Guidelines

Ideally, all cases of colorectal cancer would be detected at an early and curable stage, but, as new guidelines for late-stage colorectal cancer suggest, the world is far from perfect.

“Different regions of the world, both among and within countries, differ with respect to access to early detection,” the guideline authors wrote in JCO Global Oncology. “Many regions do not have mass or even opportunistic screening, and even within regions with mass screening, subpopulations may not have access to screening.”

The guidelines were developed by the American Society of Clinical Oncology’s Resource-Stratified Guidelines Advisory Group. Based on and adapted from existing guidelines developed by four international agencies, the ASCO guidelines take into account economic and social realities and offer recommendations for diagnosis, staging, and treatment by resource level: basic, limited, enhanced, or maximal.

“We made these guidelines to apply to countries or regions that have basic resources,” lead author E. Gabriela Chiorean, MD, of the University of Washington, Seattle, and the Seattle Cancer Care Alliance, said in an interview.

“We decided what should be the most basic resources – diagnostics, imaging, and treatment – that should be available to patients, and we make recommendations for the use of limited resources and supplies,” she added.

The guidelines pose and answer seven questions about optimal initial symptom management, diagnosis, and staging; optimal first and later lines of therapy; liver-directed therapy options for patients with late-stage colorectal cancer and liver metastases; and optimal on-treatment surveillance and follow-up strategies for patients treated for metastatic colorectal cancer.

For each question, the document offers guidance based on the availability of resources. As defined by the authors, the recommendations are stratified according to the following categories:

• Basic resources – “Core resources or fundamental services that are absolutely necessary for any cancer health care system to function.”
• Limited resources – “Second-tier resources or services that are intended to produce major improvements in outcome, such as increased survival and cost effectiveness, and are attainable with limited financial means and modest infrastructure.”
• Enhanced resources – “Third-tier resources or services that are optional but important; enhanced-level resources should produce further improvements in outcome and increase the number and quality of options and patient choice.”
• Maximal resources – “High-level/state-of-the art resources or services that may be used/available in some high-resource regions and/or may be recommended by high-resource setting guidelines that do not adapt to resource constraints but that nonetheless should be considered a lower priority than those resources or services listed in the other categories on the basis of extreme cost and/or impracticality for broad use in a resource-limited environment.”

The guidelines address common elements of symptom management for patients with acute disease, such as diagnosis involving the primary tumor, endoscopy when possible, and staging to include digital rectal exam and/or imaging when possible. The guidelines also include information tailored to resource level about chemotherapy and surgical resection.

“If, for example, a patient presents with bleeding and you suspect it to be of colorectal origin, we make recommendations that if the patient has symptoms of obstruction and bleeding and is resectable, they should undergo surgery, which should be available in countries of all resource levels,” Dr. Chiorean said.

The guidelines also recommend following the ASCO palliative care guidelines (J Clin Oncol. 2017 Jan;35[1]:96-112) for those patients who present with clinically unstable disease because of bowel obstruction, uncontrolled bleeding, or uncontrolled pain. Patients with clinically stable disease and ongoing bleeding from the primary tumor site are recommended to undergo transfusion and primary-site resection if only basic resources are available or transfusion plus multidisciplinary specialized evaluation when higher-level resources are available.

The ASCO guidelines are adapted from guidelines developed by Cancer Council Australia; the European Society for Medical Oncology; the National Institute for Health and Care Excellence, including separate recommendation for therapy combinations (https://www.nice.org.uk/guidance/ta212, https://www.nice.org.uk/guidance/ta439); and the National Comprehensive Cancer Network. Some of these guidelines have been updated since the creation of the ASCO guidelines.

ASCO funds the guideline development process. Dr. Chiorean and other authors disclosed relationships with multiple companies.

SOURCE: Chiorean EG et al. JCO Glob Oncol. 2020 Mar;6:414-38.

Ideally, all cases of colorectal cancer would be detected at an early and curable stage, but, as new guidelines for late-stage colorectal cancer suggest, the world is far from perfect.

“Different regions of the world, both among and within countries, differ with respect to access to early detection,” the guideline authors wrote in JCO Global Oncology. “Many regions do not have mass or even opportunistic screening, and even within regions with mass screening, subpopulations may not have access to screening.”

The guidelines were developed by the American Society of Clinical Oncology’s Resource-Stratified Guidelines Advisory Group. Based on and adapted from existing guidelines developed by four international agencies, the ASCO guidelines take into account economic and social realities and offer recommendations for diagnosis, staging, and treatment by resource level: basic, limited, enhanced, or maximal.

“We made these guidelines to apply to countries or regions that have basic resources,” lead author E. Gabriela Chiorean, MD, of the University of Washington, Seattle, and the Seattle Cancer Care Alliance, said in an interview.

“We decided what should be the most basic resources – diagnostics, imaging, and treatment – that should be available to patients, and we make recommendations for the use of limited resources and supplies,” she added.

The guidelines pose and answer seven questions about optimal initial symptom management, diagnosis, and staging; optimal first and later lines of therapy; liver-directed therapy options for patients with late-stage colorectal cancer and liver metastases; and optimal on-treatment surveillance and follow-up strategies for patients treated for metastatic colorectal cancer.

For each question, the document offers guidance based on the availability of resources. As defined by the authors, the recommendations are stratified according to the following categories:

• Basic resources – “Core resources or fundamental services that are absolutely necessary for any cancer health care system to function.”
• Limited resources – “Second-tier resources or services that are intended to produce major improvements in outcome, such as increased survival and cost effectiveness, and are attainable with limited financial means and modest infrastructure.”
• Enhanced resources – “Third-tier resources or services that are optional but important; enhanced-level resources should produce further improvements in outcome and increase the number and quality of options and patient choice.”
• Maximal resources – “High-level/state-of-the art resources or services that may be used/available in some high-resource regions and/or may be recommended by high-resource setting guidelines that do not adapt to resource constraints but that nonetheless should be considered a lower priority than those resources or services listed in the other categories on the basis of extreme cost and/or impracticality for broad use in a resource-limited environment.”

The guidelines address common elements of symptom management for patients with acute disease, such as diagnosis involving the primary tumor, endoscopy when possible, and staging to include digital rectal exam and/or imaging when possible. The guidelines also include information tailored to resource level about chemotherapy and surgical resection.

“If, for example, a patient presents with bleeding and you suspect it to be of colorectal origin, we make recommendations that if the patient has symptoms of obstruction and bleeding and is resectable, they should undergo surgery, which should be available in countries of all resource levels,” Dr. Chiorean said.

The guidelines also recommend following the ASCO palliative care guidelines (J Clin Oncol. 2017 Jan;35[1]:96-112) for those patients who present with clinically unstable disease because of bowel obstruction, uncontrolled bleeding, or uncontrolled pain. Patients with clinically stable disease and ongoing bleeding from the primary tumor site are recommended to undergo transfusion and primary-site resection if only basic resources are available or transfusion plus multidisciplinary specialized evaluation when higher-level resources are available.

The ASCO guidelines are adapted from guidelines developed by Cancer Council Australia; the European Society for Medical Oncology; the National Institute for Health and Care Excellence, including separate recommendation for therapy combinations (https://www.nice.org.uk/guidance/ta212, https://www.nice.org.uk/guidance/ta439); and the National Comprehensive Cancer Network. Some of these guidelines have been updated since the creation of the ASCO guidelines.

ASCO funds the guideline development process. Dr. Chiorean and other authors disclosed relationships with multiple companies.

SOURCE: Chiorean EG et al. JCO Glob Oncol. 2020 Mar;6:414-38.

Ideally, all cases of colorectal cancer would be detected at an early and curable stage, but, as new guidelines for late-stage colorectal cancer suggest, the world is far from perfect.

“Different regions of the world, both among and within countries, differ with respect to access to early detection,” the guideline authors wrote in JCO Global Oncology. “Many regions do not have mass or even opportunistic screening, and even within regions with mass screening, subpopulations may not have access to screening.”

The guidelines were developed by the American Society of Clinical Oncology’s Resource-Stratified Guidelines Advisory Group. Based on and adapted from existing guidelines developed by four international agencies, the ASCO guidelines take into account economic and social realities and offer recommendations for diagnosis, staging, and treatment by resource level: basic, limited, enhanced, or maximal.

“We made these guidelines to apply to countries or regions that have basic resources,” lead author E. Gabriela Chiorean, MD, of the University of Washington, Seattle, and the Seattle Cancer Care Alliance, said in an interview.

“We decided what should be the most basic resources – diagnostics, imaging, and treatment – that should be available to patients, and we make recommendations for the use of limited resources and supplies,” she added.

The guidelines pose and answer seven questions about optimal initial symptom management, diagnosis, and staging; optimal first and later lines of therapy; liver-directed therapy options for patients with late-stage colorectal cancer and liver metastases; and optimal on-treatment surveillance and follow-up strategies for patients treated for metastatic colorectal cancer.

For each question, the document offers guidance based on the availability of resources. As defined by the authors, the recommendations are stratified according to the following categories:

• Basic resources – “Core resources or fundamental services that are absolutely necessary for any cancer health care system to function.”
• Limited resources – “Second-tier resources or services that are intended to produce major improvements in outcome, such as increased survival and cost effectiveness, and are attainable with limited financial means and modest infrastructure.”
• Enhanced resources – “Third-tier resources or services that are optional but important; enhanced-level resources should produce further improvements in outcome and increase the number and quality of options and patient choice.”
• Maximal resources – “High-level/state-of-the art resources or services that may be used/available in some high-resource regions and/or may be recommended by high-resource setting guidelines that do not adapt to resource constraints but that nonetheless should be considered a lower priority than those resources or services listed in the other categories on the basis of extreme cost and/or impracticality for broad use in a resource-limited environment.”

The guidelines address common elements of symptom management for patients with acute disease, such as diagnosis involving the primary tumor, endoscopy when possible, and staging to include digital rectal exam and/or imaging when possible. The guidelines also include information tailored to resource level about chemotherapy and surgical resection.

“If, for example, a patient presents with bleeding and you suspect it to be of colorectal origin, we make recommendations that if the patient has symptoms of obstruction and bleeding and is resectable, they should undergo surgery, which should be available in countries of all resource levels,” Dr. Chiorean said.

The guidelines also recommend following the ASCO palliative care guidelines (J Clin Oncol. 2017 Jan;35[1]:96-112) for those patients who present with clinically unstable disease because of bowel obstruction, uncontrolled bleeding, or uncontrolled pain. Patients with clinically stable disease and ongoing bleeding from the primary tumor site are recommended to undergo transfusion and primary-site resection if only basic resources are available or transfusion plus multidisciplinary specialized evaluation when higher-level resources are available.

The ASCO guidelines are adapted from guidelines developed by Cancer Council Australia; the European Society for Medical Oncology; the National Institute for Health and Care Excellence, including separate recommendation for therapy combinations (https://www.nice.org.uk/guidance/ta212, https://www.nice.org.uk/guidance/ta439); and the National Comprehensive Cancer Network. Some of these guidelines have been updated since the creation of the ASCO guidelines.

ASCO funds the guideline development process. Dr. Chiorean and other authors disclosed relationships with multiple companies.

SOURCE: Chiorean EG et al. JCO Glob Oncol. 2020 Mar;6:414-38.

The American Society for Transplantation and Cellular Therapy (ASTCT) has released interim guidelines for the care of hematopoietic cell transplantation (HCT) and cellular therapy patients in the light of the global SARS-CoV-2 pandemic.

The guidelines, summarized briefly below, focus on diagnostic and treatment considerations, evaluation of patients prior to initializing HCT and cellular therapy, and cell donor evaluation. Much of the guideline relies upon recommendations developed by the European Society for Blood and Marrow Transplantation (ESBMT). These guidelines were updated on March 16.

The ASTCT document focuses on patient-treatment specifics and does not cover specific infection-prevention policies and procedures, instead suggesting that local and institutional guidelines, such as those from the Centers for Disease Control and Prevention, should be followed. They did recommend that, in the local presence of COVID-19, “clinic visits that are not critical should be either deferred or substituted with telemedicine visits if deemed appropriate and feasible.”
 

Diagnostic considerations

In any patient with upper or lower respiratory symptoms, obtain polymerase chain reaction (PCR) testing for SARS-CoV-2, where possible, in addition to other respiratory virus PCR testing from any respiratory sample obtained, following CDC recommendations for sample collection and processing, which are continuously being updated on the CDC website.

These recommendations include nasal sampling, rather than oral sampling, and the discouraging of nasal washes where avoidable. If nasal washing is performed, it should be done with appropriate personal protective equipment as described by the CDC. The CDC has also provided additional infection prevention and control information for known and suspected COVID-19 patients in health care settings.

In patients positive for SARS-CoV-2 in an upper respiratory tract sample, chest imaging should be considered.

Preliminary reports suggest that there may be a discrepancy between upper- and lower-tract specimen positivity. Therefore, even when SARS-CoV-2 is not detected in an upper respiratory sample, the ASTCT recommends that chest imaging should be considered for lower respiratory tract infection when clinical symptoms of lower respiratory tract infection are present, including shortness of breath, hypoxia, and tachypnea.

With regard to routine bronchoalveolar lavage, the ASTCT recommends against it if a patient tests positive for SARS-CoV-2 given the risk of transmission among health care workers. The exception is in the case of suspected coinfection based on abnormal chest imaging and in patients for whom it is clinically indicated (for example, those receiving invasive mechanical ventilation). In addition to testing bronchoalveolar lavage samples for SARS-CoV-2, “copathogens should be evaluated and treated.”

Treatment considerations

“At this point no recommendations can be made on specific therapies due to limited data and unknown risk versus benefit; additional recommendations will be forthcoming. Even less data is available for pediatric patients. Treatment for viral, bacterial, and fungal copathogens should be optimized,” according to the ASTCT.

However, the society lists several therapies currently under consideration, which may be available through compassionate-use programs and are being investigated in current clinical trials in several countries, “including lopinavir/ritonavir, ribavirin, hydroxychloroquine, darunavir/cobicistat, and interferons-alpha and -beta.” Remdesivir, in particular, is being evaluated in a National Institutes of Health–sponsored, placebo-controlled clinical trial (NCT04280705).

In case of known or suspected COVID-19 with normal imaging and no or mild symptoms, no therapy is recommended. However, if symptoms progress or imaging is abnormal, an infectious disease specialist or department should be consulted, according to the ASTCT.

Evaluation prior to HCT or cellular therapy

“There is sufficient concern that COVID-19 could have a significant impact on posttransplant or posttherapy outcomes,” according to the guidelines, and the ASTCT provided the following recommendations to be considered in known or suspected COVID-19 patients. In particular, practitioners need to weigh the risk of delaying or altering therapy plans with the risk of progression of underlying disease.

If SARS-CoV-2 is detected in a respiratory specimen, HCT or cellular therapy procedures should be deferred. Therapy should also be deferred in HCT and cellular therapy candidates with close contact with a person infected with SARS-CoV-2 and in those patients who have traveled to a high-risk area or had close contact with a person traveling from an area at high risk for COVID-19.

In the case of a patient in a community with widespread disease, “all HCT and cellular therapy candidates should undergo screening for SARS-CoV-2 infection by PCR in respiratory specimens at the time of initial evaluation and 2 days prior to conditioning/lymphodepletion, regardless of the presence of symptoms, if testing is available.”

Procedures to be deferred include peripheral blood stem cell mobilization, bone marrow harvest, T-cell collections, and conditioning/lymphodepletion. These should not be performed for at least 14 days (preferably 21 days) from the day of last contact, according to the ASTCT. Two consecutive negative PCR tests each approximately 1 week apart (deferral for 14 days minimum), should be obtained, if available.

In areas with high community spread, the guidelines also state that “interim treatment and/or longer deferral of definite therapy should be considered when feasible (for example, multiple myeloma, germ cell tumors, consolidative transplants).”

Similar considerations should be afforded to potential cellular donors. Donors with SARS-CoV-2 detected in a respiratory sample are considered ineligible. Those meeting exposure criteria for patients, as listed above, should be excluded from donation for at least 28 days. “In individual circumstances, a donor may be considered eligible if respiratory samples are negative for SARS-CoV-2 by PCR and donor is asymptomatic. Donor should be closely monitored for COVID-19.”

In the case of unrelated donors, the ASTCT recommends referral to the National Marrow Donor Program (NMDP) guidelines for updated guidance, but points out that, according to the NMDP, the Food and Drug Administration reports that there have been no reported or suspected cases of transfusion-transmitted COVID-19 to date and that “no cases of transfusion-transmission were ever reported for the other two coronaviruses that emerged during the past 2 decades [SARS, the severe acute respiratory syndrome coronavirus, and MERS-CoV, which causes Mideast respiratory syndrome].”

This article was updated 3/26/20.

[email protected]

SOURCE: ASTCT Response to COVID-19. 2020. www.astct.org/connect/astct-response-to-covid-19.

The American Society for Transplantation and Cellular Therapy (ASTCT) has released interim guidelines for the care of hematopoietic cell transplantation (HCT) and cellular therapy patients in the light of the global SARS-CoV-2 pandemic.

The guidelines, summarized briefly below, focus on diagnostic and treatment considerations, evaluation of patients prior to initializing HCT and cellular therapy, and cell donor evaluation. Much of the guideline relies upon recommendations developed by the European Society for Blood and Marrow Transplantation (ESBMT). These guidelines were updated on March 16.

The ASTCT document focuses on patient-treatment specifics and does not cover specific infection-prevention policies and procedures, instead suggesting that local and institutional guidelines, such as those from the Centers for Disease Control and Prevention, should be followed. They did recommend that, in the local presence of COVID-19, “clinic visits that are not critical should be either deferred or substituted with telemedicine visits if deemed appropriate and feasible.”
 

Diagnostic considerations

In any patient with upper or lower respiratory symptoms, obtain polymerase chain reaction (PCR) testing for SARS-CoV-2, where possible, in addition to other respiratory virus PCR testing from any respiratory sample obtained, following CDC recommendations for sample collection and processing, which are continuously being updated on the CDC website.

These recommendations include nasal sampling, rather than oral sampling, and the discouraging of nasal washes where avoidable. If nasal washing is performed, it should be done with appropriate personal protective equipment as described by the CDC. The CDC has also provided additional infection prevention and control information for known and suspected COVID-19 patients in health care settings.

In patients positive for SARS-CoV-2 in an upper respiratory tract sample, chest imaging should be considered.

Preliminary reports suggest that there may be a discrepancy between upper- and lower-tract specimen positivity. Therefore, even when SARS-CoV-2 is not detected in an upper respiratory sample, the ASTCT recommends that chest imaging should be considered for lower respiratory tract infection when clinical symptoms of lower respiratory tract infection are present, including shortness of breath, hypoxia, and tachypnea.

