Caring for older adults was one of the most rewarding parts of my years practicing as a clinical cardiologist. I appreciated their wisdom, humor, and, very often, their respect and appreciation for physicians. It was always upsetting to see them suffer a mild fall or episode of atrial fibrillation and recognize that it could have major health ramifications.

Life expectancy has improved dramatically, but longer lifespans also mean more opportunity for illness, pain, chronic disease, and dependence on others. Having successfully helped older adults live longer, the question now becomes, how can we, as physicians, add more life to those years? How can we increase their “healthspans”?

That is not just a question for geriatric care. With fewer than two practicing geriatricians for every 10,000 older individuals, it is obvious that geriatricians cannot shoulder this responsibility alone. Almost all primary care physicians and subspecialists should prepare to care for older individuals and help them age healthfully.

Susan Friedman, MD, a board-certified geriatrics and lifestyle medicine clinician at the University of Rochester School of Medicine and Dentistry, Rochester, New York, reviewed the literature on the connection between lifestyle and healthy aging and concluded that the integration of lifestyle medicine into medical care for older adults is key to compressing morbidity. The pillars of lifestyle medicine — optimal nutrition, physical activity, stress management, restorative sleep, positive social connections, and avoidance of risky substances — both individually or as a sum are associated with less chronic disease, improved engagement in life, better physical and cognitive function, less frailty, and less sarcopenia. Framing discussions with patients around the six pillars of lifestyle medicine can be an effective strategy.
 

Optimal Nutrition

For a variety of reasons, older adults, especially those living alone, often lose the desire to prepare a nourishing meal. Older adults require different protein intake than younger patients to offset age-related sarcopenia, but helping them select healthy sources of protein is imperative. Both adequate protein consumption and eating patterns high in vegetables, legumes, fruit, and nuts and low in saturated fat, red meat, and processed meat can lower the risk of developing frailty.

Asking a patient to share a 24-hour food recall, and based upon that, resourcing nutritional guidance, a lifestyle medicine program or specialist, and insurance or community resources for food-as-medicine services, is a good first step.
 

Physical Activity

Increasing general physical activity can be a tough ask for many older adults, and joint pain is a common reason they demur. Messaging around targeted exercises to mitigate falls, improve muscle strength, and reduce joint pain may be more appealing. Contemporary research demonstrates that exercise, particularly open-skill exercise that requires quick decisions (such as table tennis) can be powerful. Maintaining cognition, mood enhancement, and independence may also be motivating messages.

The first step is curiosity: What does your patient like to do? Referral to a physical therapist or an exercise specialist to provide stepwise guidance along with resourcing community opportunities can then follow.
 

Restorative Sleep

“I’m old. I don’t need as much sleep.” We’ve probably all heard older patients say this. But the National Sleep Foundation’s report on sleep health and aging indicates that the need to sleep does not decrease with age. The ability to sleep, however, may decline. Assessing and treating disordered sleep is another example of how each lifestyle medicine pillar, such as nutrition and physical activity, is multidimensional and interacts to support the functional integrity of older patients. It’s hard to feel motivated to go for a walk if you lack adequate sleep.
 

Stress Management

Exploring stress with patients can be very revealing. Do they experience stress that energizes and has a positive effect? How much of their day is spent in negatively impactful distress? Chronic stress has been shown to affect immune function in older individuals. Start conversations with your older patients to normalize the importance of stress as a health measure.
 

Positive Social Connections

Loneliness puts individuals at higher risk for heart disease, stroke, and dementia and even increases the risk for premature death by up to 60%. Yet, clinicians and patients rarely discuss social connections during medical appointments. Tools such as the UCLA Loneliness Scale exist for health practitioners to assess and identify patients at risk for loneliness, as do resources to integrate social care into the delivery of healthcare.
 

Avoidance of Risky Substances

Alcohol assessments are not just for younger patients. One study found that 5.6 million adults ages 65 or older engaged in binge drinking in the past month. Because of body changes, the negative effects of alcohol may be greater on older adults, including interactions between alcohol and commonly prescribed medications. 

Conducting a lifestyle assessment is an important way to engage with older patients and allows clinicians to identify opportunities to improve health behaviors, understand obstacles, and support patients to make lifestyle changes. It may uncover ways to remove some of the pill and treatment burdens that older adults often experience. The American College of Lifestyle Medicine (ACLM) offers clinical practice resources to support clinicians as well as “Lifestyle Medicine and Food as Medicine Essentials,” a 5.5-hour complimentary CE/CME course on food and lifestyle medicine that introduces clinicians to the therapeutic use of lifestyle medicine. ACLM also offers members interest groups focused on geriatrics, fitness, and mental health, which may be beneficial to clinicians treating older adults.

By engaging with older patients on their lifestyle behaviors, we can ensure that we are doing all we can to help them live longer — and live better.

Dr. Collings is director of lifestyle medicine, Silicon Valley Medical Development, and past president, American College of Lifestyle Medicine, Mountain View, California. She has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Caring for older adults was one of the most rewarding parts of my years practicing as a clinical cardiologist. I appreciated their wisdom, humor, and, very often, their respect and appreciation for physicians. It was always upsetting to see them suffer a mild fall or episode of atrial fibrillation and recognize that it could have major health ramifications.

Life expectancy has improved dramatically, but longer lifespans also mean more opportunity for illness, pain, chronic disease, and dependence on others. Having successfully helped older adults live longer, the question now becomes, how can we, as physicians, add more life to those years? How can we increase their “healthspans”?

That is not just a question for geriatric care. With fewer than two practicing geriatricians for every 10,000 older individuals, it is obvious that geriatricians cannot shoulder this responsibility alone. Almost all primary care physicians and subspecialists should prepare to care for older individuals and help them age healthfully.

Susan Friedman, MD, a board-certified geriatrics and lifestyle medicine clinician at the University of Rochester School of Medicine and Dentistry, Rochester, New York, reviewed the literature on the connection between lifestyle and healthy aging and concluded that the integration of lifestyle medicine into medical care for older adults is key to compressing morbidity. The pillars of lifestyle medicine — optimal nutrition, physical activity, stress management, restorative sleep, positive social connections, and avoidance of risky substances — both individually or as a sum are associated with less chronic disease, improved engagement in life, better physical and cognitive function, less frailty, and less sarcopenia. Framing discussions with patients around the six pillars of lifestyle medicine can be an effective strategy.
 

Optimal Nutrition

For a variety of reasons, older adults, especially those living alone, often lose the desire to prepare a nourishing meal. Older adults require different protein intake than younger patients to offset age-related sarcopenia, but helping them select healthy sources of protein is imperative. Both adequate protein consumption and eating patterns high in vegetables, legumes, fruit, and nuts and low in saturated fat, red meat, and processed meat can lower the risk of developing frailty.

Asking a patient to share a 24-hour food recall, and based upon that, resourcing nutritional guidance, a lifestyle medicine program or specialist, and insurance or community resources for food-as-medicine services, is a good first step.
 

Physical Activity

Increasing general physical activity can be a tough ask for many older adults, and joint pain is a common reason they demur. Messaging around targeted exercises to mitigate falls, improve muscle strength, and reduce joint pain may be more appealing. Contemporary research demonstrates that exercise, particularly open-skill exercise that requires quick decisions (such as table tennis) can be powerful. Maintaining cognition, mood enhancement, and independence may also be motivating messages.

The first step is curiosity: What does your patient like to do? Referral to a physical therapist or an exercise specialist to provide stepwise guidance along with resourcing community opportunities can then follow.
 

Restorative Sleep

“I’m old. I don’t need as much sleep.” We’ve probably all heard older patients say this. But the National Sleep Foundation’s report on sleep health and aging indicates that the need to sleep does not decrease with age. The ability to sleep, however, may decline. Assessing and treating disordered sleep is another example of how each lifestyle medicine pillar, such as nutrition and physical activity, is multidimensional and interacts to support the functional integrity of older patients. It’s hard to feel motivated to go for a walk if you lack adequate sleep.
 

Stress Management

Exploring stress with patients can be very revealing. Do they experience stress that energizes and has a positive effect? How much of their day is spent in negatively impactful distress? Chronic stress has been shown to affect immune function in older individuals. Start conversations with your older patients to normalize the importance of stress as a health measure.
 

Positive Social Connections

Loneliness puts individuals at higher risk for heart disease, stroke, and dementia and even increases the risk for premature death by up to 60%. Yet, clinicians and patients rarely discuss social connections during medical appointments. Tools such as the UCLA Loneliness Scale exist for health practitioners to assess and identify patients at risk for loneliness, as do resources to integrate social care into the delivery of healthcare.
 

Avoidance of Risky Substances

Alcohol assessments are not just for younger patients. One study found that 5.6 million adults ages 65 or older engaged in binge drinking in the past month. Because of body changes, the negative effects of alcohol may be greater on older adults, including interactions between alcohol and commonly prescribed medications. 

Conducting a lifestyle assessment is an important way to engage with older patients and allows clinicians to identify opportunities to improve health behaviors, understand obstacles, and support patients to make lifestyle changes. It may uncover ways to remove some of the pill and treatment burdens that older adults often experience. The American College of Lifestyle Medicine (ACLM) offers clinical practice resources to support clinicians as well as “Lifestyle Medicine and Food as Medicine Essentials,” a 5.5-hour complimentary CE/CME course on food and lifestyle medicine that introduces clinicians to the therapeutic use of lifestyle medicine. ACLM also offers members interest groups focused on geriatrics, fitness, and mental health, which may be beneficial to clinicians treating older adults.

By engaging with older patients on their lifestyle behaviors, we can ensure that we are doing all we can to help them live longer — and live better.

Dr. Collings is director of lifestyle medicine, Silicon Valley Medical Development, and past president, American College of Lifestyle Medicine, Mountain View, California. She has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Caring for older adults was one of the most rewarding parts of my years practicing as a clinical cardiologist. I appreciated their wisdom, humor, and, very often, their respect and appreciation for physicians. It was always upsetting to see them suffer a mild fall or episode of atrial fibrillation and recognize that it could have major health ramifications.

Life expectancy has improved dramatically, but longer lifespans also mean more opportunity for illness, pain, chronic disease, and dependence on others. Having successfully helped older adults live longer, the question now becomes, how can we, as physicians, add more life to those years? How can we increase their “healthspans”?

That is not just a question for geriatric care. With fewer than two practicing geriatricians for every 10,000 older individuals, it is obvious that geriatricians cannot shoulder this responsibility alone. Almost all primary care physicians and subspecialists should prepare to care for older individuals and help them age healthfully.

Susan Friedman, MD, a board-certified geriatrics and lifestyle medicine clinician at the University of Rochester School of Medicine and Dentistry, Rochester, New York, reviewed the literature on the connection between lifestyle and healthy aging and concluded that the integration of lifestyle medicine into medical care for older adults is key to compressing morbidity. The pillars of lifestyle medicine — optimal nutrition, physical activity, stress management, restorative sleep, positive social connections, and avoidance of risky substances — both individually or as a sum are associated with less chronic disease, improved engagement in life, better physical and cognitive function, less frailty, and less sarcopenia. Framing discussions with patients around the six pillars of lifestyle medicine can be an effective strategy.
 

Optimal Nutrition

For a variety of reasons, older adults, especially those living alone, often lose the desire to prepare a nourishing meal. Older adults require different protein intake than younger patients to offset age-related sarcopenia, but helping them select healthy sources of protein is imperative. Both adequate protein consumption and eating patterns high in vegetables, legumes, fruit, and nuts and low in saturated fat, red meat, and processed meat can lower the risk of developing frailty.

Asking a patient to share a 24-hour food recall, and based upon that, resourcing nutritional guidance, a lifestyle medicine program or specialist, and insurance or community resources for food-as-medicine services, is a good first step.
 

Physical Activity

Increasing general physical activity can be a tough ask for many older adults, and joint pain is a common reason they demur. Messaging around targeted exercises to mitigate falls, improve muscle strength, and reduce joint pain may be more appealing. Contemporary research demonstrates that exercise, particularly open-skill exercise that requires quick decisions (such as table tennis) can be powerful. Maintaining cognition, mood enhancement, and independence may also be motivating messages.

The first step is curiosity: What does your patient like to do? Referral to a physical therapist or an exercise specialist to provide stepwise guidance along with resourcing community opportunities can then follow.
 

Restorative Sleep

“I’m old. I don’t need as much sleep.” We’ve probably all heard older patients say this. But the National Sleep Foundation’s report on sleep health and aging indicates that the need to sleep does not decrease with age. The ability to sleep, however, may decline. Assessing and treating disordered sleep is another example of how each lifestyle medicine pillar, such as nutrition and physical activity, is multidimensional and interacts to support the functional integrity of older patients. It’s hard to feel motivated to go for a walk if you lack adequate sleep.
 

Stress Management

Exploring stress with patients can be very revealing. Do they experience stress that energizes and has a positive effect? How much of their day is spent in negatively impactful distress? Chronic stress has been shown to affect immune function in older individuals. Start conversations with your older patients to normalize the importance of stress as a health measure.
 

Positive Social Connections

Loneliness puts individuals at higher risk for heart disease, stroke, and dementia and even increases the risk for premature death by up to 60%. Yet, clinicians and patients rarely discuss social connections during medical appointments. Tools such as the UCLA Loneliness Scale exist for health practitioners to assess and identify patients at risk for loneliness, as do resources to integrate social care into the delivery of healthcare.
 

Avoidance of Risky Substances

Alcohol assessments are not just for younger patients. One study found that 5.6 million adults ages 65 or older engaged in binge drinking in the past month. Because of body changes, the negative effects of alcohol may be greater on older adults, including interactions between alcohol and commonly prescribed medications. 

Conducting a lifestyle assessment is an important way to engage with older patients and allows clinicians to identify opportunities to improve health behaviors, understand obstacles, and support patients to make lifestyle changes. It may uncover ways to remove some of the pill and treatment burdens that older adults often experience. The American College of Lifestyle Medicine (ACLM) offers clinical practice resources to support clinicians as well as “Lifestyle Medicine and Food as Medicine Essentials,” a 5.5-hour complimentary CE/CME course on food and lifestyle medicine that introduces clinicians to the therapeutic use of lifestyle medicine. ACLM also offers members interest groups focused on geriatrics, fitness, and mental health, which may be beneficial to clinicians treating older adults.

By engaging with older patients on their lifestyle behaviors, we can ensure that we are doing all we can to help them live longer — and live better.

Dr. Collings is director of lifestyle medicine, Silicon Valley Medical Development, and past president, American College of Lifestyle Medicine, Mountain View, California. She has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

There have been many attempts to use immunotherapy to improve outcomes in pancreatic cancer, but they haven’t worked out.

The trials, however, have focused on adding immune checkpoint inhibitors to chemotherapy in metastatic disease, leaving open the question of whether immunotherapy might have a role in the neoadjuvant setting before surgery.

In the first study to test the hypothesis, Zev A. Wainberg, MD, a gastrointestinal medical oncologist at the University of California Los Angeles, reported promising results at the American Association for Cancer Research annual meeting.

The small, single arm pilot study included 28 patients with borderline resectable pancreatic cancer, meaning that tumors had some degree of vascular involvement. About 20% of pancreatic tumors are borderline resectable, Dr. Wainberg said.

Patients received 480 mg of nivolumab intravenously every 4 weeks plus mFOLFIRINOX chemotherapy (oxaliplatin, irinotecan, leucovorin, and 5-fluorouracil) on days 1 and 15 of the 28-day cycle.

Patients who downstaged to resectable disease after three cycles went on to surgery; if not, treatment continued for another 3 months. The median number of cycles was 5.5, and almost all patients completed at least 3.

Overall, 19 of the 22 patients who proceeded to surgery (86%) had a pathologic response to neoadjuvant treatment with nivolumab: 2 complete responses, 2 near-complete responses, and 15 partial responses.

Among patients receiving surgery, 21 had R0 resections, meaning negative surgical margins with no tumor left behind. This is key because R0 resections predict longer survival, and “every effort should be made to achieve” this outcome, Dr. Wainberg said. The remaining patient had an R1 resection.

Median progression-free survival was 21.9 months among all patients and 27.3 months among the 22 patients who had resections.

Median overall survival was 34.6 months across the entire group and 44 months among those who had surgery. Overall, 82% of patients were alive at 12 months, and 77% were alive at 18 months.

The study outcomes, especially among the surgery cohort, stand in contrast to those observed in patients who receive the current standard neoadjuvant regimen for borderline resectable pancreatic cancer, mFOLFIRINOX alone, with studies finding a median overall survival of 29.8 months.

Adding nivolumab to neoadjuvant treatment also did not increase side effects. More than half of patients had grade 3 or worse adverse events, but they were all related to mFOLFIRINOX. There were no significant surgical complications, including no grade 2 or higher fistulas.

“We are very pleased” with the outcomes, Dr. Wainberg said. “We need to be studying [immune checkpoint inhibitors] earlier on in both borderline and locally advanced disease. Pancreatic cancer needs all the help it can get to engage immunity.”

Moderator Alice Ho, MD, a radiation oncologist at Duke University in Durham, North Carolina, called the R0 resection rate “stunning” in a “field that very much needs improvements and advancements.”

Dr. Ho also noted that the trial raises “a lot of interesting questions.”

For instance, why exactly is the addition of nivolumab seemingly improving outcomes?

The combination neoadjuvant therapy appeared to increase tertiary lymphoid structures, plasma cells, and CD4+ T cells — all indications that immunotherapy is having a positive impact — but the treatment also seemed to upregulate pathways for adenosine, an immunosuppressant associated with worse responses to checkpoint blockade.

A larger study is already in the works. In addition to a PD-1 blocker and mFOLFIRINOX, patients will receive a CD73 inhibitor to block adenosine production, Dr. Wainberg said.

Bristol Myers Squibb (BMS) provided the nivolumab used in the study. Dr. Wainberg is a consultant for and reported research funding from BMS and other companies. Dr. Ho had no relevant disclosures.
 

A version of this article appeared on Medscape.com.

There have been many attempts to use immunotherapy to improve outcomes in pancreatic cancer, but they haven’t worked out.

