaxis. Based in part on findings from the recently published AVERT trial of apixaban in patients initiating a new course of chemotherapy and from the CASSINI trial of rivaroxaban in patients with solid tumors or lymphoma starting systemic antineoplastic therapy, the panel added both agents as thromboprophylactic options that can be offered to high-risk cancer outpatients with no significant risk factors for bleeding or drug interactions (N Engl J Med. 2019;380:711-19; N Engl J Med. 2019;380:720-8).

Low-molecular-weight heparin (LMWH) also remains an option in such patients; consideration of therapy should involve discussion with the patient about relative benefits and harms, drug costs, and “the uncertainty surrounding duration of prophylaxis in this setting,” they wrote.

Anticoagulation for VTE. Options for initial anticoagulation include LMWH, unfractionated heparin (UFH), fondaparinux, and now rivaroxaban, with the latter added based on findings from two RCTs – the SELECT-D trial and the Hokusai VTE-Cancer study – and multiple meta-analyses (J Clin Oncol. 2018;36:2017-23; N Engl J Med. 2018;378:615-24).

Long-term anticoagulation can involve treatment with LMWH, edoxaban, or rivaroxaban for at least 6 months, all of which have improved efficacy versus vitamin K agonists (VKAs), the panel noted. However, VKAs may be used if LMWH and DOACs are not accessible.

Importantly, the literature indicates an increased risk of major bleeding with DOACs, particularly in patients with gastrointestinal malignancies and potentially in those with genitourinary malignancies. “Caution with DOACs is also warranted in other settings with high risk for mucosal bleeding,” the panel wrote.
 

Additional updates

CNS metastases. The anticoagulation recommendations were also updated to include patients with metastatic central nervous system malignancies (those with primary CNS malignancies were included previously). Both those with primary and metastatic CNS malignancy should be offered anticoagulation for established VTE as described for patients with other types of cancer. However, the panel stressed that “uncertainties remain about choice of agents and selection of patients most likely to benefit.”

“Patients with intracranial tumors are at increased risk for thrombotic complications and intracranial hemorrhage (ICH), but the presence of a stable or active primary intracranial malignancy or brain metastases is not an absolute contraindication to anticoagulation,” they wrote.

Limited evidence suggests that therapeutic anticoagulation does not increase ICH risk in patients with brain metastases, but it may increase risk in those with primary brain tumors, the panel added.

Additionally, preliminary data from a retrospective cohort of patients with metastatic brain disease and venous thrombosis suggest that DOACs may be associated with a lower risk of ICH than is LMWH in this population.

Long-term postoperative LMWH. Extended prophylaxis with LMWH for up to 4 weeks is recommended after major open or laparoscopic abdominal or pelvic surgery in cancer patients with high-risk features, such as restricted mobility, obesity, history of VTE, or with additional risk factors. Lower-risk surgical settings require case-by-case decision making about appropriate thromboprophylaxis duration, according to the update.

A 2014 RCT looking at thromboprophylaxis duration in 225 patients undergoing laparoscopic surgery for colorectal cancer prompted the addition of laparoscopic surgery to this recommendation. In that study, VTE occurred by 4 weeks in nearly 10% of patients receiving 1 week of prophylaxis and in no patients in the 4-week arm. Major bleeding occurred in one versus zero patients in the thromboprophylaxis arms, respectively (Ann Surg. April 2014;259[4]:665-9).
 

Reaffirmed recommendations

Based on the latest available data, the panel reaffirmed that most hospitalized patients with cancer and an acute medical condition require thromboprophylaxis for the duration of their hospitalization and that thromboprophylaxis should not be routinely recommended for all outpatients with cancer.

The panel also reaffirmed the need for thromboprophylaxis starting preoperatively and continuing for at least 7-10 days in patients undergoing major cancer surgery, the need for periodic assessment of VTE risk in cancer patients, and the importance of patient education about the signs and symptoms of VTE.
 

Perspective and future directions

In an interview, David H. Henry, MD, said he was pleased to see ASCO incorporate the latest DOAC data into the VTE guideline.

The AVERT and CASSINI studies, in particular, highlight the value of using the Khorana Risk Score, which considers cancer type, blood counts, and body mass index to predict the risk of thrombosis in cancer patients and to guide decisions regarding prophylaxis, said Dr. Henry, vice chair of the department of medicine and clinical professor of medicine at Penn Medicine’s Abramson Cancer Center, Philadelphia.

The DOACs also represent “a nice new development in the treatment setting,” he said, adding that it’s been long known – since the 2003 CLOT trial – that cancer patients with VTE had much lower recurrence rates with LMWH versus warfarin (Coumadin).

“Now fast forward to the modern era ... and DOACs now appear to be a good idea,” he said.

Dr. Henry also addressed the recommendation for expanded postoperative LMWH use.

“That I found interesting; I’m not sure what took them so long,” he said, explaining that National Comprehensive Cancer Network and European Society of Medical Oncology recommendations have long stated that, for patients with abdominal cancers who undergo abdominopelvic surgery, DVT prophylaxis should continue for 4 weeks.

Dr. Henry said that a survey at his center showed that those recommendations were “very poorly followed,” with surgeons giving 4 weeks of prophylaxis in just 5% of cases.

“The good news from our survey was that not many people had a VTE, despite not many people following the recommendations, but I must say I think our surgeons are catching on,” he said.

Overall, the updated guideline highlights the importance of considering the “cancer variable” when it comes to VTE prevention and treatment.

“We’ve known forever that when we diagnose a DVT or PE in the outpatient setting – and this is independent of cancer – that you should treat it. Add the cancer variable and we now know that we should worry and try to prevent the VTE in certain high-risk patients, and there are some drugs to do it with,” he said, adding that “you should worry about the person you’ve just provoked [with surgery] as well.”

An important question not addressed in the guideline update is the indefinite use of DOACs in cancer patients with ongoing risk, he said.

“When we see DVT or PE, we usually treat for 3 months – that’s the industry standard – and at the end of 3 months ... you do a time out and you say to yourself, ‘Was this person provoked?’ ” he said.

For example, if they took a long flight or if pregnancy was a factor, treatment can usually be safely stopped. However, in a cancer patient who still has cancer, the provocation continues, and the patient may require indefinite treatment.

Questions that remain involve defining “indefinite” and include whether (and which of) these drugs can be used indefinitely in such patients, Dr. Henry said.

Dr. Key reported receiving honoraria from Novo Nordisk, research funding to his institution from Baxter Biosciences, Grifols, and Pfizer, and serving as a consultant or advisor for Genentech, Roche, Uniqure, Seattle Genetics, and Shire Human Genetic Therapies. Numerous disclosures were also reported by other expert panel members.

[email protected]

The direct oral anticoagulants (DOACs) apixaban and rivaroxaban are now among the options for thromboprophylaxis in high-risk cancer outpatients with low risk for bleeding and drug interactions, according to a practice guideline update from the American Society of Clinical Oncology.

Sebastian Kaulitzki/Thinkstock

Rivaroxaban also has been added as an option for initial anticoagulation for venous thromboembolism (VTE), and both rivaroxaban and edoxaban are now options for long-term anticoagulation, Nigel S. Key, MB ChB, and colleagues wrote in the updated guideline on the prophylaxis and treatment of VTE – including deep vein thrombosis (DVT) and pulmonary embolism (PE) – in cancer patients (J Clin Oncol. 2019 Aug 5. doi: 10.1200/JCO.19.19.01461).

The addition of DOACs as options for VTE prophylaxis and treatment represents the most notable change to the guideline.

“Oral anticoagulants that target thrombin (direct thrombin inhibitor, dabigatran) or activated factor X (antifactor Xa inhibitors, rivaroxaban, apixaban, and edoxaban) are now approved for treatment of DVT or PE as well as for DVT prophylaxis following orthopedic surgery and for reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation,” the guideline panel wrote.

A systematic review of PubMed and the Cochrane Library for randomized controlled trials (RCTs) and meta-analyses of RCTs published from Aug. 1, 2014, through Dec. 4, 2018, identified 35 publications on VTE prophylaxis and treatment, including 2 RCTs of DOACs for prophylaxis and 2 others of DOAC treatment, as well as 8 publications on VTE risk assessment. A multidisciplinary expert panel appointed by ASCO and cochaired by Dr. Key of the University of North Carolina, Chapel Hill, used this evidence to develop the updated guideline.

The work was guided by “the ‘signals’ approach that is designed to identify only new, potentially practice-changing data – signals – that might translate into revised practice recommendations,” the authors explained.

DOAC-related updates

VTE prophylaxis. Based in part on findings from the recently published AVERT trial of apixaban in patients initiating a new course of chemotherapy and from the CASSINI trial of rivaroxaban in patients with solid tumors or lymphoma starting systemic antineoplastic therapy, the panel added both agents as thromboprophylactic options that can be offered to high-risk cancer outpatients with no significant risk factors for bleeding or drug interactions (N Engl J Med. 2019;380:711-19; N Engl J Med. 2019;380:720-8).

Low-molecular-weight heparin (LMWH) also remains an option in such patients; consideration of therapy should involve discussion with the patient about relative benefits and harms, drug costs, and “the uncertainty surrounding duration of prophylaxis in this setting,” they wrote.

Anticoagulation for VTE. Options for initial anticoagulation include LMWH, unfractionated heparin (UFH), fondaparinux, and now rivaroxaban, with the latter added based on findings from two RCTs – the SELECT-D trial and the Hokusai VTE-Cancer study – and multiple meta-analyses (J Clin Oncol. 2018;36:2017-23; N Engl J Med. 2018;378:615-24).

Long-term anticoagulation can involve treatment with LMWH, edoxaban, or rivaroxaban for at least 6 months, all of which have improved efficacy versus vitamin K agonists (VKAs), the panel noted. However, VKAs may be used if LMWH and DOACs are not accessible.

Importantly, the literature indicates an increased risk of major bleeding with DOACs, particularly in patients with gastrointestinal malignancies and potentially in those with genitourinary malignancies. “Caution with DOACs is also warranted in other settings with high risk for mucosal bleeding,” the panel wrote.
 

Additional updates

CNS metastases. The anticoagulation recommendations were also updated to include patients with metastatic central nervous system malignancies (those with primary CNS malignancies were included previously). Both those with primary and metastatic CNS malignancy should be offered anticoagulation for established VTE as described for patients with other types of cancer. However, the panel stressed that “uncertainties remain about choice of agents and selection of patients most likely to benefit.”

“Patients with intracranial tumors are at increased risk for thrombotic complications and intracranial hemorrhage (ICH), but the presence of a stable or active primary intracranial malignancy or brain metastases is not an absolute contraindication to anticoagulation,” they wrote.

Limited evidence suggests that therapeutic anticoagulation does not increase ICH risk in patients with brain metastases, but it may increase risk in those with primary brain tumors, the panel added.

Additionally, preliminary data from a retrospective cohort of patients with metastatic brain disease and venous thrombosis suggest that DOACs may be associated with a lower risk of ICH than is LMWH in this population.

Long-term postoperative LMWH. Extended prophylaxis with LMWH for up to 4 weeks is recommended after major open or laparoscopic abdominal or pelvic surgery in cancer patients with high-risk features, such as restricted mobility, obesity, history of VTE, or with additional risk factors. Lower-risk surgical settings require case-by-case decision making about appropriate thromboprophylaxis duration, according to the update.

A 2014 RCT looking at thromboprophylaxis duration in 225 patients undergoing laparoscopic surgery for colorectal cancer prompted the addition of laparoscopic surgery to this recommendation. In that study, VTE occurred by 4 weeks in nearly 10% of patients receiving 1 week of prophylaxis and in no patients in the 4-week arm. Major bleeding occurred in one versus zero patients in the thromboprophylaxis arms, respectively (Ann Surg. April 2014;259[4]:665-9).
 

Reaffirmed recommendations

Based on the latest available data, the panel reaffirmed that most hospitalized patients with cancer and an acute medical condition require thromboprophylaxis for the duration of their hospitalization and that thromboprophylaxis should not be routinely recommended for all outpatients with cancer.

The panel also reaffirmed the need for thromboprophylaxis starting preoperatively and continuing for at least 7-10 days in patients undergoing major cancer surgery, the need for periodic assessment of VTE risk in cancer patients, and the importance of patient education about the signs and symptoms of VTE.
 

Perspective and future directions

In an interview, David H. Henry, MD, said he was pleased to see ASCO incorporate the latest DOAC data into the VTE guideline.

The AVERT and CASSINI studies, in particular, highlight the value of using the Khorana Risk Score, which considers cancer type, blood counts, and body mass index to predict the risk of thrombosis in cancer patients and to guide decisions regarding prophylaxis, said Dr. Henry, vice chair of the department of medicine and clinical professor of medicine at Penn Medicine’s Abramson Cancer Center, Philadelphia.

The DOACs also represent “a nice new development in the treatment setting,” he said, adding that it’s been long known – since the 2003 CLOT trial – that cancer patients with VTE had much lower recurrence rates with LMWH versus warfarin (Coumadin).

“Now fast forward to the modern era ... and DOACs now appear to be a good idea,” he said.

Dr. Henry also addressed the recommendation for expanded postoperative LMWH use.

“That I found interesting; I’m not sure what took them so long,” he said, explaining that National Comprehensive Cancer Network and European Society of Medical Oncology recommendations have long stated that, for patients with abdominal cancers who undergo abdominopelvic surgery, DVT prophylaxis should continue for 4 weeks.

Dr. Henry said that a survey at his center showed that those recommendations were “very poorly followed,” with surgeons giving 4 weeks of prophylaxis in just 5% of cases.

“The good news from our survey was that not many people had a VTE, despite not many people following the recommendations, but I must say I think our surgeons are catching on,” he said.

Overall, the updated guideline highlights the importance of considering the “cancer variable” when it comes to VTE prevention and treatment.

“We’ve known forever that when we diagnose a DVT or PE in the outpatient setting – and this is independent of cancer – that you should treat it. Add the cancer variable and we now know that we should worry and try to prevent the VTE in certain high-risk patients, and there are some drugs to do it with,” he said, adding that “you should worry about the person you’ve just provoked [with surgery] as well.”

An important question not addressed in the guideline update is the indefinite use of DOACs in cancer patients with ongoing risk, he said.

“When we see DVT or PE, we usually treat for 3 months – that’s the industry standard – and at the end of 3 months ... you do a time out and you say to yourself, ‘Was this person provoked?’ ” he said.

For example, if they took a long flight or if pregnancy was a factor, treatment can usually be safely stopped. However, in a cancer patient who still has cancer, the provocation continues, and the patient may require indefinite treatment.

Questions that remain involve defining “indefinite” and include whether (and which of) these drugs can be used indefinitely in such patients, Dr. Henry said.

Dr. Key reported receiving honoraria from Novo Nordisk, research funding to his institution from Baxter Biosciences, Grifols, and Pfizer, and serving as a consultant or advisor for Genentech, Roche, Uniqure, Seattle Genetics, and Shire Human Genetic Therapies. Numerous disclosures were also reported by other expert panel members.

[email protected]

The direct oral anticoagulants (DOACs) apixaban and rivaroxaban are now among the options for thromboprophylaxis in high-risk cancer outpatients with low risk for bleeding and drug interactions, according to a practice guideline update from the American Society of Clinical Oncology.

Sebastian Kaulitzki/Thinkstock

Rivaroxaban also has been added as an option for initial anticoagulation for venous thromboembolism (VTE), and both rivaroxaban and edoxaban are now options for long-term anticoagulation, Nigel S. Key, MB ChB, and colleagues wrote in the updated guideline on the prophylaxis and treatment of VTE – including deep vein thrombosis (DVT) and pulmonary embolism (PE) – in cancer patients (J Clin Oncol. 2019 Aug 5. doi: 10.1200/JCO.19.19.01461).

The addition of DOACs as options for VTE prophylaxis and treatment represents the most notable change to the guideline.

“Oral anticoagulants that target thrombin (direct thrombin inhibitor, dabigatran) or activated factor X (antifactor Xa inhibitors, rivaroxaban, apixaban, and edoxaban) are now approved for treatment of DVT or PE as well as for DVT prophylaxis following orthopedic surgery and for reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation,” the guideline panel wrote.

A systematic review of PubMed and the Cochrane Library for randomized controlled trials (RCTs) and meta-analyses of RCTs published from Aug. 1, 2014, through Dec. 4, 2018, identified 35 publications on VTE prophylaxis and treatment, including 2 RCTs of DOACs for prophylaxis and 2 others of DOAC treatment, as well as 8 publications on VTE risk assessment. A multidisciplinary expert panel appointed by ASCO and cochaired by Dr. Key of the University of North Carolina, Chapel Hill, used this evidence to develop the updated guideline.

The work was guided by “the ‘signals’ approach that is designed to identify only new, potentially practice-changing data – signals – that might translate into revised practice recommendations,” the authors explained.

DOAC-related updates

VTE prophylaxis. Based in part on findings from the recently published AVERT trial of apixaban in patients initiating a new course of chemotherapy and from the CASSINI trial of rivaroxaban in patients with solid tumors or lymphoma starting systemic antineoplastic therapy, the panel added both agents as thromboprophylactic options that can be offered to high-risk cancer outpatients with no significant risk factors for bleeding or drug interactions (N Engl J Med. 2019;380:711-19; N Engl J Med. 2019;380:720-8).

Low-molecular-weight heparin (LMWH) also remains an option in such patients; consideration of therapy should involve discussion with the patient about relative benefits and harms, drug costs, and “the uncertainty surrounding duration of prophylaxis in this setting,” they wrote.

Anticoagulation for VTE. Options for initial anticoagulation include LMWH, unfractionated heparin (UFH), fondaparinux, and now rivaroxaban, with the latter added based on findings from two RCTs – the SELECT-D trial and the Hokusai VTE-Cancer study – and multiple meta-analyses (J Clin Oncol. 2018;36:2017-23; N Engl J Med. 2018;378:615-24).

Long-term anticoagulation can involve treatment with LMWH, edoxaban, or rivaroxaban for at least 6 months, all of which have improved efficacy versus vitamin K agonists (VKAs), the panel noted. However, VKAs may be used if LMWH and DOACs are not accessible.

Importantly, the literature indicates an increased risk of major bleeding with DOACs, particularly in patients with gastrointestinal malignancies and potentially in those with genitourinary malignancies. “Caution with DOACs is also warranted in other settings with high risk for mucosal bleeding,” the panel wrote.
 

Additional updates

CNS metastases. The anticoagulation recommendations were also updated to include patients with metastatic central nervous system malignancies (those with primary CNS malignancies were included previously). Both those with primary and metastatic CNS malignancy should be offered anticoagulation for established VTE as described for patients with other types of cancer. However, the panel stressed that “uncertainties remain about choice of agents and selection of patients most likely to benefit.”

“Patients with intracranial tumors are at increased risk for thrombotic complications and intracranial hemorrhage (ICH), but the presence of a stable or active primary intracranial malignancy or brain metastases is not an absolute contraindication to anticoagulation,” they wrote.

Limited evidence suggests that therapeutic anticoagulation does not increase ICH risk in patients with brain metastases, but it may increase risk in those with primary brain tumors, the panel added.

Additionally, preliminary data from a retrospective cohort of patients with metastatic brain disease and venous thrombosis suggest that DOACs may be associated with a lower risk of ICH than is LMWH in this population.

Long-term postoperative LMWH. Extended prophylaxis with LMWH for up to 4 weeks is recommended after major open or laparoscopic abdominal or pelvic surgery in cancer patients with high-risk features, such as restricted mobility, obesity, history of VTE, or with additional risk factors. Lower-risk surgical settings require case-by-case decision making about appropriate thromboprophylaxis duration, according to the update.

A 2014 RCT looking at thromboprophylaxis duration in 225 patients undergoing laparoscopic surgery for colorectal cancer prompted the addition of laparoscopic surgery to this recommendation. In that study, VTE occurred by 4 weeks in nearly 10% of patients receiving 1 week of prophylaxis and in no patients in the 4-week arm. Major bleeding occurred in one versus zero patients in the thromboprophylaxis arms, respectively (Ann Surg. April 2014;259[4]:665-9).
 

Reaffirmed recommendations

Based on the latest available data, the panel reaffirmed that most hospitalized patients with cancer and an acute medical condition require thromboprophylaxis for the duration of their hospitalization and that thromboprophylaxis should not be routinely recommended for all outpatients with cancer.

The panel also reaffirmed the need for thromboprophylaxis starting preoperatively and continuing for at least 7-10 days in patients undergoing major cancer surgery, the need for periodic assessment of VTE risk in cancer patients, and the importance of patient education about the signs and symptoms of VTE.
 

Perspective and future directions

In an interview, David H. Henry, MD, said he was pleased to see ASCO incorporate the latest DOAC data into the VTE guideline.

The AVERT and CASSINI studies, in particular, highlight the value of using the Khorana Risk Score, which considers cancer type, blood counts, and body mass index to predict the risk of thrombosis in cancer patients and to guide decisions regarding prophylaxis, said Dr. Henry, vice chair of the department of medicine and clinical professor of medicine at Penn Medicine’s Abramson Cancer Center, Philadelphia.

The DOACs also represent “a nice new development in the treatment setting,” he said, adding that it’s been long known – since the 2003 CLOT trial – that cancer patients with VTE had much lower recurrence rates with LMWH versus warfarin (Coumadin).

“Now fast forward to the modern era ... and DOACs now appear to be a good idea,” he said.

Dr. Henry also addressed the recommendation for expanded postoperative LMWH use.

“That I found interesting; I’m not sure what took them so long,” he said, explaining that National Comprehensive Cancer Network and European Society of Medical Oncology recommendations have long stated that, for patients with abdominal cancers who undergo abdominopelvic surgery, DVT prophylaxis should continue for 4 weeks.

Dr. Henry said that a survey at his center showed that those recommendations were “very poorly followed,” with surgeons giving 4 weeks of prophylaxis in just 5% of cases.

“The good news from our survey was that not many people had a VTE, despite not many people following the recommendations, but I must say I think our surgeons are catching on,” he said.

Overall, the updated guideline highlights the importance of considering the “cancer variable” when it comes to VTE prevention and treatment.

“We’ve known forever that when we diagnose a DVT or PE in the outpatient setting – and this is independent of cancer – that you should treat it. Add the cancer variable and we now know that we should worry and try to prevent the VTE in certain high-risk patients, and there are some drugs to do it with,” he said, adding that “you should worry about the person you’ve just provoked [with surgery] as well.”