With regard to routine bronchoalveolar lavage, the ASTCT recommends against it if a patient tests positive for SARS-CoV-2 given the risk of transmission among health care workers. The exception is in the case of suspected coinfection based on abnormal chest imaging and in patients for whom it is clinically indicated (for example, those receiving invasive mechanical ventilation). In addition to testing bronchoalveolar lavage samples for SARS-CoV-2, “copathogens should be evaluated and treated.”

Treatment considerations

“At this point no recommendations can be made on specific therapies due to limited data and unknown risk versus benefit; additional recommendations will be forthcoming. Even less data is available for pediatric patients. Treatment for viral, bacterial, and fungal copathogens should be optimized,” according to the ASTCT.

However, the society lists several therapies currently under consideration, which may be available through compassionate-use programs and are being investigated in current clinical trials in several countries, “including lopinavir/ritonavir, ribavirin, hydroxychloroquine, darunavir/cobicistat, and interferons-alpha and -beta.” Remdesivir, in particular, is being evaluated in a National Institutes of Health–sponsored, placebo-controlled clinical trial (NCT04280705).

In case of known or suspected COVID-19 with normal imaging and no or mild symptoms, no therapy is recommended. However, if symptoms progress or imaging is abnormal, an infectious disease specialist or department should be consulted, according to the ASTCT.

Evaluation prior to HCT or cellular therapy

“There is sufficient concern that COVID-19 could have a significant impact on posttransplant or posttherapy outcomes,” according to the guidelines, and the ASTCT provided the following recommendations to be considered in known or suspected COVID-19 patients. In particular, practitioners need to weigh the risk of delaying or altering therapy plans with the risk of progression of underlying disease.

If SARS-CoV-2 is detected in a respiratory specimen, HCT or cellular therapy procedures should be deferred. Therapy should also be deferred in HCT and cellular therapy candidates with close contact with a person infected with SARS-CoV-2 and in those patients who have traveled to a high-risk area or had close contact with a person traveling from an area at high risk for COVID-19.

In the case of a patient in a community with widespread disease, “all HCT and cellular therapy candidates should undergo screening for SARS-CoV-2 infection by PCR in respiratory specimens at the time of initial evaluation and 2 days prior to conditioning/lymphodepletion, regardless of the presence of symptoms, if testing is available.”

Procedures to be deferred include peripheral blood stem cell mobilization, bone marrow harvest, T-cell collections, and conditioning/lymphodepletion. These should not be performed for at least 14 days (preferably 21 days) from the day of last contact, according to the ASTCT. Two consecutive negative PCR tests each approximately 1 week apart (deferral for 14 days minimum), should be obtained, if available.

In areas with high community spread, the guidelines also state that “interim treatment and/or longer deferral of definite therapy should be considered when feasible (for example, multiple myeloma, germ cell tumors, consolidative transplants).”

Similar considerations should be afforded to potential cellular donors. Donors with SARS-CoV-2 detected in a respiratory sample are considered ineligible. Those meeting exposure criteria for patients, as listed above, should be excluded from donation for at least 28 days. “In individual circumstances, a donor may be considered eligible if respiratory samples are negative for SARS-CoV-2 by PCR and donor is asymptomatic. Donor should be closely monitored for COVID-19.”

In the case of unrelated donors, the ASTCT recommends referral to the National Marrow Donor Program (NMDP) guidelines for updated guidance, but points out that, according to the NMDP, the Food and Drug Administration reports that there have been no reported or suspected cases of transfusion-transmitted COVID-19 to date and that “no cases of transfusion-transmission were ever reported for the other two coronaviruses that emerged during the past 2 decades [SARS, the severe acute respiratory syndrome coronavirus, and MERS-CoV, which causes Mideast respiratory syndrome].”

This article was updated 3/26/20.

[email protected]

SOURCE: ASTCT Response to COVID-19. 2020. www.astct.org/connect/astct-response-to-covid-19.

The American Society for Transplantation and Cellular Therapy (ASTCT) has released interim guidelines for the care of hematopoietic cell transplantation (HCT) and cellular therapy patients in the light of the global SARS-CoV-2 pandemic.

The guidelines, summarized briefly below, focus on diagnostic and treatment considerations, evaluation of patients prior to initializing HCT and cellular therapy, and cell donor evaluation. Much of the guideline relies upon recommendations developed by the European Society for Blood and Marrow Transplantation (ESBMT). These guidelines were updated on March 16.

The ASTCT document focuses on patient-treatment specifics and does not cover specific infection-prevention policies and procedures, instead suggesting that local and institutional guidelines, such as those from the Centers for Disease Control and Prevention, should be followed. They did recommend that, in the local presence of COVID-19, “clinic visits that are not critical should be either deferred or substituted with telemedicine visits if deemed appropriate and feasible.”
 

Diagnostic considerations

In any patient with upper or lower respiratory symptoms, obtain polymerase chain reaction (PCR) testing for SARS-CoV-2, where possible, in addition to other respiratory virus PCR testing from any respiratory sample obtained, following CDC recommendations for sample collection and processing, which are continuously being updated on the CDC website.

These recommendations include nasal sampling, rather than oral sampling, and the discouraging of nasal washes where avoidable. If nasal washing is performed, it should be done with appropriate personal protective equipment as described by the CDC. The CDC has also provided additional infection prevention and control information for known and suspected COVID-19 patients in health care settings.

In patients positive for SARS-CoV-2 in an upper respiratory tract sample, chest imaging should be considered.

Preliminary reports suggest that there may be a discrepancy between upper- and lower-tract specimen positivity. Therefore, even when SARS-CoV-2 is not detected in an upper respiratory sample, the ASTCT recommends that chest imaging should be considered for lower respiratory tract infection when clinical symptoms of lower respiratory tract infection are present, including shortness of breath, hypoxia, and tachypnea.

With regard to routine bronchoalveolar lavage, the ASTCT recommends against it if a patient tests positive for SARS-CoV-2 given the risk of transmission among health care workers. The exception is in the case of suspected coinfection based on abnormal chest imaging and in patients for whom it is clinically indicated (for example, those receiving invasive mechanical ventilation). In addition to testing bronchoalveolar lavage samples for SARS-CoV-2, “copathogens should be evaluated and treated.”

Treatment considerations

“At this point no recommendations can be made on specific therapies due to limited data and unknown risk versus benefit; additional recommendations will be forthcoming. Even less data is available for pediatric patients. Treatment for viral, bacterial, and fungal copathogens should be optimized,” according to the ASTCT.

However, the society lists several therapies currently under consideration, which may be available through compassionate-use programs and are being investigated in current clinical trials in several countries, “including lopinavir/ritonavir, ribavirin, hydroxychloroquine, darunavir/cobicistat, and interferons-alpha and -beta.” Remdesivir, in particular, is being evaluated in a National Institutes of Health–sponsored, placebo-controlled clinical trial (NCT04280705).

In case of known or suspected COVID-19 with normal imaging and no or mild symptoms, no therapy is recommended. However, if symptoms progress or imaging is abnormal, an infectious disease specialist or department should be consulted, according to the ASTCT.

Evaluation prior to HCT or cellular therapy

“There is sufficient concern that COVID-19 could have a significant impact on posttransplant or posttherapy outcomes,” according to the guidelines, and the ASTCT provided the following recommendations to be considered in known or suspected COVID-19 patients. In particular, practitioners need to weigh the risk of delaying or altering therapy plans with the risk of progression of underlying disease.

If SARS-CoV-2 is detected in a respiratory specimen, HCT or cellular therapy procedures should be deferred. Therapy should also be deferred in HCT and cellular therapy candidates with close contact with a person infected with SARS-CoV-2 and in those patients who have traveled to a high-risk area or had close contact with a person traveling from an area at high risk for COVID-19.

In the case of a patient in a community with widespread disease, “all HCT and cellular therapy candidates should undergo screening for SARS-CoV-2 infection by PCR in respiratory specimens at the time of initial evaluation and 2 days prior to conditioning/lymphodepletion, regardless of the presence of symptoms, if testing is available.”

Procedures to be deferred include peripheral blood stem cell mobilization, bone marrow harvest, T-cell collections, and conditioning/lymphodepletion. These should not be performed for at least 14 days (preferably 21 days) from the day of last contact, according to the ASTCT. Two consecutive negative PCR tests each approximately 1 week apart (deferral for 14 days minimum), should be obtained, if available.

In areas with high community spread, the guidelines also state that “interim treatment and/or longer deferral of definite therapy should be considered when feasible (for example, multiple myeloma, germ cell tumors, consolidative transplants).”

Similar considerations should be afforded to potential cellular donors. Donors with SARS-CoV-2 detected in a respiratory sample are considered ineligible. Those meeting exposure criteria for patients, as listed above, should be excluded from donation for at least 28 days. “In individual circumstances, a donor may be considered eligible if respiratory samples are negative for SARS-CoV-2 by PCR and donor is asymptomatic. Donor should be closely monitored for COVID-19.”

In the case of unrelated donors, the ASTCT recommends referral to the National Marrow Donor Program (NMDP) guidelines for updated guidance, but points out that, according to the NMDP, the Food and Drug Administration reports that there have been no reported or suspected cases of transfusion-transmitted COVID-19 to date and that “no cases of transfusion-transmission were ever reported for the other two coronaviruses that emerged during the past 2 decades [SARS, the severe acute respiratory syndrome coronavirus, and MERS-CoV, which causes Mideast respiratory syndrome].”

This article was updated 3/26/20.

[email protected]

SOURCE: ASTCT Response to COVID-19. 2020. www.astct.org/connect/astct-response-to-covid-19.

For moderate to severe ulcerative colitis, treatment with any one of the leading biologic agents is superior to no treatment at all. And in treatment-naive patients, infliximab or vedolizumab should be used rather than adalimumab for inducing remission. These are key recommendations from the American Gastroenterological Association guideline for patients with moderate to severe ulcerative colitis (UC), published in Gastroenterology (doi: 10.1053/j.gastro.2020.01.006).

In all, the guideline comprises 11 recommendations for using immunomodulators, biologics, and small-molecule agents to induce and maintain remission in outpatients with moderate to severe UC and to decrease the need for colectomy in hospitalized patients with acute severe UC. The latest guideline follows a guideline for mild to moderate UC published last year (Gastroenterology. 2019;156[3]:748-64). A technical review accompanied the most recent publication (Gastroenterology. 2020. doi: 10.1053/j.gastro.2020.01.007).

An updated guideline was long overdue, lead author Joseph D. Feuerstein, MD, of Beth Israel Deaconess Medical Center, Boston, said in an interview. “The care of patients with inflammatory bowel disease – both ulcerative colitis and Crohn’s – has become increasingly complicated with many newer drugs becoming available,” he said. “The paradigm of how we are treating the disease is evolving, but we haven’t had updated, evidence-based guidelines.” Dr. Feuerstein is the lead author of this guideline.

The guideline can also aid in influencing payers’ policies that now require step-up therapy – that is, failing with the least costly drug before moving onto newer and more effective but costlier agents – Dr. Feuerstein said. “These guidelines show now that we should be treating people based on the evidence and not based on just an insurance company’s preferred policy,” he said.

The strongest recommendation is to use the tumor necrosis factor–alpha (TNF-alpha) antagonists infliximab, adalimumab, and golimumab, the anti-integrin agent vedolizumab, or the anti-interleukin 12/23 agent ustekinumab — all biologics — or the synthetic JAK inhibitor tofacitinib rather than not treating the UC. This is the only recommendation labeled as “strong,” based on “moderate quality evidence.” The relative risk profiles the committee analyzed all favored the biologics over the JAK inhibitor.

Also based on moderate evidence is the recommendation to use infliximab or vedolizumab rather than adalimumab to induce remission in patients who had taken biologic agents before. The other recommendations are based on evidence listed at “low” or “very low” quality, or citing a “knowledge gap.”

“The quality of the evidence available is variable, and we can only make our recommendations based on the quality of the evidence there, but it doesn’t negate the effects of the guideline itself,” Dr. Feuerstein said. The strong recommendation is based on randomized clinical trials that led to the Food and Drug Administration approvals, said Aline Charabaty-Pishvaian, MD, AGAF, associate professor at Johns Hopkins University, Baltimore, and director of the Inflammatory Bowel Disease Center at Sibley Memorial Hospital, Washington. “For everything else, we do not have randomized controlled trials to help make a decision, and the recommendations are made based on the interpretation of different RCTs [randomized controlled trials], knowing that these trials have different designs, patient populations, and endpoints, as well as on experts’ opinions,” she said in an interview.

The only other recommendation based on moderate quality evidence is to use infliximab or vedolizumab rather than adalimumab to induce remission in patients who haven’t previously used biologic agents. The guideline also recommends using tofacitinib in these patients in the confines of a clinical trial; and using ustekinumab or tofacitinib rather than vedolizumab or adalimumab in patients who’ve already been on infliximab, particularly if they haven’t responded to treatment.

The guideline also recommends against thiopurine monotherapy to induce remission, but, for maintenance of remission, recommends such treatment vs. none. However, the guideline suggests against methotrexate monotherapy to induce or maintain remission. And biologic monotherapy is preferred to thiopurine to induce remission, but the guideline makes no recommendation for biologic vs. thiopurine monotherapy to maintain remission. Likewise, combining vedolizumab or ustekinumab with thiopurines or methotrexate is preferred to monotherapy with either a biologic or thiopurine.

The guideline also addresses step-up therapy. It suggests biologics as a first treatment, either as monotherapy or in combination with an immunomodulator, rather than a step-up after failure with 5-aminosalicylates. Also, it recommends against continuing 5-aminosalicylates to induce or maintain remission after a patient has achieved remission with biologics as monotherapy or in combination with immunomodulators or tofacitinib.

The guideline also offers four recommendations for hospitalized patients with acute severe ulcerative colitis: use of intravenous 40-60 mg/d methylprednisolone rather than higher dose IV corticosteroids, no adjunctive antibiotics in the absence of infection; use of infliximab or cyclosporine when IV corticosteroids fail, and no recommendation on the use of intensive vs. standard infliximab dosing when IV corticosteroids fail and the patient is already on infliximab.

The guideline will be meaningful in closing the evidence gap going forward because it can help direct the design of clinical trials, Dr. Charabaty-Pishvaian said. “The guideline highlights areas of need in terms of randomized clinical trials,” she said. “We need these trials to answer the questions we ask ourselves in our daily practice when managing patients with UC: Which drug to choose as the first-line agent? Which drug is the second-line therapy when the disease doesn’t respond or loses response to the first-line agent? Do we need to use combination therapy with all biologics, or only with anti-TNF-alpha agents? For how long? Can we use vedolizumab or ustekinumab as monotherapy when used as a first-line agent? And is there any advantage in adding an immunomodulator when these agents are used as third- or fourth-line therapy?”

Dr. Feuerstein has no relevant financial relationships to disclose. Guideline author Kim Isaacs, MD, disclosed relationships with AbbVie, Takeda, UCB, Janssen and Hoffmann-Laroche. All other committee members have no relevant disclosures.

*This story was updated on 5/7/2020.

SOURCE: Feuerstein JD et al. on behalf of the AGA Institute Clinical Guidelines Committee. Gastroenterology. 2020. doi: 10.1053/j.gastro.2020.01.006.

For moderate to severe ulcerative colitis, treatment with any one of the leading biologic agents is superior to no treatment at all. And in treatment-naive patients, infliximab or vedolizumab should be used rather than adalimumab for inducing remission. These are key recommendations from the American Gastroenterological Association guideline for patients with moderate to severe ulcerative colitis (UC), published in Gastroenterology (doi: 10.1053/j.gastro.2020.01.006).

In all, the guideline comprises 11 recommendations for using immunomodulators, biologics, and small-molecule agents to induce and maintain remission in outpatients with moderate to severe UC and to decrease the need for colectomy in hospitalized patients with acute severe UC. The latest guideline follows a guideline for mild to moderate UC published last year (Gastroenterology. 2019;156[3]:748-64). A technical review accompanied the most recent publication (Gastroenterology. 2020. doi: 10.1053/j.gastro.2020.01.007).

An updated guideline was long overdue, lead author Joseph D. Feuerstein, MD, of Beth Israel Deaconess Medical Center, Boston, said in an interview. “The care of patients with inflammatory bowel disease – both ulcerative colitis and Crohn’s – has become increasingly complicated with many newer drugs becoming available,” he said. “The paradigm of how we are treating the disease is evolving, but we haven’t had updated, evidence-based guidelines.” Dr. Feuerstein is the lead author of this guideline.

The guideline can also aid in influencing payers’ policies that now require step-up therapy – that is, failing with the least costly drug before moving onto newer and more effective but costlier agents – Dr. Feuerstein said. “These guidelines show now that we should be treating people based on the evidence and not based on just an insurance company’s preferred policy,” he said.

The strongest recommendation is to use the tumor necrosis factor–alpha (TNF-alpha) antagonists infliximab, adalimumab, and golimumab, the anti-integrin agent vedolizumab, or the anti-interleukin 12/23 agent ustekinumab — all biologics — or the synthetic JAK inhibitor tofacitinib rather than not treating the UC. This is the only recommendation labeled as “strong,” based on “moderate quality evidence.” The relative risk profiles the committee analyzed all favored the biologics over the JAK inhibitor.

Also based on moderate evidence is the recommendation to use infliximab or vedolizumab rather than adalimumab to induce remission in patients who had taken biologic agents before. The other recommendations are based on evidence listed at “low” or “very low” quality, or citing a “knowledge gap.”

“The quality of the evidence available is variable, and we can only make our recommendations based on the quality of the evidence there, but it doesn’t negate the effects of the guideline itself,” Dr. Feuerstein said. The strong recommendation is based on randomized clinical trials that led to the Food and Drug Administration approvals, said Aline Charabaty-Pishvaian, MD, AGAF, associate professor at Johns Hopkins University, Baltimore, and director of the Inflammatory Bowel Disease Center at Sibley Memorial Hospital, Washington. “For everything else, we do not have randomized controlled trials to help make a decision, and the recommendations are made based on the interpretation of different RCTs [randomized controlled trials], knowing that these trials have different designs, patient populations, and endpoints, as well as on experts’ opinions,” she said in an interview.

The only other recommendation based on moderate quality evidence is to use infliximab or vedolizumab rather than adalimumab to induce remission in patients who haven’t previously used biologic agents. The guideline also recommends using tofacitinib in these patients in the confines of a clinical trial; and using ustekinumab or tofacitinib rather than vedolizumab or adalimumab in patients who’ve already been on infliximab, particularly if they haven’t responded to treatment.

The guideline also recommends against thiopurine monotherapy to induce remission, but, for maintenance of remission, recommends such treatment vs. none. However, the guideline suggests against methotrexate monotherapy to induce or maintain remission. And biologic monotherapy is preferred to thiopurine to induce remission, but the guideline makes no recommendation for biologic vs. thiopurine monotherapy to maintain remission. Likewise, combining vedolizumab or ustekinumab with thiopurines or methotrexate is preferred to monotherapy with either a biologic or thiopurine.