The trials, however, have focused on adding immune checkpoint inhibitors to chemotherapy in metastatic disease, leaving open the question of whether immunotherapy might have a role in the neoadjuvant setting before surgery.

In the first study to test the hypothesis, Zev A. Wainberg, MD, a gastrointestinal medical oncologist at the University of California Los Angeles, reported promising results at the American Association for Cancer Research annual meeting.

The small, single arm pilot study included 28 patients with borderline resectable pancreatic cancer, meaning that tumors had some degree of vascular involvement. About 20% of pancreatic tumors are borderline resectable, Dr. Wainberg said.

Patients received 480 mg of nivolumab intravenously every 4 weeks plus mFOLFIRINOX chemotherapy (oxaliplatin, irinotecan, leucovorin, and 5-fluorouracil) on days 1 and 15 of the 28-day cycle.

Patients who downstaged to resectable disease after three cycles went on to surgery; if not, treatment continued for another 3 months. The median number of cycles was 5.5, and almost all patients completed at least 3.

Overall, 19 of the 22 patients who proceeded to surgery (86%) had a pathologic response to neoadjuvant treatment with nivolumab: 2 complete responses, 2 near-complete responses, and 15 partial responses.

Among patients receiving surgery, 21 had R0 resections, meaning negative surgical margins with no tumor left behind. This is key because R0 resections predict longer survival, and “every effort should be made to achieve” this outcome, Dr. Wainberg said. The remaining patient had an R1 resection.

Median progression-free survival was 21.9 months among all patients and 27.3 months among the 22 patients who had resections.

Median overall survival was 34.6 months across the entire group and 44 months among those who had surgery. Overall, 82% of patients were alive at 12 months, and 77% were alive at 18 months.

The study outcomes, especially among the surgery cohort, stand in contrast to those observed in patients who receive the current standard neoadjuvant regimen for borderline resectable pancreatic cancer, mFOLFIRINOX alone, with studies finding a median overall survival of 29.8 months.

Adding nivolumab to neoadjuvant treatment also did not increase side effects. More than half of patients had grade 3 or worse adverse events, but they were all related to mFOLFIRINOX. There were no significant surgical complications, including no grade 2 or higher fistulas.

“We are very pleased” with the outcomes, Dr. Wainberg said. “We need to be studying [immune checkpoint inhibitors] earlier on in both borderline and locally advanced disease. Pancreatic cancer needs all the help it can get to engage immunity.”

Moderator Alice Ho, MD, a radiation oncologist at Duke University in Durham, North Carolina, called the R0 resection rate “stunning” in a “field that very much needs improvements and advancements.”

Dr. Ho also noted that the trial raises “a lot of interesting questions.”

For instance, why exactly is the addition of nivolumab seemingly improving outcomes?

The combination neoadjuvant therapy appeared to increase tertiary lymphoid structures, plasma cells, and CD4+ T cells — all indications that immunotherapy is having a positive impact — but the treatment also seemed to upregulate pathways for adenosine, an immunosuppressant associated with worse responses to checkpoint blockade.

A larger study is already in the works. In addition to a PD-1 blocker and mFOLFIRINOX, patients will receive a CD73 inhibitor to block adenosine production, Dr. Wainberg said.

Bristol Myers Squibb (BMS) provided the nivolumab used in the study. Dr. Wainberg is a consultant for and reported research funding from BMS and other companies. Dr. Ho had no relevant disclosures.
 

A version of this article appeared on Medscape.com.

There have been many attempts to use immunotherapy to improve outcomes in pancreatic cancer, but they haven’t worked out.

The trials, however, have focused on adding immune checkpoint inhibitors to chemotherapy in metastatic disease, leaving open the question of whether immunotherapy might have a role in the neoadjuvant setting before surgery.

In the first study to test the hypothesis, Zev A. Wainberg, MD, a gastrointestinal medical oncologist at the University of California Los Angeles, reported promising results at the American Association for Cancer Research annual meeting.

The small, single arm pilot study included 28 patients with borderline resectable pancreatic cancer, meaning that tumors had some degree of vascular involvement. About 20% of pancreatic tumors are borderline resectable, Dr. Wainberg said.

Patients received 480 mg of nivolumab intravenously every 4 weeks plus mFOLFIRINOX chemotherapy (oxaliplatin, irinotecan, leucovorin, and 5-fluorouracil) on days 1 and 15 of the 28-day cycle.

Patients who downstaged to resectable disease after three cycles went on to surgery; if not, treatment continued for another 3 months. The median number of cycles was 5.5, and almost all patients completed at least 3.

Overall, 19 of the 22 patients who proceeded to surgery (86%) had a pathologic response to neoadjuvant treatment with nivolumab: 2 complete responses, 2 near-complete responses, and 15 partial responses.

Among patients receiving surgery, 21 had R0 resections, meaning negative surgical margins with no tumor left behind. This is key because R0 resections predict longer survival, and “every effort should be made to achieve” this outcome, Dr. Wainberg said. The remaining patient had an R1 resection.

Median progression-free survival was 21.9 months among all patients and 27.3 months among the 22 patients who had resections.

Median overall survival was 34.6 months across the entire group and 44 months among those who had surgery. Overall, 82% of patients were alive at 12 months, and 77% were alive at 18 months.

The study outcomes, especially among the surgery cohort, stand in contrast to those observed in patients who receive the current standard neoadjuvant regimen for borderline resectable pancreatic cancer, mFOLFIRINOX alone, with studies finding a median overall survival of 29.8 months.

Adding nivolumab to neoadjuvant treatment also did not increase side effects. More than half of patients had grade 3 or worse adverse events, but they were all related to mFOLFIRINOX. There were no significant surgical complications, including no grade 2 or higher fistulas.

“We are very pleased” with the outcomes, Dr. Wainberg said. “We need to be studying [immune checkpoint inhibitors] earlier on in both borderline and locally advanced disease. Pancreatic cancer needs all the help it can get to engage immunity.”

Moderator Alice Ho, MD, a radiation oncologist at Duke University in Durham, North Carolina, called the R0 resection rate “stunning” in a “field that very much needs improvements and advancements.”

Dr. Ho also noted that the trial raises “a lot of interesting questions.”

For instance, why exactly is the addition of nivolumab seemingly improving outcomes?

The combination neoadjuvant therapy appeared to increase tertiary lymphoid structures, plasma cells, and CD4+ T cells — all indications that immunotherapy is having a positive impact — but the treatment also seemed to upregulate pathways for adenosine, an immunosuppressant associated with worse responses to checkpoint blockade.

A larger study is already in the works. In addition to a PD-1 blocker and mFOLFIRINOX, patients will receive a CD73 inhibitor to block adenosine production, Dr. Wainberg said.

Bristol Myers Squibb (BMS) provided the nivolumab used in the study. Dr. Wainberg is a consultant for and reported research funding from BMS and other companies. Dr. Ho had no relevant disclosures.
 

A version of this article appeared on Medscape.com.

You know what the happiest animal in the world is? A goldfish. You know why? It’s got a 10-second memory. Be a goldfish. — Ted Lasso

I don’t play much golf. When I do, it’s when my dad is in town. He shoots his age (78). I shoot double mine (52). He was recently here. We played and watched the Masters where he pointed out how I looked a lot like Scottie Scheffler, the now two-time Masters champion. On the 10th hole of his third round, you could see the resemblance. Scheffler’s third shot flew past the hole into the galley. He rifled the fourth past the hole on its way back toward the fairway. It was now a good distance further from the cup than a minute ago. He proceeded to misread his bogey putt, ending his misery with a double bogey. Scheffler went on to bogey the next hole and dropped from first on the leaderboard to fifth. Yes, I looked just like that on my last round. But here is where Scheffler and I differ. After a hole like that, I’d have been apoplectic, seething with self loathing. Scheffler was not. He kept moving. Head up, he sauntered to the next hole as if he had no awareness of what just transpired.

The ability to compartmentalize is useful not only to become the Masters champion, but also to become master of your day. In this way, golf is a nice approximation for life. The best golfers in the world will always have horrible shots and dreadful holes. The winning ones are often those who recover rather than continue in a downward spiral of one bad shot after another.

Dr. Benabio

Kaiser Permanente

Scheffler went on to eagle the 13th hole on that round. He eventually won the 2024 Masters Tournament. Remember that the next time you find yourself in a day that feels like it is spiraling toward disaster. Close the door on the compartment that was the last miserable hole and saunter to the next patient like it never happened.

And maybe close the clubface a bit on address for your next drive. 

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on X. Write to him at [email protected].

You know what the happiest animal in the world is? A goldfish. You know why? It’s got a 10-second memory. Be a goldfish. — Ted Lasso

I don’t play much golf. When I do, it’s when my dad is in town. He shoots his age (78). I shoot double mine (52). He was recently here. We played and watched the Masters where he pointed out how I looked a lot like Scottie Scheffler, the now two-time Masters champion. On the 10th hole of his third round, you could see the resemblance. Scheffler’s third shot flew past the hole into the galley. He rifled the fourth past the hole on its way back toward the fairway. It was now a good distance further from the cup than a minute ago. He proceeded to misread his bogey putt, ending his misery with a double bogey. Scheffler went on to bogey the next hole and dropped from first on the leaderboard to fifth. Yes, I looked just like that on my last round. But here is where Scheffler and I differ. After a hole like that, I’d have been apoplectic, seething with self loathing. Scheffler was not. He kept moving. Head up, he sauntered to the next hole as if he had no awareness of what just transpired.

The ability to compartmentalize is useful not only to become the Masters champion, but also to become master of your day. In this way, golf is a nice approximation for life. The best golfers in the world will always have horrible shots and dreadful holes. The winning ones are often those who recover rather than continue in a downward spiral of one bad shot after another.

Dr. Benabio

Kaiser Permanente

Scheffler went on to eagle the 13th hole on that round. He eventually won the 2024 Masters Tournament. Remember that the next time you find yourself in a day that feels like it is spiraling toward disaster. Close the door on the compartment that was the last miserable hole and saunter to the next patient like it never happened.

And maybe close the clubface a bit on address for your next drive. 

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on X. Write to him at [email protected].

You know what the happiest animal in the world is? A goldfish. You know why? It’s got a 10-second memory. Be a goldfish. — Ted Lasso

I don’t play much golf. When I do, it’s when my dad is in town. He shoots his age (78). I shoot double mine (52). He was recently here. We played and watched the Masters where he pointed out how I looked a lot like Scottie Scheffler, the now two-time Masters champion. On the 10th hole of his third round, you could see the resemblance. Scheffler’s third shot flew past the hole into the galley. He rifled the fourth past the hole on its way back toward the fairway. It was now a good distance further from the cup than a minute ago. He proceeded to misread his bogey putt, ending his misery with a double bogey. Scheffler went on to bogey the next hole and dropped from first on the leaderboard to fifth. Yes, I looked just like that on my last round. But here is where Scheffler and I differ. After a hole like that, I’d have been apoplectic, seething with self loathing. Scheffler was not. He kept moving. Head up, he sauntered to the next hole as if he had no awareness of what just transpired.

The ability to compartmentalize is useful not only to become the Masters champion, but also to become master of your day. In this way, golf is a nice approximation for life. The best golfers in the world will always have horrible shots and dreadful holes. The winning ones are often those who recover rather than continue in a downward spiral of one bad shot after another.

Dr. Benabio

Kaiser Permanente

Scheffler went on to eagle the 13th hole on that round. He eventually won the 2024 Masters Tournament. Remember that the next time you find yourself in a day that feels like it is spiraling toward disaster. Close the door on the compartment that was the last miserable hole and saunter to the next patient like it never happened.

And maybe close the clubface a bit on address for your next drive. 

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on X. Write to him at [email protected].

A novel CD19 chimeric antigen responder (CAR) T-cell therapy administered in exceptionally low doses and designed to reinvigorate exhausted T-cells shows impressive early results in the treatment of patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) and B-cell acute lymphoblastic leukemia (B-ALL).

“Our study showed a manageable safety profile in r/r DLBCL/B-ALL, with promising breakthrough efficacy of a 100% complete remission in all dose groups,” said first author Jingjing Ren, MD, PhD, associate director of research and development with Leman Biotech in Shenzhen, China. Dr. Ren presented these findings at the American Association for Cancer Research annual meeting held in San Diego.

While CD19 CAR T-cell therapy has been transformative in the treatment of relapsed B -cell hematological malignancies in recent years, more than half of patients relapse within a year because of inadequate CAR T persistence.

To address the problem, Dr. Ren and her colleagues developed a metabolically armed, interleukin (IL)-10-expressing CAR T-cell product called Meta10-19 for the treatment patients with r/r DLBCL or r/r B-ALL.

According to the authors, the IL-10-expressing CAR T-cells trigger “stem-like memory responses” in various lymphoid organs, which prompt a “robust tumor eradication and durable protection,” and hence, better persistence.

Preclinical studies in mice showed the Meta10-19 CAR T-cells exhibited substantially higher expansion of approximately 100-fold compared with a control CD19 CAR-T product.

Therefore, “we dramatically reduced the dose to approximately 1% to 5% of commercial products for the IL-10-expressing CD19 CAR-T for patients,” coauthor Yugang Guo, PhD, cofounder and president of Leman Biotech said in an interview.

For the ongoing, open-label clinical trial, 12 adult patients with r/r DLBCL or r/r B-ALL and confirmed CD19 expression at a hospital center in China were enrolled between December 2022 and November 2023 and treated in three cohorts, receiving doses that corresponded to 1%, 2.5%, or 5% of the doses of other commercialized CAR-T infusion products.

All patients also underwent lympho-depleting chemotherapy with cyclophosphamide and fludarabine prior to the CAR T-cell infusion.

Six patients had r/r DLBCL and the other six had r/r B-ALL; their median age was 47 and their median time since diagnosis was 1 year.

In the single-arm, intent-to-treat analysis, the treatment induced a complete remission in all 12 patients, as evaluated by PET-CT scan, nuclear magnetic resonance (NMR) spectroscopy, or minimal residual disease assessment of bone marrow.

The median time to best response was 1 month (range 0.5 to 2.2 months).

There were no cases of severe cytokine storm syndrome or neurotoxicity, which are among key limitations with current commercial CAR-T products.

All of the patients continued to have a complete remission at 3 months. Two of the 12 patients, both with B-ALL, experienced relapses, one after 4.7 months and the other at 8 months.

The authors reported that the first treated patient had maintained continuous remission as of 9 months.

In comparison with the much higher full doses of commercial CD19 CAR-T products, only about 50% of patients with DLBCL and 70% of B-ALL patients have been shown to achieve CR at 3 months, the authors reported.

“Our IL-10 expressing CAR-T sustains CR at 3 months post infusion in the context of not following allogeneic hematopoietic stem cell transplant, which suggests IL-10 expressing CAR-T is more resistant to relapse,” Dr. Guo said.

In terms of safety, six patients with DLBCL and four with B-ALL experienced grade 1 cytokine release syndrome (CRS), and two patients with B-ALL developed grade 2 CRS. There were no grade 3 or 4 CRS cases.

One patient with B-ALL developed grade 3 ICANS.

Grade 3-4 cytopenias occurred in most patients, but all were limited to no later than 90 days.

“We observed reduced CRS, with no level 3 or 4, or ICANS,” Dr. Guo said. “There was increased cytopenia, but still manageable, compared with commercial products.”

Of note, the Meta10-19 cells showed efficacy in the extremely low infusion doses even among patients with bulky mass (≥ 7.5 cm) of DLBCL, which is associated with an increased risk of relapse.

One patient had primary central nervous system lymphoma (PCNSL), a rare form of DLBCL that is known to have the worst prognosis of all non-Hodgkin lymphomas.

Due to the unique nature of CNS primary tumors, the CAR T-cell infusion dose was further reduced to 1% of the standard dose for the patient.

The patient maintained complete remission for more than 8 months before relapsing in periphery blood, but not in the CNS, Dr. Guo noted.

“Luckily, this relapse has been easily controlled by chemotherapy, and the patient is maintaining complete remission again now,” Dr. Guo said.
 

Mechanisms?

Dr. Guo noted that the mechanism believed to explain the improvements despite such low doses is that “IL-10-expressing CAR-T exhibits enhanced proliferation, cytotoxicity, and stem-like antitumor memory due to enhanced metabolic activities of oxidative phosphorylation.”

The authors noted that a key major factor limiting accessibility to CAR-T therapies is the lengthy production cycle and high costs; however, the “extremely low doses of 1% to 5% can significantly reduce the production cycle and cost of CAR T-cell therapies, increasing accessibility,” they wrote in a press statement.

Currently, more than 20 patients have achieved a CR overall, and studies with a larger cohort and longer follow-up are ongoing, Dr. Guo reported.

The research team plans to launch further clinical investigation this year into patients with solid tumors.

Commenting on the study, Hongbo Chi, PhD, the Robert G. Webster Endowed Chair in Immunology at St. Jude Children’s Research Hospital in Memphis, Tennessee, noted that, based on the abstract, “the effects are quite remarkable, considering the therapeutic efficacy observed even at the low dose.

“Results from more patients are needed to fully validate these findings, but the results to date are very encouraging,” he said.

The study was sponsored by Leman Biotech. Dr. Chi had no disclosures to report.

A novel CD19 chimeric antigen responder (CAR) T-cell therapy administered in exceptionally low doses and designed to reinvigorate exhausted T-cells shows impressive early results in the treatment of patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) and B-cell acute lymphoblastic leukemia (B-ALL).

“Our study showed a manageable safety profile in r/r DLBCL/B-ALL, with promising breakthrough efficacy of a 100% complete remission in all dose groups,” said first author Jingjing Ren, MD, PhD, associate director of research and development with Leman Biotech in Shenzhen, China. Dr. Ren presented these findings at the American Association for Cancer Research annual meeting held in San Diego.

While CD19 CAR T-cell therapy has been transformative in the treatment of relapsed B -cell hematological malignancies in recent years, more than half of patients relapse within a year because of inadequate CAR T persistence.