An important question not addressed in the guideline update is the indefinite use of DOACs in cancer patients with ongoing risk, he said.

“When we see DVT or PE, we usually treat for 3 months – that’s the industry standard – and at the end of 3 months ... you do a time out and you say to yourself, ‘Was this person provoked?’ ” he said.

For example, if they took a long flight or if pregnancy was a factor, treatment can usually be safely stopped. However, in a cancer patient who still has cancer, the provocation continues, and the patient may require indefinite treatment.

Questions that remain involve defining “indefinite” and include whether (and which of) these drugs can be used indefinitely in such patients, Dr. Henry said.

Dr. Key reported receiving honoraria from Novo Nordisk, research funding to his institution from Baxter Biosciences, Grifols, and Pfizer, and serving as a consultant or advisor for Genentech, Roche, Uniqure, Seattle Genetics, and Shire Human Genetic Therapies. Numerous disclosures were also reported by other expert panel members.

[email protected]

LAKE BUENA VISTA, FLA. – Patient Reported Outcomes Measurement Information System (PROMIS) tools developed by the National Institutes of Health provide particularly useful information for managing rheumatology patients, according to Jeffrey Curtis, MD.

Courtesy UAB Photo

The PROMIS tools – which like most patient-reported outcome (PRO) measurement tools are designed to evaluate and monitor physical, mental, and social health – can be used both for the general population and for individuals living with chronic conditions, Dr. Curtis, professor of medicine in the division of clinical immunology and rheumatology at the University of Alabama at Birmingham (UAB), said at the annual meeting of the Florida Society of Rheumatology.

The tools take a deeper dive into various symptoms and their effects; for instance, with respect to physical health, they measure fatigue, physical function, sleep disturbance, pain intensity, and pain interference – the extent to which pain “messes your patient’s life up,” explained Dr. Curtis, who also is codirector of the UAB Pharmacoepidemiology and Pharmacoeconomics Unit.

Additional physical health domains that PROs measure include dyspnea, gastrointestinal symptoms, pain behavior, pain quality, sexual function, and sleep-related impairment.

These are “things that, honestly, we don’t talk about much as a field, but absolutely affect patients with autoimmune diseases,” he said. “You know, sexual function – that doesn’t come up in my practice spontaneously very often, but there are ways you can quantify that, and for many patients that’s actually a big deal.”

The domains measured by PROMIS tools for mental health look at anxiety and depression, but also delve into alcohol use, anger, cognitive function, life satisfaction, self-efficacy for managing chronic conditions, substance use, and more. The domains for social health address ability to participate in social roles and activities, as well as companionship, satisfaction with social roles and activity, social isolation, and social support.

“You can’t go on a hike with friends [and] be far from a bathroom, because you have bad arthritis and you have Crohn’s disease. Well, that’s kind of an important thing that may or may not come up in your discussions about inflammatory arthritis associated with [inflammatory bowel disease],” he said.

Another example is a patient who is embarrassed attending social functions or wearing a swimsuit because of really bad psoriasis.

“These are the kinds of things that I’m suggesting you and I probably want to measure if we’re providing holistic care to rheumatology patients,” Dr. Curtis said.

The PROMIS tools provide a simple, user-friendly means for doing so in English, Spanish, and many other languages, he noted.

All the scales use the same 1-100 scoring range, which simplifies measurements. They are available for free by download and can be printed or used electronically for use in the office, at home, on the web, and via smartphone.

The NIH developed the PROMIS tools several years ago and validated them for multiple chronic disease populations, Dr. Curtis said, adding that the tools include multiple individual domains and overall “profiles” of varying lengths.

Most are fixed-length scales that are between 4 and 10 questions and can be completed within 30-60 seconds per scale, so several scales can be completed within 5-10 minutes.

However, some scales are longer and provide greater detail.

“The nice thing is that if you ask a few more questions you can get more precise information – there’s more of a floor and ceiling. You can detect people who do really well. You can distinguish between the marathon runners and the 5K-ers and the people who can walk 2 miles but aren’t going to run a race,” he explained.

Further, the PROMIS tools, like the 36-item Short Form Health Survey (SF-36), are benchmarked against the U.S. adult population, allowing for assessment of how a specific drug or treatment “impacts your arthritis patient on a scale that would also be relevant for somebody who doesn’t have arthritis, they have diabetes.”

The metrics and scales are the same, and that can be helpful when trying to get a payer to pay for a particular drug, he said.

“None of these are rheumatology specific; this puts PROs into a language that can help rheumatology contend for the value of the care that we provide on a scale that would be relevant for any other chronic illness, even for nonrheumatology patients,” he explained.

In addition, minimally important differences (group mean change of about 2-3 units) and minimally clinical important differences for individuals (5 units) have been established.

“So we know what the numbers mean, and this is true for all of the scales,” he said.

PROMIS tools also include computer-adaptive testing (CAT) versions, which helps to personalize the scales to provide more precise information for a given patient and eliminate irrelevant information.

Of note, PROMIS health measures are among the data that can be tracked on a smartphone using Arthritis Power, an arthritis research registry developed with the help of a recent infrastructure grant awarded to the Center for Education and Research and Therapeutics of Musculoskeletal Disorders at UAB, Dr. Curtis said.


The measures were also shown in the AWARE study to track closely with other measures, including the Clinical Disease Activity Index (CDAI), and with patient improvement on therapy.

“So these PROMIS scores are tracking with things that you and I are familiar with ... and it looks like these scores are faithfully tracking, over time, patients getting better on therapies that we would expect them to,” he said. “I think this is additional validation – not just from the National Institutes of Health and a decade of research by lots of different groups, but in our own field – that these actually correlate with disease activity ... and that when you start an effective therapy like a [tumor necrosis factor inhibitor] they’re going to improve as you would anticipate.”

Dr. Curtis reported funding from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the Patient-Centered Outcomes Research Institute. He has also consulted for or received research grants from Amgen, AbbVie, Bristol-Myers Squibb, CORRONA, Lilly, Janssen, Myriad, Novartis, Roche, Pfizer, and Sanofi/Regeneron.

[email protected]

LAKE BUENA VISTA, FLA. – Patient Reported Outcomes Measurement Information System (PROMIS) tools developed by the National Institutes of Health provide particularly useful information for managing rheumatology patients, according to Jeffrey Curtis, MD.

Courtesy UAB Photo

The PROMIS tools – which like most patient-reported outcome (PRO) measurement tools are designed to evaluate and monitor physical, mental, and social health – can be used both for the general population and for individuals living with chronic conditions, Dr. Curtis, professor of medicine in the division of clinical immunology and rheumatology at the University of Alabama at Birmingham (UAB), said at the annual meeting of the Florida Society of Rheumatology.

The tools take a deeper dive into various symptoms and their effects; for instance, with respect to physical health, they measure fatigue, physical function, sleep disturbance, pain intensity, and pain interference – the extent to which pain “messes your patient’s life up,” explained Dr. Curtis, who also is codirector of the UAB Pharmacoepidemiology and Pharmacoeconomics Unit.

Additional physical health domains that PROs measure include dyspnea, gastrointestinal symptoms, pain behavior, pain quality, sexual function, and sleep-related impairment.

These are “things that, honestly, we don’t talk about much as a field, but absolutely affect patients with autoimmune diseases,” he said. “You know, sexual function – that doesn’t come up in my practice spontaneously very often, but there are ways you can quantify that, and for many patients that’s actually a big deal.”

The domains measured by PROMIS tools for mental health look at anxiety and depression, but also delve into alcohol use, anger, cognitive function, life satisfaction, self-efficacy for managing chronic conditions, substance use, and more. The domains for social health address ability to participate in social roles and activities, as well as companionship, satisfaction with social roles and activity, social isolation, and social support.

“You can’t go on a hike with friends [and] be far from a bathroom, because you have bad arthritis and you have Crohn’s disease. Well, that’s kind of an important thing that may or may not come up in your discussions about inflammatory arthritis associated with [inflammatory bowel disease],” he said.

Another example is a patient who is embarrassed attending social functions or wearing a swimsuit because of really bad psoriasis.

“These are the kinds of things that I’m suggesting you and I probably want to measure if we’re providing holistic care to rheumatology patients,” Dr. Curtis said.

The PROMIS tools provide a simple, user-friendly means for doing so in English, Spanish, and many other languages, he noted.

All the scales use the same 1-100 scoring range, which simplifies measurements. They are available for free by download and can be printed or used electronically for use in the office, at home, on the web, and via smartphone.

The NIH developed the PROMIS tools several years ago and validated them for multiple chronic disease populations, Dr. Curtis said, adding that the tools include multiple individual domains and overall “profiles” of varying lengths.

Most are fixed-length scales that are between 4 and 10 questions and can be completed within 30-60 seconds per scale, so several scales can be completed within 5-10 minutes.

However, some scales are longer and provide greater detail.

“The nice thing is that if you ask a few more questions you can get more precise information – there’s more of a floor and ceiling. You can detect people who do really well. You can distinguish between the marathon runners and the 5K-ers and the people who can walk 2 miles but aren’t going to run a race,” he explained.

Further, the PROMIS tools, like the 36-item Short Form Health Survey (SF-36), are benchmarked against the U.S. adult population, allowing for assessment of how a specific drug or treatment “impacts your arthritis patient on a scale that would also be relevant for somebody who doesn’t have arthritis, they have diabetes.”

The metrics and scales are the same, and that can be helpful when trying to get a payer to pay for a particular drug, he said.

“None of these are rheumatology specific; this puts PROs into a language that can help rheumatology contend for the value of the care that we provide on a scale that would be relevant for any other chronic illness, even for nonrheumatology patients,” he explained.

In addition, minimally important differences (group mean change of about 2-3 units) and minimally clinical important differences for individuals (5 units) have been established.

“So we know what the numbers mean, and this is true for all of the scales,” he said.

PROMIS tools also include computer-adaptive testing (CAT) versions, which helps to personalize the scales to provide more precise information for a given patient and eliminate irrelevant information.

Of note, PROMIS health measures are among the data that can be tracked on a smartphone using Arthritis Power, an arthritis research registry developed with the help of a recent infrastructure grant awarded to the Center for Education and Research and Therapeutics of Musculoskeletal Disorders at UAB, Dr. Curtis said.


The measures were also shown in the AWARE study to track closely with other measures, including the Clinical Disease Activity Index (CDAI), and with patient improvement on therapy.

“So these PROMIS scores are tracking with things that you and I are familiar with ... and it looks like these scores are faithfully tracking, over time, patients getting better on therapies that we would expect them to,” he said. “I think this is additional validation – not just from the National Institutes of Health and a decade of research by lots of different groups, but in our own field – that these actually correlate with disease activity ... and that when you start an effective therapy like a [tumor necrosis factor inhibitor] they’re going to improve as you would anticipate.”

Dr. Curtis reported funding from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the Patient-Centered Outcomes Research Institute. He has also consulted for or received research grants from Amgen, AbbVie, Bristol-Myers Squibb, CORRONA, Lilly, Janssen, Myriad, Novartis, Roche, Pfizer, and Sanofi/Regeneron.

[email protected]

LAKE BUENA VISTA, FLA. – Patient Reported Outcomes Measurement Information System (PROMIS) tools developed by the National Institutes of Health provide particularly useful information for managing rheumatology patients, according to Jeffrey Curtis, MD.

Courtesy UAB Photo

The PROMIS tools – which like most patient-reported outcome (PRO) measurement tools are designed to evaluate and monitor physical, mental, and social health – can be used both for the general population and for individuals living with chronic conditions, Dr. Curtis, professor of medicine in the division of clinical immunology and rheumatology at the University of Alabama at Birmingham (UAB), said at the annual meeting of the Florida Society of Rheumatology.

The tools take a deeper dive into various symptoms and their effects; for instance, with respect to physical health, they measure fatigue, physical function, sleep disturbance, pain intensity, and pain interference – the extent to which pain “messes your patient’s life up,” explained Dr. Curtis, who also is codirector of the UAB Pharmacoepidemiology and Pharmacoeconomics Unit.

Additional physical health domains that PROs measure include dyspnea, gastrointestinal symptoms, pain behavior, pain quality, sexual function, and sleep-related impairment.

These are “things that, honestly, we don’t talk about much as a field, but absolutely affect patients with autoimmune diseases,” he said. “You know, sexual function – that doesn’t come up in my practice spontaneously very often, but there are ways you can quantify that, and for many patients that’s actually a big deal.”

The domains measured by PROMIS tools for mental health look at anxiety and depression, but also delve into alcohol use, anger, cognitive function, life satisfaction, self-efficacy for managing chronic conditions, substance use, and more. The domains for social health address ability to participate in social roles and activities, as well as companionship, satisfaction with social roles and activity, social isolation, and social support.

“You can’t go on a hike with friends [and] be far from a bathroom, because you have bad arthritis and you have Crohn’s disease. Well, that’s kind of an important thing that may or may not come up in your discussions about inflammatory arthritis associated with [inflammatory bowel disease],” he said.

Another example is a patient who is embarrassed attending social functions or wearing a swimsuit because of really bad psoriasis.

“These are the kinds of things that I’m suggesting you and I probably want to measure if we’re providing holistic care to rheumatology patients,” Dr. Curtis said.

The PROMIS tools provide a simple, user-friendly means for doing so in English, Spanish, and many other languages, he noted.

All the scales use the same 1-100 scoring range, which simplifies measurements. They are available for free by download and can be printed or used electronically for use in the office, at home, on the web, and via smartphone.

The NIH developed the PROMIS tools several years ago and validated them for multiple chronic disease populations, Dr. Curtis said, adding that the tools include multiple individual domains and overall “profiles” of varying lengths.

Most are fixed-length scales that are between 4 and 10 questions and can be completed within 30-60 seconds per scale, so several scales can be completed within 5-10 minutes.

However, some scales are longer and provide greater detail.

“The nice thing is that if you ask a few more questions you can get more precise information – there’s more of a floor and ceiling. You can detect people who do really well. You can distinguish between the marathon runners and the 5K-ers and the people who can walk 2 miles but aren’t going to run a race,” he explained.

Further, the PROMIS tools, like the 36-item Short Form Health Survey (SF-36), are benchmarked against the U.S. adult population, allowing for assessment of how a specific drug or treatment “impacts your arthritis patient on a scale that would also be relevant for somebody who doesn’t have arthritis, they have diabetes.”

The metrics and scales are the same, and that can be helpful when trying to get a payer to pay for a particular drug, he said.

“None of these are rheumatology specific; this puts PROs into a language that can help rheumatology contend for the value of the care that we provide on a scale that would be relevant for any other chronic illness, even for nonrheumatology patients,” he explained.

In addition, minimally important differences (group mean change of about 2-3 units) and minimally clinical important differences for individuals (5 units) have been established.

“So we know what the numbers mean, and this is true for all of the scales,” he said.

PROMIS tools also include computer-adaptive testing (CAT) versions, which helps to personalize the scales to provide more precise information for a given patient and eliminate irrelevant information.

Of note, PROMIS health measures are among the data that can be tracked on a smartphone using Arthritis Power, an arthritis research registry developed with the help of a recent infrastructure grant awarded to the Center for Education and Research and Therapeutics of Musculoskeletal Disorders at UAB, Dr. Curtis said.


The measures were also shown in the AWARE study to track closely with other measures, including the Clinical Disease Activity Index (CDAI), and with patient improvement on therapy.

“So these PROMIS scores are tracking with things that you and I are familiar with ... and it looks like these scores are faithfully tracking, over time, patients getting better on therapies that we would expect them to,” he said. “I think this is additional validation – not just from the National Institutes of Health and a decade of research by lots of different groups, but in our own field – that these actually correlate with disease activity ... and that when you start an effective therapy like a [tumor necrosis factor inhibitor] they’re going to improve as you would anticipate.”

Dr. Curtis reported funding from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the Patient-Centered Outcomes Research Institute. He has also consulted for or received research grants from Amgen, AbbVie, Bristol-Myers Squibb, CORRONA, Lilly, Janssen, Myriad, Novartis, Roche, Pfizer, and Sanofi/Regeneron.

[email protected]

LAKE BUENA VISTA, FLA. – Workforce gaps loom large in rheumatology, but efforts on both the federal and state levels address the problem, according to the chair of the American College of Rheumatology’s Government Affairs Committee, Angus B. Worthing, MD.

“We have a workforce gap that’s growing in adult arthritis; demand is increasing, and supply is decreasing,” Dr. Worthing said during an update on the committee’s activities at the annual meeting of the Florida Society of Rheumatology.

A similar “grave discrepancy” plagues pediatric rheumatology, said Dr. Worthing, a partner in a private rheumatology practice in the Washington, D.C., area.

“But these are fundamentally different,” he said, explaining that there is an oversupply of applicants for adult rheumatology fellowship spots, whereas only half of the available spots in pediatric rheumatology are being filled.

“We’re unfortunately having to turn away highly qualified [adult rheumatology] applicants, because we don’t have enough money to fund fellowship positions in the United States; about 100 doctors a year who wanted to be rheumatologists are going into other specialties,” he said. “It’s a different problem in pediatric rheumatology where you spend 2-3 extra years to earn less money than you would as a general pediatrician.”

The American College of Rheumatology is working to “find those dollars,” to alleviate the problems, he said, encouraging those who are concerned about the workforce issues to consider investing in the Rheumatology Research Foundation, which is a “huge supporter of rheumatology fellowships.”

Another proposal involves loan repayment plans for health professionals who agree to work at least 2 years in pediatric medicine.

“There’s an active bill that you can send an e-mail on right now,” Dr. Worthing said.

The bill, titled the “Educating Medical Professionals and Optimizing Workforce Efficiency and Readiness [EMPOWER] for Health Act,” represents an effort on the federal level to increase access to pediatric medical subspecialists by increasing the number who practice in underserved areas.


“It was introduced the day after we spoke on the Hill in May to leaders about this [issue],” he said.

Another effort is underway in Georgia, where a legislator who has lupus is working with the ACR on legislation that would allow the state to repay up to $25,000 on loans for cognitive specialists who agree to work in the state for a period of time.

The ACR is also working to maintain Deferred Action for Childhood Arrivals (DACA) protections for recipients pursuing medical education, who could potentially help to alleviate the shortages, he noted.

The problem of workforce issues is multifaceted and it requires a multipronged approach, Dr. Worthing said.

“It will not be solved by the American College of Rheumatology alone; I think it will end up being solved by people on the ground working with their primary care physicians and referring doctors to try to close the gap and try to see patients when they’re needed,” he said.

Dr. Worthing reported having no disclosures.

[email protected]

LAKE BUENA VISTA, FLA. – Workforce gaps loom large in rheumatology, but efforts on both the federal and state levels address the problem, according to the chair of the American College of Rheumatology’s Government Affairs Committee, Angus B. Worthing, MD.

“We have a workforce gap that’s growing in adult arthritis; demand is increasing, and supply is decreasing,” Dr. Worthing said during an update on the committee’s activities at the annual meeting of the Florida Society of Rheumatology.

A similar “grave discrepancy” plagues pediatric rheumatology, said Dr. Worthing, a partner in a private rheumatology practice in the Washington, D.C., area.

“But these are fundamentally different,” he said, explaining that there is an oversupply of applicants for adult rheumatology fellowship spots, whereas only half of the available spots in pediatric rheumatology are being filled.

“We’re unfortunately having to turn away highly qualified [adult rheumatology] applicants, because we don’t have enough money to fund fellowship positions in the United States; about 100 doctors a year who wanted to be rheumatologists are going into other specialties,” he said. “It’s a different problem in pediatric rheumatology where you spend 2-3 extra years to earn less money than you would as a general pediatrician.”

The American College of Rheumatology is working to “find those dollars,” to alleviate the problems, he said, encouraging those who are concerned about the workforce issues to consider investing in the Rheumatology Research Foundation, which is a “huge supporter of rheumatology fellowships.”

Another proposal involves loan repayment plans for health professionals who agree to work at least 2 years in pediatric medicine.

“There’s an active bill that you can send an e-mail on right now,” Dr. Worthing said.

The bill, titled the “Educating Medical Professionals and Optimizing Workforce Efficiency and Readiness [EMPOWER] for Health Act,” represents an effort on the federal level to increase access to pediatric medical subspecialists by increasing the number who practice in underserved areas.


“It was introduced the day after we spoke on the Hill in May to leaders about this [issue],” he said.

Another effort is underway in Georgia, where a legislator who has lupus is working with the ACR on legislation that would allow the state to repay up to $25,000 on loans for cognitive specialists who agree to work in the state for a period of time.

The ACR is also working to maintain Deferred Action for Childhood Arrivals (DACA) protections for recipients pursuing medical education, who could potentially help to alleviate the shortages, he noted.

The problem of workforce issues is multifaceted and it requires a multipronged approach, Dr. Worthing said.

“It will not be solved by the American College of Rheumatology alone; I think it will end up being solved by people on the ground working with their primary care physicians and referring doctors to try to close the gap and try to see patients when they’re needed,” he said.

Dr. Worthing reported having no disclosures.

[email protected]

LAKE BUENA VISTA, FLA. – Workforce gaps loom large in rheumatology, but efforts on both the federal and state levels address the problem, according to the chair of the American College of Rheumatology’s Government Affairs Committee, Angus B. Worthing, MD.

“We have a workforce gap that’s growing in adult arthritis; demand is increasing, and supply is decreasing,” Dr. Worthing said during an update on the committee’s activities at the annual meeting of the Florida Society of Rheumatology.

A similar “grave discrepancy” plagues pediatric rheumatology, said Dr. Worthing, a partner in a private rheumatology practice in the Washington, D.C., area.

“But these are fundamentally different,” he said, explaining that there is an oversupply of applicants for adult rheumatology fellowship spots, whereas only half of the available spots in pediatric rheumatology are being filled.

“We’re unfortunately having to turn away highly qualified [adult rheumatology] applicants, because we don’t have enough money to fund fellowship positions in the United States; about 100 doctors a year who wanted to be rheumatologists are going into other specialties,” he said. “It’s a different problem in pediatric rheumatology where you spend 2-3 extra years to earn less money than you would as a general pediatrician.”

The American College of Rheumatology is working to “find those dollars,” to alleviate the problems, he said, encouraging those who are concerned about the workforce issues to consider investing in the Rheumatology Research Foundation, which is a “huge supporter of rheumatology fellowships.”