The guideline also addresses step-up therapy. It suggests biologics as a first treatment, either as monotherapy or in combination with an immunomodulator, rather than a step-up after failure with 5-aminosalicylates. Also, it recommends against continuing 5-aminosalicylates to induce or maintain remission after a patient has achieved remission with biologics as monotherapy or in combination with immunomodulators or tofacitinib.

The guideline also offers four recommendations for hospitalized patients with acute severe ulcerative colitis: use of intravenous 40-60 mg/d methylprednisolone rather than higher dose IV corticosteroids, no adjunctive antibiotics in the absence of infection; use of infliximab or cyclosporine when IV corticosteroids fail, and no recommendation on the use of intensive vs. standard infliximab dosing when IV corticosteroids fail and the patient is already on infliximab.

The guideline will be meaningful in closing the evidence gap going forward because it can help direct the design of clinical trials, Dr. Charabaty-Pishvaian said. “The guideline highlights areas of need in terms of randomized clinical trials,” she said. “We need these trials to answer the questions we ask ourselves in our daily practice when managing patients with UC: Which drug to choose as the first-line agent? Which drug is the second-line therapy when the disease doesn’t respond or loses response to the first-line agent? Do we need to use combination therapy with all biologics, or only with anti-TNF-alpha agents? For how long? Can we use vedolizumab or ustekinumab as monotherapy when used as a first-line agent? And is there any advantage in adding an immunomodulator when these agents are used as third- or fourth-line therapy?”

Dr. Feuerstein has no relevant financial relationships to disclose. Guideline author Kim Isaacs, MD, disclosed relationships with AbbVie, Takeda, UCB, Janssen and Hoffmann-Laroche. All other committee members have no relevant disclosures.

*This story was updated on 5/7/2020.

SOURCE: Feuerstein JD et al. on behalf of the AGA Institute Clinical Guidelines Committee. Gastroenterology. 2020. doi: 10.1053/j.gastro.2020.01.006.

For moderate to severe ulcerative colitis, treatment with any one of the leading biologic agents is superior to no treatment at all. And in treatment-naive patients, infliximab or vedolizumab should be used rather than adalimumab for inducing remission. These are key recommendations from the American Gastroenterological Association guideline for patients with moderate to severe ulcerative colitis (UC), published in Gastroenterology (doi: 10.1053/j.gastro.2020.01.006).

In all, the guideline comprises 11 recommendations for using immunomodulators, biologics, and small-molecule agents to induce and maintain remission in outpatients with moderate to severe UC and to decrease the need for colectomy in hospitalized patients with acute severe UC. The latest guideline follows a guideline for mild to moderate UC published last year (Gastroenterology. 2019;156[3]:748-64). A technical review accompanied the most recent publication (Gastroenterology. 2020. doi: 10.1053/j.gastro.2020.01.007).

An updated guideline was long overdue, lead author Joseph D. Feuerstein, MD, of Beth Israel Deaconess Medical Center, Boston, said in an interview. “The care of patients with inflammatory bowel disease – both ulcerative colitis and Crohn’s – has become increasingly complicated with many newer drugs becoming available,” he said. “The paradigm of how we are treating the disease is evolving, but we haven’t had updated, evidence-based guidelines.” Dr. Feuerstein is the lead author of this guideline.

The guideline can also aid in influencing payers’ policies that now require step-up therapy – that is, failing with the least costly drug before moving onto newer and more effective but costlier agents – Dr. Feuerstein said. “These guidelines show now that we should be treating people based on the evidence and not based on just an insurance company’s preferred policy,” he said.

The strongest recommendation is to use the tumor necrosis factor–alpha (TNF-alpha) antagonists infliximab, adalimumab, and golimumab, the anti-integrin agent vedolizumab, or the anti-interleukin 12/23 agent ustekinumab — all biologics — or the synthetic JAK inhibitor tofacitinib rather than not treating the UC. This is the only recommendation labeled as “strong,” based on “moderate quality evidence.” The relative risk profiles the committee analyzed all favored the biologics over the JAK inhibitor.

Also based on moderate evidence is the recommendation to use infliximab or vedolizumab rather than adalimumab to induce remission in patients who had taken biologic agents before. The other recommendations are based on evidence listed at “low” or “very low” quality, or citing a “knowledge gap.”

“The quality of the evidence available is variable, and we can only make our recommendations based on the quality of the evidence there, but it doesn’t negate the effects of the guideline itself,” Dr. Feuerstein said. The strong recommendation is based on randomized clinical trials that led to the Food and Drug Administration approvals, said Aline Charabaty-Pishvaian, MD, AGAF, associate professor at Johns Hopkins University, Baltimore, and director of the Inflammatory Bowel Disease Center at Sibley Memorial Hospital, Washington. “For everything else, we do not have randomized controlled trials to help make a decision, and the recommendations are made based on the interpretation of different RCTs [randomized controlled trials], knowing that these trials have different designs, patient populations, and endpoints, as well as on experts’ opinions,” she said in an interview.

The only other recommendation based on moderate quality evidence is to use infliximab or vedolizumab rather than adalimumab to induce remission in patients who haven’t previously used biologic agents. The guideline also recommends using tofacitinib in these patients in the confines of a clinical trial; and using ustekinumab or tofacitinib rather than vedolizumab or adalimumab in patients who’ve already been on infliximab, particularly if they haven’t responded to treatment.

The guideline also recommends against thiopurine monotherapy to induce remission, but, for maintenance of remission, recommends such treatment vs. none. However, the guideline suggests against methotrexate monotherapy to induce or maintain remission. And biologic monotherapy is preferred to thiopurine to induce remission, but the guideline makes no recommendation for biologic vs. thiopurine monotherapy to maintain remission. Likewise, combining vedolizumab or ustekinumab with thiopurines or methotrexate is preferred to monotherapy with either a biologic or thiopurine.

The guideline also addresses step-up therapy. It suggests biologics as a first treatment, either as monotherapy or in combination with an immunomodulator, rather than a step-up after failure with 5-aminosalicylates. Also, it recommends against continuing 5-aminosalicylates to induce or maintain remission after a patient has achieved remission with biologics as monotherapy or in combination with immunomodulators or tofacitinib.

The guideline also offers four recommendations for hospitalized patients with acute severe ulcerative colitis: use of intravenous 40-60 mg/d methylprednisolone rather than higher dose IV corticosteroids, no adjunctive antibiotics in the absence of infection; use of infliximab or cyclosporine when IV corticosteroids fail, and no recommendation on the use of intensive vs. standard infliximab dosing when IV corticosteroids fail and the patient is already on infliximab.

The guideline will be meaningful in closing the evidence gap going forward because it can help direct the design of clinical trials, Dr. Charabaty-Pishvaian said. “The guideline highlights areas of need in terms of randomized clinical trials,” she said. “We need these trials to answer the questions we ask ourselves in our daily practice when managing patients with UC: Which drug to choose as the first-line agent? Which drug is the second-line therapy when the disease doesn’t respond or loses response to the first-line agent? Do we need to use combination therapy with all biologics, or only with anti-TNF-alpha agents? For how long? Can we use vedolizumab or ustekinumab as monotherapy when used as a first-line agent? And is there any advantage in adding an immunomodulator when these agents are used as third- or fourth-line therapy?”

Dr. Feuerstein has no relevant financial relationships to disclose. Guideline author Kim Isaacs, MD, disclosed relationships with AbbVie, Takeda, UCB, Janssen and Hoffmann-Laroche. All other committee members have no relevant disclosures.

*This story was updated on 5/7/2020.

SOURCE: Feuerstein JD et al. on behalf of the AGA Institute Clinical Guidelines Committee. Gastroenterology. 2020. doi: 10.1053/j.gastro.2020.01.006.

It’s been 11 years since the American Academy of Dermatology updated its guidelines for using nonbiologic systemic therapies for psoriasis, and now new guidelines recommend oral apremilast monotherapy and suggest a framework for a number of off-label treatments.

The guidelines, issued jointly with the National Psoriasis Foundation (NPF), were published in the Journal of the American Academy of Dermatology.

“I think we are way behind,” Alan Menter, MD, chairman of the division of dermatology at Baylor University Medical Center, Dallas, and cochair of the guideline writing committee, said in an interview. “Most other countries update their guidelines every 1 or 2 years; we were 10 years behind.” The guidelines for systemic nonbiologic drugs follow up psoriasis guidelines issued by the AAD and the NPF on pediatric patients issued earlier this year, and on phototherapy, biologic treatments, and management of comorbidities issued last year.

“A lot has happened in the last 10 years,” said cochair Craig Elmets, MD, professor of dermatology at the University of Alabama at Birmingham. “While much of the interest is on biologic agents, nonbiologics are still used quite frequently, and the guidelines for their appropriate use have changed. Use of the guidelines provides people in the health profession with the most up to date evidence-based information so they can give their patients the best care.”

The guidelines acknowledge that the medications it covers are still widely used, either by themselves or in combination with biologic agents; readily available; easy to use; and, in the case of older therapies, relatively cheap.

Methotrexate has been available since the 1970s. Given as an injection or taken orally, the guidelines recommend supplementation with folic acid to counteract methotrexate’s side effects, particularly GI upset. The guidelines note that folic acid is less expensive than folinic acid. Combination therapy with methotrexate and tumor necrosis factor (TNF) inhibitors is more effective than methotrexate monotherapy, with a similar side effect profile, the guidelines state.

Methotrexate is more widely used outside the United States, “but it is a very good, quick fix and it’s much safer in children and young people than it is in people with cardiovascular disease,” Dr. Menter noted. “It’s still the most commonly used drug worldwide because it’s cheap, and you do have to worry about the long-term toxicity which is related the liver issues.”

The guidelines say that subcutaneous administration of methotrexate “may be particularly useful” for patients on higher doses, which when taken orally, are associated with a higher risk of GI effects.

Dr. Menter referred to a 2017 study, which reported 41% of patients treated with subcutaneous methotrexate once a week achieved a Psoriasis Area and Severity Index 75 score of 41% after a year of treatment, compared with 10% of those on placebo (Lancet. 2017 Feb 4;389[10068]:528-37).

The guidelines rate strength of recommendation as class A for methotrexate for moderate to severe psoriasis in adults, recommend supplementation with folic or folinic acid to counteract GI complications and liver problems, and note that adalimumab and infliximab are more effective than methotrexate for cutaneous psoriasis. Class B recommendations for methotrexate and psoriasis include statements that patients should begin with a test dose, especially if they have impaired kidney function; methotrexate is effective for peripheral, but not axial, psoriatic arthritis (PsA); and TNF inhibitors are more effective than methotrexate for PsA.

Approved by the FDA in 2014 for psoriasis, apremilast, which inhibits phosphodiesterase-4, is the newest drug in the recommendations. The guidelines recommend its use for moderate to severe psoriasis in adults, with a class A recommendation. Patients should start on a low dose and then build up to the 30-mg, twice-daily dose over 6 days and should be counseled about the risk of depression before starting treatment. Routine laboratory testing can be considered on an individual basis.

The guidelines also lay out three recommendations (and strength of recommendation) for cyclosporine, a drug that’s been around since the 1990s: for severe, recalcitrant cases (class A); for erythrodermic, general pustular, and palmoplantar psoriasis (class B); and as short-term therapy for psoriasis flare in patients already on another drug (class C).

Acitretin is another longstanding therapy used mostly for palmar-plantar psoriasis, but it can also be used as monotherapy for plaque psoriasis as well as erythrodermic and pustular disease. It can also be used in combination with psoralens with UVA for psoriasis and combined with broadband UVB phototherapy for plaque psoriasis. The acitretin recommendations are class B.

The oral Janus kinase (JAK) inhibitor tofacitinib isn’t specifically approved for psoriasis, but it is approved for RA, PsA, and ulcerative colitis. The drug targets the JAK-STAT signaling pathway that causes inflammation. The guidelines state that tofacitinib can be considered for moderate to severe psoriasis, but lists no strength of recommendation. The recommended dose is either 5 or 10 mg orally twice a day, with a caveat that the higher dose carries a higher risk of adverse events. Patients should be evaluated for getting a zoster vaccine before they begin therapy.

“We thought that, because there was probably a small chance that it might get approved for psoriasis, that we would discuss it briefly,” Dr. Menter said of tofacitinib.

Another off-label use the guidelines address is for fumaric and acid esters, also known as fumarates, which are used to in Europe to treat moderate to severe psoriasis. Dimethyl fumarate is approved for relapsing forms of multiple sclerosis in the United States. The guidelines state that fumarates can be used for psoriasis, but offer no strength of recommendation. Side effects include gastrointestinal disturbance and flushing.

Other treatments that are also addressed in the guidelines include a host of systemic immunosuppressants and antimetabolites: azathioprine, hydroxyurea, leflunomide, mycophenolate mofetil, thioguanine, and tacrolimus, none of which are FDA approved for psoriasis. They’re rarely used for psoriasis, but may have value in selected cases, the guidelines state.

Dr. Menter said that apremilast is the only oral drug in the guidelines, but they are the wave of the future for treating psoriasis. “I think there’s a tremendous potential for new oral drugs – TK2 [thymidine kinase], the JAK inhibitors, and other drugs coming down the pipelines. The majority of patients, if you ask them their preference, would like to take an oral drug rather than an injectable drug. And it would be much easier for dermatologists, they wouldn’t have to train patients on how to do the injections.”

Dr. Menter and Dr. Elmets disclosed financial relationships with numerous pharmaceutical companies. Other authors/work group members also had disclosures related to pharmaceutical manufacturers, and several had no disclosures.

SOURCE: Menter A et al. J Am Acad Dermatol. 2020 Feb 28. doi: 10.1016/j.jaad.2020.02.044.

It’s been 11 years since the American Academy of Dermatology updated its guidelines for using nonbiologic systemic therapies for psoriasis, and now new guidelines recommend oral apremilast monotherapy and suggest a framework for a number of off-label treatments.

The guidelines, issued jointly with the National Psoriasis Foundation (NPF), were published in the Journal of the American Academy of Dermatology.

“I think we are way behind,” Alan Menter, MD, chairman of the division of dermatology at Baylor University Medical Center, Dallas, and cochair of the guideline writing committee, said in an interview. “Most other countries update their guidelines every 1 or 2 years; we were 10 years behind.” The guidelines for systemic nonbiologic drugs follow up psoriasis guidelines issued by the AAD and the NPF on pediatric patients issued earlier this year, and on phototherapy, biologic treatments, and management of comorbidities issued last year.

“A lot has happened in the last 10 years,” said cochair Craig Elmets, MD, professor of dermatology at the University of Alabama at Birmingham. “While much of the interest is on biologic agents, nonbiologics are still used quite frequently, and the guidelines for their appropriate use have changed. Use of the guidelines provides people in the health profession with the most up to date evidence-based information so they can give their patients the best care.”

The guidelines acknowledge that the medications it covers are still widely used, either by themselves or in combination with biologic agents; readily available; easy to use; and, in the case of older therapies, relatively cheap.

Methotrexate has been available since the 1970s. Given as an injection or taken orally, the guidelines recommend supplementation with folic acid to counteract methotrexate’s side effects, particularly GI upset. The guidelines note that folic acid is less expensive than folinic acid. Combination therapy with methotrexate and tumor necrosis factor (TNF) inhibitors is more effective than methotrexate monotherapy, with a similar side effect profile, the guidelines state.

Methotrexate is more widely used outside the United States, “but it is a very good, quick fix and it’s much safer in children and young people than it is in people with cardiovascular disease,” Dr. Menter noted. “It’s still the most commonly used drug worldwide because it’s cheap, and you do have to worry about the long-term toxicity which is related the liver issues.”

The guidelines say that subcutaneous administration of methotrexate “may be particularly useful” for patients on higher doses, which when taken orally, are associated with a higher risk of GI effects.

Dr. Menter referred to a 2017 study, which reported 41% of patients treated with subcutaneous methotrexate once a week achieved a Psoriasis Area and Severity Index 75 score of 41% after a year of treatment, compared with 10% of those on placebo (Lancet. 2017 Feb 4;389[10068]:528-37).

The guidelines rate strength of recommendation as class A for methotrexate for moderate to severe psoriasis in adults, recommend supplementation with folic or folinic acid to counteract GI complications and liver problems, and note that adalimumab and infliximab are more effective than methotrexate for cutaneous psoriasis. Class B recommendations for methotrexate and psoriasis include statements that patients should begin with a test dose, especially if they have impaired kidney function; methotrexate is effective for peripheral, but not axial, psoriatic arthritis (PsA); and TNF inhibitors are more effective than methotrexate for PsA.

Approved by the FDA in 2014 for psoriasis, apremilast, which inhibits phosphodiesterase-4, is the newest drug in the recommendations. The guidelines recommend its use for moderate to severe psoriasis in adults, with a class A recommendation. Patients should start on a low dose and then build up to the 30-mg, twice-daily dose over 6 days and should be counseled about the risk of depression before starting treatment. Routine laboratory testing can be considered on an individual basis.

The guidelines also lay out three recommendations (and strength of recommendation) for cyclosporine, a drug that’s been around since the 1990s: for severe, recalcitrant cases (class A); for erythrodermic, general pustular, and palmoplantar psoriasis (class B); and as short-term therapy for psoriasis flare in patients already on another drug (class C).

Acitretin is another longstanding therapy used mostly for palmar-plantar psoriasis, but it can also be used as monotherapy for plaque psoriasis as well as erythrodermic and pustular disease. It can also be used in combination with psoralens with UVA for psoriasis and combined with broadband UVB phototherapy for plaque psoriasis. The acitretin recommendations are class B.

The oral Janus kinase (JAK) inhibitor tofacitinib isn’t specifically approved for psoriasis, but it is approved for RA, PsA, and ulcerative colitis. The drug targets the JAK-STAT signaling pathway that causes inflammation. The guidelines state that tofacitinib can be considered for moderate to severe psoriasis, but lists no strength of recommendation. The recommended dose is either 5 or 10 mg orally twice a day, with a caveat that the higher dose carries a higher risk of adverse events. Patients should be evaluated for getting a zoster vaccine before they begin therapy.

“We thought that, because there was probably a small chance that it might get approved for psoriasis, that we would discuss it briefly,” Dr. Menter said of tofacitinib.

Another off-label use the guidelines address is for fumaric and acid esters, also known as fumarates, which are used to in Europe to treat moderate to severe psoriasis. Dimethyl fumarate is approved for relapsing forms of multiple sclerosis in the United States. The guidelines state that fumarates can be used for psoriasis, but offer no strength of recommendation. Side effects include gastrointestinal disturbance and flushing.