To address the problem, Dr. Ren and her colleagues developed a metabolically armed, interleukin (IL)-10-expressing CAR T-cell product called Meta10-19 for the treatment patients with r/r DLBCL or r/r B-ALL.

According to the authors, the IL-10-expressing CAR T-cells trigger “stem-like memory responses” in various lymphoid organs, which prompt a “robust tumor eradication and durable protection,” and hence, better persistence.

Preclinical studies in mice showed the Meta10-19 CAR T-cells exhibited substantially higher expansion of approximately 100-fold compared with a control CD19 CAR-T product.

Therefore, “we dramatically reduced the dose to approximately 1% to 5% of commercial products for the IL-10-expressing CD19 CAR-T for patients,” coauthor Yugang Guo, PhD, cofounder and president of Leman Biotech said in an interview.

For the ongoing, open-label clinical trial, 12 adult patients with r/r DLBCL or r/r B-ALL and confirmed CD19 expression at a hospital center in China were enrolled between December 2022 and November 2023 and treated in three cohorts, receiving doses that corresponded to 1%, 2.5%, or 5% of the doses of other commercialized CAR-T infusion products.

All patients also underwent lympho-depleting chemotherapy with cyclophosphamide and fludarabine prior to the CAR T-cell infusion.

Six patients had r/r DLBCL and the other six had r/r B-ALL; their median age was 47 and their median time since diagnosis was 1 year.

In the single-arm, intent-to-treat analysis, the treatment induced a complete remission in all 12 patients, as evaluated by PET-CT scan, nuclear magnetic resonance (NMR) spectroscopy, or minimal residual disease assessment of bone marrow.

The median time to best response was 1 month (range 0.5 to 2.2 months).

There were no cases of severe cytokine storm syndrome or neurotoxicity, which are among key limitations with current commercial CAR-T products.

All of the patients continued to have a complete remission at 3 months. Two of the 12 patients, both with B-ALL, experienced relapses, one after 4.7 months and the other at 8 months.

The authors reported that the first treated patient had maintained continuous remission as of 9 months.

In comparison with the much higher full doses of commercial CD19 CAR-T products, only about 50% of patients with DLBCL and 70% of B-ALL patients have been shown to achieve CR at 3 months, the authors reported.

“Our IL-10 expressing CAR-T sustains CR at 3 months post infusion in the context of not following allogeneic hematopoietic stem cell transplant, which suggests IL-10 expressing CAR-T is more resistant to relapse,” Dr. Guo said.

In terms of safety, six patients with DLBCL and four with B-ALL experienced grade 1 cytokine release syndrome (CRS), and two patients with B-ALL developed grade 2 CRS. There were no grade 3 or 4 CRS cases.

One patient with B-ALL developed grade 3 ICANS.

Grade 3-4 cytopenias occurred in most patients, but all were limited to no later than 90 days.

“We observed reduced CRS, with no level 3 or 4, or ICANS,” Dr. Guo said. “There was increased cytopenia, but still manageable, compared with commercial products.”

Of note, the Meta10-19 cells showed efficacy in the extremely low infusion doses even among patients with bulky mass (≥ 7.5 cm) of DLBCL, which is associated with an increased risk of relapse.

One patient had primary central nervous system lymphoma (PCNSL), a rare form of DLBCL that is known to have the worst prognosis of all non-Hodgkin lymphomas.

Due to the unique nature of CNS primary tumors, the CAR T-cell infusion dose was further reduced to 1% of the standard dose for the patient.

The patient maintained complete remission for more than 8 months before relapsing in periphery blood, but not in the CNS, Dr. Guo noted.

“Luckily, this relapse has been easily controlled by chemotherapy, and the patient is maintaining complete remission again now,” Dr. Guo said.
 

Mechanisms?

Dr. Guo noted that the mechanism believed to explain the improvements despite such low doses is that “IL-10-expressing CAR-T exhibits enhanced proliferation, cytotoxicity, and stem-like antitumor memory due to enhanced metabolic activities of oxidative phosphorylation.”

The authors noted that a key major factor limiting accessibility to CAR-T therapies is the lengthy production cycle and high costs; however, the “extremely low doses of 1% to 5% can significantly reduce the production cycle and cost of CAR T-cell therapies, increasing accessibility,” they wrote in a press statement.

Currently, more than 20 patients have achieved a CR overall, and studies with a larger cohort and longer follow-up are ongoing, Dr. Guo reported.

The research team plans to launch further clinical investigation this year into patients with solid tumors.

Commenting on the study, Hongbo Chi, PhD, the Robert G. Webster Endowed Chair in Immunology at St. Jude Children’s Research Hospital in Memphis, Tennessee, noted that, based on the abstract, “the effects are quite remarkable, considering the therapeutic efficacy observed even at the low dose.

“Results from more patients are needed to fully validate these findings, but the results to date are very encouraging,” he said.

The study was sponsored by Leman Biotech. Dr. Chi had no disclosures to report.

A novel CD19 chimeric antigen responder (CAR) T-cell therapy administered in exceptionally low doses and designed to reinvigorate exhausted T-cells shows impressive early results in the treatment of patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) and B-cell acute lymphoblastic leukemia (B-ALL).

“Our study showed a manageable safety profile in r/r DLBCL/B-ALL, with promising breakthrough efficacy of a 100% complete remission in all dose groups,” said first author Jingjing Ren, MD, PhD, associate director of research and development with Leman Biotech in Shenzhen, China. Dr. Ren presented these findings at the American Association for Cancer Research annual meeting held in San Diego.

While CD19 CAR T-cell therapy has been transformative in the treatment of relapsed B -cell hematological malignancies in recent years, more than half of patients relapse within a year because of inadequate CAR T persistence.

To address the problem, Dr. Ren and her colleagues developed a metabolically armed, interleukin (IL)-10-expressing CAR T-cell product called Meta10-19 for the treatment patients with r/r DLBCL or r/r B-ALL.

According to the authors, the IL-10-expressing CAR T-cells trigger “stem-like memory responses” in various lymphoid organs, which prompt a “robust tumor eradication and durable protection,” and hence, better persistence.

Preclinical studies in mice showed the Meta10-19 CAR T-cells exhibited substantially higher expansion of approximately 100-fold compared with a control CD19 CAR-T product.

Therefore, “we dramatically reduced the dose to approximately 1% to 5% of commercial products for the IL-10-expressing CD19 CAR-T for patients,” coauthor Yugang Guo, PhD, cofounder and president of Leman Biotech said in an interview.

For the ongoing, open-label clinical trial, 12 adult patients with r/r DLBCL or r/r B-ALL and confirmed CD19 expression at a hospital center in China were enrolled between December 2022 and November 2023 and treated in three cohorts, receiving doses that corresponded to 1%, 2.5%, or 5% of the doses of other commercialized CAR-T infusion products.

All patients also underwent lympho-depleting chemotherapy with cyclophosphamide and fludarabine prior to the CAR T-cell infusion.

Six patients had r/r DLBCL and the other six had r/r B-ALL; their median age was 47 and their median time since diagnosis was 1 year.

In the single-arm, intent-to-treat analysis, the treatment induced a complete remission in all 12 patients, as evaluated by PET-CT scan, nuclear magnetic resonance (NMR) spectroscopy, or minimal residual disease assessment of bone marrow.

The median time to best response was 1 month (range 0.5 to 2.2 months).

There were no cases of severe cytokine storm syndrome or neurotoxicity, which are among key limitations with current commercial CAR-T products.

All of the patients continued to have a complete remission at 3 months. Two of the 12 patients, both with B-ALL, experienced relapses, one after 4.7 months and the other at 8 months.

The authors reported that the first treated patient had maintained continuous remission as of 9 months.

In comparison with the much higher full doses of commercial CD19 CAR-T products, only about 50% of patients with DLBCL and 70% of B-ALL patients have been shown to achieve CR at 3 months, the authors reported.

“Our IL-10 expressing CAR-T sustains CR at 3 months post infusion in the context of not following allogeneic hematopoietic stem cell transplant, which suggests IL-10 expressing CAR-T is more resistant to relapse,” Dr. Guo said.

In terms of safety, six patients with DLBCL and four with B-ALL experienced grade 1 cytokine release syndrome (CRS), and two patients with B-ALL developed grade 2 CRS. There were no grade 3 or 4 CRS cases.

One patient with B-ALL developed grade 3 ICANS.

Grade 3-4 cytopenias occurred in most patients, but all were limited to no later than 90 days.

“We observed reduced CRS, with no level 3 or 4, or ICANS,” Dr. Guo said. “There was increased cytopenia, but still manageable, compared with commercial products.”

Of note, the Meta10-19 cells showed efficacy in the extremely low infusion doses even among patients with bulky mass (≥ 7.5 cm) of DLBCL, which is associated with an increased risk of relapse.

One patient had primary central nervous system lymphoma (PCNSL), a rare form of DLBCL that is known to have the worst prognosis of all non-Hodgkin lymphomas.

Due to the unique nature of CNS primary tumors, the CAR T-cell infusion dose was further reduced to 1% of the standard dose for the patient.

The patient maintained complete remission for more than 8 months before relapsing in periphery blood, but not in the CNS, Dr. Guo noted.

“Luckily, this relapse has been easily controlled by chemotherapy, and the patient is maintaining complete remission again now,” Dr. Guo said.
 

Mechanisms?

Dr. Guo noted that the mechanism believed to explain the improvements despite such low doses is that “IL-10-expressing CAR-T exhibits enhanced proliferation, cytotoxicity, and stem-like antitumor memory due to enhanced metabolic activities of oxidative phosphorylation.”

The authors noted that a key major factor limiting accessibility to CAR-T therapies is the lengthy production cycle and high costs; however, the “extremely low doses of 1% to 5% can significantly reduce the production cycle and cost of CAR T-cell therapies, increasing accessibility,” they wrote in a press statement.

Currently, more than 20 patients have achieved a CR overall, and studies with a larger cohort and longer follow-up are ongoing, Dr. Guo reported.

The research team plans to launch further clinical investigation this year into patients with solid tumors.

Commenting on the study, Hongbo Chi, PhD, the Robert G. Webster Endowed Chair in Immunology at St. Jude Children’s Research Hospital in Memphis, Tennessee, noted that, based on the abstract, “the effects are quite remarkable, considering the therapeutic efficacy observed even at the low dose.

“Results from more patients are needed to fully validate these findings, but the results to date are very encouraging,” he said.

The study was sponsored by Leman Biotech. Dr. Chi had no disclosures to report.

The latest research supports immune checkpoint inhibitor therapy for clear cell and non–clear cell renal cell carcinoma, but patient selection is key to optimize outcomes, according to a medical oncologist from the Dana-Farber Cancer Institute, Boston.

Michael Serzan, MD, who works in the Lank Center for Genitourinary Oncology at the institute, stated this at the 2024 National Comprehensive Cancer Network Annual Conference, during a presentation.

A systematic review and meta-analysis published in 2022 in European Urology Open Science summarized six randomized controlled trials with a total of 5121 adult patients. In the review, the researchers found that immune checkpoint inhibitors plus vascular endothelial growth factor tyrosine kinase inhibitors (VEGF TKI) were associated with consistent improvements across all risk groups for metastatic renal cell carcinoma.

Additional newer research supports the use of immunotherapy combinations or other immunotherapy plus tyrosine kinase inhibitors as first-line or adjuvant treatments for renal cell carcinoma, Dr. Serzan said during an interview. However, more genomic and histology-directed therapies are needed, he noted.
 

Tips for Evaluating Risk When Treating Renal Cell Carcinoma?

For patients with localized clear cell renal cell carcinoma who have undergone partial or radical nephrectomy, there are several models that estimate the risk of recurrence based on pathologic tumor stage, grade, histology, invasion, and the extent of necrosis, Dr. Serzan said. These models can help guide selection of patients who may be at high risk of recurrence and, therefore, may benefit from adjuvant therapy.

For patients with metastatic clear cell renal cell carcinoma, the IMDC and MSKCC prognostic models stratify patients to favorable, intermediate, and poor risk groups based on clinical and lab factors. The IMDC risk stratification model is used as a prognostic model to stratify patients diagnosed with metastatic kidney cancer, Dr. Serzan said.
 

What Research Supports Treatments for Clear Cell and Non–Clear Cell Renal Cell Carcinoma?

The US Food and Drug Administration (FDA) approved pembrolizumab in 2021 for the adjuvant treatment of renal cell carcinoma (RCC) in patients with intermediate-risk or high-risk of recurrence after nephrectomy or after nephrectomy and resection of metastatic lesions.

Pembrolizumab is the first adjuvant therapy shown to significantly improve overall survival in these patients, Dr. Serzan said. In the KEYNOTE-564 study, published in 2024 in the Journal of Clinical Oncology, pembrolizumab demonstrated an improvement in disease free survival as well as overall survival when compared with placebo.

Several similar studies of adjuvant immune checkpoint inhibitors for renal cell carcinoma involving atezolizumab vs. placebo, nivolumab plus ipilimumab vs. placebo, and nivolumab vs. observation have not shown significant benefits in terms of disease-free survival, Dr. Serzan noted.

The current NCCN Clinical Practice Guidelines in Oncology for Kidney Cancer (Version: 3.2024), which were updated this year, support the use of adjuvant pembrolizumab for patients with stage II, III, or IV clear cell renal cell carcinoma after partial or radical nephrectomy, he said.

Looking ahead, biomarkers are needed to understand the risk of recurrence, and which patients benefit from adjuvant pembrolizumab, Dr. Serzan added.
 

Where Do VEGF-TKIs Fit In?

VEGF is a treatment target for renal cancer, and angiogenesis inhibition with VEGF TKIs continues to be a subject for study, Dr. Serzan said. In the CABOSUN study, published in the Journal of Clinical Oncology in 2017, patients were randomized to cabozantinib or sunitinib. Progression-free survival was significantly greater in the cabozantinib group, but overall survival was similar between the groups.

In another randomized trial, the CheckMate 214 study, patients received either sunitinib or a combination of nivolumab plus ipilimumab in four doses given every 3 weeks, followed by nivolumab alone every 2 weeks, and these patients were stratified by risk, Dr. Serzan noted.

The median progression-free survival was 12.4 months in the combination group vs. 8.5 months in the sunitinib group for patients at intermediate or poor risk of recurrence. The median progression-free survival was significantly greater in sunitinib patients with favorable risk vs. combination patients with favorable risk (28.9 months vs. 12.4 months).

Overall survival was higher for all patients with combination therapy vs. sunitinib regardless of risk stratification.

Dr. Serzan reviewed the pros of VEGF/PD1 (programmed death-ligand 1) combinations as including a high response rate (generally 52%-72%) and a low rate of primary progressive disease (5%-12%), as well as favorable progression-free and overall survival and low rates of immune-related adverse events.

However, cons of this treatment include lack of data on treatment-free survival as well as the decrease in progression-free survival and overall survival hazard ratios over time and potential chronic VEGF/TKI toxicities, he said.
 

What Treatments Are Recommended for Metastatic Clear Cell Renal Cell Carcinoma Now?

Clear cell renal cell carcinoma (ccRCC) is the most prevalent histological subtype of kidney cancer, accounting for 70%-75% of cases, and these patients are prone to metastasis, recurrence, and resistance to radiotherapy and chemotherapy, according to authors of a recent review published in Frontiers in Oncology.

Dr. Serzan shared his preferred protocol for treatment-naive metastatic ccRCC patients, based on the NCCN guidelines for Kidney Cancer (Version: 3.2024) that had been updated in 2024.

For those with sarcomatoid features, he favors the use of nivolumab/ipilimumab combination, while those without sarcomatoid features, if highly symptomatic, may be treated with any of several combinations: nivolumab/ipilimumab, axitinib/pembrolizumab, cabozantinib/nivolumab, or lenvatinib/pembrolizumab.

For asymptomatic patients without sarcomatoid features, treatment depends on eligibility for immune checkpoint inhibitors or ipilimumab, Dr. Serzan said. His first choice for those eligible is nivolumab/ipilimumab; those not eligible for ipilimumab could receive nivolumab, pembrolizumab, axitinib/pembrolizumab, cabozantinib/nivolumab, or lenvatinib/pembrolizumab.

For patients not eligible for ICIs because of uncontrolled autoimmune disease, or high-dose glucocorticoids, Dr. Serzan recommended treatment with cabozantinib, lenvatinib/everolimus, pazopanib, or sunitinib.
 

What are Some Takeaway Points About Immunotherapy and Renal Cell Carcinoma?

“Immunotherapy has revolutionized treatment for renal cell carcinoma, with significant increases in overall survival, and a small but consistent cure fraction that was unimaginable 10 years ago,” Eric Jonasch, MD, of The University of Texas MD Anderson Cancer Center and vice-chair of the NCCN Guidelines Panel for Kidney Cancer, said in an interview.

However, challenges to implementing new treatments in clinical practice are ongoing, he said. The major challenges facing clinicians, patients, and their families include the cost of therapy, logistics of treatment administration, and managing toxicities, Dr. Jonasch said.  

Patient selection is key to optimize outcomes with immunotherapy, and shared decision-making is essential to ensure that choice of therapy matches patient expectations and needs — and to maintain clear and open channels of communication while patients are on therapy, Dr. Jonasch said. “In my clinic, we empower patients to take treatment breaks to manage side effects, thereby optimizing quality of life while maintaining treatment efficacy,” he said.

Although significant progress has been made in managing renal cell carcinoma, more research is needed to increase the proportion of patients cured, said Dr. Jonasch. “A clearer understanding of the determinants of response and resistance, which will be driven by information rich clinical trials, will help move us in that direction,” he said.

Dr. Serzan had no financial conflicts to disclose. Dr. Jonasch disclosed research support from AbbVie, Arrowhead, Aveo, BMS, Corvus, Merck, NiKang, ProfoundBio, and Telix, as well as honoraria from Aveo, Eisai, Exelixis, GlaxoSmithKline, Ipsen, Merck, Novartis, NiKang, and Takeda.

The latest research supports immune checkpoint inhibitor therapy for clear cell and non–clear cell renal cell carcinoma, but patient selection is key to optimize outcomes, according to a medical oncologist from the Dana-Farber Cancer Institute, Boston.