Another proposal involves loan repayment plans for health professionals who agree to work at least 2 years in pediatric medicine.

“There’s an active bill that you can send an e-mail on right now,” Dr. Worthing said.

The bill, titled the “Educating Medical Professionals and Optimizing Workforce Efficiency and Readiness [EMPOWER] for Health Act,” represents an effort on the federal level to increase access to pediatric medical subspecialists by increasing the number who practice in underserved areas.


“It was introduced the day after we spoke on the Hill in May to leaders about this [issue],” he said.

Another effort is underway in Georgia, where a legislator who has lupus is working with the ACR on legislation that would allow the state to repay up to $25,000 on loans for cognitive specialists who agree to work in the state for a period of time.

The ACR is also working to maintain Deferred Action for Childhood Arrivals (DACA) protections for recipients pursuing medical education, who could potentially help to alleviate the shortages, he noted.

The problem of workforce issues is multifaceted and it requires a multipronged approach, Dr. Worthing said.

“It will not be solved by the American College of Rheumatology alone; I think it will end up being solved by people on the ground working with their primary care physicians and referring doctors to try to close the gap and try to see patients when they’re needed,” he said.

Dr. Worthing reported having no disclosures.

[email protected]

NASHVILLE, TENN. – Medical management of abortion and early pregnancy loss is best achieved with both mifepristone and misoprostol, according to Sarah W. Prager, MD.

First-trimester procedures account for about 90% of elective abortions, with about two-thirds of those occurring before 8 weeks of gestation and 80% occurring in the first 10 weeks – and therefore considered eligible for medical management, Dr. Prager, director of the Family Planning Division and Family Planning Fellowship at the University of Washington, Seattle, said at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

“We estimate that it’s approximately 31% of all abortions that are done using medication, but it’s about 45% of those eligible by gestational age,” she noted.

The alternative is uterine aspiration, and in the absence of a clear contraindication, patient preference should determine management choice, she said.

The same is true for early pregnancy loss (spontaneous abortion), which is the most common complication of early pregnancy, occurring in about 20% of clinically recognized pregnancies.

“That means that there are about 1 million spontaneous abortions happening annually in the United States, and about 80% of those are in the first trimester,” Dr. Prager said.

Expectant management is an additional option for managing early pregnancy loss, she noted.

Candidates

Medical management is appropriate for patients who are undergoing elective abortion at up to about 70 days of gestation or with pregnancy loss in the first trimester.

“They should have stable vital signs, no evidence of infection, no allergies to the medications being used, no serious social or medical problems,” Dr. Prager said, explaining that “a shared decision making process” is important for patients with extreme anxiety or homelessness/lack of stable housing, for example, in order to make sure that medical management is a good option.

“While she definitely gets to have the final say, unless there is a real medical contraindication, it definitely should be part of that decision making,” Dr. Prager said, adding that adequate counseling and acceptance by the patient of the risks and side effects also are imperative.

Protocol

The most effective evidence-based treatment protocol for elective abortion through day 70 of gestation includes a 200-mg oral dose of mifepristone, followed 24-72 hours later with at-home buccal or vaginal administration of an 800-mcg dose of misoprostol, with follow up within 1-2 weeks, Dr. Prager said, citing a 2010 Cochrane review.

The Food and Drug Administration–approved protocol, which was updated in April 2016, adheres closely to those findings, except that it calls for misoprostol within 48 hours of mifepristone dosing. Optional repeat dosing of misoprostol is allowed, as well, she noted.

Buccal or vaginal administration of misoprostol is preferable to oral and sublingual administration because while the latter approaches provide more rapid onset, the former approaches provide significantly better sustained action over a 5-hour period of time.

“And by not having that big peak at the beginning, it actually decreases the side effects that women experience with the misoprostol medication,” she said.

Misoprostol can also be given alone for early pregnancy loss management – also at a dose of 800 mcg buccally or vaginally – with repeat dosing at 12-24 hours for incomplete abortion. However, new data suggest that, before about 63 days of gestation, giving two doses 3 hours apart is slightly more effective. That approach can also be repeated if necessary, Dr. Prager said.

Pain management is an important part of treatment, as both miscarriage and medication abortion can range from uncomfortable to extremely painful, depending on the patient, her prior obstetric experience, and her life experiences.

“I recommend talking to all your patients about pain management. For most people, just using some type of NSAID is probably going to be sufficient,” she said, noting that some women will require a narcotic.

Antiemetic medication may also be necessary, as some women will experience nausea and vomiting.

Complications and intervention

Major complications are rare with medical management of first-trimester abortion and early pregnancy loss, but can include ongoing pregnancy, which is infrequent but possible; incomplete abortion, which is easily managed; and allergic reactions, which are “extremely rare,” Dr. Prager said.

Hemorrhage can occur, but isn’t common and usually is at a level that doesn’t require blood transfusion. “But it does require somebody to come in, potentially needing uterine aspiration or sometimes just a second dose of misoprostol,” she said.

Serious infections are “extraordinarily uncommon,” with an actual risk of infectious death of 0.5 per 100,000, and therefore antibiotic prophylaxis is not recommended.

“This is not to say that there can’t be serious infectious problems with medication abortion, and actually also with spontaneous abortion ... but it’s extremely rare,” Dr. Prager said, adding that “there are also consequences to giving everybody antibiotics if they are not necessary. I, personally, am way more afraid of antibiotic resistance these days than I am about preventing an infection from an medication abortion.”

Intervention is necessary in certain situations, including when the gestational sac remains and when the patient continues to have clinical symptoms or has developed clinical symptoms, she said.

“Does she now show signs of infection? Is she bleeding very heavily or [is she] extremely uncomfortable with cramping? Those are all really great reasons to intervene,” she said.

Sometimes patients just prefer to switch to an alternative method of management, particularly in cases of early pregnancy loss when medical management has “not been successful after some period of time,” Dr. Prager added.

Outcomes

Studies have shown that the success rates with a single dose of 400-800 mcg of misoprostol range from 25% to 88%, and with repeat dosing for incomplete abortion at 24 hours, the success rate improves to between 80% and 88%. The success rate with placebo is 16%-60%; this indicates that “some miscarriages just happen expectantly,” Dr. Prager explained.

“We already knew that ... and that’s why expectant management is an option with early pregnancy loss,” she said, adding that expectant management works about 50% of the time – “if you wait long enough.”

However, success rates with medical management depend on the type of miscarriage; the rate is close to 100% with incomplete abortion, but for other types, such as anembryonic pregnancy or fetal demise, it is slightly less effective at about 87%, Dr. Prager noted.

When mifepristone and misoprostol are both used, success rates for early pregnancy loss range from 52% to 84% in observational trials and using nonstandard doses, and between 90% and 93% with standard dosing.

Other recent data, which led to a 2016 “reaffirmation” of an ACOG practice bulletin on medical management of first-trimester abortion, show an 83% success rate with the combination therapy in anembryonic pregnancies, and a 25% reduction in the need for further intervention (N Engl J Med. 2018;378:2161-70).

“So it really was significantly more effective to be using that addition of the mifepristone,” she said. “My take-home message about this is that, if mifepristone is something that you have easily available to you at your clinical site, absolutely use it, because it creates better outcomes for your patients. However, if it’s not available to you ... it is still perfectly reasonable for patients to choose medication management of their early pregnancy loss and use misoprostol only.

“It is effective enough, and that is just part of your informed consent.”

Postabortion care

Postmiscarriage care is important and involves several components, Dr. Prager said.

• RhoGAM treatment. The use of RhoGAM to prevent Rh immunization has been routine, but data increasingly suggest this is not necessary, and in some countries it is not given at all, particularly at 8 or fewer weeks of gestation and sometimes even during the whole first trimester for early pregnancy loss. “That is not common practice yet in the United States; I’m not recommending at this time that everybody change their practice ... but I will say that there are some really interesting studies going on right now in the United States that are looking specifically at this, and I think we may, within the next 10 years or so, change this practice of giving RhoGAM at all gestational ages,” she said.
• Counseling about bleeding. Light to moderate bleeding after abortion is common for about 2 weeks after abortion, with normal menses returning between 4 and 8 weeks, and typically around 6 weeks. “I usually ask patients to come back and see me if they have not had what seems to be a normal period to them 8 weeks following their completed process,” Dr. Prager said.
• Counseling about human chorionic gonadotropin levels. It is also helpful to inform patients that human chorionic gonadotropin may remain present for about 2-4 weeks after completed abortion, resulting in a positive pregnancy test during that time. A positive test at 4 weeks may still be normal, but warrants evaluation to determine why the patient is testing positive.
• Counseling about conception timing. Data do not support delaying repeat pregnancy after abortion. Studies show no difference in the ability to conceive or in pregnancy outcomes among women who conceive without delay after early pregnancy loss and in those who wait at least 3 months. “So what I now tell women is ‘when you’re emotionally ready to start trying to get pregnant again, it’s perfectly medically acceptable to do so. There’s no biologic reason why you have to wait,’ ” she said.
• Contraception initiation. Contraception, including IUDs, can be initiated right away after elective or spontaneous abortion. However, for IUD insertion after medical abortion, it is important to first use ultrasound to confirm complete abortion, Dr. Prager said.
• Grief counseling. This may be appropriate in cases of early pregnancy loss and for elective abortions. “Both groups of people may need some counseling, may be experiencing grief around this process – and they may not be,” she said. “I think we just need to be sensitive about asking our patients what their needs might be around this.”

Future directions

The future of medical management for first trimester abortion may involve “demedicalization,” Dr. Prager said.

“There are many papers coming out now about clinic versus home use of mifepristone,” she said, explaining that home use would require removing the FDA’s Risk Evaluation and Mitigation Strategy restriction that requires that the drug be dispensed in a clinic by a physician or physician extender.

Studies are also looking at prescriptions, pharmacist provision of mifepristone, and mailing of medications to women in rural areas.

Another area of research beyond these “really creative ways of using these medications” is whether medical management is effective beyond 10 weeks. A study that will soon be published is looking at mifepristone and two doses of misoprostol at 11 weeks, she noted.

“I think from pregnancy diagnosis through at least week 10 – soon we will see potentially week 11 – medical abortion techniques are safe, they’re effective, and they’re extremely well accepted by patients,” she said. “Also ... a diverse group of clinicians can be trained to offer medical abortion and provide back-up so that access can be improved.”

Dr. Prager reported having no financial disclosures.

[email protected]

NASHVILLE, TENN. – Medical management of abortion and early pregnancy loss is best achieved with both mifepristone and misoprostol, according to Sarah W. Prager, MD.

First-trimester procedures account for about 90% of elective abortions, with about two-thirds of those occurring before 8 weeks of gestation and 80% occurring in the first 10 weeks – and therefore considered eligible for medical management, Dr. Prager, director of the Family Planning Division and Family Planning Fellowship at the University of Washington, Seattle, said at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

“We estimate that it’s approximately 31% of all abortions that are done using medication, but it’s about 45% of those eligible by gestational age,” she noted.

The alternative is uterine aspiration, and in the absence of a clear contraindication, patient preference should determine management choice, she said.

The same is true for early pregnancy loss (spontaneous abortion), which is the most common complication of early pregnancy, occurring in about 20% of clinically recognized pregnancies.

“That means that there are about 1 million spontaneous abortions happening annually in the United States, and about 80% of those are in the first trimester,” Dr. Prager said.

Expectant management is an additional option for managing early pregnancy loss, she noted.

Candidates

Medical management is appropriate for patients who are undergoing elective abortion at up to about 70 days of gestation or with pregnancy loss in the first trimester.

“They should have stable vital signs, no evidence of infection, no allergies to the medications being used, no serious social or medical problems,” Dr. Prager said, explaining that “a shared decision making process” is important for patients with extreme anxiety or homelessness/lack of stable housing, for example, in order to make sure that medical management is a good option.

“While she definitely gets to have the final say, unless there is a real medical contraindication, it definitely should be part of that decision making,” Dr. Prager said, adding that adequate counseling and acceptance by the patient of the risks and side effects also are imperative.

Protocol

The most effective evidence-based treatment protocol for elective abortion through day 70 of gestation includes a 200-mg oral dose of mifepristone, followed 24-72 hours later with at-home buccal or vaginal administration of an 800-mcg dose of misoprostol, with follow up within 1-2 weeks, Dr. Prager said, citing a 2010 Cochrane review.

The Food and Drug Administration–approved protocol, which was updated in April 2016, adheres closely to those findings, except that it calls for misoprostol within 48 hours of mifepristone dosing. Optional repeat dosing of misoprostol is allowed, as well, she noted.

Buccal or vaginal administration of misoprostol is preferable to oral and sublingual administration because while the latter approaches provide more rapid onset, the former approaches provide significantly better sustained action over a 5-hour period of time.

“And by not having that big peak at the beginning, it actually decreases the side effects that women experience with the misoprostol medication,” she said.

Misoprostol can also be given alone for early pregnancy loss management – also at a dose of 800 mcg buccally or vaginally – with repeat dosing at 12-24 hours for incomplete abortion. However, new data suggest that, before about 63 days of gestation, giving two doses 3 hours apart is slightly more effective. That approach can also be repeated if necessary, Dr. Prager said.

Pain management is an important part of treatment, as both miscarriage and medication abortion can range from uncomfortable to extremely painful, depending on the patient, her prior obstetric experience, and her life experiences.

“I recommend talking to all your patients about pain management. For most people, just using some type of NSAID is probably going to be sufficient,” she said, noting that some women will require a narcotic.

Antiemetic medication may also be necessary, as some women will experience nausea and vomiting.

Complications and intervention

Major complications are rare with medical management of first-trimester abortion and early pregnancy loss, but can include ongoing pregnancy, which is infrequent but possible; incomplete abortion, which is easily managed; and allergic reactions, which are “extremely rare,” Dr. Prager said.

Hemorrhage can occur, but isn’t common and usually is at a level that doesn’t require blood transfusion. “But it does require somebody to come in, potentially needing uterine aspiration or sometimes just a second dose of misoprostol,” she said.

Serious infections are “extraordinarily uncommon,” with an actual risk of infectious death of 0.5 per 100,000, and therefore antibiotic prophylaxis is not recommended.

“This is not to say that there can’t be serious infectious problems with medication abortion, and actually also with spontaneous abortion ... but it’s extremely rare,” Dr. Prager said, adding that “there are also consequences to giving everybody antibiotics if they are not necessary. I, personally, am way more afraid of antibiotic resistance these days than I am about preventing an infection from an medication abortion.”

Intervention is necessary in certain situations, including when the gestational sac remains and when the patient continues to have clinical symptoms or has developed clinical symptoms, she said.

“Does she now show signs of infection? Is she bleeding very heavily or [is she] extremely uncomfortable with cramping? Those are all really great reasons to intervene,” she said.

Sometimes patients just prefer to switch to an alternative method of management, particularly in cases of early pregnancy loss when medical management has “not been successful after some period of time,” Dr. Prager added.

Outcomes

Studies have shown that the success rates with a single dose of 400-800 mcg of misoprostol range from 25% to 88%, and with repeat dosing for incomplete abortion at 24 hours, the success rate improves to between 80% and 88%. The success rate with placebo is 16%-60%; this indicates that “some miscarriages just happen expectantly,” Dr. Prager explained.

“We already knew that ... and that’s why expectant management is an option with early pregnancy loss,” she said, adding that expectant management works about 50% of the time – “if you wait long enough.”

However, success rates with medical management depend on the type of miscarriage; the rate is close to 100% with incomplete abortion, but for other types, such as anembryonic pregnancy or fetal demise, it is slightly less effective at about 87%, Dr. Prager noted.

When mifepristone and misoprostol are both used, success rates for early pregnancy loss range from 52% to 84% in observational trials and using nonstandard doses, and between 90% and 93% with standard dosing.

Other recent data, which led to a 2016 “reaffirmation” of an ACOG practice bulletin on medical management of first-trimester abortion, show an 83% success rate with the combination therapy in anembryonic pregnancies, and a 25% reduction in the need for further intervention (N Engl J Med. 2018;378:2161-70).

“So it really was significantly more effective to be using that addition of the mifepristone,” she said. “My take-home message about this is that, if mifepristone is something that you have easily available to you at your clinical site, absolutely use it, because it creates better outcomes for your patients. However, if it’s not available to you ... it is still perfectly reasonable for patients to choose medication management of their early pregnancy loss and use misoprostol only.

“It is effective enough, and that is just part of your informed consent.”

Postabortion care

Postmiscarriage care is important and involves several components, Dr. Prager said.

• RhoGAM treatment. The use of RhoGAM to prevent Rh immunization has been routine, but data increasingly suggest this is not necessary, and in some countries it is not given at all, particularly at 8 or fewer weeks of gestation and sometimes even during the whole first trimester for early pregnancy loss. “That is not common practice yet in the United States; I’m not recommending at this time that everybody change their practice ... but I will say that there are some really interesting studies going on right now in the United States that are looking specifically at this, and I think we may, within the next 10 years or so, change this practice of giving RhoGAM at all gestational ages,” she said.
• Counseling about bleeding. Light to moderate bleeding after abortion is common for about 2 weeks after abortion, with normal menses returning between 4 and 8 weeks, and typically around 6 weeks. “I usually ask patients to come back and see me if they have not had what seems to be a normal period to them 8 weeks following their completed process,” Dr. Prager said.
• Counseling about human chorionic gonadotropin levels. It is also helpful to inform patients that human chorionic gonadotropin may remain present for about 2-4 weeks after completed abortion, resulting in a positive pregnancy test during that time. A positive test at 4 weeks may still be normal, but warrants evaluation to determine why the patient is testing positive.
• Counseling about conception timing. Data do not support delaying repeat pregnancy after abortion. Studies show no difference in the ability to conceive or in pregnancy outcomes among women who conceive without delay after early pregnancy loss and in those who wait at least 3 months. “So what I now tell women is ‘when you’re emotionally ready to start trying to get pregnant again, it’s perfectly medically acceptable to do so. There’s no biologic reason why you have to wait,’ ” she said.
• Contraception initiation. Contraception, including IUDs, can be initiated right away after elective or spontaneous abortion. However, for IUD insertion after medical abortion, it is important to first use ultrasound to confirm complete abortion, Dr. Prager said.
• Grief counseling. This may be appropriate in cases of early pregnancy loss and for elective abortions. “Both groups of people may need some counseling, may be experiencing grief around this process – and they may not be,” she said. “I think we just need to be sensitive about asking our patients what their needs might be around this.”

Future directions

The future of medical management for first trimester abortion may involve “demedicalization,” Dr. Prager said.

“There are many papers coming out now about clinic versus home use of mifepristone,” she said, explaining that home use would require removing the FDA’s Risk Evaluation and Mitigation Strategy restriction that requires that the drug be dispensed in a clinic by a physician or physician extender.

Studies are also looking at prescriptions, pharmacist provision of mifepristone, and mailing of medications to women in rural areas.

Another area of research beyond these “really creative ways of using these medications” is whether medical management is effective beyond 10 weeks. A study that will soon be published is looking at mifepristone and two doses of misoprostol at 11 weeks, she noted.

“I think from pregnancy diagnosis through at least week 10 – soon we will see potentially week 11 – medical abortion techniques are safe, they’re effective, and they’re extremely well accepted by patients,” she said. “Also ... a diverse group of clinicians can be trained to offer medical abortion and provide back-up so that access can be improved.”

Dr. Prager reported having no financial disclosures.

[email protected]

NASHVILLE, TENN. – Medical management of abortion and early pregnancy loss is best achieved with both mifepristone and misoprostol, according to Sarah W. Prager, MD.

First-trimester procedures account for about 90% of elective abortions, with about two-thirds of those occurring before 8 weeks of gestation and 80% occurring in the first 10 weeks – and therefore considered eligible for medical management, Dr. Prager, director of the Family Planning Division and Family Planning Fellowship at the University of Washington, Seattle, said at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

“We estimate that it’s approximately 31% of all abortions that are done using medication, but it’s about 45% of those eligible by gestational age,” she noted.

The alternative is uterine aspiration, and in the absence of a clear contraindication, patient preference should determine management choice, she said.

The same is true for early pregnancy loss (spontaneous abortion), which is the most common complication of early pregnancy, occurring in about 20% of clinically recognized pregnancies.

“That means that there are about 1 million spontaneous abortions happening annually in the United States, and about 80% of those are in the first trimester,” Dr. Prager said.

Expectant management is an additional option for managing early pregnancy loss, she noted.

Candidates

Medical management is appropriate for patients who are undergoing elective abortion at up to about 70 days of gestation or with pregnancy loss in the first trimester.

“They should have stable vital signs, no evidence of infection, no allergies to the medications being used, no serious social or medical problems,” Dr. Prager said, explaining that “a shared decision making process” is important for patients with extreme anxiety or homelessness/lack of stable housing, for example, in order to make sure that medical management is a good option.

“While she definitely gets to have the final say, unless there is a real medical contraindication, it definitely should be part of that decision making,” Dr. Prager said, adding that adequate counseling and acceptance by the patient of the risks and side effects also are imperative.

Protocol

The most effective evidence-based treatment protocol for elective abortion through day 70 of gestation includes a 200-mg oral dose of mifepristone, followed 24-72 hours later with at-home buccal or vaginal administration of an 800-mcg dose of misoprostol, with follow up within 1-2 weeks, Dr. Prager said, citing a 2010 Cochrane review.

The Food and Drug Administration–approved protocol, which was updated in April 2016, adheres closely to those findings, except that it calls for misoprostol within 48 hours of mifepristone dosing. Optional repeat dosing of misoprostol is allowed, as well, she noted.

Buccal or vaginal administration of misoprostol is preferable to oral and sublingual administration because while the latter approaches provide more rapid onset, the former approaches provide significantly better sustained action over a 5-hour period of time.

“And by not having that big peak at the beginning, it actually decreases the side effects that women experience with the misoprostol medication,” she said.

Misoprostol can also be given alone for early pregnancy loss management – also at a dose of 800 mcg buccally or vaginally – with repeat dosing at 12-24 hours for incomplete abortion. However, new data suggest that, before about 63 days of gestation, giving two doses 3 hours apart is slightly more effective. That approach can also be repeated if necessary, Dr. Prager said.

Pain management is an important part of treatment, as both miscarriage and medication abortion can range from uncomfortable to extremely painful, depending on the patient, her prior obstetric experience, and her life experiences.