Other treatments that are also addressed in the guidelines include a host of systemic immunosuppressants and antimetabolites: azathioprine, hydroxyurea, leflunomide, mycophenolate mofetil, thioguanine, and tacrolimus, none of which are FDA approved for psoriasis. They’re rarely used for psoriasis, but may have value in selected cases, the guidelines state.

Dr. Menter said that apremilast is the only oral drug in the guidelines, but they are the wave of the future for treating psoriasis. “I think there’s a tremendous potential for new oral drugs – TK2 [thymidine kinase], the JAK inhibitors, and other drugs coming down the pipelines. The majority of patients, if you ask them their preference, would like to take an oral drug rather than an injectable drug. And it would be much easier for dermatologists, they wouldn’t have to train patients on how to do the injections.”

Dr. Menter and Dr. Elmets disclosed financial relationships with numerous pharmaceutical companies. Other authors/work group members also had disclosures related to pharmaceutical manufacturers, and several had no disclosures.

SOURCE: Menter A et al. J Am Acad Dermatol. 2020 Feb 28. doi: 10.1016/j.jaad.2020.02.044.

It’s been 11 years since the American Academy of Dermatology updated its guidelines for using nonbiologic systemic therapies for psoriasis, and now new guidelines recommend oral apremilast monotherapy and suggest a framework for a number of off-label treatments.

The guidelines, issued jointly with the National Psoriasis Foundation (NPF), were published in the Journal of the American Academy of Dermatology.

“I think we are way behind,” Alan Menter, MD, chairman of the division of dermatology at Baylor University Medical Center, Dallas, and cochair of the guideline writing committee, said in an interview. “Most other countries update their guidelines every 1 or 2 years; we were 10 years behind.” The guidelines for systemic nonbiologic drugs follow up psoriasis guidelines issued by the AAD and the NPF on pediatric patients issued earlier this year, and on phototherapy, biologic treatments, and management of comorbidities issued last year.

“A lot has happened in the last 10 years,” said cochair Craig Elmets, MD, professor of dermatology at the University of Alabama at Birmingham. “While much of the interest is on biologic agents, nonbiologics are still used quite frequently, and the guidelines for their appropriate use have changed. Use of the guidelines provides people in the health profession with the most up to date evidence-based information so they can give their patients the best care.”

The guidelines acknowledge that the medications it covers are still widely used, either by themselves or in combination with biologic agents; readily available; easy to use; and, in the case of older therapies, relatively cheap.

Methotrexate has been available since the 1970s. Given as an injection or taken orally, the guidelines recommend supplementation with folic acid to counteract methotrexate’s side effects, particularly GI upset. The guidelines note that folic acid is less expensive than folinic acid. Combination therapy with methotrexate and tumor necrosis factor (TNF) inhibitors is more effective than methotrexate monotherapy, with a similar side effect profile, the guidelines state.

Methotrexate is more widely used outside the United States, “but it is a very good, quick fix and it’s much safer in children and young people than it is in people with cardiovascular disease,” Dr. Menter noted. “It’s still the most commonly used drug worldwide because it’s cheap, and you do have to worry about the long-term toxicity which is related the liver issues.”

The guidelines say that subcutaneous administration of methotrexate “may be particularly useful” for patients on higher doses, which when taken orally, are associated with a higher risk of GI effects.

Dr. Menter referred to a 2017 study, which reported 41% of patients treated with subcutaneous methotrexate once a week achieved a Psoriasis Area and Severity Index 75 score of 41% after a year of treatment, compared with 10% of those on placebo (Lancet. 2017 Feb 4;389[10068]:528-37).

The guidelines rate strength of recommendation as class A for methotrexate for moderate to severe psoriasis in adults, recommend supplementation with folic or folinic acid to counteract GI complications and liver problems, and note that adalimumab and infliximab are more effective than methotrexate for cutaneous psoriasis. Class B recommendations for methotrexate and psoriasis include statements that patients should begin with a test dose, especially if they have impaired kidney function; methotrexate is effective for peripheral, but not axial, psoriatic arthritis (PsA); and TNF inhibitors are more effective than methotrexate for PsA.

Approved by the FDA in 2014 for psoriasis, apremilast, which inhibits phosphodiesterase-4, is the newest drug in the recommendations. The guidelines recommend its use for moderate to severe psoriasis in adults, with a class A recommendation. Patients should start on a low dose and then build up to the 30-mg, twice-daily dose over 6 days and should be counseled about the risk of depression before starting treatment. Routine laboratory testing can be considered on an individual basis.

The guidelines also lay out three recommendations (and strength of recommendation) for cyclosporine, a drug that’s been around since the 1990s: for severe, recalcitrant cases (class A); for erythrodermic, general pustular, and palmoplantar psoriasis (class B); and as short-term therapy for psoriasis flare in patients already on another drug (class C).

Acitretin is another longstanding therapy used mostly for palmar-plantar psoriasis, but it can also be used as monotherapy for plaque psoriasis as well as erythrodermic and pustular disease. It can also be used in combination with psoralens with UVA for psoriasis and combined with broadband UVB phototherapy for plaque psoriasis. The acitretin recommendations are class B.

The oral Janus kinase (JAK) inhibitor tofacitinib isn’t specifically approved for psoriasis, but it is approved for RA, PsA, and ulcerative colitis. The drug targets the JAK-STAT signaling pathway that causes inflammation. The guidelines state that tofacitinib can be considered for moderate to severe psoriasis, but lists no strength of recommendation. The recommended dose is either 5 or 10 mg orally twice a day, with a caveat that the higher dose carries a higher risk of adverse events. Patients should be evaluated for getting a zoster vaccine before they begin therapy.

“We thought that, because there was probably a small chance that it might get approved for psoriasis, that we would discuss it briefly,” Dr. Menter said of tofacitinib.

Another off-label use the guidelines address is for fumaric and acid esters, also known as fumarates, which are used to in Europe to treat moderate to severe psoriasis. Dimethyl fumarate is approved for relapsing forms of multiple sclerosis in the United States. The guidelines state that fumarates can be used for psoriasis, but offer no strength of recommendation. Side effects include gastrointestinal disturbance and flushing.

Other treatments that are also addressed in the guidelines include a host of systemic immunosuppressants and antimetabolites: azathioprine, hydroxyurea, leflunomide, mycophenolate mofetil, thioguanine, and tacrolimus, none of which are FDA approved for psoriasis. They’re rarely used for psoriasis, but may have value in selected cases, the guidelines state.

Dr. Menter said that apremilast is the only oral drug in the guidelines, but they are the wave of the future for treating psoriasis. “I think there’s a tremendous potential for new oral drugs – TK2 [thymidine kinase], the JAK inhibitors, and other drugs coming down the pipelines. The majority of patients, if you ask them their preference, would like to take an oral drug rather than an injectable drug. And it would be much easier for dermatologists, they wouldn’t have to train patients on how to do the injections.”

Dr. Menter and Dr. Elmets disclosed financial relationships with numerous pharmaceutical companies. Other authors/work group members also had disclosures related to pharmaceutical manufacturers, and several had no disclosures.

SOURCE: Menter A et al. J Am Acad Dermatol. 2020 Feb 28. doi: 10.1016/j.jaad.2020.02.044.

Less than one-third of first authors on rheumatology guidelines or recommendations are women, according to a research letter published in Annals of the Rheumatic Diseases.

Giovanni Adami, MD, from the department of medicine at the University of Verona (Italy), and coauthors examined 366 English-language guidelines and recommendations published between 2004 and 2019 around the world.

They found that only 32% featured a female first author. However, they did observe a significant trend toward increasing female first authorship over the study period, with parity first being achieved for guidelines and recommendations published in 2017.

Male-dominated first authorship was seen almost across the disease subject matter. For RA, only 18.8% of the 96 guidelines or recommendations examined had a female first author, and of the 12 documents on polymyalgia rheumatica and giant cell arteritis, none featured a female first author.

Among the 73 guidelines and recommendations relating to psoriatic arthritis and spondyloarthritis, only 23.3% featured a female first author. However, three of the six documents on polymyositis and dermatomyositis had a female lead author, the only area where parity was achieved.

The authors noted the recent establishment of the EULAR Task Force on Gender Equity in Academic Rheumatology, which they said was an important first step toward gender equity in rheumatology guidelines authorship.

“Indeed, in the last 15 years we have witnessed an increase in female representativeness,” they wrote. “Notwithstanding, efforts should be made to improve the representation of female authors nationally and internationally.”

Commenting on the findings, rheumatologist Jean Liew, MD, said an interesting thing is that, in the United States at least, rheumatology is not a male-dominated field.

“Even though the practicing clinicians in rheumatology, most of them are women ... at the top of things it’s not as equitable as what it should be,” said Dr. Liew, acting instructor and senior fellow in the division of rheumatology at the University of Washington, Seattle.

Dr. Liew, who coauthored another study showing a significant gender gap in speakers at American College of Rheumatology meetings, said there was evidence suggesting men were more likely to be promoted, get grants, and get positive reviews, which made it harder for women to advance to senior research and leadership positions.

She noted that the ACR has been making a concerted effort to improve gender balance in the choice of speakers for meetings, but said that the problem of gender inequity in rheumatology required more widespread initiatives to address.

“It really takes people being aware of the problem and being good sponsors and promoting women who are qualified,” she said in an interview. “There should be more mentorship and sponsorship for women, otherwise this will never change.”

She also commented that pursuing research careers in rheumatology was difficult enough without the additional pressures of family life. “It’s years and years of sacrifice, it’s hard to get funding, which already makes it harder, especially for women with families who feel like they have to also be there at home.”

The study had no outside funding, and the authors declared no competing interests.

SOURCE: Adami G et al. Ann Rheum Dis. 2020 Feb 26. doi: 10.1136/annrheumdis-2020-217119.

Less than one-third of first authors on rheumatology guidelines or recommendations are women, according to a research letter published in Annals of the Rheumatic Diseases.

Giovanni Adami, MD, from the department of medicine at the University of Verona (Italy), and coauthors examined 366 English-language guidelines and recommendations published between 2004 and 2019 around the world.

They found that only 32% featured a female first author. However, they did observe a significant trend toward increasing female first authorship over the study period, with parity first being achieved for guidelines and recommendations published in 2017.

Male-dominated first authorship was seen almost across the disease subject matter. For RA, only 18.8% of the 96 guidelines or recommendations examined had a female first author, and of the 12 documents on polymyalgia rheumatica and giant cell arteritis, none featured a female first author.

Among the 73 guidelines and recommendations relating to psoriatic arthritis and spondyloarthritis, only 23.3% featured a female first author. However, three of the six documents on polymyositis and dermatomyositis had a female lead author, the only area where parity was achieved.

The authors noted the recent establishment of the EULAR Task Force on Gender Equity in Academic Rheumatology, which they said was an important first step toward gender equity in rheumatology guidelines authorship.

“Indeed, in the last 15 years we have witnessed an increase in female representativeness,” they wrote. “Notwithstanding, efforts should be made to improve the representation of female authors nationally and internationally.”

Commenting on the findings, rheumatologist Jean Liew, MD, said an interesting thing is that, in the United States at least, rheumatology is not a male-dominated field.

“Even though the practicing clinicians in rheumatology, most of them are women ... at the top of things it’s not as equitable as what it should be,” said Dr. Liew, acting instructor and senior fellow in the division of rheumatology at the University of Washington, Seattle.

Dr. Liew, who coauthored another study showing a significant gender gap in speakers at American College of Rheumatology meetings, said there was evidence suggesting men were more likely to be promoted, get grants, and get positive reviews, which made it harder for women to advance to senior research and leadership positions.

She noted that the ACR has been making a concerted effort to improve gender balance in the choice of speakers for meetings, but said that the problem of gender inequity in rheumatology required more widespread initiatives to address.

“It really takes people being aware of the problem and being good sponsors and promoting women who are qualified,” she said in an interview. “There should be more mentorship and sponsorship for women, otherwise this will never change.”

She also commented that pursuing research careers in rheumatology was difficult enough without the additional pressures of family life. “It’s years and years of sacrifice, it’s hard to get funding, which already makes it harder, especially for women with families who feel like they have to also be there at home.”

The study had no outside funding, and the authors declared no competing interests.

SOURCE: Adami G et al. Ann Rheum Dis. 2020 Feb 26. doi: 10.1136/annrheumdis-2020-217119.

Less than one-third of first authors on rheumatology guidelines or recommendations are women, according to a research letter published in Annals of the Rheumatic Diseases.

Giovanni Adami, MD, from the department of medicine at the University of Verona (Italy), and coauthors examined 366 English-language guidelines and recommendations published between 2004 and 2019 around the world.

They found that only 32% featured a female first author. However, they did observe a significant trend toward increasing female first authorship over the study period, with parity first being achieved for guidelines and recommendations published in 2017.

Male-dominated first authorship was seen almost across the disease subject matter. For RA, only 18.8% of the 96 guidelines or recommendations examined had a female first author, and of the 12 documents on polymyalgia rheumatica and giant cell arteritis, none featured a female first author.

Among the 73 guidelines and recommendations relating to psoriatic arthritis and spondyloarthritis, only 23.3% featured a female first author. However, three of the six documents on polymyositis and dermatomyositis had a female lead author, the only area where parity was achieved.

The authors noted the recent establishment of the EULAR Task Force on Gender Equity in Academic Rheumatology, which they said was an important first step toward gender equity in rheumatology guidelines authorship.

“Indeed, in the last 15 years we have witnessed an increase in female representativeness,” they wrote. “Notwithstanding, efforts should be made to improve the representation of female authors nationally and internationally.”

Commenting on the findings, rheumatologist Jean Liew, MD, said an interesting thing is that, in the United States at least, rheumatology is not a male-dominated field.

“Even though the practicing clinicians in rheumatology, most of them are women ... at the top of things it’s not as equitable as what it should be,” said Dr. Liew, acting instructor and senior fellow in the division of rheumatology at the University of Washington, Seattle.

Dr. Liew, who coauthored another study showing a significant gender gap in speakers at American College of Rheumatology meetings, said there was evidence suggesting men were more likely to be promoted, get grants, and get positive reviews, which made it harder for women to advance to senior research and leadership positions.

She noted that the ACR has been making a concerted effort to improve gender balance in the choice of speakers for meetings, but said that the problem of gender inequity in rheumatology required more widespread initiatives to address.

“It really takes people being aware of the problem and being good sponsors and promoting women who are qualified,” she said in an interview. “There should be more mentorship and sponsorship for women, otherwise this will never change.”

She also commented that pursuing research careers in rheumatology was difficult enough without the additional pressures of family life. “It’s years and years of sacrifice, it’s hard to get funding, which already makes it harder, especially for women with families who feel like they have to also be there at home.”

The study had no outside funding, and the authors declared no competing interests.

SOURCE: Adami G et al. Ann Rheum Dis. 2020 Feb 26. doi: 10.1136/annrheumdis-2020-217119.

A new guideline from the American College of Rheumatology offers the organization’s first clinical recommendations on how to manage reproductive health issues in patients with rheumatic and musculoskeletal diseases (RMDs).

Bruce Jancin/MDedge News

“With the development of this guideline, the ACR recognizes the key role of clinical rheumatologists not only in managing disease activity but also in understanding the interactions of RMDs and their therapies in the context of reproductive health,” wrote Lisa R. Sammaritano, MD, of Weill Cornell Medicine and the Hospital for Special Surgery in New York, and coauthors. The guideline was published in Arthritis & Rheumatology.

To develop an evidence-based guideline on reproductive health in RMD patients, the researchers embarked on a systematic review of studies in areas like contraception, pregnancy and lactation, assisted reproductive technology (ART), fertility preservation, and hormone therapy. The guideline contains 12 ungraded good practice statements and 131 graded recommendations, all developed through the Grading of Recommendations Assessment, Development, and Evaluation methodology.

In counseling patients about these areas of care, the guideline says that rheumatologists and other clinicians “must collaborate with specialists in the fields of obstetrics-gynecology, maternal-fetal medicine, and reproductive endocrinology and infertility.”

Mitchel L. Zoler/Frontline Medical News

“One thing this guideline does well is highlight the importance of involving maternal-fetal medicine colleagues,” Alison Cahill, MD, a professor in the department of women’s health at the University of Texas at Austin and a maternal-fetal medicine specialist within UT Health Austin’s Women’s Health Institute, said when asked for comment on the guideline. “We’re always very happy to see patients ahead of time who are planning pregnancy to be able to discuss what the care plan would look like. And specifically, to address medications, if required, for their rheumatologic care.

“As we learn more and more,” she added, “we’ve come to understand that most treatments and medications are actually safe or relatively safe to take in pregnancy. Certainly, the benefit of taking them outweighs any small or theoretic risks. On the flip side, the guideline does a nice job of highlighting the importance of good disease control, both at the time of conception and during pregnancy.”
 

Contraception

In regard to contraception, the guideline strongly recommends the use of effective contraceptives – with a conditional recommendation of IUDs or a subdermal progestin implant – in fertile women with a RMD who have neither systemic lupus erythematosus (SLE) nor positive antiphospholipid antibody (aPL). They also strongly recommend discussing the use of emergency contraception with all RMD patients.

For SLE patients, the guideline strongly recommends the use of effective contraceptives in those with stable or low disease activity who are not positive for aPL. They also strongly recommend progestin‐only or IUD contraceptives over combined estrogen‐progestin contraception. For aPL-positive patients, the guideline strongly recommends against combined estrogen‐progestin contraceptives and for levonorgestrel or copper IUDs or the progestin‐only pill.
 

Assisted reproductive technology

In regard to ART, the guideline strongly recommends proceeding as needed in aPL-negative women with uncomplicated, stable RMD who are on pregnancy‐compatible medications. They also strongly recommend deferring ART in any RMD patients with moderately or severely active disease.

For aPL-positive patients undergoing ART procedures, they strongly recommend prophylactic anticoagulation with heparin or low-molecular-weight heparin (LMWH) in women with obstetric antiphospholipid syndrome (APS) and therapeutic anticoagulation in women with thrombotic APS. In patients undergoing embryo and oocyte cryopreservation, they strongly recommend continuing immunosuppressive and biologic therapies – the exception being cyclophosphamide (CYC) – for anyone in stable condition.
 

Fertility preservation

In regard to fertility preservation in patients taking CYC, the guideline strongly suggests sperm cryopreservation as good practice prior to treatment. They also conditionally recommend monthly gonadotropin‐releasing hormone agonist cotherapy in premenopausal women with RMD.

Hormone therapy

In regard to menopause and hormone therapy, the guideline strongly suggests hormone therapy as good practice in postmenopausal women with RMD, without SLE or positive aPL, and who have severe vasomotor symptoms. Hormone therapy is conditionally recommended in patients with SLE, without positive aPL, and with no contraindications. For aPL-positive patients, they strongly recommend against hormone therapy in women with obstetric and/or thrombotic APS.