Michael Serzan, MD, who works in the Lank Center for Genitourinary Oncology at the institute, stated this at the 2024 National Comprehensive Cancer Network Annual Conference, during a presentation.

A systematic review and meta-analysis published in 2022 in European Urology Open Science summarized six randomized controlled trials with a total of 5121 adult patients. In the review, the researchers found that immune checkpoint inhibitors plus vascular endothelial growth factor tyrosine kinase inhibitors (VEGF TKI) were associated with consistent improvements across all risk groups for metastatic renal cell carcinoma.

Additional newer research supports the use of immunotherapy combinations or other immunotherapy plus tyrosine kinase inhibitors as first-line or adjuvant treatments for renal cell carcinoma, Dr. Serzan said during an interview. However, more genomic and histology-directed therapies are needed, he noted.
 

Tips for Evaluating Risk When Treating Renal Cell Carcinoma?

For patients with localized clear cell renal cell carcinoma who have undergone partial or radical nephrectomy, there are several models that estimate the risk of recurrence based on pathologic tumor stage, grade, histology, invasion, and the extent of necrosis, Dr. Serzan said. These models can help guide selection of patients who may be at high risk of recurrence and, therefore, may benefit from adjuvant therapy.

For patients with metastatic clear cell renal cell carcinoma, the IMDC and MSKCC prognostic models stratify patients to favorable, intermediate, and poor risk groups based on clinical and lab factors. The IMDC risk stratification model is used as a prognostic model to stratify patients diagnosed with metastatic kidney cancer, Dr. Serzan said.
 

What Research Supports Treatments for Clear Cell and Non–Clear Cell Renal Cell Carcinoma?

The US Food and Drug Administration (FDA) approved pembrolizumab in 2021 for the adjuvant treatment of renal cell carcinoma (RCC) in patients with intermediate-risk or high-risk of recurrence after nephrectomy or after nephrectomy and resection of metastatic lesions.

Pembrolizumab is the first adjuvant therapy shown to significantly improve overall survival in these patients, Dr. Serzan said. In the KEYNOTE-564 study, published in 2024 in the Journal of Clinical Oncology, pembrolizumab demonstrated an improvement in disease free survival as well as overall survival when compared with placebo.

Several similar studies of adjuvant immune checkpoint inhibitors for renal cell carcinoma involving atezolizumab vs. placebo, nivolumab plus ipilimumab vs. placebo, and nivolumab vs. observation have not shown significant benefits in terms of disease-free survival, Dr. Serzan noted.

The current NCCN Clinical Practice Guidelines in Oncology for Kidney Cancer (Version: 3.2024), which were updated this year, support the use of adjuvant pembrolizumab for patients with stage II, III, or IV clear cell renal cell carcinoma after partial or radical nephrectomy, he said.

Looking ahead, biomarkers are needed to understand the risk of recurrence, and which patients benefit from adjuvant pembrolizumab, Dr. Serzan added.
 

Where Do VEGF-TKIs Fit In?

VEGF is a treatment target for renal cancer, and angiogenesis inhibition with VEGF TKIs continues to be a subject for study, Dr. Serzan said. In the CABOSUN study, published in the Journal of Clinical Oncology in 2017, patients were randomized to cabozantinib or sunitinib. Progression-free survival was significantly greater in the cabozantinib group, but overall survival was similar between the groups.

In another randomized trial, the CheckMate 214 study, patients received either sunitinib or a combination of nivolumab plus ipilimumab in four doses given every 3 weeks, followed by nivolumab alone every 2 weeks, and these patients were stratified by risk, Dr. Serzan noted.

The median progression-free survival was 12.4 months in the combination group vs. 8.5 months in the sunitinib group for patients at intermediate or poor risk of recurrence. The median progression-free survival was significantly greater in sunitinib patients with favorable risk vs. combination patients with favorable risk (28.9 months vs. 12.4 months).

Overall survival was higher for all patients with combination therapy vs. sunitinib regardless of risk stratification.

Dr. Serzan reviewed the pros of VEGF/PD1 (programmed death-ligand 1) combinations as including a high response rate (generally 52%-72%) and a low rate of primary progressive disease (5%-12%), as well as favorable progression-free and overall survival and low rates of immune-related adverse events.

However, cons of this treatment include lack of data on treatment-free survival as well as the decrease in progression-free survival and overall survival hazard ratios over time and potential chronic VEGF/TKI toxicities, he said.
 

What Treatments Are Recommended for Metastatic Clear Cell Renal Cell Carcinoma Now?

Clear cell renal cell carcinoma (ccRCC) is the most prevalent histological subtype of kidney cancer, accounting for 70%-75% of cases, and these patients are prone to metastasis, recurrence, and resistance to radiotherapy and chemotherapy, according to authors of a recent review published in Frontiers in Oncology.

Dr. Serzan shared his preferred protocol for treatment-naive metastatic ccRCC patients, based on the NCCN guidelines for Kidney Cancer (Version: 3.2024) that had been updated in 2024.

For those with sarcomatoid features, he favors the use of nivolumab/ipilimumab combination, while those without sarcomatoid features, if highly symptomatic, may be treated with any of several combinations: nivolumab/ipilimumab, axitinib/pembrolizumab, cabozantinib/nivolumab, or lenvatinib/pembrolizumab.

For asymptomatic patients without sarcomatoid features, treatment depends on eligibility for immune checkpoint inhibitors or ipilimumab, Dr. Serzan said. His first choice for those eligible is nivolumab/ipilimumab; those not eligible for ipilimumab could receive nivolumab, pembrolizumab, axitinib/pembrolizumab, cabozantinib/nivolumab, or lenvatinib/pembrolizumab.

For patients not eligible for ICIs because of uncontrolled autoimmune disease, or high-dose glucocorticoids, Dr. Serzan recommended treatment with cabozantinib, lenvatinib/everolimus, pazopanib, or sunitinib.
 

What are Some Takeaway Points About Immunotherapy and Renal Cell Carcinoma?

“Immunotherapy has revolutionized treatment for renal cell carcinoma, with significant increases in overall survival, and a small but consistent cure fraction that was unimaginable 10 years ago,” Eric Jonasch, MD, of The University of Texas MD Anderson Cancer Center and vice-chair of the NCCN Guidelines Panel for Kidney Cancer, said in an interview.

However, challenges to implementing new treatments in clinical practice are ongoing, he said. The major challenges facing clinicians, patients, and their families include the cost of therapy, logistics of treatment administration, and managing toxicities, Dr. Jonasch said.  

Patient selection is key to optimize outcomes with immunotherapy, and shared decision-making is essential to ensure that choice of therapy matches patient expectations and needs — and to maintain clear and open channels of communication while patients are on therapy, Dr. Jonasch said. “In my clinic, we empower patients to take treatment breaks to manage side effects, thereby optimizing quality of life while maintaining treatment efficacy,” he said.

Although significant progress has been made in managing renal cell carcinoma, more research is needed to increase the proportion of patients cured, said Dr. Jonasch. “A clearer understanding of the determinants of response and resistance, which will be driven by information rich clinical trials, will help move us in that direction,” he said.

Dr. Serzan had no financial conflicts to disclose. Dr. Jonasch disclosed research support from AbbVie, Arrowhead, Aveo, BMS, Corvus, Merck, NiKang, ProfoundBio, and Telix, as well as honoraria from Aveo, Eisai, Exelixis, GlaxoSmithKline, Ipsen, Merck, Novartis, NiKang, and Takeda.

The latest research supports immune checkpoint inhibitor therapy for clear cell and non–clear cell renal cell carcinoma, but patient selection is key to optimize outcomes, according to a medical oncologist from the Dana-Farber Cancer Institute, Boston.

Michael Serzan, MD, who works in the Lank Center for Genitourinary Oncology at the institute, stated this at the 2024 National Comprehensive Cancer Network Annual Conference, during a presentation.

A systematic review and meta-analysis published in 2022 in European Urology Open Science summarized six randomized controlled trials with a total of 5121 adult patients. In the review, the researchers found that immune checkpoint inhibitors plus vascular endothelial growth factor tyrosine kinase inhibitors (VEGF TKI) were associated with consistent improvements across all risk groups for metastatic renal cell carcinoma.

Additional newer research supports the use of immunotherapy combinations or other immunotherapy plus tyrosine kinase inhibitors as first-line or adjuvant treatments for renal cell carcinoma, Dr. Serzan said during an interview. However, more genomic and histology-directed therapies are needed, he noted.
 

Tips for Evaluating Risk When Treating Renal Cell Carcinoma?

For patients with localized clear cell renal cell carcinoma who have undergone partial or radical nephrectomy, there are several models that estimate the risk of recurrence based on pathologic tumor stage, grade, histology, invasion, and the extent of necrosis, Dr. Serzan said. These models can help guide selection of patients who may be at high risk of recurrence and, therefore, may benefit from adjuvant therapy.

For patients with metastatic clear cell renal cell carcinoma, the IMDC and MSKCC prognostic models stratify patients to favorable, intermediate, and poor risk groups based on clinical and lab factors. The IMDC risk stratification model is used as a prognostic model to stratify patients diagnosed with metastatic kidney cancer, Dr. Serzan said.
 

What Research Supports Treatments for Clear Cell and Non–Clear Cell Renal Cell Carcinoma?

The US Food and Drug Administration (FDA) approved pembrolizumab in 2021 for the adjuvant treatment of renal cell carcinoma (RCC) in patients with intermediate-risk or high-risk of recurrence after nephrectomy or after nephrectomy and resection of metastatic lesions.

Pembrolizumab is the first adjuvant therapy shown to significantly improve overall survival in these patients, Dr. Serzan said. In the KEYNOTE-564 study, published in 2024 in the Journal of Clinical Oncology, pembrolizumab demonstrated an improvement in disease free survival as well as overall survival when compared with placebo.

Several similar studies of adjuvant immune checkpoint inhibitors for renal cell carcinoma involving atezolizumab vs. placebo, nivolumab plus ipilimumab vs. placebo, and nivolumab vs. observation have not shown significant benefits in terms of disease-free survival, Dr. Serzan noted.

The current NCCN Clinical Practice Guidelines in Oncology for Kidney Cancer (Version: 3.2024), which were updated this year, support the use of adjuvant pembrolizumab for patients with stage II, III, or IV clear cell renal cell carcinoma after partial or radical nephrectomy, he said.

Looking ahead, biomarkers are needed to understand the risk of recurrence, and which patients benefit from adjuvant pembrolizumab, Dr. Serzan added.
 

Where Do VEGF-TKIs Fit In?

VEGF is a treatment target for renal cancer, and angiogenesis inhibition with VEGF TKIs continues to be a subject for study, Dr. Serzan said. In the CABOSUN study, published in the Journal of Clinical Oncology in 2017, patients were randomized to cabozantinib or sunitinib. Progression-free survival was significantly greater in the cabozantinib group, but overall survival was similar between the groups.

In another randomized trial, the CheckMate 214 study, patients received either sunitinib or a combination of nivolumab plus ipilimumab in four doses given every 3 weeks, followed by nivolumab alone every 2 weeks, and these patients were stratified by risk, Dr. Serzan noted.

The median progression-free survival was 12.4 months in the combination group vs. 8.5 months in the sunitinib group for patients at intermediate or poor risk of recurrence. The median progression-free survival was significantly greater in sunitinib patients with favorable risk vs. combination patients with favorable risk (28.9 months vs. 12.4 months).

Overall survival was higher for all patients with combination therapy vs. sunitinib regardless of risk stratification.

Dr. Serzan reviewed the pros of VEGF/PD1 (programmed death-ligand 1) combinations as including a high response rate (generally 52%-72%) and a low rate of primary progressive disease (5%-12%), as well as favorable progression-free and overall survival and low rates of immune-related adverse events.

However, cons of this treatment include lack of data on treatment-free survival as well as the decrease in progression-free survival and overall survival hazard ratios over time and potential chronic VEGF/TKI toxicities, he said.
 

What Treatments Are Recommended for Metastatic Clear Cell Renal Cell Carcinoma Now?

Clear cell renal cell carcinoma (ccRCC) is the most prevalent histological subtype of kidney cancer, accounting for 70%-75% of cases, and these patients are prone to metastasis, recurrence, and resistance to radiotherapy and chemotherapy, according to authors of a recent review published in Frontiers in Oncology.

Dr. Serzan shared his preferred protocol for treatment-naive metastatic ccRCC patients, based on the NCCN guidelines for Kidney Cancer (Version: 3.2024) that had been updated in 2024.

For those with sarcomatoid features, he favors the use of nivolumab/ipilimumab combination, while those without sarcomatoid features, if highly symptomatic, may be treated with any of several combinations: nivolumab/ipilimumab, axitinib/pembrolizumab, cabozantinib/nivolumab, or lenvatinib/pembrolizumab.

For asymptomatic patients without sarcomatoid features, treatment depends on eligibility for immune checkpoint inhibitors or ipilimumab, Dr. Serzan said. His first choice for those eligible is nivolumab/ipilimumab; those not eligible for ipilimumab could receive nivolumab, pembrolizumab, axitinib/pembrolizumab, cabozantinib/nivolumab, or lenvatinib/pembrolizumab.

For patients not eligible for ICIs because of uncontrolled autoimmune disease, or high-dose glucocorticoids, Dr. Serzan recommended treatment with cabozantinib, lenvatinib/everolimus, pazopanib, or sunitinib.
 

What are Some Takeaway Points About Immunotherapy and Renal Cell Carcinoma?

“Immunotherapy has revolutionized treatment for renal cell carcinoma, with significant increases in overall survival, and a small but consistent cure fraction that was unimaginable 10 years ago,” Eric Jonasch, MD, of The University of Texas MD Anderson Cancer Center and vice-chair of the NCCN Guidelines Panel for Kidney Cancer, said in an interview.

However, challenges to implementing new treatments in clinical practice are ongoing, he said. The major challenges facing clinicians, patients, and their families include the cost of therapy, logistics of treatment administration, and managing toxicities, Dr. Jonasch said.  

Patient selection is key to optimize outcomes with immunotherapy, and shared decision-making is essential to ensure that choice of therapy matches patient expectations and needs — and to maintain clear and open channels of communication while patients are on therapy, Dr. Jonasch said. “In my clinic, we empower patients to take treatment breaks to manage side effects, thereby optimizing quality of life while maintaining treatment efficacy,” he said.

Although significant progress has been made in managing renal cell carcinoma, more research is needed to increase the proportion of patients cured, said Dr. Jonasch. “A clearer understanding of the determinants of response and resistance, which will be driven by information rich clinical trials, will help move us in that direction,” he said.

Dr. Serzan had no financial conflicts to disclose. Dr. Jonasch disclosed research support from AbbVie, Arrowhead, Aveo, BMS, Corvus, Merck, NiKang, ProfoundBio, and Telix, as well as honoraria from Aveo, Eisai, Exelixis, GlaxoSmithKline, Ipsen, Merck, Novartis, NiKang, and Takeda.

Patients with granulomatosis with polyangiitis (GPA) who scored high on a sinonasal symptom test are nearly three times as likely to relapse, according to a new study.

These patients reported higher scores months and up to 2 years before a disease flare, despite having low disease activity otherwise.

The study uses a different approach to try to predict relapse, compared with measuring biomarkers in lab tests, said Zachary Wallace, MD, a rheumatologist at Massachusetts General Hospital in Boston, Massachusetts. He was not involved with the study.

“It’s exciting because it might suggest that we could use something as simple as a survey to stratify someone’s risk of relapse,” he told this news organization.

Antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) is a rare disease, with an estimated prevalence of 200-400 cases per million people. It is also heterogeneous, which makes it difficult to predict the risk for relapse for a given patient.

“Investigators have long searched for a reliable prognostic marker that identifies patients at high vs low risk of relapse in AAV but, except for ANCA type, no prognostic biomarker is routinely used to inform treatment decision-making,” wrote lead author Ellen Romich, MD, a rheumatology fellow at the University of Pennsylvania in Philadelphia, Pennsylvania, and colleagues.

Proteinase 3-ANCA (compared with myeloperoxidase-ANCA) has been tied to a higher risk for relapse, as well as gastrointestinal complications, sinonasal disease, and patient global assessment scores. In this new study, Dr. Romich and colleagues evaluated if patient-reported outcomes of sinonasal disease could predict AAV disease activity and relapse.

Researchers used data from a prospective, longitudinal cohort study through the University of Pennsylvania Vasculitis Center from 2016 to 2022. They included 107 patients with GPA, 40 patients with eosinophilic granulomatosis with polyangiitis (EGPA), 21 patients with microscopic polyangiitis (MPA), and 51 healthy controls.

Patients completed a median of four clinic visits during the duration of the study.

During each visit, patients filled out the 22-item SinoNasal Outcome Test (SNOT-22), a validated questionnaire that assesses rhinosinusitis. The tool asks patients to rate a list of symptoms from 0 to 5 in five categories: Rhinologic, extra-nasal, ear and face, psychologic, and sleep. The possible total score ranges from 0 to 110.

Disease activity was measured via the Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis. The results were published online in Arthritis Care & Research.

Patients were, on average, 55 years old with an AAV duration of 3 years. (The mean age of healthy participants was 59.) More than half (58%) of patients were female, and 95% were White. The majority had a history of a flare (54%), and 60% of those flares had sinonasal involvement.

Even in remission, patients with AAV generally had on average higher SNOT-22 scores than healthy comparators (20 vs 5). Higher disease activity also correlated with higher SNOT-22 scores.

In patients with GPA, a high SNOT-22 score (total score of 41 or above) was associated with an increased risk for relapse within 2 years (hazard ratio, 2.7; P = .02). This association was not found for EGPA or MPA. This higher risk remained in a sensitivity analysis that included only patients with no history of sinonasal disease.

“Interestingly, among patients with GPA, SNOT-22 scores are elevated months to years prior to onset of systemic relapse but remain low in patients in sustained remission,” the authors wrote.