“I recommend talking to all your patients about pain management. For most people, just using some type of NSAID is probably going to be sufficient,” she said, noting that some women will require a narcotic.

Antiemetic medication may also be necessary, as some women will experience nausea and vomiting.

Complications and intervention

Major complications are rare with medical management of first-trimester abortion and early pregnancy loss, but can include ongoing pregnancy, which is infrequent but possible; incomplete abortion, which is easily managed; and allergic reactions, which are “extremely rare,” Dr. Prager said.

Hemorrhage can occur, but isn’t common and usually is at a level that doesn’t require blood transfusion. “But it does require somebody to come in, potentially needing uterine aspiration or sometimes just a second dose of misoprostol,” she said.

Serious infections are “extraordinarily uncommon,” with an actual risk of infectious death of 0.5 per 100,000, and therefore antibiotic prophylaxis is not recommended.

“This is not to say that there can’t be serious infectious problems with medication abortion, and actually also with spontaneous abortion ... but it’s extremely rare,” Dr. Prager said, adding that “there are also consequences to giving everybody antibiotics if they are not necessary. I, personally, am way more afraid of antibiotic resistance these days than I am about preventing an infection from an medication abortion.”

Intervention is necessary in certain situations, including when the gestational sac remains and when the patient continues to have clinical symptoms or has developed clinical symptoms, she said.

“Does she now show signs of infection? Is she bleeding very heavily or [is she] extremely uncomfortable with cramping? Those are all really great reasons to intervene,” she said.

Sometimes patients just prefer to switch to an alternative method of management, particularly in cases of early pregnancy loss when medical management has “not been successful after some period of time,” Dr. Prager added.

Outcomes

Studies have shown that the success rates with a single dose of 400-800 mcg of misoprostol range from 25% to 88%, and with repeat dosing for incomplete abortion at 24 hours, the success rate improves to between 80% and 88%. The success rate with placebo is 16%-60%; this indicates that “some miscarriages just happen expectantly,” Dr. Prager explained.

“We already knew that ... and that’s why expectant management is an option with early pregnancy loss,” she said, adding that expectant management works about 50% of the time – “if you wait long enough.”

However, success rates with medical management depend on the type of miscarriage; the rate is close to 100% with incomplete abortion, but for other types, such as anembryonic pregnancy or fetal demise, it is slightly less effective at about 87%, Dr. Prager noted.

When mifepristone and misoprostol are both used, success rates for early pregnancy loss range from 52% to 84% in observational trials and using nonstandard doses, and between 90% and 93% with standard dosing.

Other recent data, which led to a 2016 “reaffirmation” of an ACOG practice bulletin on medical management of first-trimester abortion, show an 83% success rate with the combination therapy in anembryonic pregnancies, and a 25% reduction in the need for further intervention (N Engl J Med. 2018;378:2161-70).

“So it really was significantly more effective to be using that addition of the mifepristone,” she said. “My take-home message about this is that, if mifepristone is something that you have easily available to you at your clinical site, absolutely use it, because it creates better outcomes for your patients. However, if it’s not available to you ... it is still perfectly reasonable for patients to choose medication management of their early pregnancy loss and use misoprostol only.

“It is effective enough, and that is just part of your informed consent.”

Postabortion care

Postmiscarriage care is important and involves several components, Dr. Prager said.

• RhoGAM treatment. The use of RhoGAM to prevent Rh immunization has been routine, but data increasingly suggest this is not necessary, and in some countries it is not given at all, particularly at 8 or fewer weeks of gestation and sometimes even during the whole first trimester for early pregnancy loss. “That is not common practice yet in the United States; I’m not recommending at this time that everybody change their practice ... but I will say that there are some really interesting studies going on right now in the United States that are looking specifically at this, and I think we may, within the next 10 years or so, change this practice of giving RhoGAM at all gestational ages,” she said.
• Counseling about bleeding. Light to moderate bleeding after abortion is common for about 2 weeks after abortion, with normal menses returning between 4 and 8 weeks, and typically around 6 weeks. “I usually ask patients to come back and see me if they have not had what seems to be a normal period to them 8 weeks following their completed process,” Dr. Prager said.
• Counseling about human chorionic gonadotropin levels. It is also helpful to inform patients that human chorionic gonadotropin may remain present for about 2-4 weeks after completed abortion, resulting in a positive pregnancy test during that time. A positive test at 4 weeks may still be normal, but warrants evaluation to determine why the patient is testing positive.
• Counseling about conception timing. Data do not support delaying repeat pregnancy after abortion. Studies show no difference in the ability to conceive or in pregnancy outcomes among women who conceive without delay after early pregnancy loss and in those who wait at least 3 months. “So what I now tell women is ‘when you’re emotionally ready to start trying to get pregnant again, it’s perfectly medically acceptable to do so. There’s no biologic reason why you have to wait,’ ” she said.
• Contraception initiation. Contraception, including IUDs, can be initiated right away after elective or spontaneous abortion. However, for IUD insertion after medical abortion, it is important to first use ultrasound to confirm complete abortion, Dr. Prager said.
• Grief counseling. This may be appropriate in cases of early pregnancy loss and for elective abortions. “Both groups of people may need some counseling, may be experiencing grief around this process – and they may not be,” she said. “I think we just need to be sensitive about asking our patients what their needs might be around this.”

Future directions

The future of medical management for first trimester abortion may involve “demedicalization,” Dr. Prager said.

“There are many papers coming out now about clinic versus home use of mifepristone,” she said, explaining that home use would require removing the FDA’s Risk Evaluation and Mitigation Strategy restriction that requires that the drug be dispensed in a clinic by a physician or physician extender.

Studies are also looking at prescriptions, pharmacist provision of mifepristone, and mailing of medications to women in rural areas.

Another area of research beyond these “really creative ways of using these medications” is whether medical management is effective beyond 10 weeks. A study that will soon be published is looking at mifepristone and two doses of misoprostol at 11 weeks, she noted.

“I think from pregnancy diagnosis through at least week 10 – soon we will see potentially week 11 – medical abortion techniques are safe, they’re effective, and they’re extremely well accepted by patients,” she said. “Also ... a diverse group of clinicians can be trained to offer medical abortion and provide back-up so that access can be improved.”

Dr. Prager reported having no financial disclosures.

[email protected]

NASHVILLE, TENN. – Surgery and medication each offer a generally safe and effective approach for managing second-trimester fetal demise, according to Sarah W. Prager, MD.

Therefore, in the absence of clear contraindications in settings where both options are available, patient preference should prevail, Dr. Prager, director of the family planning division and family planning fellowship at the University of Washington, Seattle, said at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

However, shared decision-making is imperative, she said.

Shared decision-making “can be extremely important for satisfaction with this process,” she said, explaining that provider-driven decisions can be paternalistic and often are based on what the provider might do in the same situation.

“But that may not be what the patient wants,” she added.

Conversely, patient-led decision-making can lead to information overload.

“She’s coming to you because you’re the expert. She wants your opinion on this,” Dr. Prager said, noting that sharing the process through “information transfer” allows for the “best, most appropriate decision” to be made.

“Patient engagement is the practice of actively involving and supporting the patient in health care and treatment decision-making activities, and this is really what I’m talking about,” she said, adding that patient engagement is “critically important in many situations, and especially in the setting of pregnancy loss.”

That’s because patients feel powerless in this situation, she explained. Engaging them in the decision-making process can “give them a little bit of that power back” by respecting autonomy, enhancing agency, improving health status, reducing decisional conflict, and limiting test use, thereby improving overall satisfaction.

Two randomized control trials, each designed to compare surgical management and medical management for terminations at up to 20 weeks of gestation, highlight the role and importance of patient preference, Dr. Prager said.

The first – a 2004 study – was stopped early because of slow enrollment, with 29 of 47 eligible subjects declining randomization. Among 93% of those who declined, there was a preference for surgical management. The second, a 2010 study, enrolled 122 patients after 107 of 229 eligible subjects (47%) declined randomization, again because most (67%) preferred surgery (BJOG. 2004;111[2]:148-53; BJOG. 2010;117[12]:1512-20).

Reasons given for preferring surgical management included less psychological trauma and deeper anesthesia, whereas reasons given for induction preference included less wait time and a desire to avoid general anesthesia.

Helping patients make the best decision requires a discussion about potential complications for each approach, Dr. Prager said.

Surgical management, which involves dilation and evacuation (D&E), is used for about 95% of second-trimester abortions overall, but medical management may be underreported, particularly for management of pregnancy loss, Dr. Prager said. “We don’t have clear statistics” in that setting.

The overall rate of complications is low for surgical management, with data suggesting a rate of up to 4%. Uterine perforation occurs in 0.2%-0.3% of procedures, cervical laceration occurs in up to 1%, and retained placenta occurs in less than 1%, she said.

The complication rate for medical management – induction with either misoprostol or mifepristone + misoprostol (the latter is the recommended approach) – is much higher at up to 29%, but that includes retained placenta, which happens in up to 10% of procedures. Uterine rupture occurs in 0.04%-0.28% of procedures, she said.

“With either surgical management or medication management of pregnancy loss, we need to keep in mind the possibility of disseminated intravascular coagulation, which is rare, but certainly possible,” she said.

Other factors that may be important to patients deciding between surgical and medical management for second-trimester fetal loss include:

• Anesthesia, which is local plus intravenous sedation for surgery, compared with IV narcotics and potentially an epidural or other type of regional anesthesia for medical management.
• Duration, which is 5-20 minutes for surgery, compared with 6-11 hours with mifepristone + misoprostol, and up to 20 hours with misoprostol alone.
• Location, which is done on an outpatient basis for surgery, compared with inpatient care for medical management.
• Cost, which is $1,000-$5,000 for surgery vs. $3,000-$9,000 for medical management.
• Contact with the fetus, which typically involves the possibility of partial viewing and an opportunity to obtain footprints as a memento if an intact procedure is attempted during surgery vs. full viewing and possibly holding the baby after delivery following medical management. This is often the key deciding factor for patients.
• Provider factors, in terms of training and skills. Surgery involves a need for specialized training, whereas medical management requires no extra training, she said, adding that “not all ob.gyns. across the country are competent or comfortable providing a D&E, particularly in the later second-trimester time period.” However, the availability of family planing fellowships will increase the number of centers across the country where both options will be available, she noted.
• The possibility of fetal autopsy, which surgery often (but not always) allows, but medical management always allows.
• Involvement level, which is provider heavy for surgery vs. patient heavy for medical management.

“Moving toward an evidence-based, patient-centered care model requires a lot of us, as providers, to really work at dropping our assumptions. We often have strong opinions about what we think we would do in that setting, and it can be tricky for us to set that aside and allow patients to really ask questions and discuss their values so that we can then advocate best for our patients after they know exactly what their options are,” she said.

Dr. Prager reported having no relevant disclosures.

[email protected]

NASHVILLE, TENN. – Surgery and medication each offer a generally safe and effective approach for managing second-trimester fetal demise, according to Sarah W. Prager, MD.

Therefore, in the absence of clear contraindications in settings where both options are available, patient preference should prevail, Dr. Prager, director of the family planning division and family planning fellowship at the University of Washington, Seattle, said at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

However, shared decision-making is imperative, she said.

Shared decision-making “can be extremely important for satisfaction with this process,” she said, explaining that provider-driven decisions can be paternalistic and often are based on what the provider might do in the same situation.

“But that may not be what the patient wants,” she added.

Conversely, patient-led decision-making can lead to information overload.

“She’s coming to you because you’re the expert. She wants your opinion on this,” Dr. Prager said, noting that sharing the process through “information transfer” allows for the “best, most appropriate decision” to be made.

“Patient engagement is the practice of actively involving and supporting the patient in health care and treatment decision-making activities, and this is really what I’m talking about,” she said, adding that patient engagement is “critically important in many situations, and especially in the setting of pregnancy loss.”

That’s because patients feel powerless in this situation, she explained. Engaging them in the decision-making process can “give them a little bit of that power back” by respecting autonomy, enhancing agency, improving health status, reducing decisional conflict, and limiting test use, thereby improving overall satisfaction.

Two randomized control trials, each designed to compare surgical management and medical management for terminations at up to 20 weeks of gestation, highlight the role and importance of patient preference, Dr. Prager said.

The first – a 2004 study – was stopped early because of slow enrollment, with 29 of 47 eligible subjects declining randomization. Among 93% of those who declined, there was a preference for surgical management. The second, a 2010 study, enrolled 122 patients after 107 of 229 eligible subjects (47%) declined randomization, again because most (67%) preferred surgery (BJOG. 2004;111[2]:148-53; BJOG. 2010;117[12]:1512-20).

Reasons given for preferring surgical management included less psychological trauma and deeper anesthesia, whereas reasons given for induction preference included less wait time and a desire to avoid general anesthesia.

Helping patients make the best decision requires a discussion about potential complications for each approach, Dr. Prager said.

Surgical management, which involves dilation and evacuation (D&E), is used for about 95% of second-trimester abortions overall, but medical management may be underreported, particularly for management of pregnancy loss, Dr. Prager said. “We don’t have clear statistics” in that setting.

The overall rate of complications is low for surgical management, with data suggesting a rate of up to 4%. Uterine perforation occurs in 0.2%-0.3% of procedures, cervical laceration occurs in up to 1%, and retained placenta occurs in less than 1%, she said.

The complication rate for medical management – induction with either misoprostol or mifepristone + misoprostol (the latter is the recommended approach) – is much higher at up to 29%, but that includes retained placenta, which happens in up to 10% of procedures. Uterine rupture occurs in 0.04%-0.28% of procedures, she said.

“With either surgical management or medication management of pregnancy loss, we need to keep in mind the possibility of disseminated intravascular coagulation, which is rare, but certainly possible,” she said.

Other factors that may be important to patients deciding between surgical and medical management for second-trimester fetal loss include:

• Anesthesia, which is local plus intravenous sedation for surgery, compared with IV narcotics and potentially an epidural or other type of regional anesthesia for medical management.
• Duration, which is 5-20 minutes for surgery, compared with 6-11 hours with mifepristone + misoprostol, and up to 20 hours with misoprostol alone.
• Location, which is done on an outpatient basis for surgery, compared with inpatient care for medical management.
• Cost, which is $1,000-$5,000 for surgery vs. $3,000-$9,000 for medical management.
• Contact with the fetus, which typically involves the possibility of partial viewing and an opportunity to obtain footprints as a memento if an intact procedure is attempted during surgery vs. full viewing and possibly holding the baby after delivery following medical management. This is often the key deciding factor for patients.
• Provider factors, in terms of training and skills. Surgery involves a need for specialized training, whereas medical management requires no extra training, she said, adding that “not all ob.gyns. across the country are competent or comfortable providing a D&E, particularly in the later second-trimester time period.” However, the availability of family planing fellowships will increase the number of centers across the country where both options will be available, she noted.
• The possibility of fetal autopsy, which surgery often (but not always) allows, but medical management always allows.
• Involvement level, which is provider heavy for surgery vs. patient heavy for medical management.

“Moving toward an evidence-based, patient-centered care model requires a lot of us, as providers, to really work at dropping our assumptions. We often have strong opinions about what we think we would do in that setting, and it can be tricky for us to set that aside and allow patients to really ask questions and discuss their values so that we can then advocate best for our patients after they know exactly what their options are,” she said.

Dr. Prager reported having no relevant disclosures.

[email protected]

NASHVILLE, TENN. – Surgery and medication each offer a generally safe and effective approach for managing second-trimester fetal demise, according to Sarah W. Prager, MD.

Therefore, in the absence of clear contraindications in settings where both options are available, patient preference should prevail, Dr. Prager, director of the family planning division and family planning fellowship at the University of Washington, Seattle, said at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

However, shared decision-making is imperative, she said.

Shared decision-making “can be extremely important for satisfaction with this process,” she said, explaining that provider-driven decisions can be paternalistic and often are based on what the provider might do in the same situation.

“But that may not be what the patient wants,” she added.

Conversely, patient-led decision-making can lead to information overload.

“She’s coming to you because you’re the expert. She wants your opinion on this,” Dr. Prager said, noting that sharing the process through “information transfer” allows for the “best, most appropriate decision” to be made.

“Patient engagement is the practice of actively involving and supporting the patient in health care and treatment decision-making activities, and this is really what I’m talking about,” she said, adding that patient engagement is “critically important in many situations, and especially in the setting of pregnancy loss.”

That’s because patients feel powerless in this situation, she explained. Engaging them in the decision-making process can “give them a little bit of that power back” by respecting autonomy, enhancing agency, improving health status, reducing decisional conflict, and limiting test use, thereby improving overall satisfaction.

Two randomized control trials, each designed to compare surgical management and medical management for terminations at up to 20 weeks of gestation, highlight the role and importance of patient preference, Dr. Prager said.

The first – a 2004 study – was stopped early because of slow enrollment, with 29 of 47 eligible subjects declining randomization. Among 93% of those who declined, there was a preference for surgical management. The second, a 2010 study, enrolled 122 patients after 107 of 229 eligible subjects (47%) declined randomization, again because most (67%) preferred surgery (BJOG. 2004;111[2]:148-53; BJOG. 2010;117[12]:1512-20).

Reasons given for preferring surgical management included less psychological trauma and deeper anesthesia, whereas reasons given for induction preference included less wait time and a desire to avoid general anesthesia.

Helping patients make the best decision requires a discussion about potential complications for each approach, Dr. Prager said.

Surgical management, which involves dilation and evacuation (D&E), is used for about 95% of second-trimester abortions overall, but medical management may be underreported, particularly for management of pregnancy loss, Dr. Prager said. “We don’t have clear statistics” in that setting.

The overall rate of complications is low for surgical management, with data suggesting a rate of up to 4%. Uterine perforation occurs in 0.2%-0.3% of procedures, cervical laceration occurs in up to 1%, and retained placenta occurs in less than 1%, she said.

The complication rate for medical management – induction with either misoprostol or mifepristone + misoprostol (the latter is the recommended approach) – is much higher at up to 29%, but that includes retained placenta, which happens in up to 10% of procedures. Uterine rupture occurs in 0.04%-0.28% of procedures, she said.

“With either surgical management or medication management of pregnancy loss, we need to keep in mind the possibility of disseminated intravascular coagulation, which is rare, but certainly possible,” she said.

Other factors that may be important to patients deciding between surgical and medical management for second-trimester fetal loss include:

• Anesthesia, which is local plus intravenous sedation for surgery, compared with IV narcotics and potentially an epidural or other type of regional anesthesia for medical management.
• Duration, which is 5-20 minutes for surgery, compared with 6-11 hours with mifepristone + misoprostol, and up to 20 hours with misoprostol alone.
• Location, which is done on an outpatient basis for surgery, compared with inpatient care for medical management.
• Cost, which is $1,000-$5,000 for surgery vs. $3,000-$9,000 for medical management.
• Contact with the fetus, which typically involves the possibility of partial viewing and an opportunity to obtain footprints as a memento if an intact procedure is attempted during surgery vs. full viewing and possibly holding the baby after delivery following medical management. This is often the key deciding factor for patients.
• Provider factors, in terms of training and skills. Surgery involves a need for specialized training, whereas medical management requires no extra training, she said, adding that “not all ob.gyns. across the country are competent or comfortable providing a D&E, particularly in the later second-trimester time period.” However, the availability of family planing fellowships will increase the number of centers across the country where both options will be available, she noted.
• The possibility of fetal autopsy, which surgery often (but not always) allows, but medical management always allows.
• Involvement level, which is provider heavy for surgery vs. patient heavy for medical management.

“Moving toward an evidence-based, patient-centered care model requires a lot of us, as providers, to really work at dropping our assumptions. We often have strong opinions about what we think we would do in that setting, and it can be tricky for us to set that aside and allow patients to really ask questions and discuss their values so that we can then advocate best for our patients after they know exactly what their options are,” she said.

Dr. Prager reported having no relevant disclosures.

[email protected]

LAKE BUENA VISTA, FLA. – Patient-reported outcomes (PROs) have the potential to transform patient care in rheumatology, according to Jeffrey Curtis, MD.

Courtesy UAB Photo

“You probably already use a lot of PROs in your data; even if you measure nothing via a questionnaire, you are still collecting it in a qualitative way – you just might not call it that,” he told attendees at the annual meeting of the Florida Society of Rheumatology.

The key to making the most of PROs is efficient collection of relevant, interpretable, actionable data for improving patient care and outcomes, said Dr. Curtis, professor of medicine in the division of clinical immunology and rheumatology at the University of Alabama at Birmingham.
 

PROs: The “what” and “why”

A wide variety of tools are available to capture PROs during daily practice, Dr. Curtis said. Active data capture tools include rheumatology- or domain-specific measures such as the Bath Ankylosing Spondylitis Disease Activity and Functional Indices (BASDAI and BASFI), the Routine Assessment of Patient Index Data 3 (RAPID3), the original and Multidimensional Health Assessment Questionnaires (HAQ and MDHAQ), as well as disease-agnostic measures like the 36-item Short Form Survey (SF-36), EuroQol-5D (EQ-5D), the Work Productivity and Activity Impairment Questionnaire (WPAI), and the National Institutes of Health Patient-Reported Outcomes Measurement Information System (PROMIS) instruments, he explained, adding that passive data also can be derived from various sources, including social media platforms, activity trackers, and reports regarding balance and falls, sleep quality and duration, heart rate and rhythm, and galvanic skin resistance.

Many of these measures represent things patients can track at home between office visits, he said.

However, such measures represent “what we could have” in terms of patient data, whereas “what we do have” falls far short of that, he noted, citing a study in which he and his colleagues found that the use of quantitative measurement for U.S. rheumatoid arthritis (RA) patients is increasing over time, but remains low with only 58% of 439 rheumatologists who responded to an email survey reporting use of such measures (J Rheumatol. 2018;45[1]:40-4).

Those using the measures were more likely to be in group practice and to prescribe tumor necrosis factor inhibitors, and the tools they reported using most often were the HAQ (35.5%) and RAPID3 (27.1%).

Reasons given for not using quantitative measurement included time constraints and electronic availability.

Of note, simulated case scenarios included in the study demonstrated that providing more quantitative information increased the likelihood that a patient would change to a different disease-modifying antirheumatic drug or biologic.

Almost anything clinically relevant can be quantified, but it’s really hard to improve and address problems you’re not measuring, Dr. Curtis said.