Pregnancy assessment and management

Among the many recommendations regarding pregnancy assessment and management, the guideline strongly suggests counseling women with RMD who are considering pregnancy to take into account the improved outcomes for pregnant women with low disease activity. They strongly recommend that women considering pregnancy should switch to pregnancy‐compatible medication and pause to assess its efficacy and tolerability before moving forward, along with strongly recommending that pregnant women with active disease initiate or continue a pregnancy‐compatible steroid‐sparing medication. They also recommend testing for anti‐Ro/SS-A and anti‐La/SS-B in women with SLE, Sjögren’s syndrome, systemic sclerosis, or rheumatoid arthritis, but only once and only before or early in the pregnancy.

For women with systemic sclerosis who develop scleroderma renal crisis during pregnancy, the authors strongly advise using ACE inhibitors or angiotensin receptor blockers “because the risk of maternal or fetal death with untreated disease is higher than the risk associated with use of these medications during pregnancy.”

Among women with SLE, the recommendations strongly call for testing either before or early in pregnancy for anticardiolipin antibody, anti–beta2-glycoprotein I, or positive lupus anticoagulant, as well as initiating or continuing hydroxychloroquine (HCQ) if possible. Starting in the first trimester, the authors also conditionally recommend that SLE patients take low-dose aspirin daily

For pregnant women who test positive for aPL but do not meet criteria for obstetric or thrombotic APS, the guideline conditionally recommends prophylactic treatment with low-dose aspirin daily to protect against preeclampsia. When obstetric APS criteria are met, the guideline strongly advises combined treatment with daily low-dose aspirin and prophylactic-dose heparin (or LMWH), as well as prophylactic-dose anticoagulation for 6-12 weeks post partum. When patients have thrombotic APS, this combination treatment should contain heparin dose at a therapeutic level throughout pregnancy and postpartum. However, the authors conditionally recommend against giving low-dose aspirin plus prophylactic-dose heparin to women without obstetric APS. For refractory obstetric APS, the guideline also contains recommendations that are conditionally against treatment with intravenous immunoglobulin or an increased LMWH dose and strongly against adding prednisone to prophylactic-dose heparin or LMWH and low-dose aspirin. In pregnant patients with primary APS, the authors conditionally advise adding HCQ to prophylactic-dose heparin or LMWH and low-dose aspirin therapy. However, women with aPL who do not meet APS criteria or have another indication for HCQ are conditionally advised against prophylactic treatment with the antimalarial.

For women with Anti-Ro/SS-A and/or anti-La/SS-B antibodies in pregnancy, there is conditional advice to use HCQ. When there is no history of an infant with complete heart block or neonatal lupus erythematosus among women with these antibodies, the guideline conditionally advises serial fetal echocardiography (less often than weekly) starting between 16 and 18 weeks and continuing through 26 weeks, but this should be weekly when there is a prior history. Treatment with oral dexamethasone 4 mg daily is conditionally advised when there is echocardiographic evidence of fetal first- or second-degree heart block, but dexamethasone is not recommended when complete heart block is present.

Finally, in regard to medication use, the authors strongly recommend that men who are planning to be fathers continue on HCQ, azathioprine, 6‐mercaptopurine, colchicine, or tumor necrosis factor inhibitors. Conditional treatment recommendations for men planning for pregnancy include methotrexate, mycophenolate mofetil/mycophenolic acid (MMF), leflunomide, sulfasalazine, calcineurin inhibitors, and NSAIDs. They also strongly recommend that this group of men discontinue CYC and thalidomide.

Pregnant women are strongly recommended to discontinue methotrexate, leflunomide (with cholestyramine washout if there are detectable serum levels of its metabolite prior to pregnancy or as soon as it is confirmed), MMF, CYC, and thalidomide within 3 months prior to conception, and they strongly recommend HCQ (in women with SLE), azathioprine/6‐mercaptopurine, colchicine, or sulfasalazine for use throughout pregnancy. They strongly recommend a combination of low‐dose aspirin and prophylactic‐dose heparin for pregnant women with obstetric APS, along with low‐dose aspirin and therapeutic‐dose heparin for women with thrombotic APS throughout pregnancy and postpartum. However, for women with SLE and those who test positive for aPL but do not meet criteria for obstetric or thrombotic APS, the authors conditionally recommend low-dose aspirin starting in the first trimester.

The guideline suggests that women with RMD should be encouraged to breastfeed if they are willing and able; they also suggest that disease control be maintained through lactation‐compatible medications and that the risks and benefits be reviewed on a patient-by-patient basis. Treatment with HCQ, colchicine, sulfasalazine, rituximab, and all tumor necrosis factor inhibitors are strongly recommended as being compatible with breastfeeding, and they strongly recommend against using CYC, leflunomide, MMF, and thalidomide while breastfeeding.

The authors acknowledged the limitations of their guideline, including the literature review being conducted on studies involving adults and an “inability to include recommendations for uncommon but important clinical situations,” including those involving transgender patients and hormonal therapies.

The authors reported numerous potential conflicts of interest, including receiving research support, consulting fees, speaking fees, and honoraria from various pharmaceutical companies.

SOURCE: Sammaritano LR et al. Arthritis Rheumatol. 2020 Feb 23. doi: 10.1002/art.41191.

A new guideline from the American College of Rheumatology offers the organization’s first clinical recommendations on how to manage reproductive health issues in patients with rheumatic and musculoskeletal diseases (RMDs).

Bruce Jancin/MDedge News

“With the development of this guideline, the ACR recognizes the key role of clinical rheumatologists not only in managing disease activity but also in understanding the interactions of RMDs and their therapies in the context of reproductive health,” wrote Lisa R. Sammaritano, MD, of Weill Cornell Medicine and the Hospital for Special Surgery in New York, and coauthors. The guideline was published in Arthritis & Rheumatology.

To develop an evidence-based guideline on reproductive health in RMD patients, the researchers embarked on a systematic review of studies in areas like contraception, pregnancy and lactation, assisted reproductive technology (ART), fertility preservation, and hormone therapy. The guideline contains 12 ungraded good practice statements and 131 graded recommendations, all developed through the Grading of Recommendations Assessment, Development, and Evaluation methodology.

In counseling patients about these areas of care, the guideline says that rheumatologists and other clinicians “must collaborate with specialists in the fields of obstetrics-gynecology, maternal-fetal medicine, and reproductive endocrinology and infertility.”

Mitchel L. Zoler/Frontline Medical News

“One thing this guideline does well is highlight the importance of involving maternal-fetal medicine colleagues,” Alison Cahill, MD, a professor in the department of women’s health at the University of Texas at Austin and a maternal-fetal medicine specialist within UT Health Austin’s Women’s Health Institute, said when asked for comment on the guideline. “We’re always very happy to see patients ahead of time who are planning pregnancy to be able to discuss what the care plan would look like. And specifically, to address medications, if required, for their rheumatologic care.

“As we learn more and more,” she added, “we’ve come to understand that most treatments and medications are actually safe or relatively safe to take in pregnancy. Certainly, the benefit of taking them outweighs any small or theoretic risks. On the flip side, the guideline does a nice job of highlighting the importance of good disease control, both at the time of conception and during pregnancy.”
 

Contraception

In regard to contraception, the guideline strongly recommends the use of effective contraceptives – with a conditional recommendation of IUDs or a subdermal progestin implant – in fertile women with a RMD who have neither systemic lupus erythematosus (SLE) nor positive antiphospholipid antibody (aPL). They also strongly recommend discussing the use of emergency contraception with all RMD patients.

For SLE patients, the guideline strongly recommends the use of effective contraceptives in those with stable or low disease activity who are not positive for aPL. They also strongly recommend progestin‐only or IUD contraceptives over combined estrogen‐progestin contraception. For aPL-positive patients, the guideline strongly recommends against combined estrogen‐progestin contraceptives and for levonorgestrel or copper IUDs or the progestin‐only pill.
 

Assisted reproductive technology

In regard to ART, the guideline strongly recommends proceeding as needed in aPL-negative women with uncomplicated, stable RMD who are on pregnancy‐compatible medications. They also strongly recommend deferring ART in any RMD patients with moderately or severely active disease.

For aPL-positive patients undergoing ART procedures, they strongly recommend prophylactic anticoagulation with heparin or low-molecular-weight heparin (LMWH) in women with obstetric antiphospholipid syndrome (APS) and therapeutic anticoagulation in women with thrombotic APS. In patients undergoing embryo and oocyte cryopreservation, they strongly recommend continuing immunosuppressive and biologic therapies – the exception being cyclophosphamide (CYC) – for anyone in stable condition.
 

Fertility preservation

In regard to fertility preservation in patients taking CYC, the guideline strongly suggests sperm cryopreservation as good practice prior to treatment. They also conditionally recommend monthly gonadotropin‐releasing hormone agonist cotherapy in premenopausal women with RMD.

Hormone therapy

In regard to menopause and hormone therapy, the guideline strongly suggests hormone therapy as good practice in postmenopausal women with RMD, without SLE or positive aPL, and who have severe vasomotor symptoms. Hormone therapy is conditionally recommended in patients with SLE, without positive aPL, and with no contraindications. For aPL-positive patients, they strongly recommend against hormone therapy in women with obstetric and/or thrombotic APS.

Pregnancy assessment and management

Among the many recommendations regarding pregnancy assessment and management, the guideline strongly suggests counseling women with RMD who are considering pregnancy to take into account the improved outcomes for pregnant women with low disease activity. They strongly recommend that women considering pregnancy should switch to pregnancy‐compatible medication and pause to assess its efficacy and tolerability before moving forward, along with strongly recommending that pregnant women with active disease initiate or continue a pregnancy‐compatible steroid‐sparing medication. They also recommend testing for anti‐Ro/SS-A and anti‐La/SS-B in women with SLE, Sjögren’s syndrome, systemic sclerosis, or rheumatoid arthritis, but only once and only before or early in the pregnancy.

For women with systemic sclerosis who develop scleroderma renal crisis during pregnancy, the authors strongly advise using ACE inhibitors or angiotensin receptor blockers “because the risk of maternal or fetal death with untreated disease is higher than the risk associated with use of these medications during pregnancy.”

Among women with SLE, the recommendations strongly call for testing either before or early in pregnancy for anticardiolipin antibody, anti–beta2-glycoprotein I, or positive lupus anticoagulant, as well as initiating or continuing hydroxychloroquine (HCQ) if possible. Starting in the first trimester, the authors also conditionally recommend that SLE patients take low-dose aspirin daily

For pregnant women who test positive for aPL but do not meet criteria for obstetric or thrombotic APS, the guideline conditionally recommends prophylactic treatment with low-dose aspirin daily to protect against preeclampsia. When obstetric APS criteria are met, the guideline strongly advises combined treatment with daily low-dose aspirin and prophylactic-dose heparin (or LMWH), as well as prophylactic-dose anticoagulation for 6-12 weeks post partum. When patients have thrombotic APS, this combination treatment should contain heparin dose at a therapeutic level throughout pregnancy and postpartum. However, the authors conditionally recommend against giving low-dose aspirin plus prophylactic-dose heparin to women without obstetric APS. For refractory obstetric APS, the guideline also contains recommendations that are conditionally against treatment with intravenous immunoglobulin or an increased LMWH dose and strongly against adding prednisone to prophylactic-dose heparin or LMWH and low-dose aspirin. In pregnant patients with primary APS, the authors conditionally advise adding HCQ to prophylactic-dose heparin or LMWH and low-dose aspirin therapy. However, women with aPL who do not meet APS criteria or have another indication for HCQ are conditionally advised against prophylactic treatment with the antimalarial.

For women with Anti-Ro/SS-A and/or anti-La/SS-B antibodies in pregnancy, there is conditional advice to use HCQ. When there is no history of an infant with complete heart block or neonatal lupus erythematosus among women with these antibodies, the guideline conditionally advises serial fetal echocardiography (less often than weekly) starting between 16 and 18 weeks and continuing through 26 weeks, but this should be weekly when there is a prior history. Treatment with oral dexamethasone 4 mg daily is conditionally advised when there is echocardiographic evidence of fetal first- or second-degree heart block, but dexamethasone is not recommended when complete heart block is present.

Finally, in regard to medication use, the authors strongly recommend that men who are planning to be fathers continue on HCQ, azathioprine, 6‐mercaptopurine, colchicine, or tumor necrosis factor inhibitors. Conditional treatment recommendations for men planning for pregnancy include methotrexate, mycophenolate mofetil/mycophenolic acid (MMF), leflunomide, sulfasalazine, calcineurin inhibitors, and NSAIDs. They also strongly recommend that this group of men discontinue CYC and thalidomide.

Pregnant women are strongly recommended to discontinue methotrexate, leflunomide (with cholestyramine washout if there are detectable serum levels of its metabolite prior to pregnancy or as soon as it is confirmed), MMF, CYC, and thalidomide within 3 months prior to conception, and they strongly recommend HCQ (in women with SLE), azathioprine/6‐mercaptopurine, colchicine, or sulfasalazine for use throughout pregnancy. They strongly recommend a combination of low‐dose aspirin and prophylactic‐dose heparin for pregnant women with obstetric APS, along with low‐dose aspirin and therapeutic‐dose heparin for women with thrombotic APS throughout pregnancy and postpartum. However, for women with SLE and those who test positive for aPL but do not meet criteria for obstetric or thrombotic APS, the authors conditionally recommend low-dose aspirin starting in the first trimester.

The guideline suggests that women with RMD should be encouraged to breastfeed if they are willing and able; they also suggest that disease control be maintained through lactation‐compatible medications and that the risks and benefits be reviewed on a patient-by-patient basis. Treatment with HCQ, colchicine, sulfasalazine, rituximab, and all tumor necrosis factor inhibitors are strongly recommended as being compatible with breastfeeding, and they strongly recommend against using CYC, leflunomide, MMF, and thalidomide while breastfeeding.

The authors acknowledged the limitations of their guideline, including the literature review being conducted on studies involving adults and an “inability to include recommendations for uncommon but important clinical situations,” including those involving transgender patients and hormonal therapies.

The authors reported numerous potential conflicts of interest, including receiving research support, consulting fees, speaking fees, and honoraria from various pharmaceutical companies.

SOURCE: Sammaritano LR et al. Arthritis Rheumatol. 2020 Feb 23. doi: 10.1002/art.41191.

A new guideline from the American College of Rheumatology offers the organization’s first clinical recommendations on how to manage reproductive health issues in patients with rheumatic and musculoskeletal diseases (RMDs).

Bruce Jancin/MDedge News

“With the development of this guideline, the ACR recognizes the key role of clinical rheumatologists not only in managing disease activity but also in understanding the interactions of RMDs and their therapies in the context of reproductive health,” wrote Lisa R. Sammaritano, MD, of Weill Cornell Medicine and the Hospital for Special Surgery in New York, and coauthors. The guideline was published in Arthritis & Rheumatology.

To develop an evidence-based guideline on reproductive health in RMD patients, the researchers embarked on a systematic review of studies in areas like contraception, pregnancy and lactation, assisted reproductive technology (ART), fertility preservation, and hormone therapy. The guideline contains 12 ungraded good practice statements and 131 graded recommendations, all developed through the Grading of Recommendations Assessment, Development, and Evaluation methodology.

In counseling patients about these areas of care, the guideline says that rheumatologists and other clinicians “must collaborate with specialists in the fields of obstetrics-gynecology, maternal-fetal medicine, and reproductive endocrinology and infertility.”

Mitchel L. Zoler/Frontline Medical News

“One thing this guideline does well is highlight the importance of involving maternal-fetal medicine colleagues,” Alison Cahill, MD, a professor in the department of women’s health at the University of Texas at Austin and a maternal-fetal medicine specialist within UT Health Austin’s Women’s Health Institute, said when asked for comment on the guideline. “We’re always very happy to see patients ahead of time who are planning pregnancy to be able to discuss what the care plan would look like. And specifically, to address medications, if required, for their rheumatologic care.

“As we learn more and more,” she added, “we’ve come to understand that most treatments and medications are actually safe or relatively safe to take in pregnancy. Certainly, the benefit of taking them outweighs any small or theoretic risks. On the flip side, the guideline does a nice job of highlighting the importance of good disease control, both at the time of conception and during pregnancy.”
 

Contraception

In regard to contraception, the guideline strongly recommends the use of effective contraceptives – with a conditional recommendation of IUDs or a subdermal progestin implant – in fertile women with a RMD who have neither systemic lupus erythematosus (SLE) nor positive antiphospholipid antibody (aPL). They also strongly recommend discussing the use of emergency contraception with all RMD patients.

For SLE patients, the guideline strongly recommends the use of effective contraceptives in those with stable or low disease activity who are not positive for aPL. They also strongly recommend progestin‐only or IUD contraceptives over combined estrogen‐progestin contraception. For aPL-positive patients, the guideline strongly recommends against combined estrogen‐progestin contraceptives and for levonorgestrel or copper IUDs or the progestin‐only pill.
 

Assisted reproductive technology

In regard to ART, the guideline strongly recommends proceeding as needed in aPL-negative women with uncomplicated, stable RMD who are on pregnancy‐compatible medications. They also strongly recommend deferring ART in any RMD patients with moderately or severely active disease.

For aPL-positive patients undergoing ART procedures, they strongly recommend prophylactic anticoagulation with heparin or low-molecular-weight heparin (LMWH) in women with obstetric antiphospholipid syndrome (APS) and therapeutic anticoagulation in women with thrombotic APS. In patients undergoing embryo and oocyte cryopreservation, they strongly recommend continuing immunosuppressive and biologic therapies – the exception being cyclophosphamide (CYC) – for anyone in stable condition.
 

Fertility preservation

In regard to fertility preservation in patients taking CYC, the guideline strongly suggests sperm cryopreservation as good practice prior to treatment. They also conditionally recommend monthly gonadotropin‐releasing hormone agonist cotherapy in premenopausal women with RMD.

Hormone therapy

In regard to menopause and hormone therapy, the guideline strongly suggests hormone therapy as good practice in postmenopausal women with RMD, without SLE or positive aPL, and who have severe vasomotor symptoms. Hormone therapy is conditionally recommended in patients with SLE, without positive aPL, and with no contraindications. For aPL-positive patients, they strongly recommend against hormone therapy in women with obstetric and/or thrombotic APS.

Pregnancy assessment and management

Among the many recommendations regarding pregnancy assessment and management, the guideline strongly suggests counseling women with RMD who are considering pregnancy to take into account the improved outcomes for pregnant women with low disease activity. They strongly recommend that women considering pregnancy should switch to pregnancy‐compatible medication and pause to assess its efficacy and tolerability before moving forward, along with strongly recommending that pregnant women with active disease initiate or continue a pregnancy‐compatible steroid‐sparing medication. They also recommend testing for anti‐Ro/SS-A and anti‐La/SS-B in women with SLE, Sjögren’s syndrome, systemic sclerosis, or rheumatoid arthritis, but only once and only before or early in the pregnancy.