While other patient-reported outcomes have been validated for AAV, SNOT-22 may provide more detail on upper airway disease, commented Paul Monach, MD, PhD, an adjunct associate professor of medicine at the Boston University Chobanian & Avedisian School of Medicine and a rheumatologist at the VA Boston Healthcare System, Boston, Massachusetts.

“Upper airway GPA has not been studied as much as systemic GPA and MPA,” he told this news organization. “There are very few clinical trials, and we need better outcome measures like this.”

Dr. Romich noted that this work is still in the “early stages,” and SNOT-22 will need to be further studied and validated in other patient cohorts before its inclusion in clinical practice.

“There’s certainly more work that needs to be done to understand how the SNOT-22 questionnaire works in this patient population,” she said, including its predictive value compared with other known risk factors for relapse. “But I think it’s something that’s promising that we could use as a patient-reported outcome to try to, visit-to-visit, track their sinonasal symptoms.”

This study was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases and an NIH Rheumatology Research Training Grant. Dr. Romich, Dr. Wallace, and Monach reported no other relevant disclosures.

A version of this article appeared on Medscape.com.

Patients with granulomatosis with polyangiitis (GPA) who scored high on a sinonasal symptom test are nearly three times as likely to relapse, according to a new study.

These patients reported higher scores months and up to 2 years before a disease flare, despite having low disease activity otherwise.

The study uses a different approach to try to predict relapse, compared with measuring biomarkers in lab tests, said Zachary Wallace, MD, a rheumatologist at Massachusetts General Hospital in Boston, Massachusetts. He was not involved with the study.

“It’s exciting because it might suggest that we could use something as simple as a survey to stratify someone’s risk of relapse,” he told this news organization.

Antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) is a rare disease, with an estimated prevalence of 200-400 cases per million people. It is also heterogeneous, which makes it difficult to predict the risk for relapse for a given patient.

“Investigators have long searched for a reliable prognostic marker that identifies patients at high vs low risk of relapse in AAV but, except for ANCA type, no prognostic biomarker is routinely used to inform treatment decision-making,” wrote lead author Ellen Romich, MD, a rheumatology fellow at the University of Pennsylvania in Philadelphia, Pennsylvania, and colleagues.

Proteinase 3-ANCA (compared with myeloperoxidase-ANCA) has been tied to a higher risk for relapse, as well as gastrointestinal complications, sinonasal disease, and patient global assessment scores. In this new study, Dr. Romich and colleagues evaluated if patient-reported outcomes of sinonasal disease could predict AAV disease activity and relapse.

Researchers used data from a prospective, longitudinal cohort study through the University of Pennsylvania Vasculitis Center from 2016 to 2022. They included 107 patients with GPA, 40 patients with eosinophilic granulomatosis with polyangiitis (EGPA), 21 patients with microscopic polyangiitis (MPA), and 51 healthy controls.

Patients completed a median of four clinic visits during the duration of the study.

During each visit, patients filled out the 22-item SinoNasal Outcome Test (SNOT-22), a validated questionnaire that assesses rhinosinusitis. The tool asks patients to rate a list of symptoms from 0 to 5 in five categories: Rhinologic, extra-nasal, ear and face, psychologic, and sleep. The possible total score ranges from 0 to 110.

Disease activity was measured via the Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis. The results were published online in Arthritis Care & Research.

Patients were, on average, 55 years old with an AAV duration of 3 years. (The mean age of healthy participants was 59.) More than half (58%) of patients were female, and 95% were White. The majority had a history of a flare (54%), and 60% of those flares had sinonasal involvement.

Even in remission, patients with AAV generally had on average higher SNOT-22 scores than healthy comparators (20 vs 5). Higher disease activity also correlated with higher SNOT-22 scores.

In patients with GPA, a high SNOT-22 score (total score of 41 or above) was associated with an increased risk for relapse within 2 years (hazard ratio, 2.7; P = .02). This association was not found for EGPA or MPA. This higher risk remained in a sensitivity analysis that included only patients with no history of sinonasal disease.

“Interestingly, among patients with GPA, SNOT-22 scores are elevated months to years prior to onset of systemic relapse but remain low in patients in sustained remission,” the authors wrote.

While other patient-reported outcomes have been validated for AAV, SNOT-22 may provide more detail on upper airway disease, commented Paul Monach, MD, PhD, an adjunct associate professor of medicine at the Boston University Chobanian & Avedisian School of Medicine and a rheumatologist at the VA Boston Healthcare System, Boston, Massachusetts.

“Upper airway GPA has not been studied as much as systemic GPA and MPA,” he told this news organization. “There are very few clinical trials, and we need better outcome measures like this.”

Dr. Romich noted that this work is still in the “early stages,” and SNOT-22 will need to be further studied and validated in other patient cohorts before its inclusion in clinical practice.

“There’s certainly more work that needs to be done to understand how the SNOT-22 questionnaire works in this patient population,” she said, including its predictive value compared with other known risk factors for relapse. “But I think it’s something that’s promising that we could use as a patient-reported outcome to try to, visit-to-visit, track their sinonasal symptoms.”

This study was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases and an NIH Rheumatology Research Training Grant. Dr. Romich, Dr. Wallace, and Monach reported no other relevant disclosures.

A version of this article appeared on Medscape.com.

Patients with granulomatosis with polyangiitis (GPA) who scored high on a sinonasal symptom test are nearly three times as likely to relapse, according to a new study.

These patients reported higher scores months and up to 2 years before a disease flare, despite having low disease activity otherwise.

The study uses a different approach to try to predict relapse, compared with measuring biomarkers in lab tests, said Zachary Wallace, MD, a rheumatologist at Massachusetts General Hospital in Boston, Massachusetts. He was not involved with the study.

“It’s exciting because it might suggest that we could use something as simple as a survey to stratify someone’s risk of relapse,” he told this news organization.

Antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) is a rare disease, with an estimated prevalence of 200-400 cases per million people. It is also heterogeneous, which makes it difficult to predict the risk for relapse for a given patient.

“Investigators have long searched for a reliable prognostic marker that identifies patients at high vs low risk of relapse in AAV but, except for ANCA type, no prognostic biomarker is routinely used to inform treatment decision-making,” wrote lead author Ellen Romich, MD, a rheumatology fellow at the University of Pennsylvania in Philadelphia, Pennsylvania, and colleagues.

Proteinase 3-ANCA (compared with myeloperoxidase-ANCA) has been tied to a higher risk for relapse, as well as gastrointestinal complications, sinonasal disease, and patient global assessment scores. In this new study, Dr. Romich and colleagues evaluated if patient-reported outcomes of sinonasal disease could predict AAV disease activity and relapse.

Researchers used data from a prospective, longitudinal cohort study through the University of Pennsylvania Vasculitis Center from 2016 to 2022. They included 107 patients with GPA, 40 patients with eosinophilic granulomatosis with polyangiitis (EGPA), 21 patients with microscopic polyangiitis (MPA), and 51 healthy controls.

Patients completed a median of four clinic visits during the duration of the study.

During each visit, patients filled out the 22-item SinoNasal Outcome Test (SNOT-22), a validated questionnaire that assesses rhinosinusitis. The tool asks patients to rate a list of symptoms from 0 to 5 in five categories: Rhinologic, extra-nasal, ear and face, psychologic, and sleep. The possible total score ranges from 0 to 110.

Disease activity was measured via the Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis. The results were published online in Arthritis Care & Research.

Patients were, on average, 55 years old with an AAV duration of 3 years. (The mean age of healthy participants was 59.) More than half (58%) of patients were female, and 95% were White. The majority had a history of a flare (54%), and 60% of those flares had sinonasal involvement.

Even in remission, patients with AAV generally had on average higher SNOT-22 scores than healthy comparators (20 vs 5). Higher disease activity also correlated with higher SNOT-22 scores.

In patients with GPA, a high SNOT-22 score (total score of 41 or above) was associated with an increased risk for relapse within 2 years (hazard ratio, 2.7; P = .02). This association was not found for EGPA or MPA. This higher risk remained in a sensitivity analysis that included only patients with no history of sinonasal disease.

“Interestingly, among patients with GPA, SNOT-22 scores are elevated months to years prior to onset of systemic relapse but remain low in patients in sustained remission,” the authors wrote.

While other patient-reported outcomes have been validated for AAV, SNOT-22 may provide more detail on upper airway disease, commented Paul Monach, MD, PhD, an adjunct associate professor of medicine at the Boston University Chobanian & Avedisian School of Medicine and a rheumatologist at the VA Boston Healthcare System, Boston, Massachusetts.

“Upper airway GPA has not been studied as much as systemic GPA and MPA,” he told this news organization. “There are very few clinical trials, and we need better outcome measures like this.”

Dr. Romich noted that this work is still in the “early stages,” and SNOT-22 will need to be further studied and validated in other patient cohorts before its inclusion in clinical practice.

“There’s certainly more work that needs to be done to understand how the SNOT-22 questionnaire works in this patient population,” she said, including its predictive value compared with other known risk factors for relapse. “But I think it’s something that’s promising that we could use as a patient-reported outcome to try to, visit-to-visit, track their sinonasal symptoms.”

This study was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases and an NIH Rheumatology Research Training Grant. Dr. Romich, Dr. Wallace, and Monach reported no other relevant disclosures.

A version of this article appeared on Medscape.com.

Picture a healthcare system where physicians aren’t bogged down by excessive charting but are instead fully present with their patients, offering undivided attention and personalized care. In a recent X post, Stuart Blitz, COO and co-founder of Hone Health, sparked a thought-provoking conversation. “The problem with US healthcare is physicians are burned out since they spend way too much time charting, not enough with patients,” he wrote. “If you created a health system that did zero charting, you’d attract the best physicians and all patients would go there. Who is working on this?” 

This resonates with many in the medical community, myself included, because the strain of extensive documentation detracts from patient care. Having worked in both large and small healthcare systems, I know the burden of extensive charting is a palpable challenge, often detracting from the time we can devote to our patients.

The first part of this two-part series examines the overarching benefits of artificial intelligence (AI)–based clinical documentation in modern healthcare, a field witnessing a paradigm shift thanks to advancements in AI.
 

Transformative Evolution of Clinical Documentation

The transition from manual documentation to AI-driven solutions marks a significant shift in the field, with a number of products in development including Nuance, Abridge, Ambience, ScribeAmerica, 3M, and DeepScribe. These tools use ambient clinical intelligence (ACI) to automate documentation, capturing patient conversations and translating them into structured clinical summaries. This innovation aligns with the vision of reducing charting burdens and enhancing patient-physician interactions.

How does it work? ACI refers to a sophisticated form of AI applied in healthcare settings, particularly focusing on enhancing the clinical documentation process without disrupting the natural flow of the consultation. Here’s a technical yet practical breakdown of ACI and the algorithms it typically employs:

Data capture and processing: ACI systems employ various sensors and processing units, typically integrated into clinical settings. These sensors, like microphones and cameras, gather diverse data such as audio from patient-doctor dialogues and visual cues. This information is then processed in real-time or near–real-time.

Natural language processing (NLP): A core component of ACI is advanced NLP algorithms. These algorithms analyze the captured audio data, transcribing spoken words into text. NLP goes beyond mere transcription; it involves understanding context, extracting relevant medical information (like symptoms, diagnoses, and treatment plans), and interpreting the nuances of human language.

Deep learning: Machine learning, particularly deep-learning techniques, are employed to improve the accuracy of ACI systems continually. These algorithms can learn from vast datasets of clinical interactions, enhancing their ability to transcribe and interpret future conversations accurately. As they learn, they become better at understanding different accents, complex medical terms, and variations in speech patterns.

Integration with electronic health records (EHRs): ACI systems are often designed to integrate seamlessly with existing EHR systems. They can automatically populate patient records with information from patient-clinician interactions, reducing manual entry and potential errors.

Customization and personalization: Many ACI systems offer customizable templates or allow clinicians to tailor documentation workflows. This flexibility ensures that the output aligns with the specific needs and preferences of healthcare providers.

Ethical and privacy considerations: ACI systems must navigate significant ethical and privacy concerns, especially related to patient consent and data security. These systems need to comply with healthcare privacy regulations such as HIPAA. They need to securely manage sensitive patient data and restrict access to authorized personnel only.
 

Broad-Spectrum Benefits of AI in Documentation

• Reducing clinician burnout: By automating the documentation process, AI tools like DAX Copilot alleviate a significant contributor to physician burnout, enabling clinicians to focus more on patient care.
• Enhanced patient care: With AI handling documentation, clinicians can engage more with their patients, leading to improved care quality and patient satisfaction.
• Data accuracy and quality: AI-driven documentation captures detailed patient encounters accurately, ensuring high-quality and comprehensive medical records.
• Response to the growing need for efficient healthcare: AI-based documentation is a direct response to the growing call for more efficient healthcare practices, where clinicians spend less time on paperwork and more with patients.

The shift toward AI-based clinical documentation represents a critical step in addressing the inefficiencies in healthcare systems. It’s a move towards a more patient-centered approach, where clinicians can focus more on patient care by reducing the time spent on excessive charting. Hopefully, we can integrate these solutions into our clinics at a large enough scale to make such an impact.

In the next column, we will explore in-depth insights from Kenneth Harper at Nuance on the technical implementation of these tools, with DAX as an example.

I would love to read your comments on AI in clinical trials as well as other AI-related topics. Write me at [email protected] or find me on X @DrBonillaOnc.

Dr. Loaiza-Bonilla is the co-founder and chief medical officer at Massive Bio, a company connecting patients to clinical trials using artificial intelligence. His research and professional interests focus on precision medicine, clinical trial design, digital health, entrepreneurship, and patient advocacy. Dr Loaiza-Bonilla serves as medical director of oncology research at Capital Health in New Jersey, where he maintains a connection to patient care by attending to patients 2 days a week. He has served as a consultant for Verify, PSI CRO, Bayer, AstraZeneca, Cardinal Health, BrightInsight, The Lynx Group, Fresenius, Pfizer, Ipsen, and Guardant; served as a speaker or a member of a speakers bureau for Amgen, Guardant, Eisai, Ipsen, Natera, Merck, Bristol-Myers Squibb, and AstraZeneca. He holds a 5% or greater equity interest in Massive Bio.

A version of this article appeared on Medscape.com.

Picture a healthcare system where physicians aren’t bogged down by excessive charting but are instead fully present with their patients, offering undivided attention and personalized care. In a recent X post, Stuart Blitz, COO and co-founder of Hone Health, sparked a thought-provoking conversation. “The problem with US healthcare is physicians are burned out since they spend way too much time charting, not enough with patients,” he wrote. “If you created a health system that did zero charting, you’d attract the best physicians and all patients would go there. Who is working on this?” 

This resonates with many in the medical community, myself included, because the strain of extensive documentation detracts from patient care. Having worked in both large and small healthcare systems, I know the burden of extensive charting is a palpable challenge, often detracting from the time we can devote to our patients.

The first part of this two-part series examines the overarching benefits of artificial intelligence (AI)–based clinical documentation in modern healthcare, a field witnessing a paradigm shift thanks to advancements in AI.
 

Transformative Evolution of Clinical Documentation

The transition from manual documentation to AI-driven solutions marks a significant shift in the field, with a number of products in development including Nuance, Abridge, Ambience, ScribeAmerica, 3M, and DeepScribe. These tools use ambient clinical intelligence (ACI) to automate documentation, capturing patient conversations and translating them into structured clinical summaries. This innovation aligns with the vision of reducing charting burdens and enhancing patient-physician interactions.

How does it work? ACI refers to a sophisticated form of AI applied in healthcare settings, particularly focusing on enhancing the clinical documentation process without disrupting the natural flow of the consultation. Here’s a technical yet practical breakdown of ACI and the algorithms it typically employs:

Data capture and processing: ACI systems employ various sensors and processing units, typically integrated into clinical settings. These sensors, like microphones and cameras, gather diverse data such as audio from patient-doctor dialogues and visual cues. This information is then processed in real-time or near–real-time.

Natural language processing (NLP): A core component of ACI is advanced NLP algorithms. These algorithms analyze the captured audio data, transcribing spoken words into text. NLP goes beyond mere transcription; it involves understanding context, extracting relevant medical information (like symptoms, diagnoses, and treatment plans), and interpreting the nuances of human language.

Deep learning: Machine learning, particularly deep-learning techniques, are employed to improve the accuracy of ACI systems continually. These algorithms can learn from vast datasets of clinical interactions, enhancing their ability to transcribe and interpret future conversations accurately. As they learn, they become better at understanding different accents, complex medical terms, and variations in speech patterns.

Integration with electronic health records (EHRs): ACI systems are often designed to integrate seamlessly with existing EHR systems. They can automatically populate patient records with information from patient-clinician interactions, reducing manual entry and potential errors.

Customization and personalization: Many ACI systems offer customizable templates or allow clinicians to tailor documentation workflows. This flexibility ensures that the output aligns with the specific needs and preferences of healthcare providers.

Ethical and privacy considerations: ACI systems must navigate significant ethical and privacy concerns, especially related to patient consent and data security. These systems need to comply with healthcare privacy regulations such as HIPAA. They need to securely manage sensitive patient data and restrict access to authorized personnel only.
 

Broad-Spectrum Benefits of AI in Documentation

• Reducing clinician burnout: By automating the documentation process, AI tools like DAX Copilot alleviate a significant contributor to physician burnout, enabling clinicians to focus more on patient care.
• Enhanced patient care: With AI handling documentation, clinicians can engage more with their patients, leading to improved care quality and patient satisfaction.
• Data accuracy and quality: AI-driven documentation captures detailed patient encounters accurately, ensuring high-quality and comprehensive medical records.
• Response to the growing need for efficient healthcare: AI-based documentation is a direct response to the growing call for more efficient healthcare practices, where clinicians spend less time on paperwork and more with patients.

The shift toward AI-based clinical documentation represents a critical step in addressing the inefficiencies in healthcare systems. It’s a move towards a more patient-centered approach, where clinicians can focus more on patient care by reducing the time spent on excessive charting. Hopefully, we can integrate these solutions into our clinics at a large enough scale to make such an impact.