“I would contend that PROs are an important part of holistic rheumatology care, and they absolutely impact real and perceived treatment responses,” he added.

In fact, in a study presented at the 2018 European League Against Rheumatism Congress, he and his colleagues found that PROMIS scores with respect to pain interference, sleep disturbance, and fatigue tracked closely with RA patients’ view of their health status and with Clinical Disease Activity Index (CDAI) scores.
 

PROs: The “how”

“Is it merely enough to collect patient data? Is that going to solve the problem? Well, probably not – it really needs to be actionable,” he said. “Outcomes don’t get better by themselves; you really need to be collecting data that you, personally, will find valuable for your patients, and ideally it needs to mean something to patients.”

Many of these suggestions are potentially actionable, he noted.

“You can download these forms on paper; this is already connected or connectable to some people’s electronic health record,” he said. “At a minimum, talk to your EHR vendor about whether this might be available, and if not, why not.”

Choose in-office tools that are quick and simple to use, he advised, noting that he finds 6-8 minutes ideal for patient completion of questionnaires and other measures.

“It’s quite reasonable to write a PRO order,” he said. “The notion would be that you decide what specific PROs you want Mrs. Smith to give you, how often you’d like for her to tell you about those things (what you want from her might be different from the next patient), and she can give you that data from a smartphone or maybe something that she wears, and only the data that you asked for comes back.”

Successful collection of such data requires patient engagement in the process, he said, noting that the Center for Education and Research and Therapeutics of Musculoskeletal Disorders at UAB was recently awarded a grant to help develop an arthritis research registry called Arthritis Power, through which patients can provide data via smartphones, track their own health outcomes, participate in studies and surveys, access educational tools, and receive reminders and feedback.

“One of the things that’s quite important to help engage patients is to encourage them. This isn’t one-way data transfer,” he said.

Keeping them engaged requires “contributive science messaging.” That is, telling them they are “part of something bigger [and that they are] helping answer research questions that patients care about.”

It also helps to “bring back value to them” by explaining that you can help them make their data useful for improving their health and that you can derive insights for or with them based on their data.

“You can ‘game-ify’ it and make it fun,” he said, adding that leveraging the social connections associated with some tools can also help.

However, the promise of better access to needed resources, physicians, and the health care system is perhaps the most compelling point for patient engagement, he said.

“[You can say] to your patient, ‘Mrs. Smith, I’d really like to have your Fitbit or Apple Watch data, and I’d like you to tell me how you’re doing, on your smartphone, once or twice a month – it will take about 10 minutes – because I, as your doctor, think I can take better care of you,’ ” he said. “If that’s the ask, I think that might be the most compelling reason for patients to say yes.”

Of note, a number of patient measures are now compensable, Dr. Curtis said, mentioning depression screening using a PROMIS instrument as one example.

Additionally, two American College of Rheumatology work groups are revising the ACR recommendations on functional status measures and will soon generate an “ACR-approved list” of measures, he said.

He stressed, however, that it in addition to understanding the value of specific tools, it is important to know their limitations.

In the PREDICT study, he and his colleagues demonstrated that patient-reported RAPID3 data, when compared with investigator-based CDAI data for assessing RA patients’ response to certolizumab at 12 weeks and predicting response at 52 weeks, resulted in 11.9% fewer patients being classified as responders (64.7% vs. 76.4%), but the actual response rates at week 52 were similar, with 31.5% and 32.3% of patients in the groups, respectively, achieving a low level of disease activity (Arthritis Rheumatol. 2015;67[12]:3104-12).

The concern regarding the finding is that an insurance company may refuse to continue paying for a drug because of the perceived lack of response and thereby unnecessarily force a switch to an alternate drug based on faulty data, he explained.

“That would be the real-world analog of what this trial evaluated,” he said, adding that this has important implications for treat-to-target, pay-for-performance, and merit-based incentive payment systems. “My point is that we need to know the limitations of our tools ... and it’s to not let insurance [companies] write rules for us ... based upon certain tools that have limitations.”

Dr. Curtis reported funding from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the Patient-Centered Outcomes Research Institute. He has also consulted for or received research grants from Amgen, AbbVie, Bristol-Myers Squibb, CORRONA, Lilly, Janssen, Myriad, Novartis, Roche, Pfizer, and Sanofi/Regeneron.

[email protected]

LAKE BUENA VISTA, FLA. – Patient-reported outcomes (PROs) have the potential to transform patient care in rheumatology, according to Jeffrey Curtis, MD.

Courtesy UAB Photo

“You probably already use a lot of PROs in your data; even if you measure nothing via a questionnaire, you are still collecting it in a qualitative way – you just might not call it that,” he told attendees at the annual meeting of the Florida Society of Rheumatology.

The key to making the most of PROs is efficient collection of relevant, interpretable, actionable data for improving patient care and outcomes, said Dr. Curtis, professor of medicine in the division of clinical immunology and rheumatology at the University of Alabama at Birmingham.
 

PROs: The “what” and “why”

A wide variety of tools are available to capture PROs during daily practice, Dr. Curtis said. Active data capture tools include rheumatology- or domain-specific measures such as the Bath Ankylosing Spondylitis Disease Activity and Functional Indices (BASDAI and BASFI), the Routine Assessment of Patient Index Data 3 (RAPID3), the original and Multidimensional Health Assessment Questionnaires (HAQ and MDHAQ), as well as disease-agnostic measures like the 36-item Short Form Survey (SF-36), EuroQol-5D (EQ-5D), the Work Productivity and Activity Impairment Questionnaire (WPAI), and the National Institutes of Health Patient-Reported Outcomes Measurement Information System (PROMIS) instruments, he explained, adding that passive data also can be derived from various sources, including social media platforms, activity trackers, and reports regarding balance and falls, sleep quality and duration, heart rate and rhythm, and galvanic skin resistance.

Many of these measures represent things patients can track at home between office visits, he said.

However, such measures represent “what we could have” in terms of patient data, whereas “what we do have” falls far short of that, he noted, citing a study in which he and his colleagues found that the use of quantitative measurement for U.S. rheumatoid arthritis (RA) patients is increasing over time, but remains low with only 58% of 439 rheumatologists who responded to an email survey reporting use of such measures (J Rheumatol. 2018;45[1]:40-4).

Those using the measures were more likely to be in group practice and to prescribe tumor necrosis factor inhibitors, and the tools they reported using most often were the HAQ (35.5%) and RAPID3 (27.1%).

Reasons given for not using quantitative measurement included time constraints and electronic availability.

Of note, simulated case scenarios included in the study demonstrated that providing more quantitative information increased the likelihood that a patient would change to a different disease-modifying antirheumatic drug or biologic.

Almost anything clinically relevant can be quantified, but it’s really hard to improve and address problems you’re not measuring, Dr. Curtis said.

“I would contend that PROs are an important part of holistic rheumatology care, and they absolutely impact real and perceived treatment responses,” he added.

In fact, in a study presented at the 2018 European League Against Rheumatism Congress, he and his colleagues found that PROMIS scores with respect to pain interference, sleep disturbance, and fatigue tracked closely with RA patients’ view of their health status and with Clinical Disease Activity Index (CDAI) scores.
 

PROs: The “how”

“Is it merely enough to collect patient data? Is that going to solve the problem? Well, probably not – it really needs to be actionable,” he said. “Outcomes don’t get better by themselves; you really need to be collecting data that you, personally, will find valuable for your patients, and ideally it needs to mean something to patients.”

Many of these suggestions are potentially actionable, he noted.

“You can download these forms on paper; this is already connected or connectable to some people’s electronic health record,” he said. “At a minimum, talk to your EHR vendor about whether this might be available, and if not, why not.”

Choose in-office tools that are quick and simple to use, he advised, noting that he finds 6-8 minutes ideal for patient completion of questionnaires and other measures.

“It’s quite reasonable to write a PRO order,” he said. “The notion would be that you decide what specific PROs you want Mrs. Smith to give you, how often you’d like for her to tell you about those things (what you want from her might be different from the next patient), and she can give you that data from a smartphone or maybe something that she wears, and only the data that you asked for comes back.”

Successful collection of such data requires patient engagement in the process, he said, noting that the Center for Education and Research and Therapeutics of Musculoskeletal Disorders at UAB was recently awarded a grant to help develop an arthritis research registry called Arthritis Power, through which patients can provide data via smartphones, track their own health outcomes, participate in studies and surveys, access educational tools, and receive reminders and feedback.

“One of the things that’s quite important to help engage patients is to encourage them. This isn’t one-way data transfer,” he said.

Keeping them engaged requires “contributive science messaging.” That is, telling them they are “part of something bigger [and that they are] helping answer research questions that patients care about.”

It also helps to “bring back value to them” by explaining that you can help them make their data useful for improving their health and that you can derive insights for or with them based on their data.

“You can ‘game-ify’ it and make it fun,” he said, adding that leveraging the social connections associated with some tools can also help.

However, the promise of better access to needed resources, physicians, and the health care system is perhaps the most compelling point for patient engagement, he said.

“[You can say] to your patient, ‘Mrs. Smith, I’d really like to have your Fitbit or Apple Watch data, and I’d like you to tell me how you’re doing, on your smartphone, once or twice a month – it will take about 10 minutes – because I, as your doctor, think I can take better care of you,’ ” he said. “If that’s the ask, I think that might be the most compelling reason for patients to say yes.”

Of note, a number of patient measures are now compensable, Dr. Curtis said, mentioning depression screening using a PROMIS instrument as one example.

Additionally, two American College of Rheumatology work groups are revising the ACR recommendations on functional status measures and will soon generate an “ACR-approved list” of measures, he said.

He stressed, however, that it in addition to understanding the value of specific tools, it is important to know their limitations.

In the PREDICT study, he and his colleagues demonstrated that patient-reported RAPID3 data, when compared with investigator-based CDAI data for assessing RA patients’ response to certolizumab at 12 weeks and predicting response at 52 weeks, resulted in 11.9% fewer patients being classified as responders (64.7% vs. 76.4%), but the actual response rates at week 52 were similar, with 31.5% and 32.3% of patients in the groups, respectively, achieving a low level of disease activity (Arthritis Rheumatol. 2015;67[12]:3104-12).

The concern regarding the finding is that an insurance company may refuse to continue paying for a drug because of the perceived lack of response and thereby unnecessarily force a switch to an alternate drug based on faulty data, he explained.

“That would be the real-world analog of what this trial evaluated,” he said, adding that this has important implications for treat-to-target, pay-for-performance, and merit-based incentive payment systems. “My point is that we need to know the limitations of our tools ... and it’s to not let insurance [companies] write rules for us ... based upon certain tools that have limitations.”

Dr. Curtis reported funding from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the Patient-Centered Outcomes Research Institute. He has also consulted for or received research grants from Amgen, AbbVie, Bristol-Myers Squibb, CORRONA, Lilly, Janssen, Myriad, Novartis, Roche, Pfizer, and Sanofi/Regeneron.

[email protected]

LAKE BUENA VISTA, FLA. – Patient-reported outcomes (PROs) have the potential to transform patient care in rheumatology, according to Jeffrey Curtis, MD.

Courtesy UAB Photo

“You probably already use a lot of PROs in your data; even if you measure nothing via a questionnaire, you are still collecting it in a qualitative way – you just might not call it that,” he told attendees at the annual meeting of the Florida Society of Rheumatology.

The key to making the most of PROs is efficient collection of relevant, interpretable, actionable data for improving patient care and outcomes, said Dr. Curtis, professor of medicine in the division of clinical immunology and rheumatology at the University of Alabama at Birmingham.
 

PROs: The “what” and “why”

A wide variety of tools are available to capture PROs during daily practice, Dr. Curtis said. Active data capture tools include rheumatology- or domain-specific measures such as the Bath Ankylosing Spondylitis Disease Activity and Functional Indices (BASDAI and BASFI), the Routine Assessment of Patient Index Data 3 (RAPID3), the original and Multidimensional Health Assessment Questionnaires (HAQ and MDHAQ), as well as disease-agnostic measures like the 36-item Short Form Survey (SF-36), EuroQol-5D (EQ-5D), the Work Productivity and Activity Impairment Questionnaire (WPAI), and the National Institutes of Health Patient-Reported Outcomes Measurement Information System (PROMIS) instruments, he explained, adding that passive data also can be derived from various sources, including social media platforms, activity trackers, and reports regarding balance and falls, sleep quality and duration, heart rate and rhythm, and galvanic skin resistance.

Many of these measures represent things patients can track at home between office visits, he said.

However, such measures represent “what we could have” in terms of patient data, whereas “what we do have” falls far short of that, he noted, citing a study in which he and his colleagues found that the use of quantitative measurement for U.S. rheumatoid arthritis (RA) patients is increasing over time, but remains low with only 58% of 439 rheumatologists who responded to an email survey reporting use of such measures (J Rheumatol. 2018;45[1]:40-4).

Those using the measures were more likely to be in group practice and to prescribe tumor necrosis factor inhibitors, and the tools they reported using most often were the HAQ (35.5%) and RAPID3 (27.1%).

Reasons given for not using quantitative measurement included time constraints and electronic availability.

Of note, simulated case scenarios included in the study demonstrated that providing more quantitative information increased the likelihood that a patient would change to a different disease-modifying antirheumatic drug or biologic.

Almost anything clinically relevant can be quantified, but it’s really hard to improve and address problems you’re not measuring, Dr. Curtis said.

“I would contend that PROs are an important part of holistic rheumatology care, and they absolutely impact real and perceived treatment responses,” he added.

In fact, in a study presented at the 2018 European League Against Rheumatism Congress, he and his colleagues found that PROMIS scores with respect to pain interference, sleep disturbance, and fatigue tracked closely with RA patients’ view of their health status and with Clinical Disease Activity Index (CDAI) scores.
 

PROs: The “how”

“Is it merely enough to collect patient data? Is that going to solve the problem? Well, probably not – it really needs to be actionable,” he said. “Outcomes don’t get better by themselves; you really need to be collecting data that you, personally, will find valuable for your patients, and ideally it needs to mean something to patients.”

Many of these suggestions are potentially actionable, he noted.

“You can download these forms on paper; this is already connected or connectable to some people’s electronic health record,” he said. “At a minimum, talk to your EHR vendor about whether this might be available, and if not, why not.”

Choose in-office tools that are quick and simple to use, he advised, noting that he finds 6-8 minutes ideal for patient completion of questionnaires and other measures.

“It’s quite reasonable to write a PRO order,” he said. “The notion would be that you decide what specific PROs you want Mrs. Smith to give you, how often you’d like for her to tell you about those things (what you want from her might be different from the next patient), and she can give you that data from a smartphone or maybe something that she wears, and only the data that you asked for comes back.”

Successful collection of such data requires patient engagement in the process, he said, noting that the Center for Education and Research and Therapeutics of Musculoskeletal Disorders at UAB was recently awarded a grant to help develop an arthritis research registry called Arthritis Power, through which patients can provide data via smartphones, track their own health outcomes, participate in studies and surveys, access educational tools, and receive reminders and feedback.

“One of the things that’s quite important to help engage patients is to encourage them. This isn’t one-way data transfer,” he said.

Keeping them engaged requires “contributive science messaging.” That is, telling them they are “part of something bigger [and that they are] helping answer research questions that patients care about.”

It also helps to “bring back value to them” by explaining that you can help them make their data useful for improving their health and that you can derive insights for or with them based on their data.

“You can ‘game-ify’ it and make it fun,” he said, adding that leveraging the social connections associated with some tools can also help.

However, the promise of better access to needed resources, physicians, and the health care system is perhaps the most compelling point for patient engagement, he said.

“[You can say] to your patient, ‘Mrs. Smith, I’d really like to have your Fitbit or Apple Watch data, and I’d like you to tell me how you’re doing, on your smartphone, once or twice a month – it will take about 10 minutes – because I, as your doctor, think I can take better care of you,’ ” he said. “If that’s the ask, I think that might be the most compelling reason for patients to say yes.”

Of note, a number of patient measures are now compensable, Dr. Curtis said, mentioning depression screening using a PROMIS instrument as one example.

Additionally, two American College of Rheumatology work groups are revising the ACR recommendations on functional status measures and will soon generate an “ACR-approved list” of measures, he said.

He stressed, however, that it in addition to understanding the value of specific tools, it is important to know their limitations.

In the PREDICT study, he and his colleagues demonstrated that patient-reported RAPID3 data, when compared with investigator-based CDAI data for assessing RA patients’ response to certolizumab at 12 weeks and predicting response at 52 weeks, resulted in 11.9% fewer patients being classified as responders (64.7% vs. 76.4%), but the actual response rates at week 52 were similar, with 31.5% and 32.3% of patients in the groups, respectively, achieving a low level of disease activity (Arthritis Rheumatol. 2015;67[12]:3104-12).

The concern regarding the finding is that an insurance company may refuse to continue paying for a drug because of the perceived lack of response and thereby unnecessarily force a switch to an alternate drug based on faulty data, he explained.

“That would be the real-world analog of what this trial evaluated,” he said, adding that this has important implications for treat-to-target, pay-for-performance, and merit-based incentive payment systems. “My point is that we need to know the limitations of our tools ... and it’s to not let insurance [companies] write rules for us ... based upon certain tools that have limitations.”

Dr. Curtis reported funding from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the Patient-Centered Outcomes Research Institute. He has also consulted for or received research grants from Amgen, AbbVie, Bristol-Myers Squibb, CORRONA, Lilly, Janssen, Myriad, Novartis, Roche, Pfizer, and Sanofi/Regeneron.

[email protected]

LAKE BUENA VISTA, FLA. – Rheumatologists comprise a “tiny sliver” of the U.S. physician pie chart, but their voices are nevertheless being heard and making a difference regarding policies that affect the specialty, according to Angus B. Worthing, MD.

However, given the myriad policy issues on the table, more and louder voices are needed, he said at the annual meeting of the Florida Society of Rheumatology, where, as chair of the American College of Rheumatology’s Government Affairs Committee, he provided an “advocacy update” on the committee’s activities.

Recent ACR “wins” as outlined by Dr. Worthing include:

• The postponement and modification of proposed cuts to Evaluation & Management (E/M) current procedural terminology (CPT) codes.

“Last summer, Medicare proposed that instead of having low-complexity to high-complexity E/M codes, they would condense all of the doctor visits into one code, which would obviously enhance the reimbursement for low complexity, but ding and penalize the reimbursement for high-complexity visits like ours,” said Dr. Worthing, who also is a partner in a private rheumatology practice in the Washington area.

An ACR press release on the proposal led to pivotal coverage of the issue in the New York Times. “It looks like not only did they postpone those cuts, they modified [the proposal], and we’ll find out any day now in the proposal for the next year’s physician fee schedule whether they’ll scrap it entirely and instead try to plus-up E/M code reimbursement for complex patients.”

• The elimination of proposed Merit-based Incentive Payment System (MIPS) adjustments on Medicare drug reimbursement.

A cut to fee-for-service reimbursement for drug costs as a MIPS penalty could have quickly bankrupted rheumatology practices, Dr. Worthing said.

“[The success] was largely out of rheumatologists and others saying that this could quickly stop access to these treatments, because we wouldn’t be able to provide them,” he noted.

• The dampening of proposed musculoskeletal ultrasound reimbursement cuts in Medicare.

Ultrasound is a safe, effective, dynamic, and relatively low-cost diagnostic tool, but Medicare has been considering “absurd” cuts to reimbursement, Dr. Worthing said.

“We’ve been able to have good conversations with Medicare ... to bring that argument to Medicare, and we’ll find out – again, when the physician fee schedule comes out – whether they’ll continue the plan to cut diagnostic ultrasound reimbursement or whether they’ll stop cutting it.”

• The inclusion of more favorable Medicare Advantage regulations for step therapy “grandfathering.”

Medicare Advantage plans were given the chance last summer to use step therapy in Part B medicines for the first time.

“The ACR quickly told the executive branch and officials at [the Department of Health & Human Services (HHS)], that this would not be good for our patients getting medications,” Dr. Worthing said.

Going forward with that plan, and looking back just 108 days to allow people to stay on their medications – as was proposed – wouldn’t work, as some drugs are dosed every 4-6 months, or every year or every 2 years, he said.

“The look of astonishment on the [HHS] deputy secretary’s face when I told him that there was a drug in the U.S. that you give every 2 years was helpful for me to know that these people really need to hear from us before they issue these kinds of regulations,” he said.

The administration listened to the rheumatologists and is going to look back 365 days to keep people on their drugs, he said.

The ACR took the lead on these recent successes, but was also involved in a number of other wins achieved through multisociety efforts, he said.

Examples include securing a $2 billion increase in National Institutes of Health funding, eliminating “gag clauses” that prevent pharmacists from informing patients when it’s cheaper to just buy a drug rather than using their insurance; getting rid of annual caps on physical and other rehabilitation therapy for patients meeting their targets; repealing (before it could take effect) of the Independent Payment Advisory Board established by the Affordable Care Act; and – at least for now – continuing Deferred Action for Childhood Arrivals (DACA) protections that could allow recipients to stay in the country, study, and become doctors, and potentially provide care for up to 100,000 Americans, according to an estimate by the American Medical Association.

Dr. Worthing also noted that the ACR has an Insurance Subcommittee that has been instrumental in many of these and other policy wins, and he encouraged rheumatologists to contact the committee at [email protected] to report any sort of “canary-in-the-coal-mine” issues, such as refusal of coverage for a new step therapy, service, or item in your clinic that seems “absurd; doesn’t have merit.”

Send a copy of the policy behind the denial (with private health information redacted), or complete a Health Plan Complaint Form, which can be accessed at the website, he advised.

Rheumatologists can make their voices heard in other ways, he said. The ACR has a number of ongoing advocacy efforts addressing things like drug-pricing models, biosimilar agent interchangeability pathways, step therapy reform, workforce issues, and the need for higher dual X-ray absorptiometry (DXA) reimbursement.

The ACR’s Legislative Action Center offers prewritten letters on a number of timely topics, as well as information about legislators and legislation. An app is available that provides alerts about important legislation.

A timely example is DXA-related, bipartisan, bicameral legislation currently on the table that would more than double reimbursement and “improve access to this critical screening tool,” he said.

“Right now is an excellent time to tell your legislators – and there’s a prewritten letter at the [site] – that this is an important topic,” he said. “Right now, as we get into bills that might come out, spending bills or health-related bills coming up to 2020, it would be wonderful to get a lot of support behind this so that it might be added into some kind of package.”