For women with systemic sclerosis who develop scleroderma renal crisis during pregnancy, the authors strongly advise using ACE inhibitors or angiotensin receptor blockers “because the risk of maternal or fetal death with untreated disease is higher than the risk associated with use of these medications during pregnancy.”

Among women with SLE, the recommendations strongly call for testing either before or early in pregnancy for anticardiolipin antibody, anti–beta2-glycoprotein I, or positive lupus anticoagulant, as well as initiating or continuing hydroxychloroquine (HCQ) if possible. Starting in the first trimester, the authors also conditionally recommend that SLE patients take low-dose aspirin daily

For pregnant women who test positive for aPL but do not meet criteria for obstetric or thrombotic APS, the guideline conditionally recommends prophylactic treatment with low-dose aspirin daily to protect against preeclampsia. When obstetric APS criteria are met, the guideline strongly advises combined treatment with daily low-dose aspirin and prophylactic-dose heparin (or LMWH), as well as prophylactic-dose anticoagulation for 6-12 weeks post partum. When patients have thrombotic APS, this combination treatment should contain heparin dose at a therapeutic level throughout pregnancy and postpartum. However, the authors conditionally recommend against giving low-dose aspirin plus prophylactic-dose heparin to women without obstetric APS. For refractory obstetric APS, the guideline also contains recommendations that are conditionally against treatment with intravenous immunoglobulin or an increased LMWH dose and strongly against adding prednisone to prophylactic-dose heparin or LMWH and low-dose aspirin. In pregnant patients with primary APS, the authors conditionally advise adding HCQ to prophylactic-dose heparin or LMWH and low-dose aspirin therapy. However, women with aPL who do not meet APS criteria or have another indication for HCQ are conditionally advised against prophylactic treatment with the antimalarial.

For women with Anti-Ro/SS-A and/or anti-La/SS-B antibodies in pregnancy, there is conditional advice to use HCQ. When there is no history of an infant with complete heart block or neonatal lupus erythematosus among women with these antibodies, the guideline conditionally advises serial fetal echocardiography (less often than weekly) starting between 16 and 18 weeks and continuing through 26 weeks, but this should be weekly when there is a prior history. Treatment with oral dexamethasone 4 mg daily is conditionally advised when there is echocardiographic evidence of fetal first- or second-degree heart block, but dexamethasone is not recommended when complete heart block is present.

Finally, in regard to medication use, the authors strongly recommend that men who are planning to be fathers continue on HCQ, azathioprine, 6‐mercaptopurine, colchicine, or tumor necrosis factor inhibitors. Conditional treatment recommendations for men planning for pregnancy include methotrexate, mycophenolate mofetil/mycophenolic acid (MMF), leflunomide, sulfasalazine, calcineurin inhibitors, and NSAIDs. They also strongly recommend that this group of men discontinue CYC and thalidomide.

Pregnant women are strongly recommended to discontinue methotrexate, leflunomide (with cholestyramine washout if there are detectable serum levels of its metabolite prior to pregnancy or as soon as it is confirmed), MMF, CYC, and thalidomide within 3 months prior to conception, and they strongly recommend HCQ (in women with SLE), azathioprine/6‐mercaptopurine, colchicine, or sulfasalazine for use throughout pregnancy. They strongly recommend a combination of low‐dose aspirin and prophylactic‐dose heparin for pregnant women with obstetric APS, along with low‐dose aspirin and therapeutic‐dose heparin for women with thrombotic APS throughout pregnancy and postpartum. However, for women with SLE and those who test positive for aPL but do not meet criteria for obstetric or thrombotic APS, the authors conditionally recommend low-dose aspirin starting in the first trimester.

The guideline suggests that women with RMD should be encouraged to breastfeed if they are willing and able; they also suggest that disease control be maintained through lactation‐compatible medications and that the risks and benefits be reviewed on a patient-by-patient basis. Treatment with HCQ, colchicine, sulfasalazine, rituximab, and all tumor necrosis factor inhibitors are strongly recommended as being compatible with breastfeeding, and they strongly recommend against using CYC, leflunomide, MMF, and thalidomide while breastfeeding.

The authors acknowledged the limitations of their guideline, including the literature review being conducted on studies involving adults and an “inability to include recommendations for uncommon but important clinical situations,” including those involving transgender patients and hormonal therapies.

The authors reported numerous potential conflicts of interest, including receiving research support, consulting fees, speaking fees, and honoraria from various pharmaceutical companies.

SOURCE: Sammaritano LR et al. Arthritis Rheumatol. 2020 Feb 23. doi: 10.1002/art.41191.

Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease that affects hair follicles, with predilection for intertriginous sites. The prevalence of HS ranges from 0.1% to 2%, with HS significantly affecting the quality of life for patients, with both physical and emotional consequences.

Guidelines from the U.S. and Canadian Hidradenitis Suppurativa Foundations provide a summary of management and treatment for patients.
 

Grading

Hurley staging is recommended to determine therapies. Stage I is classified by recurrent nodules and abscesses with minimal scars. Stage II is classified by one or a limited number of sinuses and/or scarring within a body region. Stage III is classified by multiple or extensive sinuses and/or scarring. The Dermatology Life Quality Index and pain visual analog scale scores can be used in addition to the Hurley staging for management.

Diagnostic testing/comorbidities screening

There is limited evidence for microbiological testing for HS because skin flora is the main bacteria cultured. Patients should be screened for smoking use, diabetes, metabolic syndrome, depression/anxiety, follicular occlusion tetrad, and squamous cell carcinoma. Some studies have suggested an association between the severity of HS and smoking; therefore, smoking cessation is recommended. Patients should also be counseled on weight loss.

Zinc supplementation (90 mg daily) may be helpful. However, there is insufficient evidence for recommendations to avoid diary, brewer’s yeast, friction, deodorant, depilation, or shaving. There is also insufficient data to support vitamin D supplementation.
 

Topical/intralesional therapies

Expert opinion supports the use of chlorhexidine, benzoyl peroxide, or zinc pyrithione. A keratolytic and antiseptic cream such as resorcinol 15% cream may be used but can cause contact dermatitis. Topical clindamycin may decrease pustules formation, but it can increase resistance to Staphylococcus aureus. Triamcinolone intravlesional injections may decrease inflamed HS lesions in the short term.

Systemic antibiotics

Systemic antibiotics have been used for decades to treat HS. Tetracyclines for a 12-week course or long-term maintenance can be used in mild to moderate HS. Clindamycin and rifampin combination can be used as second-line therapy for mild to moderate HS. Moxifloxacin, metronidazole, and rifampin combination can also be considered second-line treatment for moderate to severe disease. Dapsone can be used in patients with Hurley stage I or II for maintenance therapy. Ertapenem IV can be used as a rescue or as bridge therapy for severe disease.

The duration of antibiotics and frequency of use depends on each patient and resistance.

Hormonal agents and retinoids

Although androgens may influence HS, evidence for hormonal agents is limited. Hormonal agents, such as ethinyl estradiol and spironolactone, can be considered for females with mild to moderate HS. Retinoids may be considered as a second- or third-line agent, especially in patients with severe acne and HS.

Immunosuppressants and biologics

Immunosuppressants such as methotrexate and azathioprine provide limited benefit; therefore, they are not recommended. Colchicine with minocycline may provide slight benefit in refractory mild to moderate HS. Cyclosporine may be considered in recalcitrant, severe HS. Systemic corticosteroids can be used short term for acute flares or long term for severe HS.

Biologic therapy is becoming more common and the choice of therapy for moderate to severe HS. Adalimumab is currently the only Food and Drug Administration–approved tumor necrosis factor–inhibitor treatment for HS. Other biologics – including infliximab, anakinra, and ustekinumab – may be effective for HS, but optimal dosing needs to be determined.
 

Pain management

While there are no studies about pain in HS, acute pain management should include topical analgesics and oral nonsteroidal anti-inflammatory drugs. Anticonvulsants such as pregabalin or gabapentin may help with neuropathic pain, and opioids can be considered if there is no improvement with first-line agents.

Surgical management

Recurrent nodules and tunnels can be deroofed or excised. Acute abscesses may be relieved by incision and drainage. Extensive lesions may require wide local scalpel excision, carbon dioxide laser excision, or electrosurgical excision. Surgery alone does not affect the biology of HS; therefore, surgical interventions should be reserved for disease that is not managed by medical therapy.

The bottom line

HS is a chronic inflammatory condition with complex medical management and surgical treatment options. Hurley staging I-III can be used to grade severity and determine therapy. Management of pain, tobacco cessation, weight loss, and mental health are important aspects of HS. Zinc supplementation (90 mg daily) may be helpful. Experts opinion supports the use of chlorhexidine, benzoyl peroxide or zinc pyrithione.

Acute lesions may be managed with short-term oral or intralesional corticosteroids, as well as deroofing or incision and drainage. Moderate-to-severe HS may be managed with systemic antibiotics or biologics and surgical therapy. Adalimumab is the only FDA-approved biologic for treatment of HS.

Dr. Chuong is a second-year resident in the family medicine residency program at Abington (Pa.) Jefferson Health. Dr. Skolnik is professor of family and community medicine at Jefferson Medical College, Philadelphia, and an associate director of the family medicine residency program at Abington Jefferson Health.

References

Alikhan A, Sayed C, Alavi A, et al. North American clinical management guidelines for hidradenitis suppurativa: A publication from the United States and Canadian Hidradenitis Suppurativa Foundations. Part I: Diagnosis, evaluation, and the use of complementary and procedural management. J Am Acad Dermatol. 2019 Jul;81(1):76-90.

Alikhan A, Sayed C, Alavi A, et al. North American clinical management guidelines for hidradenitis suppurativa: A publication form the United States and Canadian Hidradenitis Suppurativa Foundations. Part II: Topical, intralesional, and systemic medical management. J Am Acad Dermatol. 2019 Jul;81(1):91-101.

Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease that affects hair follicles, with predilection for intertriginous sites. The prevalence of HS ranges from 0.1% to 2%, with HS significantly affecting the quality of life for patients, with both physical and emotional consequences.

Guidelines from the U.S. and Canadian Hidradenitis Suppurativa Foundations provide a summary of management and treatment for patients.
 

Grading

Hurley staging is recommended to determine therapies. Stage I is classified by recurrent nodules and abscesses with minimal scars. Stage II is classified by one or a limited number of sinuses and/or scarring within a body region. Stage III is classified by multiple or extensive sinuses and/or scarring. The Dermatology Life Quality Index and pain visual analog scale scores can be used in addition to the Hurley staging for management.

Diagnostic testing/comorbidities screening

There is limited evidence for microbiological testing for HS because skin flora is the main bacteria cultured. Patients should be screened for smoking use, diabetes, metabolic syndrome, depression/anxiety, follicular occlusion tetrad, and squamous cell carcinoma. Some studies have suggested an association between the severity of HS and smoking; therefore, smoking cessation is recommended. Patients should also be counseled on weight loss.

Zinc supplementation (90 mg daily) may be helpful. However, there is insufficient evidence for recommendations to avoid diary, brewer’s yeast, friction, deodorant, depilation, or shaving. There is also insufficient data to support vitamin D supplementation.
 

Topical/intralesional therapies

Expert opinion supports the use of chlorhexidine, benzoyl peroxide, or zinc pyrithione. A keratolytic and antiseptic cream such as resorcinol 15% cream may be used but can cause contact dermatitis. Topical clindamycin may decrease pustules formation, but it can increase resistance to Staphylococcus aureus. Triamcinolone intravlesional injections may decrease inflamed HS lesions in the short term.

Systemic antibiotics

Systemic antibiotics have been used for decades to treat HS. Tetracyclines for a 12-week course or long-term maintenance can be used in mild to moderate HS. Clindamycin and rifampin combination can be used as second-line therapy for mild to moderate HS. Moxifloxacin, metronidazole, and rifampin combination can also be considered second-line treatment for moderate to severe disease. Dapsone can be used in patients with Hurley stage I or II for maintenance therapy. Ertapenem IV can be used as a rescue or as bridge therapy for severe disease.

The duration of antibiotics and frequency of use depends on each patient and resistance.

Hormonal agents and retinoids

Although androgens may influence HS, evidence for hormonal agents is limited. Hormonal agents, such as ethinyl estradiol and spironolactone, can be considered for females with mild to moderate HS. Retinoids may be considered as a second- or third-line agent, especially in patients with severe acne and HS.

Immunosuppressants and biologics

Immunosuppressants such as methotrexate and azathioprine provide limited benefit; therefore, they are not recommended. Colchicine with minocycline may provide slight benefit in refractory mild to moderate HS. Cyclosporine may be considered in recalcitrant, severe HS. Systemic corticosteroids can be used short term for acute flares or long term for severe HS.

Biologic therapy is becoming more common and the choice of therapy for moderate to severe HS. Adalimumab is currently the only Food and Drug Administration–approved tumor necrosis factor–inhibitor treatment for HS. Other biologics – including infliximab, anakinra, and ustekinumab – may be effective for HS, but optimal dosing needs to be determined.
 

Pain management

While there are no studies about pain in HS, acute pain management should include topical analgesics and oral nonsteroidal anti-inflammatory drugs. Anticonvulsants such as pregabalin or gabapentin may help with neuropathic pain, and opioids can be considered if there is no improvement with first-line agents.

Surgical management

Recurrent nodules and tunnels can be deroofed or excised. Acute abscesses may be relieved by incision and drainage. Extensive lesions may require wide local scalpel excision, carbon dioxide laser excision, or electrosurgical excision. Surgery alone does not affect the biology of HS; therefore, surgical interventions should be reserved for disease that is not managed by medical therapy.

The bottom line

HS is a chronic inflammatory condition with complex medical management and surgical treatment options. Hurley staging I-III can be used to grade severity and determine therapy. Management of pain, tobacco cessation, weight loss, and mental health are important aspects of HS. Zinc supplementation (90 mg daily) may be helpful. Experts opinion supports the use of chlorhexidine, benzoyl peroxide or zinc pyrithione.

Acute lesions may be managed with short-term oral or intralesional corticosteroids, as well as deroofing or incision and drainage. Moderate-to-severe HS may be managed with systemic antibiotics or biologics and surgical therapy. Adalimumab is the only FDA-approved biologic for treatment of HS.

Dr. Chuong is a second-year resident in the family medicine residency program at Abington (Pa.) Jefferson Health. Dr. Skolnik is professor of family and community medicine at Jefferson Medical College, Philadelphia, and an associate director of the family medicine residency program at Abington Jefferson Health.

References

Alikhan A, Sayed C, Alavi A, et al. North American clinical management guidelines for hidradenitis suppurativa: A publication from the United States and Canadian Hidradenitis Suppurativa Foundations. Part I: Diagnosis, evaluation, and the use of complementary and procedural management. J Am Acad Dermatol. 2019 Jul;81(1):76-90.

Alikhan A, Sayed C, Alavi A, et al. North American clinical management guidelines for hidradenitis suppurativa: A publication form the United States and Canadian Hidradenitis Suppurativa Foundations. Part II: Topical, intralesional, and systemic medical management. J Am Acad Dermatol. 2019 Jul;81(1):91-101.

Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease that affects hair follicles, with predilection for intertriginous sites. The prevalence of HS ranges from 0.1% to 2%, with HS significantly affecting the quality of life for patients, with both physical and emotional consequences.

Guidelines from the U.S. and Canadian Hidradenitis Suppurativa Foundations provide a summary of management and treatment for patients.
 

Grading

Hurley staging is recommended to determine therapies. Stage I is classified by recurrent nodules and abscesses with minimal scars. Stage II is classified by one or a limited number of sinuses and/or scarring within a body region. Stage III is classified by multiple or extensive sinuses and/or scarring. The Dermatology Life Quality Index and pain visual analog scale scores can be used in addition to the Hurley staging for management.

Diagnostic testing/comorbidities screening

There is limited evidence for microbiological testing for HS because skin flora is the main bacteria cultured. Patients should be screened for smoking use, diabetes, metabolic syndrome, depression/anxiety, follicular occlusion tetrad, and squamous cell carcinoma. Some studies have suggested an association between the severity of HS and smoking; therefore, smoking cessation is recommended. Patients should also be counseled on weight loss.

Zinc supplementation (90 mg daily) may be helpful. However, there is insufficient evidence for recommendations to avoid diary, brewer’s yeast, friction, deodorant, depilation, or shaving. There is also insufficient data to support vitamin D supplementation.
 

Topical/intralesional therapies

Expert opinion supports the use of chlorhexidine, benzoyl peroxide, or zinc pyrithione. A keratolytic and antiseptic cream such as resorcinol 15% cream may be used but can cause contact dermatitis. Topical clindamycin may decrease pustules formation, but it can increase resistance to Staphylococcus aureus. Triamcinolone intravlesional injections may decrease inflamed HS lesions in the short term.

Systemic antibiotics

Systemic antibiotics have been used for decades to treat HS. Tetracyclines for a 12-week course or long-term maintenance can be used in mild to moderate HS. Clindamycin and rifampin combination can be used as second-line therapy for mild to moderate HS. Moxifloxacin, metronidazole, and rifampin combination can also be considered second-line treatment for moderate to severe disease. Dapsone can be used in patients with Hurley stage I or II for maintenance therapy. Ertapenem IV can be used as a rescue or as bridge therapy for severe disease.

The duration of antibiotics and frequency of use depends on each patient and resistance.

Hormonal agents and retinoids

Although androgens may influence HS, evidence for hormonal agents is limited. Hormonal agents, such as ethinyl estradiol and spironolactone, can be considered for females with mild to moderate HS. Retinoids may be considered as a second- or third-line agent, especially in patients with severe acne and HS.

Immunosuppressants and biologics

Immunosuppressants such as methotrexate and azathioprine provide limited benefit; therefore, they are not recommended. Colchicine with minocycline may provide slight benefit in refractory mild to moderate HS. Cyclosporine may be considered in recalcitrant, severe HS. Systemic corticosteroids can be used short term for acute flares or long term for severe HS.

Biologic therapy is becoming more common and the choice of therapy for moderate to severe HS. Adalimumab is currently the only Food and Drug Administration–approved tumor necrosis factor–inhibitor treatment for HS. Other biologics – including infliximab, anakinra, and ustekinumab – may be effective for HS, but optimal dosing needs to be determined.
 

Pain management

While there are no studies about pain in HS, acute pain management should include topical analgesics and oral nonsteroidal anti-inflammatory drugs. Anticonvulsants such as pregabalin or gabapentin may help with neuropathic pain, and opioids can be considered if there is no improvement with first-line agents.

Surgical management

Recurrent nodules and tunnels can be deroofed or excised. Acute abscesses may be relieved by incision and drainage. Extensive lesions may require wide local scalpel excision, carbon dioxide laser excision, or electrosurgical excision. Surgery alone does not affect the biology of HS; therefore, surgical interventions should be reserved for disease that is not managed by medical therapy.