In the next column, we will explore in-depth insights from Kenneth Harper at Nuance on the technical implementation of these tools, with DAX as an example.

I would love to read your comments on AI in clinical trials as well as other AI-related topics. Write me at [email protected] or find me on X @DrBonillaOnc.

Dr. Loaiza-Bonilla is the co-founder and chief medical officer at Massive Bio, a company connecting patients to clinical trials using artificial intelligence. His research and professional interests focus on precision medicine, clinical trial design, digital health, entrepreneurship, and patient advocacy. Dr Loaiza-Bonilla serves as medical director of oncology research at Capital Health in New Jersey, where he maintains a connection to patient care by attending to patients 2 days a week. He has served as a consultant for Verify, PSI CRO, Bayer, AstraZeneca, Cardinal Health, BrightInsight, The Lynx Group, Fresenius, Pfizer, Ipsen, and Guardant; served as a speaker or a member of a speakers bureau for Amgen, Guardant, Eisai, Ipsen, Natera, Merck, Bristol-Myers Squibb, and AstraZeneca. He holds a 5% or greater equity interest in Massive Bio.

A version of this article appeared on Medscape.com.

Picture a healthcare system where physicians aren’t bogged down by excessive charting but are instead fully present with their patients, offering undivided attention and personalized care. In a recent X post, Stuart Blitz, COO and co-founder of Hone Health, sparked a thought-provoking conversation. “The problem with US healthcare is physicians are burned out since they spend way too much time charting, not enough with patients,” he wrote. “If you created a health system that did zero charting, you’d attract the best physicians and all patients would go there. Who is working on this?” 

This resonates with many in the medical community, myself included, because the strain of extensive documentation detracts from patient care. Having worked in both large and small healthcare systems, I know the burden of extensive charting is a palpable challenge, often detracting from the time we can devote to our patients.

The first part of this two-part series examines the overarching benefits of artificial intelligence (AI)–based clinical documentation in modern healthcare, a field witnessing a paradigm shift thanks to advancements in AI.
 

Transformative Evolution of Clinical Documentation

The transition from manual documentation to AI-driven solutions marks a significant shift in the field, with a number of products in development including Nuance, Abridge, Ambience, ScribeAmerica, 3M, and DeepScribe. These tools use ambient clinical intelligence (ACI) to automate documentation, capturing patient conversations and translating them into structured clinical summaries. This innovation aligns with the vision of reducing charting burdens and enhancing patient-physician interactions.

How does it work? ACI refers to a sophisticated form of AI applied in healthcare settings, particularly focusing on enhancing the clinical documentation process without disrupting the natural flow of the consultation. Here’s a technical yet practical breakdown of ACI and the algorithms it typically employs:

Data capture and processing: ACI systems employ various sensors and processing units, typically integrated into clinical settings. These sensors, like microphones and cameras, gather diverse data such as audio from patient-doctor dialogues and visual cues. This information is then processed in real-time or near–real-time.

Natural language processing (NLP): A core component of ACI is advanced NLP algorithms. These algorithms analyze the captured audio data, transcribing spoken words into text. NLP goes beyond mere transcription; it involves understanding context, extracting relevant medical information (like symptoms, diagnoses, and treatment plans), and interpreting the nuances of human language.

Deep learning: Machine learning, particularly deep-learning techniques, are employed to improve the accuracy of ACI systems continually. These algorithms can learn from vast datasets of clinical interactions, enhancing their ability to transcribe and interpret future conversations accurately. As they learn, they become better at understanding different accents, complex medical terms, and variations in speech patterns.

Integration with electronic health records (EHRs): ACI systems are often designed to integrate seamlessly with existing EHR systems. They can automatically populate patient records with information from patient-clinician interactions, reducing manual entry and potential errors.

Customization and personalization: Many ACI systems offer customizable templates or allow clinicians to tailor documentation workflows. This flexibility ensures that the output aligns with the specific needs and preferences of healthcare providers.

Ethical and privacy considerations: ACI systems must navigate significant ethical and privacy concerns, especially related to patient consent and data security. These systems need to comply with healthcare privacy regulations such as HIPAA. They need to securely manage sensitive patient data and restrict access to authorized personnel only.
 

Broad-Spectrum Benefits of AI in Documentation

• Reducing clinician burnout: By automating the documentation process, AI tools like DAX Copilot alleviate a significant contributor to physician burnout, enabling clinicians to focus more on patient care.
• Enhanced patient care: With AI handling documentation, clinicians can engage more with their patients, leading to improved care quality and patient satisfaction.
• Data accuracy and quality: AI-driven documentation captures detailed patient encounters accurately, ensuring high-quality and comprehensive medical records.
• Response to the growing need for efficient healthcare: AI-based documentation is a direct response to the growing call for more efficient healthcare practices, where clinicians spend less time on paperwork and more with patients.

The shift toward AI-based clinical documentation represents a critical step in addressing the inefficiencies in healthcare systems. It’s a move towards a more patient-centered approach, where clinicians can focus more on patient care by reducing the time spent on excessive charting. Hopefully, we can integrate these solutions into our clinics at a large enough scale to make such an impact.

In the next column, we will explore in-depth insights from Kenneth Harper at Nuance on the technical implementation of these tools, with DAX as an example.

I would love to read your comments on AI in clinical trials as well as other AI-related topics. Write me at [email protected] or find me on X @DrBonillaOnc.

Dr. Loaiza-Bonilla is the co-founder and chief medical officer at Massive Bio, a company connecting patients to clinical trials using artificial intelligence. His research and professional interests focus on precision medicine, clinical trial design, digital health, entrepreneurship, and patient advocacy. Dr Loaiza-Bonilla serves as medical director of oncology research at Capital Health in New Jersey, where he maintains a connection to patient care by attending to patients 2 days a week. He has served as a consultant for Verify, PSI CRO, Bayer, AstraZeneca, Cardinal Health, BrightInsight, The Lynx Group, Fresenius, Pfizer, Ipsen, and Guardant; served as a speaker or a member of a speakers bureau for Amgen, Guardant, Eisai, Ipsen, Natera, Merck, Bristol-Myers Squibb, and AstraZeneca. He holds a 5% or greater equity interest in Massive Bio.

A version of this article appeared on Medscape.com.

Patient-reported outcomes (PROs) in rheumatology are not just personal lists of physical complaints or so-called “organ recitals.” In fact, PROs can both guide treatment decisions in daily practice and serve as key endpoints for clinical trials.

That’s the informed opinion of Clifton O. Bingham III, MD, director of the Johns Arthritis Center in Baltimore, Maryland, who discussed clinical and research applications of PROs at the 2024 Rheumatoid Arthritis Research Summit presented by the Arthritis Foundation and the Hospital for Special Surgery in New York City.

Johns Hopkins Medicine, Johns Hopkins Division of Rheumatology

“Integrating PROs into practice settings can enhance the clinician’s ability to understand their patients and monitor disease impact, and they are increasingly available for clinical care and are being qualified for outcome measures for clinical trials,” Dr. Bingham said.

“I posit to you that some of this ability to better characterize things like anxiety and depression levels of patients more precisely may help us to identify those patients who are less likely to respond to therapy and may require different interventions than disease-modifying therapies for their disease,” he told the audience.
 

PRO Examples

The term PRO encompasses a broad range of measures that may include health-related quality of life measures, symptoms and their affects, patient satisfaction, and the patient’s experience with care.

PROs are important for rheumatology care and research because “we now have the capacity to make what we used to think were the subjective experiences of disease more objective. We now have ways that we can put numbers and measurements to the experiences that patients have about their illness and use that information as a way to understand more about the patients who are in front of us and also how their disease changes over time,” Dr. Bingham said.

Patients are the best — or in some cases, the only — judges of many aspects of their health, and they are best suited to report on certain events and outcomes, he said.

PROs that are currently included in core outcome measures used to guide care and in clinical trials in pain scores as reported by visual analog scales; functioning, as measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI); and patient global assessment.

In international qualitative studies in which patients with rheumatoid arthritis (RA) were asked what was most important to them, the usual suspects of pain, function, and fatigue were routinely cited across the studies. But patients in studies from these groups (RAPP-PI, RAID, and OMERACT) also said that other factors important to their well-being included good sleep, enjoyment of life, independence, ability to participate in valued activities, and freedom from emotional distress, Dr. Bingham noted.
 

The Promise of PROMIS

The science of clinical measurement has advanced dramatically during his career, as Dr. Bingham said.

“There have been significant changes in the science behind how you develop and validate outcomes measures. The fields of clinimetrics and psychometrics have evolved substantially. These are now grounded in what we call ‘modern measurement’ approaches, which focus on item-response theory, constructing interval scales of measurement in things that are very precise in their ability to detect change over time,” he said.

One such measurement instrument is the Patient-Reported Outcome Measurement Information System (PROMIS®), developed at the National Institutes of Health using advanced measurement science.

The system, administered through either computer or paper questionnaires, is designed to improve precision of health-related quality of life assessments in multiple domains, including most domains identified by patients with RA. It uses a T-score metric standardized to the US population.

“You can use this in a disease like rheumatoid arthritis, and you can find out how patients are doing in reference to the normative United States populations,” he said.

Dr. Bingham noted that his team has “very good data” to show that PROMIS system significantly outperforms existing instruments such as the HAQ.
 

How It Works

The system uses item banks, each with multiple items. For example, there are approximately 150 items for the physical function assessment portion. All the items are scored along a continuum, “from people who are completely disabled to those who can run marathons,” Dr. Bingham said.

Each item on the scale has a question and response component, ranging from “are you able to get in and out of bed?” to “are you able to walk from one room to another?” to “are you able to run 5 miles?”

To evaluate the PROMIS scale, Dr. Bingham and colleagues looked at the distribution of PROMIS T-scores for 1029 patients with RA at their center. The scales showed that patients with RA have higher levels of pain, fatigue, and sleep disturbances, as well as worse physical function, than population norms.

Dr. Bingham and colleagues also evaluated the performance of the system in patients with active RA who were starting on or switching to a different disease-modifying antirheumatic drug (DMARD). As they reported in 2019, among 106 participants who completed the 12-week study, all PROMIS scores improved after DMARD initiation (P ≤ .05). In addition, except for the depression domain, changes in all assessed PROMIS measures correlated with changes in Clinical Disease Activity Index scores.

To see whether integrating PROs into routine clinics could have an effect on care, Dr. Bingham and colleagues conducted a prospective cohort study, which showed that with the additional patient-reported data, clinicians changed or adjusted RA treatment in 16%-19% of visits, identified new symptoms in 27%-38%, and suggested nonpharmacologic interventions in 4%-11%.

“This is information that’s being used, and it’s going into changing medical decision making,” he said.

Summarizing his work, Dr. Bingham told the audience “I hope that I have convinced you that patients with RA prioritize domains that are impacted by their disease. PROMIS measures are really state-of-the-science methods to evaluate multiple aspects of health-related quality of life, and what I’ll note to you is that these have been translated into multiple languages internationally. There are Spanish-language versions, there are Chinese language versions, there are versions for every country in the [European Union] that have been validated and can be used.”
 

It’s a Start

In the Q & A following the presentation, Daniel H. Solomon, MD, MPH, from Brigham and Women’s Hospital in Boston, commented that “the measurement issues and automating measurements seems like it’s a fundamental practice issue — how to manage the system and how to manage patients better, and I feel like we’re kind of scratching the surface.”

He said that artificial intelligence and PROs in clinic offer some promise for improving care but added that “we can do better than this. We can figure out better systems for measuring PROs: Having patients measure PROs, having patients tell us about their PROs so they don’t have to come in, or coming in only when they need to come in, when they’re really flaring. There are lots of innovative ways of thinking about these tools, and it feels like we’re kind of on the cusp of really taking advantage.”

Dr. Bingham’s work is supported by the Patient-Centered Outcomes Research Institute, National Institutes of Health, Ira T. Fine Discovery Fund, Johns Hopkins Arthritis Center Discovery Fund, Camille J. Morgan Arthritis Research and Education Fund, and Scheer Family Foundation and Joanne and John Rogers. He disclosed consulting for AbbVie, Janssen, Lilly, and Sanofi and serving as a board member of the PROMIS health organization, co-chair of the Omeract Technical Advisory Group, and member of the C-PATH RA PRO working group. Dr. Solomon had no relevant disclosures.

A version of this article appeared on Medscape.com.

Patient-reported outcomes (PROs) in rheumatology are not just personal lists of physical complaints or so-called “organ recitals.” In fact, PROs can both guide treatment decisions in daily practice and serve as key endpoints for clinical trials.

That’s the informed opinion of Clifton O. Bingham III, MD, director of the Johns Arthritis Center in Baltimore, Maryland, who discussed clinical and research applications of PROs at the 2024 Rheumatoid Arthritis Research Summit presented by the Arthritis Foundation and the Hospital for Special Surgery in New York City.

Johns Hopkins Medicine, Johns Hopkins Division of Rheumatology

“Integrating PROs into practice settings can enhance the clinician’s ability to understand their patients and monitor disease impact, and they are increasingly available for clinical care and are being qualified for outcome measures for clinical trials,” Dr. Bingham said.

“I posit to you that some of this ability to better characterize things like anxiety and depression levels of patients more precisely may help us to identify those patients who are less likely to respond to therapy and may require different interventions than disease-modifying therapies for their disease,” he told the audience.
 

PRO Examples

The term PRO encompasses a broad range of measures that may include health-related quality of life measures, symptoms and their affects, patient satisfaction, and the patient’s experience with care.

PROs are important for rheumatology care and research because “we now have the capacity to make what we used to think were the subjective experiences of disease more objective. We now have ways that we can put numbers and measurements to the experiences that patients have about their illness and use that information as a way to understand more about the patients who are in front of us and also how their disease changes over time,” Dr. Bingham said.

Patients are the best — or in some cases, the only — judges of many aspects of their health, and they are best suited to report on certain events and outcomes, he said.

PROs that are currently included in core outcome measures used to guide care and in clinical trials in pain scores as reported by visual analog scales; functioning, as measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI); and patient global assessment.

In international qualitative studies in which patients with rheumatoid arthritis (RA) were asked what was most important to them, the usual suspects of pain, function, and fatigue were routinely cited across the studies. But patients in studies from these groups (RAPP-PI, RAID, and OMERACT) also said that other factors important to their well-being included good sleep, enjoyment of life, independence, ability to participate in valued activities, and freedom from emotional distress, Dr. Bingham noted.
 

The Promise of PROMIS

The science of clinical measurement has advanced dramatically during his career, as Dr. Bingham said.

“There have been significant changes in the science behind how you develop and validate outcomes measures. The fields of clinimetrics and psychometrics have evolved substantially. These are now grounded in what we call ‘modern measurement’ approaches, which focus on item-response theory, constructing interval scales of measurement in things that are very precise in their ability to detect change over time,” he said.

One such measurement instrument is the Patient-Reported Outcome Measurement Information System (PROMIS®), developed at the National Institutes of Health using advanced measurement science.

The system, administered through either computer or paper questionnaires, is designed to improve precision of health-related quality of life assessments in multiple domains, including most domains identified by patients with RA. It uses a T-score metric standardized to the US population.

“You can use this in a disease like rheumatoid arthritis, and you can find out how patients are doing in reference to the normative United States populations,” he said.

Dr. Bingham noted that his team has “very good data” to show that PROMIS system significantly outperforms existing instruments such as the HAQ.
 

How It Works

The system uses item banks, each with multiple items. For example, there are approximately 150 items for the physical function assessment portion. All the items are scored along a continuum, “from people who are completely disabled to those who can run marathons,” Dr. Bingham said.

Each item on the scale has a question and response component, ranging from “are you able to get in and out of bed?” to “are you able to walk from one room to another?” to “are you able to run 5 miles?”

To evaluate the PROMIS scale, Dr. Bingham and colleagues looked at the distribution of PROMIS T-scores for 1029 patients with RA at their center. The scales showed that patients with RA have higher levels of pain, fatigue, and sleep disturbances, as well as worse physical function, than population norms.

Dr. Bingham and colleagues also evaluated the performance of the system in patients with active RA who were starting on or switching to a different disease-modifying antirheumatic drug (DMARD). As they reported in 2019, among 106 participants who completed the 12-week study, all PROMIS scores improved after DMARD initiation (P ≤ .05). In addition, except for the depression domain, changes in all assessed PROMIS measures correlated with changes in Clinical Disease Activity Index scores.

To see whether integrating PROs into routine clinics could have an effect on care, Dr. Bingham and colleagues conducted a prospective cohort study, which showed that with the additional patient-reported data, clinicians changed or adjusted RA treatment in 16%-19% of visits, identified new symptoms in 27%-38%, and suggested nonpharmacologic interventions in 4%-11%.

“This is information that’s being used, and it’s going into changing medical decision making,” he said.

Summarizing his work, Dr. Bingham told the audience “I hope that I have convinced you that patients with RA prioritize domains that are impacted by their disease. PROMIS measures are really state-of-the-science methods to evaluate multiple aspects of health-related quality of life, and what I’ll note to you is that these have been translated into multiple languages internationally. There are Spanish-language versions, there are Chinese language versions, there are versions for every country in the [European Union] that have been validated and can be used.”
 

It’s a Start

In the Q & A following the presentation, Daniel H. Solomon, MD, MPH, from Brigham and Women’s Hospital in Boston, commented that “the measurement issues and automating measurements seems like it’s a fundamental practice issue — how to manage the system and how to manage patients better, and I feel like we’re kind of scratching the surface.”

He said that artificial intelligence and PROs in clinic offer some promise for improving care but added that “we can do better than this. We can figure out better systems for measuring PROs: Having patients measure PROs, having patients tell us about their PROs so they don’t have to come in, or coming in only when they need to come in, when they’re really flaring. There are lots of innovative ways of thinking about these tools, and it feels like we’re kind of on the cusp of really taking advantage.”