A similar prewritten letter regarding an active bill that addresses paying off student loans for pediatricians going into subspecialties like pediatric rheumatology also is on the table and could help address workforce shortages, he noted.

“The First Amendment protects your right to petition the government for redress of grievances. I don’t have to tell you this is an era of huge tumult ... protecting [democracy and institutions], protecting your organizations, raising your voice is really important right now,” he said, referencing his new Twitter hashtag that encourages doing one #ThingADay. “You could think of advocacy as an extension of the Hippocratic oath to do no harm on a government and social level.”

Quoting Margaret Mead, Dr. Worthing reminded rheumatologists that their voices matter despite (and in fact, because of) their small numbers: “Never doubt that a small group of thoughtful, committed citizens can change the world; indeed, it’s the only thing that ever has.”

Dr. Worthing reported having no disclosures.

[email protected]

LAKE BUENA VISTA, FLA. – Rheumatologists comprise a “tiny sliver” of the U.S. physician pie chart, but their voices are nevertheless being heard and making a difference regarding policies that affect the specialty, according to Angus B. Worthing, MD.

However, given the myriad policy issues on the table, more and louder voices are needed, he said at the annual meeting of the Florida Society of Rheumatology, where, as chair of the American College of Rheumatology’s Government Affairs Committee, he provided an “advocacy update” on the committee’s activities.

Recent ACR “wins” as outlined by Dr. Worthing include:

• The postponement and modification of proposed cuts to Evaluation & Management (E/M) current procedural terminology (CPT) codes.

“Last summer, Medicare proposed that instead of having low-complexity to high-complexity E/M codes, they would condense all of the doctor visits into one code, which would obviously enhance the reimbursement for low complexity, but ding and penalize the reimbursement for high-complexity visits like ours,” said Dr. Worthing, who also is a partner in a private rheumatology practice in the Washington area.

An ACR press release on the proposal led to pivotal coverage of the issue in the New York Times. “It looks like not only did they postpone those cuts, they modified [the proposal], and we’ll find out any day now in the proposal for the next year’s physician fee schedule whether they’ll scrap it entirely and instead try to plus-up E/M code reimbursement for complex patients.”

• The elimination of proposed Merit-based Incentive Payment System (MIPS) adjustments on Medicare drug reimbursement.

A cut to fee-for-service reimbursement for drug costs as a MIPS penalty could have quickly bankrupted rheumatology practices, Dr. Worthing said.

“[The success] was largely out of rheumatologists and others saying that this could quickly stop access to these treatments, because we wouldn’t be able to provide them,” he noted.

• The dampening of proposed musculoskeletal ultrasound reimbursement cuts in Medicare.

Ultrasound is a safe, effective, dynamic, and relatively low-cost diagnostic tool, but Medicare has been considering “absurd” cuts to reimbursement, Dr. Worthing said.

“We’ve been able to have good conversations with Medicare ... to bring that argument to Medicare, and we’ll find out – again, when the physician fee schedule comes out – whether they’ll continue the plan to cut diagnostic ultrasound reimbursement or whether they’ll stop cutting it.”

• The inclusion of more favorable Medicare Advantage regulations for step therapy “grandfathering.”

Medicare Advantage plans were given the chance last summer to use step therapy in Part B medicines for the first time.

“The ACR quickly told the executive branch and officials at [the Department of Health & Human Services (HHS)], that this would not be good for our patients getting medications,” Dr. Worthing said.

Going forward with that plan, and looking back just 108 days to allow people to stay on their medications – as was proposed – wouldn’t work, as some drugs are dosed every 4-6 months, or every year or every 2 years, he said.

“The look of astonishment on the [HHS] deputy secretary’s face when I told him that there was a drug in the U.S. that you give every 2 years was helpful for me to know that these people really need to hear from us before they issue these kinds of regulations,” he said.

The administration listened to the rheumatologists and is going to look back 365 days to keep people on their drugs, he said.

The ACR took the lead on these recent successes, but was also involved in a number of other wins achieved through multisociety efforts, he said.

Examples include securing a $2 billion increase in National Institutes of Health funding, eliminating “gag clauses” that prevent pharmacists from informing patients when it’s cheaper to just buy a drug rather than using their insurance; getting rid of annual caps on physical and other rehabilitation therapy for patients meeting their targets; repealing (before it could take effect) of the Independent Payment Advisory Board established by the Affordable Care Act; and – at least for now – continuing Deferred Action for Childhood Arrivals (DACA) protections that could allow recipients to stay in the country, study, and become doctors, and potentially provide care for up to 100,000 Americans, according to an estimate by the American Medical Association.

Dr. Worthing also noted that the ACR has an Insurance Subcommittee that has been instrumental in many of these and other policy wins, and he encouraged rheumatologists to contact the committee at [email protected] to report any sort of “canary-in-the-coal-mine” issues, such as refusal of coverage for a new step therapy, service, or item in your clinic that seems “absurd; doesn’t have merit.”

Send a copy of the policy behind the denial (with private health information redacted), or complete a Health Plan Complaint Form, which can be accessed at the website, he advised.

Rheumatologists can make their voices heard in other ways, he said. The ACR has a number of ongoing advocacy efforts addressing things like drug-pricing models, biosimilar agent interchangeability pathways, step therapy reform, workforce issues, and the need for higher dual X-ray absorptiometry (DXA) reimbursement.

The ACR’s Legislative Action Center offers prewritten letters on a number of timely topics, as well as information about legislators and legislation. An app is available that provides alerts about important legislation.

A timely example is DXA-related, bipartisan, bicameral legislation currently on the table that would more than double reimbursement and “improve access to this critical screening tool,” he said.

“Right now is an excellent time to tell your legislators – and there’s a prewritten letter at the [site] – that this is an important topic,” he said. “Right now, as we get into bills that might come out, spending bills or health-related bills coming up to 2020, it would be wonderful to get a lot of support behind this so that it might be added into some kind of package.”

A similar prewritten letter regarding an active bill that addresses paying off student loans for pediatricians going into subspecialties like pediatric rheumatology also is on the table and could help address workforce shortages, he noted.

“The First Amendment protects your right to petition the government for redress of grievances. I don’t have to tell you this is an era of huge tumult ... protecting [democracy and institutions], protecting your organizations, raising your voice is really important right now,” he said, referencing his new Twitter hashtag that encourages doing one #ThingADay. “You could think of advocacy as an extension of the Hippocratic oath to do no harm on a government and social level.”

Quoting Margaret Mead, Dr. Worthing reminded rheumatologists that their voices matter despite (and in fact, because of) their small numbers: “Never doubt that a small group of thoughtful, committed citizens can change the world; indeed, it’s the only thing that ever has.”

Dr. Worthing reported having no disclosures.

[email protected]

LAKE BUENA VISTA, FLA. – Rheumatologists comprise a “tiny sliver” of the U.S. physician pie chart, but their voices are nevertheless being heard and making a difference regarding policies that affect the specialty, according to Angus B. Worthing, MD.

However, given the myriad policy issues on the table, more and louder voices are needed, he said at the annual meeting of the Florida Society of Rheumatology, where, as chair of the American College of Rheumatology’s Government Affairs Committee, he provided an “advocacy update” on the committee’s activities.

Recent ACR “wins” as outlined by Dr. Worthing include:

• The postponement and modification of proposed cuts to Evaluation & Management (E/M) current procedural terminology (CPT) codes.

“Last summer, Medicare proposed that instead of having low-complexity to high-complexity E/M codes, they would condense all of the doctor visits into one code, which would obviously enhance the reimbursement for low complexity, but ding and penalize the reimbursement for high-complexity visits like ours,” said Dr. Worthing, who also is a partner in a private rheumatology practice in the Washington area.

An ACR press release on the proposal led to pivotal coverage of the issue in the New York Times. “It looks like not only did they postpone those cuts, they modified [the proposal], and we’ll find out any day now in the proposal for the next year’s physician fee schedule whether they’ll scrap it entirely and instead try to plus-up E/M code reimbursement for complex patients.”

• The elimination of proposed Merit-based Incentive Payment System (MIPS) adjustments on Medicare drug reimbursement.

A cut to fee-for-service reimbursement for drug costs as a MIPS penalty could have quickly bankrupted rheumatology practices, Dr. Worthing said.

“[The success] was largely out of rheumatologists and others saying that this could quickly stop access to these treatments, because we wouldn’t be able to provide them,” he noted.

• The dampening of proposed musculoskeletal ultrasound reimbursement cuts in Medicare.

Ultrasound is a safe, effective, dynamic, and relatively low-cost diagnostic tool, but Medicare has been considering “absurd” cuts to reimbursement, Dr. Worthing said.

“We’ve been able to have good conversations with Medicare ... to bring that argument to Medicare, and we’ll find out – again, when the physician fee schedule comes out – whether they’ll continue the plan to cut diagnostic ultrasound reimbursement or whether they’ll stop cutting it.”

• The inclusion of more favorable Medicare Advantage regulations for step therapy “grandfathering.”

Medicare Advantage plans were given the chance last summer to use step therapy in Part B medicines for the first time.

“The ACR quickly told the executive branch and officials at [the Department of Health & Human Services (HHS)], that this would not be good for our patients getting medications,” Dr. Worthing said.

Going forward with that plan, and looking back just 108 days to allow people to stay on their medications – as was proposed – wouldn’t work, as some drugs are dosed every 4-6 months, or every year or every 2 years, he said.

“The look of astonishment on the [HHS] deputy secretary’s face when I told him that there was a drug in the U.S. that you give every 2 years was helpful for me to know that these people really need to hear from us before they issue these kinds of regulations,” he said.

The administration listened to the rheumatologists and is going to look back 365 days to keep people on their drugs, he said.

The ACR took the lead on these recent successes, but was also involved in a number of other wins achieved through multisociety efforts, he said.

Examples include securing a $2 billion increase in National Institutes of Health funding, eliminating “gag clauses” that prevent pharmacists from informing patients when it’s cheaper to just buy a drug rather than using their insurance; getting rid of annual caps on physical and other rehabilitation therapy for patients meeting their targets; repealing (before it could take effect) of the Independent Payment Advisory Board established by the Affordable Care Act; and – at least for now – continuing Deferred Action for Childhood Arrivals (DACA) protections that could allow recipients to stay in the country, study, and become doctors, and potentially provide care for up to 100,000 Americans, according to an estimate by the American Medical Association.

Dr. Worthing also noted that the ACR has an Insurance Subcommittee that has been instrumental in many of these and other policy wins, and he encouraged rheumatologists to contact the committee at [email protected] to report any sort of “canary-in-the-coal-mine” issues, such as refusal of coverage for a new step therapy, service, or item in your clinic that seems “absurd; doesn’t have merit.”

Send a copy of the policy behind the denial (with private health information redacted), or complete a Health Plan Complaint Form, which can be accessed at the website, he advised.

Rheumatologists can make their voices heard in other ways, he said. The ACR has a number of ongoing advocacy efforts addressing things like drug-pricing models, biosimilar agent interchangeability pathways, step therapy reform, workforce issues, and the need for higher dual X-ray absorptiometry (DXA) reimbursement.

The ACR’s Legislative Action Center offers prewritten letters on a number of timely topics, as well as information about legislators and legislation. An app is available that provides alerts about important legislation.

A timely example is DXA-related, bipartisan, bicameral legislation currently on the table that would more than double reimbursement and “improve access to this critical screening tool,” he said.

“Right now is an excellent time to tell your legislators – and there’s a prewritten letter at the [site] – that this is an important topic,” he said. “Right now, as we get into bills that might come out, spending bills or health-related bills coming up to 2020, it would be wonderful to get a lot of support behind this so that it might be added into some kind of package.”

A similar prewritten letter regarding an active bill that addresses paying off student loans for pediatricians going into subspecialties like pediatric rheumatology also is on the table and could help address workforce shortages, he noted.

“The First Amendment protects your right to petition the government for redress of grievances. I don’t have to tell you this is an era of huge tumult ... protecting [democracy and institutions], protecting your organizations, raising your voice is really important right now,” he said, referencing his new Twitter hashtag that encourages doing one #ThingADay. “You could think of advocacy as an extension of the Hippocratic oath to do no harm on a government and social level.”

Quoting Margaret Mead, Dr. Worthing reminded rheumatologists that their voices matter despite (and in fact, because of) their small numbers: “Never doubt that a small group of thoughtful, committed citizens can change the world; indeed, it’s the only thing that ever has.”

Dr. Worthing reported having no disclosures.

[email protected]

LAKE BUENA VISTA, FLA. – When it comes to lupus nephritis, the guidelines – and prevailing wisdom – don’t always get it quite right, according to Michelle A. Petri, MD.

Mitchel L. Zoler/MDedge News

During an update at the annual meeting of the Florida Society of Rheumatology, she outlined five key components of lupus nephritis treatment, and the status of the evidence for each.

Antihypertensive therapy

Antihypertensive therapy isn’t just for hypertension in patients with lupus nephritis – it’s for reducing proteinuria and preventing renal fibrosis, said Dr. Petri, professor of medicine and director of the Hopkins Lupus Center at Johns Hopkins University, Baltimore.

“I get a lot of push-back on this,” she added, explaining that other physicians often will stop the treatment as she prescribed it, because they believe it’s unnecessary.

She described a case involving a 33-year-old African American man with blood pressure of 132/86 mm Hg and grade 3+ ankle edema. Laboratory tests were remarkable for hematocrit (33.4%), white blood cell count (3.1), erythrocyte sedimentation rate (67 mm/hr) and urinalysis (2+ protein by dipstick, 3 red cells/high-power field, no casts). Additionally, 24-hour urine protein showed 400 mg of microalbumin, and he had a positive antinuclear antibody test, positive anti–double stranded DNA, and low complement.

“I’m going to argue really strenuously that he has to be on an ACE inhibitor or an ARB [angiotensin receptor blocker],” she said, explaining that even before an immunosuppressant therapy is started, optimizing ACE inhibitor or ARB therapy can reduce proteinuria by 50%.

The “sweet spot” for blood pressure in these patients is between 110 and 129, she said.

“You don’t want it too low, because you might hurt renal perfusion, but you sure don’t want it above 130,” she said.

The problem is that many physicians think 110 or 112 is too low.

“Not for a lupus nephritis patient,” she said. “It’s really where we want to be.”

ACE inhibitors and ARBs are preferable for reaching this goal, she said, noting that calcium channel blockers have been linked with shorter time to renal failure.

Hydroxychloroquine

Everyone with lupus nephritis should be on hydroxychloroquine, Dr. Petri argued.

“It improves renal outcomes,” she said. “It more than triples the chance that a patient will have a complete renal response.”

Guidelines from the American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) are in agreement on this, she said.

Even the renal guidelines for lupus nephritis now include hydroxychloroquine as mandatory, she added, noting that it is not necessary to check glucose-6-phosphate dehydrogenase (G6PD) before starting treatment.

In fact, a recent study showed that only 2 of 11 patients with G6PD deficiency had episodes of hemolysis, and those episodes did not occur during hydroxychloroquine therapy. The authors concluded that the routine measurement of G6PD levels and withholding therapy among African American patients with G6PD deficiency is not supported, she said (Arthritis Care Res. 2018;70[3]:481-5).

“Of course, if your patient has renal insufficiency you’re going to have to reduce the dose in half,” she noted.
 

Vitamin D

Modestly increasing 25-hydroxyvitamin D can “greatly, significantly reduce the urine protein – with no cost, with no toxicity,” Dr. Petri said.

In a 2013 study, she and her colleagues showed that a 20‐ng/mL increase in the 25(OH)vitamin D level was associated with a 21% decrease in the odds of having a high disease-activity score, and with a 15% decrease in the odds of having clinically important proteinuria (Arthritis Rheumatol. 2013;65[7]:1865-71).

“But you’ll be fascinated to hear that vitamin D may be an antifibrotic drug, as well,” she noted. “This has been proven in animal models of pulmonary fibrosis ... and although we don’t have proof in lupus nephritis, the animal models are so strong that I think absolutely everybody with lupus nephritis needs to be on vitamin D, both to reduce proteinuria and then, hopefully, as a very cheap antifibrotic drug.”
 

Mycophenolate mofetil

The case Dr. Petri presented involved a patient with International Society of Nephrology class IV disease.

Left untreated, he would be in end-stage renal disease within a year, she said.

“But even with my maximal treatment he has a 23% chance of being in end-stage renal disease in 20 years,” she noted.

This patient had a high National Institutes of Health activity index, but low chronicity, and there were no crescents.

“The reason I mention this is because crescents mean rapidly progressive [glomerular nephritis],” she said. “That’s very urgent; it’s one of the situations where even I will dump on the steroids, because you’ve got to do something fast.”

In this case, however, the best induction therapy is mycophenolate mofetil, she said.

“Boy, our guidelines are wishy-washy on this, and they shouldn’t be,” she said, explaining that “because he’s African American, there are very clear data that mycophenolate is better than cyclophosphamide – our guidelines need to make that very clear.”

In fact, mycophenolate should be the first choice of induction therapy in all cases, except those involving rapidly progressive glomerulonephritis (RPGN), for which cyclophosphamide should be given for at least 3 months before trying to transition to mycophenolate, she stressed.

After about 1 year of treatment, 50% of patients will be complete renal responders, she noted, adding that “in Caucasians, mycophenolate is as good as cyclophosphamide, and in African Americans, mycophenolate is much better.”

“So mycophenolate has won, and for good reason. But is it sufficient to have 50% of patients be complete renal responders at 1 year?” she asked, noting the risk for renal fibrosis in those who respond late in that year or not at all.

“So we really need something that’s much more successful.”
 

Steroids

How much prednisone should lupus nephritis patients get?

As little as possible, according to Dr. Petri.

“I want you to think back to all those times you were taught during you fellowship about dumping on as much prednisone as possible,” she said. “[They] probably aren’t correct.”

She also pulled no punches when it comes to the ACR and EULAR guidelines on prednisone use.

“Both ... are wrong,” she said, explaining that the ACR guidelines are “top-heavy” on prednisone in calling for 0.5-1 mg/kg/day.

“One mg/kg? Like everybody’s the same? I do not object to 1 mg/kg if it’s RPGN, but not for everybody else,” she said.

EULAR guidelines are “less generous,” calling for 0.5 mg/kg/day for 4 weeks, and they make it clear that “you better taper that stuff off.”

“I like that part,” she said. “But still, you’re starting out with a lot of steroid.”

Why the objection? Data show that prednisone is directly or indirectly responsible for 80% of organ damage over 15 years, she said (J Rheumatol. 2003;30[9]:1955-9).

“It’s bad enough to have lupus nephritis; why should you have to be poisoned with prednisone, as well?” she asked. “Now, if the people on prednisone did better, of course I’d have to back off, wouldn’t I?”

Recent data, however, suggest that lupus nephritis patients who are treated with prednisone end up doing worse, and studies being performed outside the United States are beginning to use lower doses of prednisone, she said.

“The rest of the world is lowering the prednisone; our guidelines need to catch up,” she said, adding that she sees no reason why this shouldn’t apply in lupus nephritis.

“Their prednisone should be less than 6 mg, and doses above that level increase organ damage by 50%,” she said, citing a 2009 study in which she and her colleagues found that the hazard ratio for organ damage with prednisone vs. no prednisone was 1.50 for cumulative average doses of 180-360 mg/month, compared with 1.16 for doses up to 180 mg/month (J Rheumatol. 2009;36[3]:560-4).

Even a 20-mg dose has been linked with a fivefold increase the risk of a vascular incident, she added, citing another such study (Am J Epidemiol. 2012;176:708-19).

Dr. Petri is a consultant for GlaxoSmithKline, Merck EMD Serono, Lilly, Janssen, Amgen, Novartis, Exagen, Inova Diagnostics, AstraZeneca, Blackrock Pharma, Glenmark, and UCB.

[email protected]

LAKE BUENA VISTA, FLA. – When it comes to lupus nephritis, the guidelines – and prevailing wisdom – don’t always get it quite right, according to Michelle A. Petri, MD.

Mitchel L. Zoler/MDedge News

During an update at the annual meeting of the Florida Society of Rheumatology, she outlined five key components of lupus nephritis treatment, and the status of the evidence for each.

Antihypertensive therapy

Antihypertensive therapy isn’t just for hypertension in patients with lupus nephritis – it’s for reducing proteinuria and preventing renal fibrosis, said Dr. Petri, professor of medicine and director of the Hopkins Lupus Center at Johns Hopkins University, Baltimore.

“I get a lot of push-back on this,” she added, explaining that other physicians often will stop the treatment as she prescribed it, because they believe it’s unnecessary.

She described a case involving a 33-year-old African American man with blood pressure of 132/86 mm Hg and grade 3+ ankle edema. Laboratory tests were remarkable for hematocrit (33.4%), white blood cell count (3.1), erythrocyte sedimentation rate (67 mm/hr) and urinalysis (2+ protein by dipstick, 3 red cells/high-power field, no casts). Additionally, 24-hour urine protein showed 400 mg of microalbumin, and he had a positive antinuclear antibody test, positive anti–double stranded DNA, and low complement.

“I’m going to argue really strenuously that he has to be on an ACE inhibitor or an ARB [angiotensin receptor blocker],” she said, explaining that even before an immunosuppressant therapy is started, optimizing ACE inhibitor or ARB therapy can reduce proteinuria by 50%.

The “sweet spot” for blood pressure in these patients is between 110 and 129, she said.

“You don’t want it too low, because you might hurt renal perfusion, but you sure don’t want it above 130,” she said.

The problem is that many physicians think 110 or 112 is too low.

“Not for a lupus nephritis patient,” she said. “It’s really where we want to be.”

ACE inhibitors and ARBs are preferable for reaching this goal, she said, noting that calcium channel blockers have been linked with shorter time to renal failure.

Hydroxychloroquine

Everyone with lupus nephritis should be on hydroxychloroquine, Dr. Petri argued.

“It improves renal outcomes,” she said. “It more than triples the chance that a patient will have a complete renal response.”

Guidelines from the American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) are in agreement on this, she said.

Even the renal guidelines for lupus nephritis now include hydroxychloroquine as mandatory, she added, noting that it is not necessary to check glucose-6-phosphate dehydrogenase (G6PD) before starting treatment.