The bottom line

HS is a chronic inflammatory condition with complex medical management and surgical treatment options. Hurley staging I-III can be used to grade severity and determine therapy. Management of pain, tobacco cessation, weight loss, and mental health are important aspects of HS. Zinc supplementation (90 mg daily) may be helpful. Experts opinion supports the use of chlorhexidine, benzoyl peroxide or zinc pyrithione.

Acute lesions may be managed with short-term oral or intralesional corticosteroids, as well as deroofing or incision and drainage. Moderate-to-severe HS may be managed with systemic antibiotics or biologics and surgical therapy. Adalimumab is the only FDA-approved biologic for treatment of HS.

Dr. Chuong is a second-year resident in the family medicine residency program at Abington (Pa.) Jefferson Health. Dr. Skolnik is professor of family and community medicine at Jefferson Medical College, Philadelphia, and an associate director of the family medicine residency program at Abington Jefferson Health.

References

Alikhan A, Sayed C, Alavi A, et al. North American clinical management guidelines for hidradenitis suppurativa: A publication from the United States and Canadian Hidradenitis Suppurativa Foundations. Part I: Diagnosis, evaluation, and the use of complementary and procedural management. J Am Acad Dermatol. 2019 Jul;81(1):76-90.

Alikhan A, Sayed C, Alavi A, et al. North American clinical management guidelines for hidradenitis suppurativa: A publication form the United States and Canadian Hidradenitis Suppurativa Foundations. Part II: Topical, intralesional, and systemic medical management. J Am Acad Dermatol. 2019 Jul;81(1):91-101.

Over one-third of undisclosed industry payments made to physician-authors of American College of Rheumatology clinical practice guidelines were relevant to guideline recommendations, according to a recent review in Arthritis & Rheumatology.

frankpeters/Getty Images

Since 2014, 56 of 89 total physician-authors across five ACR clinical practice guidelines have been paid a total of $9,728,751 from industry sources. Nineteen of 89 authors received $1,961,362 in industry payments that were directly relevant to a guideline’s recommendations, and $699,561 of these payments (35.7%) were undisclosed, according to Cole Wayant, of the Oklahoma State University Center for Health Sciences, Tulsa, and colleagues.

The ACR’s Policy and Procedure Manual for Clinical Practice Guidelines, last updated in January 2015, allows up to 49% of authors in a clinical practice guideline to have financial conflicts of interest, including intellectual conflicts of interest, and requires them to report those relationships. When the ACR creates a call for letters of interest for a guideline, it includes a list of companies and organizations that could be affected by the guideline topic. To be considered conflict free, an author must not have ties to these companies and organizations for 1 year before the deadline on the letter of interest and 1 year after a guideline is published. This policy extends to members of an ACR guideline development group, literature review team, and voting panel. Under these guidelines, an author who has any relationship with a company is considered conflicted, which counts toward this total.

Mr. Wayant and colleagues performed a cross-sectional study of five ACR guidelines published since August 2014 on axial spondyloarthritis (27 authors), glucocorticoid-induced osteoporosis (21 authors), RA (26 authors), perioperative management of antirheumatic medication (31 authors), and polymyalgia rheumatica (46 authors). Using the Open Payments Database, the researchers searched for any general (speaking fees, consulting fees, education, honoraria, travel, food, or beverage payments) research, associated research, and ownership (stocks or dividends) relationships reported by guideline authors in the 12 months before a guideline was published. The guidelines on axial spondyloarthritis, glucocorticoid-induced osteoporosis, and RA contained specific recommendations for classes of medications or branded drugs, and conflicts from authors in those guidelines were assessed to determine relevancy of those payments.

Of the 56 physician-authors who received at least one payment (62.9%), the median payment was $522. However, 51 authors reported receiving more than $1,000, 42 authors reported more than $10,000, 20 authors reported more than $100,000, and 2 authors reported more than $1 million. Overall, 14 of 56 authors (25.0%) reported having no financial conflicts of interest, but did in fact receive some payment, and $4,189,090 of the $9,728,751 (43.1%) was not reported. The researchers said that the 19 authors with directly relevant payments were members of the voting panel (11 authors), literature review team (6 authors), and core leadership team (3 authors).

Physician-authors of clinical practice guidelines receiving payments from industry is not an issue specific to rheumatology. In an interview, Mr. Wayant said that authors of clinical guidelines across many different medical specialties often work closely with industry and hold “numerous conflicts of interest.”

“If professional societies are meant to be the public face of specialty providers, one would expect the guideline authors to resemble all society members,” Mr. Wayant said. “However, we routinely find that authors of professional society guidelines have large financial conflicts of interest that exceed the national average, indicating that the views and opinions of guideline authors may not reflect the opinion of most providers.”

These financial relationships between industry and physician authors have been shown to affect research results. A Cochrane Review published in 2017 evaluating industry sponsorship and research outcomes found that studies sponsored by industry were more likely to have favorable efficacy results and conclusions, compared with studies not sponsored by industry sources (Cochrane Database Syst Rev. 2017 Feb 16;2:MR000033). As medical societies continue to become more involved with clinical practice guidelines, recommendations from physician-authors with financial ties to industry can present a conflict of interest. Recommendations in clinical practice guidelines often affect reimbursement of a drug from insurance, and an author can vote for a drug recommendation in a guideline that may not match patient values and preferences, noted Mr. Wayant.

“These authors are fundamentally different from the average rheumatologist that stays up to date with the medical literature, in terms of financial ties to industry,” he said. “Removing the influence of for-profit companies from guideline development cannot harm the rigor of the guideline recommendations, since many medical professionals without conflicts are experts in evidence-based medicine and study appraisal.”

Being financially linked to industry does not automatically make one the most qualified candidate for deciding which therapies are best for patients, Mr. Wayant explained, and guidelines should reflect the values of patients and the medical profession, rather than industry.

“Given the importance of guidelines, [we] encourage the ACR and all professional societies to do everything possible to be above reproach and seek out authors who do not have financial conflicts to write the guidelines,” he said.

The authors reported having no funding source for the study. One author reported serving on an advisory board for Janssen involving infliximab and golimumab, for Sanofi Genzyme involving sarilumab, and receiving payment for a survey from Comsort. The other authors reported having no conflicts of interest.

SOURCE: Wayant C et al. Arthritis Rheumatol. 2020 Feb 10. doi: 10.1002/art.41224.

Over one-third of undisclosed industry payments made to physician-authors of American College of Rheumatology clinical practice guidelines were relevant to guideline recommendations, according to a recent review in Arthritis & Rheumatology.

frankpeters/Getty Images

Since 2014, 56 of 89 total physician-authors across five ACR clinical practice guidelines have been paid a total of $9,728,751 from industry sources. Nineteen of 89 authors received $1,961,362 in industry payments that were directly relevant to a guideline’s recommendations, and $699,561 of these payments (35.7%) were undisclosed, according to Cole Wayant, of the Oklahoma State University Center for Health Sciences, Tulsa, and colleagues.

The ACR’s Policy and Procedure Manual for Clinical Practice Guidelines, last updated in January 2015, allows up to 49% of authors in a clinical practice guideline to have financial conflicts of interest, including intellectual conflicts of interest, and requires them to report those relationships. When the ACR creates a call for letters of interest for a guideline, it includes a list of companies and organizations that could be affected by the guideline topic. To be considered conflict free, an author must not have ties to these companies and organizations for 1 year before the deadline on the letter of interest and 1 year after a guideline is published. This policy extends to members of an ACR guideline development group, literature review team, and voting panel. Under these guidelines, an author who has any relationship with a company is considered conflicted, which counts toward this total.

Mr. Wayant and colleagues performed a cross-sectional study of five ACR guidelines published since August 2014 on axial spondyloarthritis (27 authors), glucocorticoid-induced osteoporosis (21 authors), RA (26 authors), perioperative management of antirheumatic medication (31 authors), and polymyalgia rheumatica (46 authors). Using the Open Payments Database, the researchers searched for any general (speaking fees, consulting fees, education, honoraria, travel, food, or beverage payments) research, associated research, and ownership (stocks or dividends) relationships reported by guideline authors in the 12 months before a guideline was published. The guidelines on axial spondyloarthritis, glucocorticoid-induced osteoporosis, and RA contained specific recommendations for classes of medications or branded drugs, and conflicts from authors in those guidelines were assessed to determine relevancy of those payments.

Of the 56 physician-authors who received at least one payment (62.9%), the median payment was $522. However, 51 authors reported receiving more than $1,000, 42 authors reported more than $10,000, 20 authors reported more than $100,000, and 2 authors reported more than $1 million. Overall, 14 of 56 authors (25.0%) reported having no financial conflicts of interest, but did in fact receive some payment, and $4,189,090 of the $9,728,751 (43.1%) was not reported. The researchers said that the 19 authors with directly relevant payments were members of the voting panel (11 authors), literature review team (6 authors), and core leadership team (3 authors).

Physician-authors of clinical practice guidelines receiving payments from industry is not an issue specific to rheumatology. In an interview, Mr. Wayant said that authors of clinical guidelines across many different medical specialties often work closely with industry and hold “numerous conflicts of interest.”

“If professional societies are meant to be the public face of specialty providers, one would expect the guideline authors to resemble all society members,” Mr. Wayant said. “However, we routinely find that authors of professional society guidelines have large financial conflicts of interest that exceed the national average, indicating that the views and opinions of guideline authors may not reflect the opinion of most providers.”

These financial relationships between industry and physician authors have been shown to affect research results. A Cochrane Review published in 2017 evaluating industry sponsorship and research outcomes found that studies sponsored by industry were more likely to have favorable efficacy results and conclusions, compared with studies not sponsored by industry sources (Cochrane Database Syst Rev. 2017 Feb 16;2:MR000033). As medical societies continue to become more involved with clinical practice guidelines, recommendations from physician-authors with financial ties to industry can present a conflict of interest. Recommendations in clinical practice guidelines often affect reimbursement of a drug from insurance, and an author can vote for a drug recommendation in a guideline that may not match patient values and preferences, noted Mr. Wayant.

“These authors are fundamentally different from the average rheumatologist that stays up to date with the medical literature, in terms of financial ties to industry,” he said. “Removing the influence of for-profit companies from guideline development cannot harm the rigor of the guideline recommendations, since many medical professionals without conflicts are experts in evidence-based medicine and study appraisal.”

Being financially linked to industry does not automatically make one the most qualified candidate for deciding which therapies are best for patients, Mr. Wayant explained, and guidelines should reflect the values of patients and the medical profession, rather than industry.

“Given the importance of guidelines, [we] encourage the ACR and all professional societies to do everything possible to be above reproach and seek out authors who do not have financial conflicts to write the guidelines,” he said.

The authors reported having no funding source for the study. One author reported serving on an advisory board for Janssen involving infliximab and golimumab, for Sanofi Genzyme involving sarilumab, and receiving payment for a survey from Comsort. The other authors reported having no conflicts of interest.

SOURCE: Wayant C et al. Arthritis Rheumatol. 2020 Feb 10. doi: 10.1002/art.41224.

Over one-third of undisclosed industry payments made to physician-authors of American College of Rheumatology clinical practice guidelines were relevant to guideline recommendations, according to a recent review in Arthritis & Rheumatology.

frankpeters/Getty Images

Since 2014, 56 of 89 total physician-authors across five ACR clinical practice guidelines have been paid a total of $9,728,751 from industry sources. Nineteen of 89 authors received $1,961,362 in industry payments that were directly relevant to a guideline’s recommendations, and $699,561 of these payments (35.7%) were undisclosed, according to Cole Wayant, of the Oklahoma State University Center for Health Sciences, Tulsa, and colleagues.

The ACR’s Policy and Procedure Manual for Clinical Practice Guidelines, last updated in January 2015, allows up to 49% of authors in a clinical practice guideline to have financial conflicts of interest, including intellectual conflicts of interest, and requires them to report those relationships. When the ACR creates a call for letters of interest for a guideline, it includes a list of companies and organizations that could be affected by the guideline topic. To be considered conflict free, an author must not have ties to these companies and organizations for 1 year before the deadline on the letter of interest and 1 year after a guideline is published. This policy extends to members of an ACR guideline development group, literature review team, and voting panel. Under these guidelines, an author who has any relationship with a company is considered conflicted, which counts toward this total.

Mr. Wayant and colleagues performed a cross-sectional study of five ACR guidelines published since August 2014 on axial spondyloarthritis (27 authors), glucocorticoid-induced osteoporosis (21 authors), RA (26 authors), perioperative management of antirheumatic medication (31 authors), and polymyalgia rheumatica (46 authors). Using the Open Payments Database, the researchers searched for any general (speaking fees, consulting fees, education, honoraria, travel, food, or beverage payments) research, associated research, and ownership (stocks or dividends) relationships reported by guideline authors in the 12 months before a guideline was published. The guidelines on axial spondyloarthritis, glucocorticoid-induced osteoporosis, and RA contained specific recommendations for classes of medications or branded drugs, and conflicts from authors in those guidelines were assessed to determine relevancy of those payments.

Of the 56 physician-authors who received at least one payment (62.9%), the median payment was $522. However, 51 authors reported receiving more than $1,000, 42 authors reported more than $10,000, 20 authors reported more than $100,000, and 2 authors reported more than $1 million. Overall, 14 of 56 authors (25.0%) reported having no financial conflicts of interest, but did in fact receive some payment, and $4,189,090 of the $9,728,751 (43.1%) was not reported. The researchers said that the 19 authors with directly relevant payments were members of the voting panel (11 authors), literature review team (6 authors), and core leadership team (3 authors).

Physician-authors of clinical practice guidelines receiving payments from industry is not an issue specific to rheumatology. In an interview, Mr. Wayant said that authors of clinical guidelines across many different medical specialties often work closely with industry and hold “numerous conflicts of interest.”

“If professional societies are meant to be the public face of specialty providers, one would expect the guideline authors to resemble all society members,” Mr. Wayant said. “However, we routinely find that authors of professional society guidelines have large financial conflicts of interest that exceed the national average, indicating that the views and opinions of guideline authors may not reflect the opinion of most providers.”

These financial relationships between industry and physician authors have been shown to affect research results. A Cochrane Review published in 2017 evaluating industry sponsorship and research outcomes found that studies sponsored by industry were more likely to have favorable efficacy results and conclusions, compared with studies not sponsored by industry sources (Cochrane Database Syst Rev. 2017 Feb 16;2:MR000033). As medical societies continue to become more involved with clinical practice guidelines, recommendations from physician-authors with financial ties to industry can present a conflict of interest. Recommendations in clinical practice guidelines often affect reimbursement of a drug from insurance, and an author can vote for a drug recommendation in a guideline that may not match patient values and preferences, noted Mr. Wayant.

“These authors are fundamentally different from the average rheumatologist that stays up to date with the medical literature, in terms of financial ties to industry,” he said. “Removing the influence of for-profit companies from guideline development cannot harm the rigor of the guideline recommendations, since many medical professionals without conflicts are experts in evidence-based medicine and study appraisal.”

Being financially linked to industry does not automatically make one the most qualified candidate for deciding which therapies are best for patients, Mr. Wayant explained, and guidelines should reflect the values of patients and the medical profession, rather than industry.

“Given the importance of guidelines, [we] encourage the ACR and all professional societies to do everything possible to be above reproach and seek out authors who do not have financial conflicts to write the guidelines,” he said.

The authors reported having no funding source for the study. One author reported serving on an advisory board for Janssen involving infliximab and golimumab, for Sanofi Genzyme involving sarilumab, and receiving payment for a survey from Comsort. The other authors reported having no conflicts of interest.

SOURCE: Wayant C et al. Arthritis Rheumatol. 2020 Feb 10. doi: 10.1002/art.41224.

The American College of Cardiology on Feb. 13, 2020, released a clinical bulletin that aims to address cardiac implications of the current epidemic of the novel coronavirus, now known as COVID-19.

The bulletin, reviewed and approved by the college’s Science and Quality Oversight Committee, “provides background on the epidemic, which was first reported in late December 2019, and looks at early cardiac implications from case reports,” the ACC noted in a press release. “It also provides information on the potential cardiac implications from analog viral respiratory pandemics and offers early clinical guidance given current COVID-19 uncertainty.”

The document looks at some early cardiac implications of the infection. For example, early case reports suggest patients with underlying conditions are at higher risk of complications or mortality from the virus, with up to 50% of hospitalized patients having a chronic medical illness, the authors wrote.

About 40% of hospitalized patients confirmed to have the virus have cardiovascular or cerebrovascular disease, they noted.

In a recent case report on 138 hospitalized COVID-19 patients, they noted, 19.6% developed acute respiratory distress syndrome, 16.7% developed arrhythmia, 8.7% developed shock, 7.2% developed acute cardiac injury, and 3.6% developed acute kidney injury. “Rates of complication were universally higher for ICU patients,” they wrote.

“The first reported death was a 61-year-old male, with a long history of smoking, who succumbed to acute respiratory distress, heart failure, and cardiac arrest,” the document noted. “Early, unpublished first-hand reports suggest at least some patients develop myocarditis.”

Stressing the current uncertainty about the virus, the bulletin provides the following clinical guidance:

• COVID-19 is spread through droplets and can live for substantial periods outside the body; containment and prevention using standard public health and personal strategies for preventing the spread of communicable disease remains the priority.
• In geographies with active COVID-19 transmission (mainly China), it is reasonable to advise patients with underlying cardiovascular disease of the potential increased risk and to encourage additional, reasonable precautions.
• Older adults are less likely to present with fever, thus close assessment for other symptoms such as cough or shortness of breath is warranted.
• Some experts have suggested that the rigorous use of guideline-directed, plaque-stabilizing agents could offer additional protection to cardiovascular disease (CVD) patients during a widespread outbreak (statins, beta-blockers, ACE inhibitors, acetylsalicylic acid); however, such therapies should be tailored to individual patients.
• It is important for patients with CVD to remain current with vaccinations, including the pneumococcal vaccine, given the increased risk of secondary bacterial infection; it would also be prudent to receive vaccination to prevent another source of fever which could be initially confused with coronavirus infection.
• It may be reasonable to triage COVID-19 patients according to the presence of underlying cardiovascular, respiratory, renal, and other chronic diseases for prioritized treatment.
• Providers are cautioned that classic symptoms and presentation of acute MI may be overshadowed in the context of coronavirus, resulting in underdiagnosis.
• For CVD patients in geographies without widespread COVID-19, emphasis should remain on the threat from influenza, the importance of vaccination and frequent handwashing, and continued adherence to all guideline-directed therapy for underlying chronic conditions.
• COVID-19 is a fast-moving epidemic with an uncertain clinical profile; providers should be prepared for guidance to shift as more information becomes available.

The full clinical update is available here.

This article first appeared on Medscape.com.