Dr. Bingham’s work is supported by the Patient-Centered Outcomes Research Institute, National Institutes of Health, Ira T. Fine Discovery Fund, Johns Hopkins Arthritis Center Discovery Fund, Camille J. Morgan Arthritis Research and Education Fund, and Scheer Family Foundation and Joanne and John Rogers. He disclosed consulting for AbbVie, Janssen, Lilly, and Sanofi and serving as a board member of the PROMIS health organization, co-chair of the Omeract Technical Advisory Group, and member of the C-PATH RA PRO working group. Dr. Solomon had no relevant disclosures.

A version of this article appeared on Medscape.com.

Patient-reported outcomes (PROs) in rheumatology are not just personal lists of physical complaints or so-called “organ recitals.” In fact, PROs can both guide treatment decisions in daily practice and serve as key endpoints for clinical trials.

That’s the informed opinion of Clifton O. Bingham III, MD, director of the Johns Arthritis Center in Baltimore, Maryland, who discussed clinical and research applications of PROs at the 2024 Rheumatoid Arthritis Research Summit presented by the Arthritis Foundation and the Hospital for Special Surgery in New York City.

Johns Hopkins Medicine, Johns Hopkins Division of Rheumatology

“Integrating PROs into practice settings can enhance the clinician’s ability to understand their patients and monitor disease impact, and they are increasingly available for clinical care and are being qualified for outcome measures for clinical trials,” Dr. Bingham said.

“I posit to you that some of this ability to better characterize things like anxiety and depression levels of patients more precisely may help us to identify those patients who are less likely to respond to therapy and may require different interventions than disease-modifying therapies for their disease,” he told the audience.
 

PRO Examples

The term PRO encompasses a broad range of measures that may include health-related quality of life measures, symptoms and their affects, patient satisfaction, and the patient’s experience with care.

PROs are important for rheumatology care and research because “we now have the capacity to make what we used to think were the subjective experiences of disease more objective. We now have ways that we can put numbers and measurements to the experiences that patients have about their illness and use that information as a way to understand more about the patients who are in front of us and also how their disease changes over time,” Dr. Bingham said.

Patients are the best — or in some cases, the only — judges of many aspects of their health, and they are best suited to report on certain events and outcomes, he said.

PROs that are currently included in core outcome measures used to guide care and in clinical trials in pain scores as reported by visual analog scales; functioning, as measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI); and patient global assessment.

In international qualitative studies in which patients with rheumatoid arthritis (RA) were asked what was most important to them, the usual suspects of pain, function, and fatigue were routinely cited across the studies. But patients in studies from these groups (RAPP-PI, RAID, and OMERACT) also said that other factors important to their well-being included good sleep, enjoyment of life, independence, ability to participate in valued activities, and freedom from emotional distress, Dr. Bingham noted.
 

The Promise of PROMIS

The science of clinical measurement has advanced dramatically during his career, as Dr. Bingham said.

“There have been significant changes in the science behind how you develop and validate outcomes measures. The fields of clinimetrics and psychometrics have evolved substantially. These are now grounded in what we call ‘modern measurement’ approaches, which focus on item-response theory, constructing interval scales of measurement in things that are very precise in their ability to detect change over time,” he said.

One such measurement instrument is the Patient-Reported Outcome Measurement Information System (PROMIS®), developed at the National Institutes of Health using advanced measurement science.

The system, administered through either computer or paper questionnaires, is designed to improve precision of health-related quality of life assessments in multiple domains, including most domains identified by patients with RA. It uses a T-score metric standardized to the US population.

“You can use this in a disease like rheumatoid arthritis, and you can find out how patients are doing in reference to the normative United States populations,” he said.

Dr. Bingham noted that his team has “very good data” to show that PROMIS system significantly outperforms existing instruments such as the HAQ.
 

How It Works

The system uses item banks, each with multiple items. For example, there are approximately 150 items for the physical function assessment portion. All the items are scored along a continuum, “from people who are completely disabled to those who can run marathons,” Dr. Bingham said.

Each item on the scale has a question and response component, ranging from “are you able to get in and out of bed?” to “are you able to walk from one room to another?” to “are you able to run 5 miles?”

To evaluate the PROMIS scale, Dr. Bingham and colleagues looked at the distribution of PROMIS T-scores for 1029 patients with RA at their center. The scales showed that patients with RA have higher levels of pain, fatigue, and sleep disturbances, as well as worse physical function, than population norms.

Dr. Bingham and colleagues also evaluated the performance of the system in patients with active RA who were starting on or switching to a different disease-modifying antirheumatic drug (DMARD). As they reported in 2019, among 106 participants who completed the 12-week study, all PROMIS scores improved after DMARD initiation (P ≤ .05). In addition, except for the depression domain, changes in all assessed PROMIS measures correlated with changes in Clinical Disease Activity Index scores.

To see whether integrating PROs into routine clinics could have an effect on care, Dr. Bingham and colleagues conducted a prospective cohort study, which showed that with the additional patient-reported data, clinicians changed or adjusted RA treatment in 16%-19% of visits, identified new symptoms in 27%-38%, and suggested nonpharmacologic interventions in 4%-11%.

“This is information that’s being used, and it’s going into changing medical decision making,” he said.

Summarizing his work, Dr. Bingham told the audience “I hope that I have convinced you that patients with RA prioritize domains that are impacted by their disease. PROMIS measures are really state-of-the-science methods to evaluate multiple aspects of health-related quality of life, and what I’ll note to you is that these have been translated into multiple languages internationally. There are Spanish-language versions, there are Chinese language versions, there are versions for every country in the [European Union] that have been validated and can be used.”
 

It’s a Start

In the Q & A following the presentation, Daniel H. Solomon, MD, MPH, from Brigham and Women’s Hospital in Boston, commented that “the measurement issues and automating measurements seems like it’s a fundamental practice issue — how to manage the system and how to manage patients better, and I feel like we’re kind of scratching the surface.”

He said that artificial intelligence and PROs in clinic offer some promise for improving care but added that “we can do better than this. We can figure out better systems for measuring PROs: Having patients measure PROs, having patients tell us about their PROs so they don’t have to come in, or coming in only when they need to come in, when they’re really flaring. There are lots of innovative ways of thinking about these tools, and it feels like we’re kind of on the cusp of really taking advantage.”

Dr. Bingham’s work is supported by the Patient-Centered Outcomes Research Institute, National Institutes of Health, Ira T. Fine Discovery Fund, Johns Hopkins Arthritis Center Discovery Fund, Camille J. Morgan Arthritis Research and Education Fund, and Scheer Family Foundation and Joanne and John Rogers. He disclosed consulting for AbbVie, Janssen, Lilly, and Sanofi and serving as a board member of the PROMIS health organization, co-chair of the Omeract Technical Advisory Group, and member of the C-PATH RA PRO working group. Dr. Solomon had no relevant disclosures.

A version of this article appeared on Medscape.com.

Pregnant physicians may receive more workplace accommodations and protection against discrimination thanks to an updated rule from the US Equal Employment Opportunity Commission (EEOC). The guidelines could prevent women from losing critical career momentum. 

The Pregnant Workers Fairness Act (PWFA) aims to help workers balance professional demands with healthy pregnancies. It requires employers to provide reasonable accommodations for a “worker’s known limitations,” including physical or mental conditions associated with “pregnancy, childbirth, or related medical conditions.”

Reasonable accommodations vary but may involve time off to attend healthcare appointments or recover from childbirth, extra breaks during a shift, shorter work hours, or the ability to sit instead of stand. Private and public sector employers, including state and local governments, federal agencies, and employment agencies, must abide by the new guidelines unless they can provide evidence that doing so will cause undue hardship. 

Female doctors have historically encountered significant barriers to family planning. Years of training cause them to delay having children, often leading to higher rates of infertility, miscarriage, and pregnancy complications than in the general population. 

Some specialties, like surgeons, are particularly at risk, with 42% reporting at least one pregnancy loss. Most surgeons work their regular schedules until delivery despite desiring workload reductions, commonly citing unsupportive workplaces as a reason for not seeking accommodations. 

Trauma surgeon Qaali Hussein, MD, became pregnant with her first child during her intern year in 2008. She told this news organization that her residency program didn’t even have a maternity policy at the time, and her male supervisor was certain that motherhood would end her surgical career. 

She shared how “women usually waited until the end of their training to get pregnant. No one had ever gotten pregnant during the program and returned from maternity leave. I was the first to do so, so there wasn’t a policy or any program support to say, ‘What can we do to help?’ ”

Dr. Hussein used her vacation and sick time, returning to work 4 weeks after delivery. She had five more children, including twins her chief year and another baby during fellowship training in 2014. 

Each subsequent pregnancy was met with the same response from program leadership, she recalled. “They’d say, ‘This is it. You may have been able to do the first and second child, but this one will be impossible.’ ”

After the PWFA regulations first became enforceable in June, the EEOC accepted public feedback. The guidelines received nearly 100,000 comments, spurred mainly by the inclusion of abortion care as a qualifying condition for which an employee could receive accommodations. About 54,000 comments called for abortion to be excluded from the final rule, and 40,000 supported keeping the clause. 

The EEOC issued the final rule on April 15. It includes abortion care. However, the updated rule “does not require any employee to have — or not to have — an abortion, does not require taxpayers to pay for any abortions, and does not compel health care providers to provide any abortions,” the unpublished version of the final rule said. It is scheduled to take effect 60 days after its publication in the Federal Register on April 19.
 

Increasing Support for Doctor-Moms

The PWFA supplements other EEOC protections, such as pregnancy discrimination under Title VII of the Civil Rights Act of 1964 and access to reasonable accommodations under the Americans with Disabilities Act. In addition, it builds upon Department of Labor regulations, like the PUMP Act for breastfeeding employees and the Family and Medical Leave Act, which provides 12 weeks of unpaid, job-protected leave for the arrival of a child or certain medical conditions.

FMLA applies only to employees who have worked full-time for at least 12 months for an employer with 50 or more employees. Meanwhile, the unpaid, job-protected leave under the PWFA has no waiting period, lowers the required number of employees to 15, and permits accommodations for up to 40 weeks. 

Employers are encouraged to honor “common and simple” requests, like using a closer parking space or pumping or nursing at work, without requiring a doctor’s note, the rule said. 

Efforts to improve family leave policies for physicians and residents have been gaining traction. In 2021, the American Board of Medical Specialties began requiring its member boards with training programs lasting 2 or more years to allow at least 6 weeks off for parental, caregiver, and medical leave. This time can be taken without exhausting vacation or sick leave or requiring an extension in training. Over half of the 24 member boards permit leave beyond 6 weeks, including the American Boards of Allergy and Immunology, Emergency Medicine, Family Medicine, Radiology, and Surgery. 

Estefania Oliveros, MD, MSc, cardiologist and assistant professor at the Lewis Katz School of Medicine at Temple University, Philadelphia, told this news organization that the Accreditation Council for Graduate Medical Education also requires that residents and fellows receive 6 weeks of paid leave. 

“We add to that vacation time, so it gives them at least 8 weeks,” she said. The school has created spaces for nursing mothers — something neither she nor Dr. Hussein had access to when breastfeeding — and encourages the attendings to be proactive in excusing pregnant fellows for appointments. 

This differs significantly from her fellowship training experience 6 years ago at another institution, where she worked without accommodations until the day before her cesarean delivery. Dr. Oliveros had to use all her vacation time for recovery, returning to the program after 4 weeks instead of the recommended 6. 

“And that’s the story you hear all the time. Not because people are ill-intended; I just don’t think the system is designed to accommodate women, so we lose a lot of talent that way,” said Dr. Oliveros, whose 2019 survey in the Journal of the American College of Cardiology called for more support and protections for pregnant doctors. 

Both doctors believe the PWFA will be beneficial but only if leadership in the field takes up the cause. 

“The cultures of these institutions determine whether women feel safe or even confident enough to have children in medical school or residency,” said Dr. Hussein. 
 

A version of this article appeared on Medscape.com.

Pregnant physicians may receive more workplace accommodations and protection against discrimination thanks to an updated rule from the US Equal Employment Opportunity Commission (EEOC). The guidelines could prevent women from losing critical career momentum. 

The Pregnant Workers Fairness Act (PWFA) aims to help workers balance professional demands with healthy pregnancies. It requires employers to provide reasonable accommodations for a “worker’s known limitations,” including physical or mental conditions associated with “pregnancy, childbirth, or related medical conditions.”

Reasonable accommodations vary but may involve time off to attend healthcare appointments or recover from childbirth, extra breaks during a shift, shorter work hours, or the ability to sit instead of stand. Private and public sector employers, including state and local governments, federal agencies, and employment agencies, must abide by the new guidelines unless they can provide evidence that doing so will cause undue hardship. 

Female doctors have historically encountered significant barriers to family planning. Years of training cause them to delay having children, often leading to higher rates of infertility, miscarriage, and pregnancy complications than in the general population. 

Some specialties, like surgeons, are particularly at risk, with 42% reporting at least one pregnancy loss. Most surgeons work their regular schedules until delivery despite desiring workload reductions, commonly citing unsupportive workplaces as a reason for not seeking accommodations. 

Trauma surgeon Qaali Hussein, MD, became pregnant with her first child during her intern year in 2008. She told this news organization that her residency program didn’t even have a maternity policy at the time, and her male supervisor was certain that motherhood would end her surgical career. 

She shared how “women usually waited until the end of their training to get pregnant. No one had ever gotten pregnant during the program and returned from maternity leave. I was the first to do so, so there wasn’t a policy or any program support to say, ‘What can we do to help?’ ”

Dr. Hussein used her vacation and sick time, returning to work 4 weeks after delivery. She had five more children, including twins her chief year and another baby during fellowship training in 2014. 

Each subsequent pregnancy was met with the same response from program leadership, she recalled. “They’d say, ‘This is it. You may have been able to do the first and second child, but this one will be impossible.’ ”

After the PWFA regulations first became enforceable in June, the EEOC accepted public feedback. The guidelines received nearly 100,000 comments, spurred mainly by the inclusion of abortion care as a qualifying condition for which an employee could receive accommodations. About 54,000 comments called for abortion to be excluded from the final rule, and 40,000 supported keeping the clause. 

The EEOC issued the final rule on April 15. It includes abortion care. However, the updated rule “does not require any employee to have — or not to have — an abortion, does not require taxpayers to pay for any abortions, and does not compel health care providers to provide any abortions,” the unpublished version of the final rule said. It is scheduled to take effect 60 days after its publication in the Federal Register on April 19.
 

Increasing Support for Doctor-Moms

The PWFA supplements other EEOC protections, such as pregnancy discrimination under Title VII of the Civil Rights Act of 1964 and access to reasonable accommodations under the Americans with Disabilities Act. In addition, it builds upon Department of Labor regulations, like the PUMP Act for breastfeeding employees and the Family and Medical Leave Act, which provides 12 weeks of unpaid, job-protected leave for the arrival of a child or certain medical conditions.

FMLA applies only to employees who have worked full-time for at least 12 months for an employer with 50 or more employees. Meanwhile, the unpaid, job-protected leave under the PWFA has no waiting period, lowers the required number of employees to 15, and permits accommodations for up to 40 weeks. 

Employers are encouraged to honor “common and simple” requests, like using a closer parking space or pumping or nursing at work, without requiring a doctor’s note, the rule said. 

Efforts to improve family leave policies for physicians and residents have been gaining traction. In 2021, the American Board of Medical Specialties began requiring its member boards with training programs lasting 2 or more years to allow at least 6 weeks off for parental, caregiver, and medical leave. This time can be taken without exhausting vacation or sick leave or requiring an extension in training. Over half of the 24 member boards permit leave beyond 6 weeks, including the American Boards of Allergy and Immunology, Emergency Medicine, Family Medicine, Radiology, and Surgery. 

Estefania Oliveros, MD, MSc, cardiologist and assistant professor at the Lewis Katz School of Medicine at Temple University, Philadelphia, told this news organization that the Accreditation Council for Graduate Medical Education also requires that residents and fellows receive 6 weeks of paid leave. 

“We add to that vacation time, so it gives them at least 8 weeks,” she said. The school has created spaces for nursing mothers — something neither she nor Dr. Hussein had access to when breastfeeding — and encourages the attendings to be proactive in excusing pregnant fellows for appointments. 

This differs significantly from her fellowship training experience 6 years ago at another institution, where she worked without accommodations until the day before her cesarean delivery. Dr. Oliveros had to use all her vacation time for recovery, returning to the program after 4 weeks instead of the recommended 6. 

“And that’s the story you hear all the time. Not because people are ill-intended; I just don’t think the system is designed to accommodate women, so we lose a lot of talent that way,” said Dr. Oliveros, whose 2019 survey in the Journal of the American College of Cardiology called for more support and protections for pregnant doctors. 

Both doctors believe the PWFA will be beneficial but only if leadership in the field takes up the cause. 

“The cultures of these institutions determine whether women feel safe or even confident enough to have children in medical school or residency,” said Dr. Hussein. 
 

A version of this article appeared on Medscape.com.

Pregnant physicians may receive more workplace accommodations and protection against discrimination thanks to an updated rule from the US Equal Employment Opportunity Commission (EEOC). The guidelines could prevent women from losing critical career momentum. 

The Pregnant Workers Fairness Act (PWFA) aims to help workers balance professional demands with healthy pregnancies. It requires employers to provide reasonable accommodations for a “worker’s known limitations,” including physical or mental conditions associated with “pregnancy, childbirth, or related medical conditions.”

Reasonable accommodations vary but may involve time off to attend healthcare appointments or recover from childbirth, extra breaks during a shift, shorter work hours, or the ability to sit instead of stand. Private and public sector employers, including state and local governments, federal agencies, and employment agencies, must abide by the new guidelines unless they can provide evidence that doing so will cause undue hardship. 

Female doctors have historically encountered significant barriers to family planning. Years of training cause them to delay having children, often leading to higher rates of infertility, miscarriage, and pregnancy complications than in the general population. 

Some specialties, like surgeons, are particularly at risk, with 42% reporting at least one pregnancy loss. Most surgeons work their regular schedules until delivery despite desiring workload reductions, commonly citing unsupportive workplaces as a reason for not seeking accommodations. 