In fact, a recent study showed that only 2 of 11 patients with G6PD deficiency had episodes of hemolysis, and those episodes did not occur during hydroxychloroquine therapy. The authors concluded that the routine measurement of G6PD levels and withholding therapy among African American patients with G6PD deficiency is not supported, she said (Arthritis Care Res. 2018;70[3]:481-5).

“Of course, if your patient has renal insufficiency you’re going to have to reduce the dose in half,” she noted.
 

Vitamin D

Modestly increasing 25-hydroxyvitamin D can “greatly, significantly reduce the urine protein – with no cost, with no toxicity,” Dr. Petri said.

In a 2013 study, she and her colleagues showed that a 20‐ng/mL increase in the 25(OH)vitamin D level was associated with a 21% decrease in the odds of having a high disease-activity score, and with a 15% decrease in the odds of having clinically important proteinuria (Arthritis Rheumatol. 2013;65[7]:1865-71).

“But you’ll be fascinated to hear that vitamin D may be an antifibrotic drug, as well,” she noted. “This has been proven in animal models of pulmonary fibrosis ... and although we don’t have proof in lupus nephritis, the animal models are so strong that I think absolutely everybody with lupus nephritis needs to be on vitamin D, both to reduce proteinuria and then, hopefully, as a very cheap antifibrotic drug.”
 

Mycophenolate mofetil

The case Dr. Petri presented involved a patient with International Society of Nephrology class IV disease.

Left untreated, he would be in end-stage renal disease within a year, she said.

“But even with my maximal treatment he has a 23% chance of being in end-stage renal disease in 20 years,” she noted.

This patient had a high National Institutes of Health activity index, but low chronicity, and there were no crescents.

“The reason I mention this is because crescents mean rapidly progressive [glomerular nephritis],” she said. “That’s very urgent; it’s one of the situations where even I will dump on the steroids, because you’ve got to do something fast.”

In this case, however, the best induction therapy is mycophenolate mofetil, she said.

“Boy, our guidelines are wishy-washy on this, and they shouldn’t be,” she said, explaining that “because he’s African American, there are very clear data that mycophenolate is better than cyclophosphamide – our guidelines need to make that very clear.”

In fact, mycophenolate should be the first choice of induction therapy in all cases, except those involving rapidly progressive glomerulonephritis (RPGN), for which cyclophosphamide should be given for at least 3 months before trying to transition to mycophenolate, she stressed.

After about 1 year of treatment, 50% of patients will be complete renal responders, she noted, adding that “in Caucasians, mycophenolate is as good as cyclophosphamide, and in African Americans, mycophenolate is much better.”

“So mycophenolate has won, and for good reason. But is it sufficient to have 50% of patients be complete renal responders at 1 year?” she asked, noting the risk for renal fibrosis in those who respond late in that year or not at all.

“So we really need something that’s much more successful.”
 

Steroids

How much prednisone should lupus nephritis patients get?

As little as possible, according to Dr. Petri.

“I want you to think back to all those times you were taught during you fellowship about dumping on as much prednisone as possible,” she said. “[They] probably aren’t correct.”

She also pulled no punches when it comes to the ACR and EULAR guidelines on prednisone use.

“Both ... are wrong,” she said, explaining that the ACR guidelines are “top-heavy” on prednisone in calling for 0.5-1 mg/kg/day.

“One mg/kg? Like everybody’s the same? I do not object to 1 mg/kg if it’s RPGN, but not for everybody else,” she said.

EULAR guidelines are “less generous,” calling for 0.5 mg/kg/day for 4 weeks, and they make it clear that “you better taper that stuff off.”

“I like that part,” she said. “But still, you’re starting out with a lot of steroid.”

Why the objection? Data show that prednisone is directly or indirectly responsible for 80% of organ damage over 15 years, she said (J Rheumatol. 2003;30[9]:1955-9).

“It’s bad enough to have lupus nephritis; why should you have to be poisoned with prednisone, as well?” she asked. “Now, if the people on prednisone did better, of course I’d have to back off, wouldn’t I?”

Recent data, however, suggest that lupus nephritis patients who are treated with prednisone end up doing worse, and studies being performed outside the United States are beginning to use lower doses of prednisone, she said.

“The rest of the world is lowering the prednisone; our guidelines need to catch up,” she said, adding that she sees no reason why this shouldn’t apply in lupus nephritis.

“Their prednisone should be less than 6 mg, and doses above that level increase organ damage by 50%,” she said, citing a 2009 study in which she and her colleagues found that the hazard ratio for organ damage with prednisone vs. no prednisone was 1.50 for cumulative average doses of 180-360 mg/month, compared with 1.16 for doses up to 180 mg/month (J Rheumatol. 2009;36[3]:560-4).

Even a 20-mg dose has been linked with a fivefold increase the risk of a vascular incident, she added, citing another such study (Am J Epidemiol. 2012;176:708-19).

Dr. Petri is a consultant for GlaxoSmithKline, Merck EMD Serono, Lilly, Janssen, Amgen, Novartis, Exagen, Inova Diagnostics, AstraZeneca, Blackrock Pharma, Glenmark, and UCB.

[email protected]

LAKE BUENA VISTA, FLA. – When it comes to lupus nephritis, the guidelines – and prevailing wisdom – don’t always get it quite right, according to Michelle A. Petri, MD.

Mitchel L. Zoler/MDedge News

During an update at the annual meeting of the Florida Society of Rheumatology, she outlined five key components of lupus nephritis treatment, and the status of the evidence for each.

Antihypertensive therapy

Antihypertensive therapy isn’t just for hypertension in patients with lupus nephritis – it’s for reducing proteinuria and preventing renal fibrosis, said Dr. Petri, professor of medicine and director of the Hopkins Lupus Center at Johns Hopkins University, Baltimore.

“I get a lot of push-back on this,” she added, explaining that other physicians often will stop the treatment as she prescribed it, because they believe it’s unnecessary.

She described a case involving a 33-year-old African American man with blood pressure of 132/86 mm Hg and grade 3+ ankle edema. Laboratory tests were remarkable for hematocrit (33.4%), white blood cell count (3.1), erythrocyte sedimentation rate (67 mm/hr) and urinalysis (2+ protein by dipstick, 3 red cells/high-power field, no casts). Additionally, 24-hour urine protein showed 400 mg of microalbumin, and he had a positive antinuclear antibody test, positive anti–double stranded DNA, and low complement.

“I’m going to argue really strenuously that he has to be on an ACE inhibitor or an ARB [angiotensin receptor blocker],” she said, explaining that even before an immunosuppressant therapy is started, optimizing ACE inhibitor or ARB therapy can reduce proteinuria by 50%.

The “sweet spot” for blood pressure in these patients is between 110 and 129, she said.

“You don’t want it too low, because you might hurt renal perfusion, but you sure don’t want it above 130,” she said.

The problem is that many physicians think 110 or 112 is too low.

“Not for a lupus nephritis patient,” she said. “It’s really where we want to be.”

ACE inhibitors and ARBs are preferable for reaching this goal, she said, noting that calcium channel blockers have been linked with shorter time to renal failure.

Hydroxychloroquine

Everyone with lupus nephritis should be on hydroxychloroquine, Dr. Petri argued.

“It improves renal outcomes,” she said. “It more than triples the chance that a patient will have a complete renal response.”

Guidelines from the American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) are in agreement on this, she said.

Even the renal guidelines for lupus nephritis now include hydroxychloroquine as mandatory, she added, noting that it is not necessary to check glucose-6-phosphate dehydrogenase (G6PD) before starting treatment.

In fact, a recent study showed that only 2 of 11 patients with G6PD deficiency had episodes of hemolysis, and those episodes did not occur during hydroxychloroquine therapy. The authors concluded that the routine measurement of G6PD levels and withholding therapy among African American patients with G6PD deficiency is not supported, she said (Arthritis Care Res. 2018;70[3]:481-5).

“Of course, if your patient has renal insufficiency you’re going to have to reduce the dose in half,” she noted.
 

Vitamin D

Modestly increasing 25-hydroxyvitamin D can “greatly, significantly reduce the urine protein – with no cost, with no toxicity,” Dr. Petri said.

In a 2013 study, she and her colleagues showed that a 20‐ng/mL increase in the 25(OH)vitamin D level was associated with a 21% decrease in the odds of having a high disease-activity score, and with a 15% decrease in the odds of having clinically important proteinuria (Arthritis Rheumatol. 2013;65[7]:1865-71).

“But you’ll be fascinated to hear that vitamin D may be an antifibrotic drug, as well,” she noted. “This has been proven in animal models of pulmonary fibrosis ... and although we don’t have proof in lupus nephritis, the animal models are so strong that I think absolutely everybody with lupus nephritis needs to be on vitamin D, both to reduce proteinuria and then, hopefully, as a very cheap antifibrotic drug.”
 

Mycophenolate mofetil

The case Dr. Petri presented involved a patient with International Society of Nephrology class IV disease.

Left untreated, he would be in end-stage renal disease within a year, she said.

“But even with my maximal treatment he has a 23% chance of being in end-stage renal disease in 20 years,” she noted.

This patient had a high National Institutes of Health activity index, but low chronicity, and there were no crescents.

“The reason I mention this is because crescents mean rapidly progressive [glomerular nephritis],” she said. “That’s very urgent; it’s one of the situations where even I will dump on the steroids, because you’ve got to do something fast.”

In this case, however, the best induction therapy is mycophenolate mofetil, she said.

“Boy, our guidelines are wishy-washy on this, and they shouldn’t be,” she said, explaining that “because he’s African American, there are very clear data that mycophenolate is better than cyclophosphamide – our guidelines need to make that very clear.”

In fact, mycophenolate should be the first choice of induction therapy in all cases, except those involving rapidly progressive glomerulonephritis (RPGN), for which cyclophosphamide should be given for at least 3 months before trying to transition to mycophenolate, she stressed.

After about 1 year of treatment, 50% of patients will be complete renal responders, she noted, adding that “in Caucasians, mycophenolate is as good as cyclophosphamide, and in African Americans, mycophenolate is much better.”

“So mycophenolate has won, and for good reason. But is it sufficient to have 50% of patients be complete renal responders at 1 year?” she asked, noting the risk for renal fibrosis in those who respond late in that year or not at all.

“So we really need something that’s much more successful.”
 

Steroids

How much prednisone should lupus nephritis patients get?

As little as possible, according to Dr. Petri.

“I want you to think back to all those times you were taught during you fellowship about dumping on as much prednisone as possible,” she said. “[They] probably aren’t correct.”

She also pulled no punches when it comes to the ACR and EULAR guidelines on prednisone use.

“Both ... are wrong,” she said, explaining that the ACR guidelines are “top-heavy” on prednisone in calling for 0.5-1 mg/kg/day.

“One mg/kg? Like everybody’s the same? I do not object to 1 mg/kg if it’s RPGN, but not for everybody else,” she said.

EULAR guidelines are “less generous,” calling for 0.5 mg/kg/day for 4 weeks, and they make it clear that “you better taper that stuff off.”

“I like that part,” she said. “But still, you’re starting out with a lot of steroid.”

Why the objection? Data show that prednisone is directly or indirectly responsible for 80% of organ damage over 15 years, she said (J Rheumatol. 2003;30[9]:1955-9).

“It’s bad enough to have lupus nephritis; why should you have to be poisoned with prednisone, as well?” she asked. “Now, if the people on prednisone did better, of course I’d have to back off, wouldn’t I?”

Recent data, however, suggest that lupus nephritis patients who are treated with prednisone end up doing worse, and studies being performed outside the United States are beginning to use lower doses of prednisone, she said.

“The rest of the world is lowering the prednisone; our guidelines need to catch up,” she said, adding that she sees no reason why this shouldn’t apply in lupus nephritis.

“Their prednisone should be less than 6 mg, and doses above that level increase organ damage by 50%,” she said, citing a 2009 study in which she and her colleagues found that the hazard ratio for organ damage with prednisone vs. no prednisone was 1.50 for cumulative average doses of 180-360 mg/month, compared with 1.16 for doses up to 180 mg/month (J Rheumatol. 2009;36[3]:560-4).

Even a 20-mg dose has been linked with a fivefold increase the risk of a vascular incident, she added, citing another such study (Am J Epidemiol. 2012;176:708-19).

Dr. Petri is a consultant for GlaxoSmithKline, Merck EMD Serono, Lilly, Janssen, Amgen, Novartis, Exagen, Inova Diagnostics, AstraZeneca, Blackrock Pharma, Glenmark, and UCB.

[email protected]

LAKE BUENA VISTA, FLA. – “Crude and uninformed.”

That’s how Leonard H. Calabrese, DO, described the general approach to managing immune-related adverse events (irAEs) in cancer patients treated with checkpoint inhibitor therapy.

Rheumatologists have the expertise to change that, he said during a presentation at the annual meeting of the Florida Society of Rheumatology.

“The therapy is where it’s at – this is where rheumatologists come into play,” said Dr. Calabrese, professor of medicine and chair of clinical immunology at the Cleveland Clinic.

According to relevant guidelines, such as those recently developed by the American Society of Clinical Oncology/National Comprehensive Cancer Network and the Society for the Immunotherapy of Cancer, irAEs are graded on a severity-based scale. Grade 1 events are mild and generally require observation; grade 2 events may include arthralgias and myalgias that are typically treated with symptomatic therapy; grade 3 events involve more serious conditions and may require hospitalization; and grade 4 events are life-threatening and may require targeted therapies.

“Grade 3 – these would be people with profound polyarthritis, vasculitis, myositis – rely heavily on glucocorticoids, and if patients don’t tolerate glucocorticoids or don’t respond to tapering doses, consider the use of [disease-modifying antirheumatic drugs],” he said, noting that the guidelines are vaguely written and refer to both conventional and biologic DMARDs.

“This is all anecdotal at the present time; this is a story to be discovered as we move along,” he explained.

A recommendation for the use of targeted therapies, such as tumor necrosis factor inhibitors, anti-interleukin (IL)-6, and antimetabolites, in patients with the most advanced disease is similarly vague and just represents “the beginning of the beginning,” he said.

The “crude and uninformed” nature of the current approach to irAEs, as he described it, is related to a failure to consider the immunopathogenesis of specific conditions.

“The oncologists, who have done such an incredible job with this – learning about derm[atitis] and colitis that respond to steroids and infliximab, immediately extrapolated that steroids and infliximab are for everything,” he said. “They give it for pneumonitis, they give it for [central nervous system] disease, they give it for everything.”

However, there’s no pathophysiologic basis for doing so, and not surprisingly, some patients don’t respond.

“Here we are sitting on this amazing armamentarium of targeted therapies and only now just starting to ask the questions: ‘Do they offer benefit for these irAEs? Do they offer risk? Will they blunt the antitumoral response of this?’ ” he said.

A “Personal View” published in Lancet Oncology in January 2019 was among the first from the oncology arena to pose these questions (20[1]:PE54-64. doi: 10.1016/S1470-2045[18]30828-3).

“It said, ‘well maybe we should look at the immunopathogenesis of each of these diseases and then pick the therapy – if it’s IL-17 mediated, we’ve got drugs for that; if it’s IL-1 mediated, we’ve got drugs for that; if it’s interferon-mediated, we can deal with that,’ ” he said. “The problem is we don’t yet have detailed immunopathogenic knowledge of these diseases, but it’s coming.”

Data needed to define best treatments

Data also are emerging to define the roles of various targeted therapies for treating irAEs, but most of the evidence remains anecdotal, he said.

For example, anecdotal reports suggest that rituximab has some efficacy in cytopenias, arthritis, and myositis, and a case report suggests that secukinumab and other IL-17 inhibitors may have benefit in psoriasis and inflammatory bowel disease with tumoral progression, he said.

A reasonable question has been whether attacking T cells might be worthwhile given that “these things are all T-cell mediated,” but until very recently, “no one has had the temerity to actually do this,” he said.

However, two cases reported in the June 13 issue of the New England Journal of Medicine described “very successful” treatment of checkpoint inhibitor-associated myocarditis. One case described the use of alemtuzumab in a 71-year-old woman being treated with first-line pembrolizumab for stage IV melanoma, and another case involved the use of abatacept for severe, glucocorticoid-refractory myocarditis in a 66-year-old woman who had been treated with nivolumab for metastatic lung cancer (2019;380:2375-6 and 2377-79).Dr. Calabrese urged rheumatologists who are interested in addressing the treatment of irAEs to “get involved.”

“People need good rheumatologists, and I will tell you that whoever your oncologists are who you refer patients to for cancer – they’re seeing this and they need help,” he said. “Particularly outside of these big major centers, just having someone to lean on is very important.”

Keep in mind, however, that triage is very important, he said, stressing that patients with irAEs “actually need to be seen.”

Between three and five new irAE patients are being seen each week at the Cleveland Clinic, he noted.
 

Need for multidisciplinary collaboration

Collaboration was the focus of an article in the June 2019 issue of the Journal of the National Comprehensive Cancer Network, which looked at the value of a virtual “multidisciplinary toxicity team” for managing cancer irAEs. The investigators found that such an approach was feasible, used by oncology providers, and effective for facilitating toxicity identification and management.

A number of other recent studies have attempted to assess confidence and knowledge of rheumatologists and others with respect to the treatment of irAEs in cancer patients, and the findings highlight the need for education at the oncologist, specialist, generalist, and advanced practitioner level, Dr. Calabrese said, adding that the findings also highlight a need for assistance from “big pharma, which makes these drugs,” in supporting this type of education.

The need for “novel venues for such educational interchange” also was the topic of a study on a new Cleveland Clinic irAE tumor board that he and his colleagues presented at the 2018 annual meeting of the American College of Rheumatology.

The study showed that the tumor board, which is now “one of the most popular conferences at the clinic,” has educational value for participants, and “may increase skill and confidence in patient management.”

“We just present case after case of new things. Last week was autoimmune lipodystrophy from checkpoint inhibitors,” he said, noting that the rheumatologists and oncologists at the clinic co-chair the events.

In another 2018 article, he and coauthor Xavier Mariette, MD, further highlighted the “evolving role of the rheumatologist” in managing cancer treatment–related irAEs.

“We think that rheumatologists have a lot to offer here,” he said. “We understand these drugs better than all of these guys, and as we gain more knowledge in this field, we have guidance, and counsel, and experience to add to this.”

He encouraged rheumatologists to “stay tuned on this, follow this along,” adding that their help is needed.

“It’s really simple – talk to your oncologists and say, ‘Hey, what are you doing with these patients?’ – and I think you’ll have something new, exciting, and invigorating.”

Dr. Calabrese reported serving as a consultant and/or speaker for Bristol-Myers Squibb, Genentech, AbbVie, Pfizer, Crescendo Bioscience, UCB, Janssen, Gilead, Sanofi-Regeneron, Novartis, AstraZeneca, and Amgen.

[email protected]

LAKE BUENA VISTA, FLA. – “Crude and uninformed.”

That’s how Leonard H. Calabrese, DO, described the general approach to managing immune-related adverse events (irAEs) in cancer patients treated with checkpoint inhibitor therapy.

Rheumatologists have the expertise to change that, he said during a presentation at the annual meeting of the Florida Society of Rheumatology.

“The therapy is where it’s at – this is where rheumatologists come into play,” said Dr. Calabrese, professor of medicine and chair of clinical immunology at the Cleveland Clinic.

According to relevant guidelines, such as those recently developed by the American Society of Clinical Oncology/National Comprehensive Cancer Network and the Society for the Immunotherapy of Cancer, irAEs are graded on a severity-based scale. Grade 1 events are mild and generally require observation; grade 2 events may include arthralgias and myalgias that are typically treated with symptomatic therapy; grade 3 events involve more serious conditions and may require hospitalization; and grade 4 events are life-threatening and may require targeted therapies.

“Grade 3 – these would be people with profound polyarthritis, vasculitis, myositis – rely heavily on glucocorticoids, and if patients don’t tolerate glucocorticoids or don’t respond to tapering doses, consider the use of [disease-modifying antirheumatic drugs],” he said, noting that the guidelines are vaguely written and refer to both conventional and biologic DMARDs.

“This is all anecdotal at the present time; this is a story to be discovered as we move along,” he explained.

A recommendation for the use of targeted therapies, such as tumor necrosis factor inhibitors, anti-interleukin (IL)-6, and antimetabolites, in patients with the most advanced disease is similarly vague and just represents “the beginning of the beginning,” he said.

The “crude and uninformed” nature of the current approach to irAEs, as he described it, is related to a failure to consider the immunopathogenesis of specific conditions.

“The oncologists, who have done such an incredible job with this – learning about derm[atitis] and colitis that respond to steroids and infliximab, immediately extrapolated that steroids and infliximab are for everything,” he said. “They give it for pneumonitis, they give it for [central nervous system] disease, they give it for everything.”

However, there’s no pathophysiologic basis for doing so, and not surprisingly, some patients don’t respond.

“Here we are sitting on this amazing armamentarium of targeted therapies and only now just starting to ask the questions: ‘Do they offer benefit for these irAEs? Do they offer risk? Will they blunt the antitumoral response of this?’ ” he said.

A “Personal View” published in Lancet Oncology in January 2019 was among the first from the oncology arena to pose these questions (20[1]:PE54-64. doi: 10.1016/S1470-2045[18]30828-3).

“It said, ‘well maybe we should look at the immunopathogenesis of each of these diseases and then pick the therapy – if it’s IL-17 mediated, we’ve got drugs for that; if it’s IL-1 mediated, we’ve got drugs for that; if it’s interferon-mediated, we can deal with that,’ ” he said. “The problem is we don’t yet have detailed immunopathogenic knowledge of these diseases, but it’s coming.”

Data needed to define best treatments

Data also are emerging to define the roles of various targeted therapies for treating irAEs, but most of the evidence remains anecdotal, he said.

For example, anecdotal reports suggest that rituximab has some efficacy in cytopenias, arthritis, and myositis, and a case report suggests that secukinumab and other IL-17 inhibitors may have benefit in psoriasis and inflammatory bowel disease with tumoral progression, he said.

A reasonable question has been whether attacking T cells might be worthwhile given that “these things are all T-cell mediated,” but until very recently, “no one has had the temerity to actually do this,” he said.