The American College of Cardiology on Feb. 13, 2020, released a clinical bulletin that aims to address cardiac implications of the current epidemic of the novel coronavirus, now known as COVID-19.

The bulletin, reviewed and approved by the college’s Science and Quality Oversight Committee, “provides background on the epidemic, which was first reported in late December 2019, and looks at early cardiac implications from case reports,” the ACC noted in a press release. “It also provides information on the potential cardiac implications from analog viral respiratory pandemics and offers early clinical guidance given current COVID-19 uncertainty.”

The document looks at some early cardiac implications of the infection. For example, early case reports suggest patients with underlying conditions are at higher risk of complications or mortality from the virus, with up to 50% of hospitalized patients having a chronic medical illness, the authors wrote.

About 40% of hospitalized patients confirmed to have the virus have cardiovascular or cerebrovascular disease, they noted.

In a recent case report on 138 hospitalized COVID-19 patients, they noted, 19.6% developed acute respiratory distress syndrome, 16.7% developed arrhythmia, 8.7% developed shock, 7.2% developed acute cardiac injury, and 3.6% developed acute kidney injury. “Rates of complication were universally higher for ICU patients,” they wrote.

“The first reported death was a 61-year-old male, with a long history of smoking, who succumbed to acute respiratory distress, heart failure, and cardiac arrest,” the document noted. “Early, unpublished first-hand reports suggest at least some patients develop myocarditis.”

Stressing the current uncertainty about the virus, the bulletin provides the following clinical guidance:

• COVID-19 is spread through droplets and can live for substantial periods outside the body; containment and prevention using standard public health and personal strategies for preventing the spread of communicable disease remains the priority.
• In geographies with active COVID-19 transmission (mainly China), it is reasonable to advise patients with underlying cardiovascular disease of the potential increased risk and to encourage additional, reasonable precautions.
• Older adults are less likely to present with fever, thus close assessment for other symptoms such as cough or shortness of breath is warranted.
• Some experts have suggested that the rigorous use of guideline-directed, plaque-stabilizing agents could offer additional protection to cardiovascular disease (CVD) patients during a widespread outbreak (statins, beta-blockers, ACE inhibitors, acetylsalicylic acid); however, such therapies should be tailored to individual patients.
• It is important for patients with CVD to remain current with vaccinations, including the pneumococcal vaccine, given the increased risk of secondary bacterial infection; it would also be prudent to receive vaccination to prevent another source of fever which could be initially confused with coronavirus infection.
• It may be reasonable to triage COVID-19 patients according to the presence of underlying cardiovascular, respiratory, renal, and other chronic diseases for prioritized treatment.
• Providers are cautioned that classic symptoms and presentation of acute MI may be overshadowed in the context of coronavirus, resulting in underdiagnosis.
• For CVD patients in geographies without widespread COVID-19, emphasis should remain on the threat from influenza, the importance of vaccination and frequent handwashing, and continued adherence to all guideline-directed therapy for underlying chronic conditions.
• COVID-19 is a fast-moving epidemic with an uncertain clinical profile; providers should be prepared for guidance to shift as more information becomes available.

The full clinical update is available here.

This article first appeared on Medscape.com.

The American College of Cardiology on Feb. 13, 2020, released a clinical bulletin that aims to address cardiac implications of the current epidemic of the novel coronavirus, now known as COVID-19.

The bulletin, reviewed and approved by the college’s Science and Quality Oversight Committee, “provides background on the epidemic, which was first reported in late December 2019, and looks at early cardiac implications from case reports,” the ACC noted in a press release. “It also provides information on the potential cardiac implications from analog viral respiratory pandemics and offers early clinical guidance given current COVID-19 uncertainty.”

The document looks at some early cardiac implications of the infection. For example, early case reports suggest patients with underlying conditions are at higher risk of complications or mortality from the virus, with up to 50% of hospitalized patients having a chronic medical illness, the authors wrote.

About 40% of hospitalized patients confirmed to have the virus have cardiovascular or cerebrovascular disease, they noted.

In a recent case report on 138 hospitalized COVID-19 patients, they noted, 19.6% developed acute respiratory distress syndrome, 16.7% developed arrhythmia, 8.7% developed shock, 7.2% developed acute cardiac injury, and 3.6% developed acute kidney injury. “Rates of complication were universally higher for ICU patients,” they wrote.

“The first reported death was a 61-year-old male, with a long history of smoking, who succumbed to acute respiratory distress, heart failure, and cardiac arrest,” the document noted. “Early, unpublished first-hand reports suggest at least some patients develop myocarditis.”

Stressing the current uncertainty about the virus, the bulletin provides the following clinical guidance:

• COVID-19 is spread through droplets and can live for substantial periods outside the body; containment and prevention using standard public health and personal strategies for preventing the spread of communicable disease remains the priority.
• In geographies with active COVID-19 transmission (mainly China), it is reasonable to advise patients with underlying cardiovascular disease of the potential increased risk and to encourage additional, reasonable precautions.
• Older adults are less likely to present with fever, thus close assessment for other symptoms such as cough or shortness of breath is warranted.
• Some experts have suggested that the rigorous use of guideline-directed, plaque-stabilizing agents could offer additional protection to cardiovascular disease (CVD) patients during a widespread outbreak (statins, beta-blockers, ACE inhibitors, acetylsalicylic acid); however, such therapies should be tailored to individual patients.
• It is important for patients with CVD to remain current with vaccinations, including the pneumococcal vaccine, given the increased risk of secondary bacterial infection; it would also be prudent to receive vaccination to prevent another source of fever which could be initially confused with coronavirus infection.
• It may be reasonable to triage COVID-19 patients according to the presence of underlying cardiovascular, respiratory, renal, and other chronic diseases for prioritized treatment.
• Providers are cautioned that classic symptoms and presentation of acute MI may be overshadowed in the context of coronavirus, resulting in underdiagnosis.
• For CVD patients in geographies without widespread COVID-19, emphasis should remain on the threat from influenza, the importance of vaccination and frequent handwashing, and continued adherence to all guideline-directed therapy for underlying chronic conditions.
• COVID-19 is a fast-moving epidemic with an uncertain clinical profile; providers should be prepared for guidance to shift as more information becomes available.

The full clinical update is available here.

This article first appeared on Medscape.com.

The American Academy of Neurology (AAN) has issued a new guideline for the treatment of sleep problems in children and teenagers with autism spectrum disorders (ASD). The guideline was published online ahead of print Feb. 12 in Neurology.

“While up to 40% of children and teens in the general population will have sleep problems at some point during their childhood, such problems usually lessen with age,” lead author Ashura Williams Buckley, MD, director of the Sleep and Neurodevelopment Service at the National Institute of Mental Health in Bethesda, Md., said in a press release. “For children and teens with autism, sleep problems are more common and more likely to persist, resulting in poor health and poor quality of life. Some sleep problems may be directly related to autism, but others are not. Regardless, autism symptoms may make sleep problems worse.”
 

Few evidence-based treatments are available

Dr. Williams Buckley and colleagues developed the current guideline to evaluate which pharmacologic, behavioral, and complementary and alternative medicine (CAM) interventions improve bedtime resistance, sleep onset latency, sleep continuity, total sleep time, and daytime behavior in children and adolescents with ASD. The panel evaluated 900 abstracts of articles that had been included in systematic reviews, as well as 1,087 additional abstracts. One hundred thirty-nine articles were potentially relevant, 12 met criteria for data extraction, and eight were rated class III or higher and were included in the panel’s review.

The authors observed what they called a dearth of evidence-based treatments for sleep dysregulation in ASD. Evidence indicates that melatonin, with or without cognitive–behavioral therapy (CBT), improves several sleep outcomes, compared with placebo. “Evidence for other interventions is largely lacking,” wrote Dr. Williams Buckley and colleagues. They observed a lack of long-term safety data for melatonin in children, which they considered concerning, because melatonin affects the hypothalamic–gonadal axis and can potentially influence pubertal development.
 

Screening for comorbid conditions and concomitant medications

The guideline recommends that clinicians assess children with ASD and sleep disturbances for coexisting conditions and concomitant medications that could be contributing to these sleep disturbances. They should ensure that children receive appropriate treatment for coexisting conditions and adjust or discontinue potentially problematic medications appropriately, according to the guideline.

Furthermore, clinicians should counsel parents or guardians about behavioral strategies as a first-line treatment for improving sleep function. These strategies could be administered alone or with pharmacologic or neutraceutical approaches as needed, according to the authors. Suggested behavioral approaches include unmodified extinction (i.e., imposing a bedtime and ignoring a child’s protests), graduated extinction (i.e., ignoring protests for a specified period before responding), positive routines (i.e., establishing pre-bedtime calming rituals), and bedtime fading (i.e., putting a child to bed close to the time he or she begins to fall asleep).

If a child’s contributing coexisting conditions and medications have been addressed and behavioral strategies have not been helpful, clinicians should offer melatonin, according to the guideline. Because over-the-counter formulations contain variable concentrations of melatonin, clinicians should write a prescription for it or recommend high-purity pharmaceutical grade melatonin. The initial dose should be 1-3 mg/day at 60-30 minutes before bedtime. The dose can be titrated to 10 mg/day. Clinicians also should counsel children and their parents about potential adverse events of melatonin and the lack of long-term safety data, according to the guideline.

In addition, clinicians should advise children and parents that no evidence supports the routine use of weighted blankets or specialized mattress technology for improving sleep. Parents who ask about weighted blankets should be told that the reviewed trial reported no serious adverse events with this intervention, and that blankets could be a reasonable nonpharmacologic approach for some patients, according to the guideline.
 

Optimal outcome measures are undefined

Dr. Williams Buckley and colleagues also suggested areas for future research. Investigators have not yet defined optimal outcome measures (e.g., questionnaires, polysomnography, and actigraphy) that balance tolerability and accuracy, they wrote. Clinically important differences for most measures also have yet to be determined. Researchers should investigate whether long-term adverse events are associated with chronic melatonin use and study patients with ASD and comorbid mood disorders, wrote the authors. “Research tying the underlying neurobiology in early-life sleep disruption to behavior might help clinicians and researchers understand which treatments might work for which people with ASD,” they concluded.

The AAN supported the development of the guideline. Dr. Williams Buckley had no conflicts of interest. Six authors had conflicts of interest that the AAN deemed not significant enough to prevent their participation in the development of the guideline.

[email protected]

SOURCE: Williams Buckley A et al. Neurology. 2020;94:393-405. doi: 10.1212/WNL0000000000009033.

The American Academy of Neurology (AAN) has issued a new guideline for the treatment of sleep problems in children and teenagers with autism spectrum disorders (ASD). The guideline was published online ahead of print Feb. 12 in Neurology.

“While up to 40% of children and teens in the general population will have sleep problems at some point during their childhood, such problems usually lessen with age,” lead author Ashura Williams Buckley, MD, director of the Sleep and Neurodevelopment Service at the National Institute of Mental Health in Bethesda, Md., said in a press release. “For children and teens with autism, sleep problems are more common and more likely to persist, resulting in poor health and poor quality of life. Some sleep problems may be directly related to autism, but others are not. Regardless, autism symptoms may make sleep problems worse.”
 

Few evidence-based treatments are available

Dr. Williams Buckley and colleagues developed the current guideline to evaluate which pharmacologic, behavioral, and complementary and alternative medicine (CAM) interventions improve bedtime resistance, sleep onset latency, sleep continuity, total sleep time, and daytime behavior in children and adolescents with ASD. The panel evaluated 900 abstracts of articles that had been included in systematic reviews, as well as 1,087 additional abstracts. One hundred thirty-nine articles were potentially relevant, 12 met criteria for data extraction, and eight were rated class III or higher and were included in the panel’s review.

The authors observed what they called a dearth of evidence-based treatments for sleep dysregulation in ASD. Evidence indicates that melatonin, with or without cognitive–behavioral therapy (CBT), improves several sleep outcomes, compared with placebo. “Evidence for other interventions is largely lacking,” wrote Dr. Williams Buckley and colleagues. They observed a lack of long-term safety data for melatonin in children, which they considered concerning, because melatonin affects the hypothalamic–gonadal axis and can potentially influence pubertal development.
 

Screening for comorbid conditions and concomitant medications

The guideline recommends that clinicians assess children with ASD and sleep disturbances for coexisting conditions and concomitant medications that could be contributing to these sleep disturbances. They should ensure that children receive appropriate treatment for coexisting conditions and adjust or discontinue potentially problematic medications appropriately, according to the guideline.

Furthermore, clinicians should counsel parents or guardians about behavioral strategies as a first-line treatment for improving sleep function. These strategies could be administered alone or with pharmacologic or neutraceutical approaches as needed, according to the authors. Suggested behavioral approaches include unmodified extinction (i.e., imposing a bedtime and ignoring a child’s protests), graduated extinction (i.e., ignoring protests for a specified period before responding), positive routines (i.e., establishing pre-bedtime calming rituals), and bedtime fading (i.e., putting a child to bed close to the time he or she begins to fall asleep).

If a child’s contributing coexisting conditions and medications have been addressed and behavioral strategies have not been helpful, clinicians should offer melatonin, according to the guideline. Because over-the-counter formulations contain variable concentrations of melatonin, clinicians should write a prescription for it or recommend high-purity pharmaceutical grade melatonin. The initial dose should be 1-3 mg/day at 60-30 minutes before bedtime. The dose can be titrated to 10 mg/day. Clinicians also should counsel children and their parents about potential adverse events of melatonin and the lack of long-term safety data, according to the guideline.

In addition, clinicians should advise children and parents that no evidence supports the routine use of weighted blankets or specialized mattress technology for improving sleep. Parents who ask about weighted blankets should be told that the reviewed trial reported no serious adverse events with this intervention, and that blankets could be a reasonable nonpharmacologic approach for some patients, according to the guideline.
 

Optimal outcome measures are undefined

Dr. Williams Buckley and colleagues also suggested areas for future research. Investigators have not yet defined optimal outcome measures (e.g., questionnaires, polysomnography, and actigraphy) that balance tolerability and accuracy, they wrote. Clinically important differences for most measures also have yet to be determined. Researchers should investigate whether long-term adverse events are associated with chronic melatonin use and study patients with ASD and comorbid mood disorders, wrote the authors. “Research tying the underlying neurobiology in early-life sleep disruption to behavior might help clinicians and researchers understand which treatments might work for which people with ASD,” they concluded.

The AAN supported the development of the guideline. Dr. Williams Buckley had no conflicts of interest. Six authors had conflicts of interest that the AAN deemed not significant enough to prevent their participation in the development of the guideline.

[email protected]

SOURCE: Williams Buckley A et al. Neurology. 2020;94:393-405. doi: 10.1212/WNL0000000000009033.

The American Academy of Neurology (AAN) has issued a new guideline for the treatment of sleep problems in children and teenagers with autism spectrum disorders (ASD). The guideline was published online ahead of print Feb. 12 in Neurology.

“While up to 40% of children and teens in the general population will have sleep problems at some point during their childhood, such problems usually lessen with age,” lead author Ashura Williams Buckley, MD, director of the Sleep and Neurodevelopment Service at the National Institute of Mental Health in Bethesda, Md., said in a press release. “For children and teens with autism, sleep problems are more common and more likely to persist, resulting in poor health and poor quality of life. Some sleep problems may be directly related to autism, but others are not. Regardless, autism symptoms may make sleep problems worse.”
 

Few evidence-based treatments are available

Dr. Williams Buckley and colleagues developed the current guideline to evaluate which pharmacologic, behavioral, and complementary and alternative medicine (CAM) interventions improve bedtime resistance, sleep onset latency, sleep continuity, total sleep time, and daytime behavior in children and adolescents with ASD. The panel evaluated 900 abstracts of articles that had been included in systematic reviews, as well as 1,087 additional abstracts. One hundred thirty-nine articles were potentially relevant, 12 met criteria for data extraction, and eight were rated class III or higher and were included in the panel’s review.

The authors observed what they called a dearth of evidence-based treatments for sleep dysregulation in ASD. Evidence indicates that melatonin, with or without cognitive–behavioral therapy (CBT), improves several sleep outcomes, compared with placebo. “Evidence for other interventions is largely lacking,” wrote Dr. Williams Buckley and colleagues. They observed a lack of long-term safety data for melatonin in children, which they considered concerning, because melatonin affects the hypothalamic–gonadal axis and can potentially influence pubertal development.
 

Screening for comorbid conditions and concomitant medications

The guideline recommends that clinicians assess children with ASD and sleep disturbances for coexisting conditions and concomitant medications that could be contributing to these sleep disturbances. They should ensure that children receive appropriate treatment for coexisting conditions and adjust or discontinue potentially problematic medications appropriately, according to the guideline.

Furthermore, clinicians should counsel parents or guardians about behavioral strategies as a first-line treatment for improving sleep function. These strategies could be administered alone or with pharmacologic or neutraceutical approaches as needed, according to the authors. Suggested behavioral approaches include unmodified extinction (i.e., imposing a bedtime and ignoring a child’s protests), graduated extinction (i.e., ignoring protests for a specified period before responding), positive routines (i.e., establishing pre-bedtime calming rituals), and bedtime fading (i.e., putting a child to bed close to the time he or she begins to fall asleep).

If a child’s contributing coexisting conditions and medications have been addressed and behavioral strategies have not been helpful, clinicians should offer melatonin, according to the guideline. Because over-the-counter formulations contain variable concentrations of melatonin, clinicians should write a prescription for it or recommend high-purity pharmaceutical grade melatonin. The initial dose should be 1-3 mg/day at 60-30 minutes before bedtime. The dose can be titrated to 10 mg/day. Clinicians also should counsel children and their parents about potential adverse events of melatonin and the lack of long-term safety data, according to the guideline.

In addition, clinicians should advise children and parents that no evidence supports the routine use of weighted blankets or specialized mattress technology for improving sleep. Parents who ask about weighted blankets should be told that the reviewed trial reported no serious adverse events with this intervention, and that blankets could be a reasonable nonpharmacologic approach for some patients, according to the guideline.
 

Optimal outcome measures are undefined

Dr. Williams Buckley and colleagues also suggested areas for future research. Investigators have not yet defined optimal outcome measures (e.g., questionnaires, polysomnography, and actigraphy) that balance tolerability and accuracy, they wrote. Clinically important differences for most measures also have yet to be determined. Researchers should investigate whether long-term adverse events are associated with chronic melatonin use and study patients with ASD and comorbid mood disorders, wrote the authors. “Research tying the underlying neurobiology in early-life sleep disruption to behavior might help clinicians and researchers understand which treatments might work for which people with ASD,” they concluded.

The AAN supported the development of the guideline. Dr. Williams Buckley had no conflicts of interest. Six authors had conflicts of interest that the AAN deemed not significant enough to prevent their participation in the development of the guideline.

[email protected]

SOURCE: Williams Buckley A et al. Neurology. 2020;94:393-405. doi: 10.1212/WNL0000000000009033.