Trauma surgeon Qaali Hussein, MD, became pregnant with her first child during her intern year in 2008. She told this news organization that her residency program didn’t even have a maternity policy at the time, and her male supervisor was certain that motherhood would end her surgical career. 

She shared how “women usually waited until the end of their training to get pregnant. No one had ever gotten pregnant during the program and returned from maternity leave. I was the first to do so, so there wasn’t a policy or any program support to say, ‘What can we do to help?’ ”

Dr. Hussein used her vacation and sick time, returning to work 4 weeks after delivery. She had five more children, including twins her chief year and another baby during fellowship training in 2014. 

Each subsequent pregnancy was met with the same response from program leadership, she recalled. “They’d say, ‘This is it. You may have been able to do the first and second child, but this one will be impossible.’ ”

After the PWFA regulations first became enforceable in June, the EEOC accepted public feedback. The guidelines received nearly 100,000 comments, spurred mainly by the inclusion of abortion care as a qualifying condition for which an employee could receive accommodations. About 54,000 comments called for abortion to be excluded from the final rule, and 40,000 supported keeping the clause. 

The EEOC issued the final rule on April 15. It includes abortion care. However, the updated rule “does not require any employee to have — or not to have — an abortion, does not require taxpayers to pay for any abortions, and does not compel health care providers to provide any abortions,” the unpublished version of the final rule said. It is scheduled to take effect 60 days after its publication in the Federal Register on April 19.
 

Increasing Support for Doctor-Moms

The PWFA supplements other EEOC protections, such as pregnancy discrimination under Title VII of the Civil Rights Act of 1964 and access to reasonable accommodations under the Americans with Disabilities Act. In addition, it builds upon Department of Labor regulations, like the PUMP Act for breastfeeding employees and the Family and Medical Leave Act, which provides 12 weeks of unpaid, job-protected leave for the arrival of a child or certain medical conditions.

FMLA applies only to employees who have worked full-time for at least 12 months for an employer with 50 or more employees. Meanwhile, the unpaid, job-protected leave under the PWFA has no waiting period, lowers the required number of employees to 15, and permits accommodations for up to 40 weeks. 

Employers are encouraged to honor “common and simple” requests, like using a closer parking space or pumping or nursing at work, without requiring a doctor’s note, the rule said. 

Efforts to improve family leave policies for physicians and residents have been gaining traction. In 2021, the American Board of Medical Specialties began requiring its member boards with training programs lasting 2 or more years to allow at least 6 weeks off for parental, caregiver, and medical leave. This time can be taken without exhausting vacation or sick leave or requiring an extension in training. Over half of the 24 member boards permit leave beyond 6 weeks, including the American Boards of Allergy and Immunology, Emergency Medicine, Family Medicine, Radiology, and Surgery. 

Estefania Oliveros, MD, MSc, cardiologist and assistant professor at the Lewis Katz School of Medicine at Temple University, Philadelphia, told this news organization that the Accreditation Council for Graduate Medical Education also requires that residents and fellows receive 6 weeks of paid leave. 

“We add to that vacation time, so it gives them at least 8 weeks,” she said. The school has created spaces for nursing mothers — something neither she nor Dr. Hussein had access to when breastfeeding — and encourages the attendings to be proactive in excusing pregnant fellows for appointments. 

This differs significantly from her fellowship training experience 6 years ago at another institution, where she worked without accommodations until the day before her cesarean delivery. Dr. Oliveros had to use all her vacation time for recovery, returning to the program after 4 weeks instead of the recommended 6. 

“And that’s the story you hear all the time. Not because people are ill-intended; I just don’t think the system is designed to accommodate women, so we lose a lot of talent that way,” said Dr. Oliveros, whose 2019 survey in the Journal of the American College of Cardiology called for more support and protections for pregnant doctors. 

Both doctors believe the PWFA will be beneficial but only if leadership in the field takes up the cause. 

“The cultures of these institutions determine whether women feel safe or even confident enough to have children in medical school or residency,” said Dr. Hussein. 
 

A version of this article appeared on Medscape.com.

LONDON — Weight loss, glycemic control, fatty liver, and the need for insulin all showed improvement in patients with both refractory type 2 diabetes and obesity after a gut liner known as EndoBarrier (RESET, Morphic Medical, United States) was implanted for 1 year, showed data.

Two years after the liner’s removal, 80% of patients continued to show significant improvement, while 20% returned to baseline.

Presenting results at the Diabetes UK Professional Conference (DUKPC) 2024, the researchers, led by Bob Ryder, MD, FRCP, from the Department of Diabetes, Birmingham City Hospital, Birmingham, England, aimed to assess the safety and efficacy of EndoBarrier, as well as maintenance of efficacy 24 months after the device removal.

“We think EndoBarrier finds its place between the end of all the earlier measures and the possible option of bariatric surgery, and these data show that it can lead to tremendous weight loss and improvement in A1c,” Dr. Ryder said in an interview.

Commenting on how most patients had responded to use of the device, Dr. Ryder said, “People with obesity are often very unhappy and have tried everything over many years to no effect; however, this gut liner provided the opportunity to shift out of this state, and they often become so happy with the result they were determined to stick with it and continue with a healthier lifestyle including much more exercise.”
 

Convenient, Reversible Procedure

Ninety consecutive patients from Birmingham, all with longstanding, poorly controlled, type 2 diabetes and obesity, underwent the implantation procedure, and 60 of these attended follow-up visits 2 years post implantation.

Unlike permanent and more invasive weight loss surgeries, the EndoBarrier device is reversible and fitted with a straightforward procedure.

The thin impermeable sleeve is inserted via an approximate 1-hour endoscopy, enabling the patient to return home the same day. It lines the first 60 cm of the small intestine. Digested food passes through it without absorption and then makes contact with pancreatic and bile juices at the other end. This triggers a change in the metabolism of glucose and nutrients through modulating gut hormones and gut bacteria, as well as disrupting bile flow.

“Because the food bypasses the small intestine, the first time the food is encountered is in an area where it is not normally found, and this causes a reaction where signals are sent to the brain to stop eating,” explained Dr. Ryder.

Due to a license for 1 year of use, the gut liner was removed after a year via a 30-minute endoscopy procedure.
 

Over Half Maintained Full Improvement 2 Years Post Removal

A total of 60/90 (66%) attended follow-up visits and comprised the data presented. Mean age was 51.2 years, 47% were men, 50% were White, mean body mass index (BMI) was 41.5 kg/m², and mean A1c was 9.3%. Duration of type 2 diabetes was a median of 11 years, and 60% were taking insulin.

Patients followed dietary requirements for the initial phase after implantation. “During the first week, they followed a liquid diet, then during week 2 — mushy food, and then they were told to chew it really well to avoid blockage,” said Dr. Ryder.

Mean weight loss on removal of the liner (at 12 months post implantation) was 16.7 kg (P < .001), while BMI dropped by mean 6 kg/m², A1c dropped by a mean of 1.8%, and mean systolic blood pressure by 10.9 mm Hg.

Just over half (32/60, 53%) showed maintenance of fully sustained improvement 2 years after removal of the liner — defined as no significant difference after 2 years between weight loss (mean, 96-97 kg) and similarly for A1c improvement (7.6%-7.4%).

Sixteen of 60 (27%) showed partially sustained improvement over the 2 years of follow-up, with BMI increasing from a mean of 116.8 kg to 128.6 kg and A1c increasing from 7.5% to 8.4%. While 20% (12/60) returned to baseline.

Of the 36/60 people using insulin prior to EndoBarrier treatment, 10 (27.8%) were no longer using insulin at 2 years post removal.

Thirteen of 90 (14%) had early removal of the gut liner due to gastrointestinal hemorrhage (five), liver abscess (two), other abscess (one), and gastrointestinal symptoms (five), but they all made a full recovery; after removal, most experienced benefit despite the adverse event, reported Dr. Ryder.

Sarah Davies, MBBCh, a GP at Woodlands Medical Centre, Cardiff, Wales, agreed that EndoBarrier might be a viable option for patients struggling with obesity. “As GPs, we are the first port of call for these patients. It’s very novel, I hadn’t heard of it before. I like how it’s a noninvasive way for my patients to lose weight and maintain that even after EndoBarrier has been removed.”

Outcomes are being monitored in an ongoing global registry to help determine if EndoBarrier is a safe and effective treatment for individuals with type 2 diabetes and obesity. Dr. Ryder noted that a similar study with 3 years of follow-up showed similar results. Further results will be presented by Dr. Ryder at the upcoming meeting of the American Diabetes Association.

EndoBarrier is currently not approved in the United States. It is awaiting United Kingdom and European CE mark, which the manufacturer hope will be granted this summer. The license will be for patients with BMI of 35-50 kg/m².
 

A version of this article appeared on Medscape.com.

LONDON — Weight loss, glycemic control, fatty liver, and the need for insulin all showed improvement in patients with both refractory type 2 diabetes and obesity after a gut liner known as EndoBarrier (RESET, Morphic Medical, United States) was implanted for 1 year, showed data.

Two years after the liner’s removal, 80% of patients continued to show significant improvement, while 20% returned to baseline.

Presenting results at the Diabetes UK Professional Conference (DUKPC) 2024, the researchers, led by Bob Ryder, MD, FRCP, from the Department of Diabetes, Birmingham City Hospital, Birmingham, England, aimed to assess the safety and efficacy of EndoBarrier, as well as maintenance of efficacy 24 months after the device removal.

“We think EndoBarrier finds its place between the end of all the earlier measures and the possible option of bariatric surgery, and these data show that it can lead to tremendous weight loss and improvement in A1c,” Dr. Ryder said in an interview.

Commenting on how most patients had responded to use of the device, Dr. Ryder said, “People with obesity are often very unhappy and have tried everything over many years to no effect; however, this gut liner provided the opportunity to shift out of this state, and they often become so happy with the result they were determined to stick with it and continue with a healthier lifestyle including much more exercise.”
 

Convenient, Reversible Procedure

Ninety consecutive patients from Birmingham, all with longstanding, poorly controlled, type 2 diabetes and obesity, underwent the implantation procedure, and 60 of these attended follow-up visits 2 years post implantation.

Unlike permanent and more invasive weight loss surgeries, the EndoBarrier device is reversible and fitted with a straightforward procedure.

The thin impermeable sleeve is inserted via an approximate 1-hour endoscopy, enabling the patient to return home the same day. It lines the first 60 cm of the small intestine. Digested food passes through it without absorption and then makes contact with pancreatic and bile juices at the other end. This triggers a change in the metabolism of glucose and nutrients through modulating gut hormones and gut bacteria, as well as disrupting bile flow.

“Because the food bypasses the small intestine, the first time the food is encountered is in an area where it is not normally found, and this causes a reaction where signals are sent to the brain to stop eating,” explained Dr. Ryder.

Due to a license for 1 year of use, the gut liner was removed after a year via a 30-minute endoscopy procedure.
 

Over Half Maintained Full Improvement 2 Years Post Removal

A total of 60/90 (66%) attended follow-up visits and comprised the data presented. Mean age was 51.2 years, 47% were men, 50% were White, mean body mass index (BMI) was 41.5 kg/m², and mean A1c was 9.3%. Duration of type 2 diabetes was a median of 11 years, and 60% were taking insulin.

Patients followed dietary requirements for the initial phase after implantation. “During the first week, they followed a liquid diet, then during week 2 — mushy food, and then they were told to chew it really well to avoid blockage,” said Dr. Ryder.

Mean weight loss on removal of the liner (at 12 months post implantation) was 16.7 kg (P < .001), while BMI dropped by mean 6 kg/m², A1c dropped by a mean of 1.8%, and mean systolic blood pressure by 10.9 mm Hg.

Just over half (32/60, 53%) showed maintenance of fully sustained improvement 2 years after removal of the liner — defined as no significant difference after 2 years between weight loss (mean, 96-97 kg) and similarly for A1c improvement (7.6%-7.4%).

Sixteen of 60 (27%) showed partially sustained improvement over the 2 years of follow-up, with BMI increasing from a mean of 116.8 kg to 128.6 kg and A1c increasing from 7.5% to 8.4%. While 20% (12/60) returned to baseline.

Of the 36/60 people using insulin prior to EndoBarrier treatment, 10 (27.8%) were no longer using insulin at 2 years post removal.

Thirteen of 90 (14%) had early removal of the gut liner due to gastrointestinal hemorrhage (five), liver abscess (two), other abscess (one), and gastrointestinal symptoms (five), but they all made a full recovery; after removal, most experienced benefit despite the adverse event, reported Dr. Ryder.

Sarah Davies, MBBCh, a GP at Woodlands Medical Centre, Cardiff, Wales, agreed that EndoBarrier might be a viable option for patients struggling with obesity. “As GPs, we are the first port of call for these patients. It’s very novel, I hadn’t heard of it before. I like how it’s a noninvasive way for my patients to lose weight and maintain that even after EndoBarrier has been removed.”

Outcomes are being monitored in an ongoing global registry to help determine if EndoBarrier is a safe and effective treatment for individuals with type 2 diabetes and obesity. Dr. Ryder noted that a similar study with 3 years of follow-up showed similar results. Further results will be presented by Dr. Ryder at the upcoming meeting of the American Diabetes Association.

EndoBarrier is currently not approved in the United States. It is awaiting United Kingdom and European CE mark, which the manufacturer hope will be granted this summer. The license will be for patients with BMI of 35-50 kg/m².
 

A version of this article appeared on Medscape.com.

LONDON — Weight loss, glycemic control, fatty liver, and the need for insulin all showed improvement in patients with both refractory type 2 diabetes and obesity after a gut liner known as EndoBarrier (RESET, Morphic Medical, United States) was implanted for 1 year, showed data.

Two years after the liner’s removal, 80% of patients continued to show significant improvement, while 20% returned to baseline.

Presenting results at the Diabetes UK Professional Conference (DUKPC) 2024, the researchers, led by Bob Ryder, MD, FRCP, from the Department of Diabetes, Birmingham City Hospital, Birmingham, England, aimed to assess the safety and efficacy of EndoBarrier, as well as maintenance of efficacy 24 months after the device removal.

“We think EndoBarrier finds its place between the end of all the earlier measures and the possible option of bariatric surgery, and these data show that it can lead to tremendous weight loss and improvement in A1c,” Dr. Ryder said in an interview.

Commenting on how most patients had responded to use of the device, Dr. Ryder said, “People with obesity are often very unhappy and have tried everything over many years to no effect; however, this gut liner provided the opportunity to shift out of this state, and they often become so happy with the result they were determined to stick with it and continue with a healthier lifestyle including much more exercise.”
 

Convenient, Reversible Procedure

Ninety consecutive patients from Birmingham, all with longstanding, poorly controlled, type 2 diabetes and obesity, underwent the implantation procedure, and 60 of these attended follow-up visits 2 years post implantation.

Unlike permanent and more invasive weight loss surgeries, the EndoBarrier device is reversible and fitted with a straightforward procedure.

The thin impermeable sleeve is inserted via an approximate 1-hour endoscopy, enabling the patient to return home the same day. It lines the first 60 cm of the small intestine. Digested food passes through it without absorption and then makes contact with pancreatic and bile juices at the other end. This triggers a change in the metabolism of glucose and nutrients through modulating gut hormones and gut bacteria, as well as disrupting bile flow.

“Because the food bypasses the small intestine, the first time the food is encountered is in an area where it is not normally found, and this causes a reaction where signals are sent to the brain to stop eating,” explained Dr. Ryder.

Due to a license for 1 year of use, the gut liner was removed after a year via a 30-minute endoscopy procedure.
 

Over Half Maintained Full Improvement 2 Years Post Removal

A total of 60/90 (66%) attended follow-up visits and comprised the data presented. Mean age was 51.2 years, 47% were men, 50% were White, mean body mass index (BMI) was 41.5 kg/m², and mean A1c was 9.3%. Duration of type 2 diabetes was a median of 11 years, and 60% were taking insulin.

Patients followed dietary requirements for the initial phase after implantation. “During the first week, they followed a liquid diet, then during week 2 — mushy food, and then they were told to chew it really well to avoid blockage,” said Dr. Ryder.

Mean weight loss on removal of the liner (at 12 months post implantation) was 16.7 kg (P < .001), while BMI dropped by mean 6 kg/m², A1c dropped by a mean of 1.8%, and mean systolic blood pressure by 10.9 mm Hg.

Just over half (32/60, 53%) showed maintenance of fully sustained improvement 2 years after removal of the liner — defined as no significant difference after 2 years between weight loss (mean, 96-97 kg) and similarly for A1c improvement (7.6%-7.4%).

Sixteen of 60 (27%) showed partially sustained improvement over the 2 years of follow-up, with BMI increasing from a mean of 116.8 kg to 128.6 kg and A1c increasing from 7.5% to 8.4%. While 20% (12/60) returned to baseline.

Of the 36/60 people using insulin prior to EndoBarrier treatment, 10 (27.8%) were no longer using insulin at 2 years post removal.

Thirteen of 90 (14%) had early removal of the gut liner due to gastrointestinal hemorrhage (five), liver abscess (two), other abscess (one), and gastrointestinal symptoms (five), but they all made a full recovery; after removal, most experienced benefit despite the adverse event, reported Dr. Ryder.

Sarah Davies, MBBCh, a GP at Woodlands Medical Centre, Cardiff, Wales, agreed that EndoBarrier might be a viable option for patients struggling with obesity. “As GPs, we are the first port of call for these patients. It’s very novel, I hadn’t heard of it before. I like how it’s a noninvasive way for my patients to lose weight and maintain that even after EndoBarrier has been removed.”

Outcomes are being monitored in an ongoing global registry to help determine if EndoBarrier is a safe and effective treatment for individuals with type 2 diabetes and obesity. Dr. Ryder noted that a similar study with 3 years of follow-up showed similar results. Further results will be presented by Dr. Ryder at the upcoming meeting of the American Diabetes Association.

EndoBarrier is currently not approved in the United States. It is awaiting United Kingdom and European CE mark, which the manufacturer hope will be granted this summer. The license will be for patients with BMI of 35-50 kg/m².
 

A version of this article appeared on Medscape.com.