However, two cases reported in the June 13 issue of the New England Journal of Medicine described “very successful” treatment of checkpoint inhibitor-associated myocarditis. One case described the use of alemtuzumab in a 71-year-old woman being treated with first-line pembrolizumab for stage IV melanoma, and another case involved the use of abatacept for severe, glucocorticoid-refractory myocarditis in a 66-year-old woman who had been treated with nivolumab for metastatic lung cancer (2019;380:2375-6 and 2377-79).Dr. Calabrese urged rheumatologists who are interested in addressing the treatment of irAEs to “get involved.”

“People need good rheumatologists, and I will tell you that whoever your oncologists are who you refer patients to for cancer – they’re seeing this and they need help,” he said. “Particularly outside of these big major centers, just having someone to lean on is very important.”

Keep in mind, however, that triage is very important, he said, stressing that patients with irAEs “actually need to be seen.”

Between three and five new irAE patients are being seen each week at the Cleveland Clinic, he noted.
 

Need for multidisciplinary collaboration

Collaboration was the focus of an article in the June 2019 issue of the Journal of the National Comprehensive Cancer Network, which looked at the value of a virtual “multidisciplinary toxicity team” for managing cancer irAEs. The investigators found that such an approach was feasible, used by oncology providers, and effective for facilitating toxicity identification and management.

A number of other recent studies have attempted to assess confidence and knowledge of rheumatologists and others with respect to the treatment of irAEs in cancer patients, and the findings highlight the need for education at the oncologist, specialist, generalist, and advanced practitioner level, Dr. Calabrese said, adding that the findings also highlight a need for assistance from “big pharma, which makes these drugs,” in supporting this type of education.

The need for “novel venues for such educational interchange” also was the topic of a study on a new Cleveland Clinic irAE tumor board that he and his colleagues presented at the 2018 annual meeting of the American College of Rheumatology.

The study showed that the tumor board, which is now “one of the most popular conferences at the clinic,” has educational value for participants, and “may increase skill and confidence in patient management.”

“We just present case after case of new things. Last week was autoimmune lipodystrophy from checkpoint inhibitors,” he said, noting that the rheumatologists and oncologists at the clinic co-chair the events.

In another 2018 article, he and coauthor Xavier Mariette, MD, further highlighted the “evolving role of the rheumatologist” in managing cancer treatment–related irAEs.

“We think that rheumatologists have a lot to offer here,” he said. “We understand these drugs better than all of these guys, and as we gain more knowledge in this field, we have guidance, and counsel, and experience to add to this.”

He encouraged rheumatologists to “stay tuned on this, follow this along,” adding that their help is needed.

“It’s really simple – talk to your oncologists and say, ‘Hey, what are you doing with these patients?’ – and I think you’ll have something new, exciting, and invigorating.”

Dr. Calabrese reported serving as a consultant and/or speaker for Bristol-Myers Squibb, Genentech, AbbVie, Pfizer, Crescendo Bioscience, UCB, Janssen, Gilead, Sanofi-Regeneron, Novartis, AstraZeneca, and Amgen.

[email protected]

LAKE BUENA VISTA, FLA. – “Crude and uninformed.”

That’s how Leonard H. Calabrese, DO, described the general approach to managing immune-related adverse events (irAEs) in cancer patients treated with checkpoint inhibitor therapy.

Rheumatologists have the expertise to change that, he said during a presentation at the annual meeting of the Florida Society of Rheumatology.

“The therapy is where it’s at – this is where rheumatologists come into play,” said Dr. Calabrese, professor of medicine and chair of clinical immunology at the Cleveland Clinic.

According to relevant guidelines, such as those recently developed by the American Society of Clinical Oncology/National Comprehensive Cancer Network and the Society for the Immunotherapy of Cancer, irAEs are graded on a severity-based scale. Grade 1 events are mild and generally require observation; grade 2 events may include arthralgias and myalgias that are typically treated with symptomatic therapy; grade 3 events involve more serious conditions and may require hospitalization; and grade 4 events are life-threatening and may require targeted therapies.

“Grade 3 – these would be people with profound polyarthritis, vasculitis, myositis – rely heavily on glucocorticoids, and if patients don’t tolerate glucocorticoids or don’t respond to tapering doses, consider the use of [disease-modifying antirheumatic drugs],” he said, noting that the guidelines are vaguely written and refer to both conventional and biologic DMARDs.

“This is all anecdotal at the present time; this is a story to be discovered as we move along,” he explained.

A recommendation for the use of targeted therapies, such as tumor necrosis factor inhibitors, anti-interleukin (IL)-6, and antimetabolites, in patients with the most advanced disease is similarly vague and just represents “the beginning of the beginning,” he said.

The “crude and uninformed” nature of the current approach to irAEs, as he described it, is related to a failure to consider the immunopathogenesis of specific conditions.

“The oncologists, who have done such an incredible job with this – learning about derm[atitis] and colitis that respond to steroids and infliximab, immediately extrapolated that steroids and infliximab are for everything,” he said. “They give it for pneumonitis, they give it for [central nervous system] disease, they give it for everything.”

However, there’s no pathophysiologic basis for doing so, and not surprisingly, some patients don’t respond.

“Here we are sitting on this amazing armamentarium of targeted therapies and only now just starting to ask the questions: ‘Do they offer benefit for these irAEs? Do they offer risk? Will they blunt the antitumoral response of this?’ ” he said.

A “Personal View” published in Lancet Oncology in January 2019 was among the first from the oncology arena to pose these questions (20[1]:PE54-64. doi: 10.1016/S1470-2045[18]30828-3).

“It said, ‘well maybe we should look at the immunopathogenesis of each of these diseases and then pick the therapy – if it’s IL-17 mediated, we’ve got drugs for that; if it’s IL-1 mediated, we’ve got drugs for that; if it’s interferon-mediated, we can deal with that,’ ” he said. “The problem is we don’t yet have detailed immunopathogenic knowledge of these diseases, but it’s coming.”

Data needed to define best treatments

Data also are emerging to define the roles of various targeted therapies for treating irAEs, but most of the evidence remains anecdotal, he said.

For example, anecdotal reports suggest that rituximab has some efficacy in cytopenias, arthritis, and myositis, and a case report suggests that secukinumab and other IL-17 inhibitors may have benefit in psoriasis and inflammatory bowel disease with tumoral progression, he said.

A reasonable question has been whether attacking T cells might be worthwhile given that “these things are all T-cell mediated,” but until very recently, “no one has had the temerity to actually do this,” he said.

However, two cases reported in the June 13 issue of the New England Journal of Medicine described “very successful” treatment of checkpoint inhibitor-associated myocarditis. One case described the use of alemtuzumab in a 71-year-old woman being treated with first-line pembrolizumab for stage IV melanoma, and another case involved the use of abatacept for severe, glucocorticoid-refractory myocarditis in a 66-year-old woman who had been treated with nivolumab for metastatic lung cancer (2019;380:2375-6 and 2377-79).Dr. Calabrese urged rheumatologists who are interested in addressing the treatment of irAEs to “get involved.”

“People need good rheumatologists, and I will tell you that whoever your oncologists are who you refer patients to for cancer – they’re seeing this and they need help,” he said. “Particularly outside of these big major centers, just having someone to lean on is very important.”

Keep in mind, however, that triage is very important, he said, stressing that patients with irAEs “actually need to be seen.”

Between three and five new irAE patients are being seen each week at the Cleveland Clinic, he noted.
 

Need for multidisciplinary collaboration

Collaboration was the focus of an article in the June 2019 issue of the Journal of the National Comprehensive Cancer Network, which looked at the value of a virtual “multidisciplinary toxicity team” for managing cancer irAEs. The investigators found that such an approach was feasible, used by oncology providers, and effective for facilitating toxicity identification and management.

A number of other recent studies have attempted to assess confidence and knowledge of rheumatologists and others with respect to the treatment of irAEs in cancer patients, and the findings highlight the need for education at the oncologist, specialist, generalist, and advanced practitioner level, Dr. Calabrese said, adding that the findings also highlight a need for assistance from “big pharma, which makes these drugs,” in supporting this type of education.

The need for “novel venues for such educational interchange” also was the topic of a study on a new Cleveland Clinic irAE tumor board that he and his colleagues presented at the 2018 annual meeting of the American College of Rheumatology.

The study showed that the tumor board, which is now “one of the most popular conferences at the clinic,” has educational value for participants, and “may increase skill and confidence in patient management.”

“We just present case after case of new things. Last week was autoimmune lipodystrophy from checkpoint inhibitors,” he said, noting that the rheumatologists and oncologists at the clinic co-chair the events.

In another 2018 article, he and coauthor Xavier Mariette, MD, further highlighted the “evolving role of the rheumatologist” in managing cancer treatment–related irAEs.

“We think that rheumatologists have a lot to offer here,” he said. “We understand these drugs better than all of these guys, and as we gain more knowledge in this field, we have guidance, and counsel, and experience to add to this.”

He encouraged rheumatologists to “stay tuned on this, follow this along,” adding that their help is needed.

“It’s really simple – talk to your oncologists and say, ‘Hey, what are you doing with these patients?’ – and I think you’ll have something new, exciting, and invigorating.”

Dr. Calabrese reported serving as a consultant and/or speaker for Bristol-Myers Squibb, Genentech, AbbVie, Pfizer, Crescendo Bioscience, UCB, Janssen, Gilead, Sanofi-Regeneron, Novartis, AstraZeneca, and Amgen.

[email protected]

LAKE BUENA VISTA, FLA. – Wellness is an antidote to burnout.

That was the message from psychotherapist and author Saundra Jain, PsyD, during a talk focused on “reigniting the flame” in both professional and personal life.

©stanciuc/thinkstockphotos.com

“Wellness is not an afterthought. It simply cannot be,” she said at the annual meeting of the Florida Society of Rheumatology. The “data demand that wellness be elevated.”

That’s true both for patient care and for self care, she stressed, noting that by “wellness” she is referring to the 1948 World Health Organization definition: “... a state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity.”

Wellness-enhancing practices – she discussed five that have “the most robust dataset”: exercise, nutrition, mindfulness, social connectedness, and sleep – can improve well-being and reduce burnout through a number of mechanisms, not the least of which are reduced inflammation and reduced depression and anxiety, said Dr. Jain, adjunct clinical affiliate for the School of Nursing at the University of Texas at Austin.

For example, regular exercise is known to reduce chronic inflammation, and the effect has been shown to be independent of weight loss, she noted (Sports Med. 2013;43[4]:243-56).

Mindfulness also has been shown to reduce cortisol production in response to a psychological stressor, and thus may positively affect inflammatory responses, she said (Brain Behav Immun. 2013;27:174-184).

People struggle with the concept of mindfulness, because for many it is a bit foreign to their experience, she said, adding that “what we don’t know, we’re sometimes a little bit afraid of.

“But the data around mindfulness, honestly, is robust – it really, really is,” she said, adding that “you can take people who have not meditated at all, and in 8 weeks impact their inflammation.

“So you don’t have to be a long-term meditator – you do not have to meditate for 18 hours a day sitting in a lotus position in a serene, beautiful location.”

There is no right or wrong way to meditate; it’s all about the practice, she added.

In an effort to help her own patients find wellness, Dr. Jain cofounded the WILD 5 Wellness program and coauthored a related workbook and program called KickStart30 designed to help kick-start the wellness journey.

WILD stands for Wellness Interventions for Life’s Demands, and the program combines the five key evidence-based wellness elements into an easy-to-follow program, she said.

The KickStart30 workbook is available for purchase, with all profits benefiting mental health charities. The approach is as applicable for physician wellness as for patient wellness, she said. The program is simple, prescriptive, trackable, and self-contained, she added.

Wellness-enhancing practices as recommended in the program include:

• 30 minutes of exercise daily for 30 days, with an aim of at least moderate intensity.
• 10 minutes of mindfulness practice each day for 30 days. (Free guided meditations, which she and her colleagues use in their studies of the program, are available at www.WILD5Meditations.com, but a number of other guided meditation apps are available online, she said.) “Of the apps that are available, Headspace, without a doubt, is my favorite,” she said. It requires a paid subscription, but “is so worth it.”
• Implementation of at least four of six sleep hygiene practices each day for 30 days.
• Meeting or calling a minimum of two friends or family members each day for 30 days.
• Logging meals/snacks/beverages/alcohol consumption each day for 30 days, following the Mediterranean-DASH intervention for Neurodegenerative Delay (MIND) diet principles as closely as possible.

Program success requires effort, not perfection, in following the recommendations, and measurement and tracking are essential, Dr. Jain said, noting that a simple tracking tool – the KickStart30–HERO Wellness Scale – was validated in a recent study that has been accepted for publication in Annals of Psychology in the coming months).

A prior study of 82 participants, which she presented in 2016 in a poster at the 29th Annual U.S. Psychiatric and Mental Health Congress, showed that completion of the KickStart30 program was associated with improvements on a variety of wellness measures, including happiness (30%), enthusiasm (51%), resilience 63%, and optimism (45%), she said.

Participants also experienced important improvements in disease markers, including depression (43% based on the 9-item Patient Health Questionnaire), anxiety (40% as measured by the 7-item Generalized Anxiety Disorder scale), and sleep quality (29% based on the 9-item Pittsburgh Sleep Quality Index).

“The one thing I want when you leave and you think about this session is a feeling ... that ‘there are actually things that I can do to improve my wellness.’ There’s something about the power, the synergy between the elements ... it’s reigniting the flame, the interest in wellness,” she said, adding that taking care of others requires “learning to take better care of ourselves.”

“We have to walk the walk of wellness; we cannot simply sit in the ivory tower and talk about it,” she said. “To be genuine and to really engage our patients, we have to walk the walk.”

Dr. Jain is cofounder of the WILD 5 Wellness program, and has served on advisory boards or panels for numerous pharmaceutical companies and other organizations.

[email protected]

LAKE BUENA VISTA, FLA. – Wellness is an antidote to burnout.

That was the message from psychotherapist and author Saundra Jain, PsyD, during a talk focused on “reigniting the flame” in both professional and personal life.

©stanciuc/thinkstockphotos.com

“Wellness is not an afterthought. It simply cannot be,” she said at the annual meeting of the Florida Society of Rheumatology. The “data demand that wellness be elevated.”

That’s true both for patient care and for self care, she stressed, noting that by “wellness” she is referring to the 1948 World Health Organization definition: “... a state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity.”

Wellness-enhancing practices – she discussed five that have “the most robust dataset”: exercise, nutrition, mindfulness, social connectedness, and sleep – can improve well-being and reduce burnout through a number of mechanisms, not the least of which are reduced inflammation and reduced depression and anxiety, said Dr. Jain, adjunct clinical affiliate for the School of Nursing at the University of Texas at Austin.

For example, regular exercise is known to reduce chronic inflammation, and the effect has been shown to be independent of weight loss, she noted (Sports Med. 2013;43[4]:243-56).

Mindfulness also has been shown to reduce cortisol production in response to a psychological stressor, and thus may positively affect inflammatory responses, she said (Brain Behav Immun. 2013;27:174-184).

People struggle with the concept of mindfulness, because for many it is a bit foreign to their experience, she said, adding that “what we don’t know, we’re sometimes a little bit afraid of.

“But the data around mindfulness, honestly, is robust – it really, really is,” she said, adding that “you can take people who have not meditated at all, and in 8 weeks impact their inflammation.

“So you don’t have to be a long-term meditator – you do not have to meditate for 18 hours a day sitting in a lotus position in a serene, beautiful location.”

There is no right or wrong way to meditate; it’s all about the practice, she added.

In an effort to help her own patients find wellness, Dr. Jain cofounded the WILD 5 Wellness program and coauthored a related workbook and program called KickStart30 designed to help kick-start the wellness journey.

WILD stands for Wellness Interventions for Life’s Demands, and the program combines the five key evidence-based wellness elements into an easy-to-follow program, she said.

The KickStart30 workbook is available for purchase, with all profits benefiting mental health charities. The approach is as applicable for physician wellness as for patient wellness, she said. The program is simple, prescriptive, trackable, and self-contained, she added.

Wellness-enhancing practices as recommended in the program include:

• 30 minutes of exercise daily for 30 days, with an aim of at least moderate intensity.
• 10 minutes of mindfulness practice each day for 30 days. (Free guided meditations, which she and her colleagues use in their studies of the program, are available at www.WILD5Meditations.com, but a number of other guided meditation apps are available online, she said.) “Of the apps that are available, Headspace, without a doubt, is my favorite,” she said. It requires a paid subscription, but “is so worth it.”
• Implementation of at least four of six sleep hygiene practices each day for 30 days.
• Meeting or calling a minimum of two friends or family members each day for 30 days.
• Logging meals/snacks/beverages/alcohol consumption each day for 30 days, following the Mediterranean-DASH intervention for Neurodegenerative Delay (MIND) diet principles as closely as possible.

Program success requires effort, not perfection, in following the recommendations, and measurement and tracking are essential, Dr. Jain said, noting that a simple tracking tool – the KickStart30–HERO Wellness Scale – was validated in a recent study that has been accepted for publication in Annals of Psychology in the coming months).

A prior study of 82 participants, which she presented in 2016 in a poster at the 29th Annual U.S. Psychiatric and Mental Health Congress, showed that completion of the KickStart30 program was associated with improvements on a variety of wellness measures, including happiness (30%), enthusiasm (51%), resilience 63%, and optimism (45%), she said.

Participants also experienced important improvements in disease markers, including depression (43% based on the 9-item Patient Health Questionnaire), anxiety (40% as measured by the 7-item Generalized Anxiety Disorder scale), and sleep quality (29% based on the 9-item Pittsburgh Sleep Quality Index).

“The one thing I want when you leave and you think about this session is a feeling ... that ‘there are actually things that I can do to improve my wellness.’ There’s something about the power, the synergy between the elements ... it’s reigniting the flame, the interest in wellness,” she said, adding that taking care of others requires “learning to take better care of ourselves.”

“We have to walk the walk of wellness; we cannot simply sit in the ivory tower and talk about it,” she said. “To be genuine and to really engage our patients, we have to walk the walk.”

Dr. Jain is cofounder of the WILD 5 Wellness program, and has served on advisory boards or panels for numerous pharmaceutical companies and other organizations.

[email protected]

LAKE BUENA VISTA, FLA. – Wellness is an antidote to burnout.

That was the message from psychotherapist and author Saundra Jain, PsyD, during a talk focused on “reigniting the flame” in both professional and personal life.

©stanciuc/thinkstockphotos.com

“Wellness is not an afterthought. It simply cannot be,” she said at the annual meeting of the Florida Society of Rheumatology. The “data demand that wellness be elevated.”

That’s true both for patient care and for self care, she stressed, noting that by “wellness” she is referring to the 1948 World Health Organization definition: “... a state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity.”

Wellness-enhancing practices – she discussed five that have “the most robust dataset”: exercise, nutrition, mindfulness, social connectedness, and sleep – can improve well-being and reduce burnout through a number of mechanisms, not the least of which are reduced inflammation and reduced depression and anxiety, said Dr. Jain, adjunct clinical affiliate for the School of Nursing at the University of Texas at Austin.

For example, regular exercise is known to reduce chronic inflammation, and the effect has been shown to be independent of weight loss, she noted (Sports Med. 2013;43[4]:243-56).

Mindfulness also has been shown to reduce cortisol production in response to a psychological stressor, and thus may positively affect inflammatory responses, she said (Brain Behav Immun. 2013;27:174-184).

People struggle with the concept of mindfulness, because for many it is a bit foreign to their experience, she said, adding that “what we don’t know, we’re sometimes a little bit afraid of.

“But the data around mindfulness, honestly, is robust – it really, really is,” she said, adding that “you can take people who have not meditated at all, and in 8 weeks impact their inflammation.

“So you don’t have to be a long-term meditator – you do not have to meditate for 18 hours a day sitting in a lotus position in a serene, beautiful location.”

There is no right or wrong way to meditate; it’s all about the practice, she added.

In an effort to help her own patients find wellness, Dr. Jain cofounded the WILD 5 Wellness program and coauthored a related workbook and program called KickStart30 designed to help kick-start the wellness journey.

WILD stands for Wellness Interventions for Life’s Demands, and the program combines the five key evidence-based wellness elements into an easy-to-follow program, she said.

The KickStart30 workbook is available for purchase, with all profits benefiting mental health charities. The approach is as applicable for physician wellness as for patient wellness, she said. The program is simple, prescriptive, trackable, and self-contained, she added.

Wellness-enhancing practices as recommended in the program include:

• 30 minutes of exercise daily for 30 days, with an aim of at least moderate intensity.
• 10 minutes of mindfulness practice each day for 30 days. (Free guided meditations, which she and her colleagues use in their studies of the program, are available at www.WILD5Meditations.com, but a number of other guided meditation apps are available online, she said.) “Of the apps that are available, Headspace, without a doubt, is my favorite,” she said. It requires a paid subscription, but “is so worth it.”
• Implementation of at least four of six sleep hygiene practices each day for 30 days.
• Meeting or calling a minimum of two friends or family members each day for 30 days.
• Logging meals/snacks/beverages/alcohol consumption each day for 30 days, following the Mediterranean-DASH intervention for Neurodegenerative Delay (MIND) diet principles as closely as possible.

Program success requires effort, not perfection, in following the recommendations, and measurement and tracking are essential, Dr. Jain said, noting that a simple tracking tool – the KickStart30–HERO Wellness Scale – was validated in a recent study that has been accepted for publication in Annals of Psychology in the coming months).

A prior study of 82 participants, which she presented in 2016 in a poster at the 29th Annual U.S. Psychiatric and Mental Health Congress, showed that completion of the KickStart30 program was associated with improvements on a variety of wellness measures, including happiness (30%), enthusiasm (51%), resilience 63%, and optimism (45%), she said.

Participants also experienced important improvements in disease markers, including depression (43% based on the 9-item Patient Health Questionnaire), anxiety (40% as measured by the 7-item Generalized Anxiety Disorder scale), and sleep quality (29% based on the 9-item Pittsburgh Sleep Quality Index).

“The one thing I want when you leave and you think about this session is a feeling ... that ‘there are actually things that I can do to improve my wellness.’ There’s something about the power, the synergy between the elements ... it’s reigniting the flame, the interest in wellness,” she said, adding that taking care of others requires “learning to take better care of ourselves.”

“We have to walk the walk of wellness; we cannot simply sit in the ivory tower and talk about it,” she said. “To be genuine and to really engage our patients, we have to walk the walk.”

Dr. Jain is cofounder of the WILD 5 Wellness program, and has served on advisory boards or panels for numerous pharmaceutical companies and other organizations.

[email protected]