MDedge Dermatology

PHOENIX — Immunosuppression is an independent risk factor for poorer outcomes in patients with cutaneous squamous cell carcinoma (cSCC), according to new research that was presented at the American College of Mohs Surgery (ACMS) 2024 annual meeting.

Even though immunosuppression is strongly associated with an increased risk for cSCC, studies to date have generally not shown it to be an independent risk factor for metastasis and disease-specific death (DSD), after accounting for primary tumor stage.

“Solid organ transplant puts patients at risk for developing cutaneous squamous cell carcinoma, and it’s more likely to have aggressive features,” said study author Jason Klein, MD, PhD, a dermatology resident at University of Texas Southwestern Medical Center, Dallas. “But it’s still not known if immunosuppression is an independent risk factor.”

Other groups “have tried to tackle this, but they have all primarily been single-institution data,” he noted, adding that “results so far have been tipping the scale towards immunosuppression not being an independent risk factor” for worse outcomes.

Immunosuppressed individuals face a greater risk for cSCC than the general population and often present with more aggressive, multifocal disease. However, Dr. Klein explained that a previous retrospective study comprising a cohort of approximately 7600 tumors from two centers reported that immunosuppression was not an independent risk factor for both tumor metastasis and cancer-specific death after adjusting for tumor characteristics.

Tipped the Scale

Therefore, the goal of the current study was to repeat this analysis but in a much larger retrospective cohort. Dr. Klein and his colleagues pooled cSCC data from 12 dermatology centers (11 academic and one private) that were located in the United States, Spain, and Brazil. The cohort included 4392 patients (3769 immunocompetent patients and 623 immunosuppressed patients) with 19,237 tumors (15,191 immunocompetent and 4046 immunosuppressed). Study endpoints included local recurrence, metastasis (nodal, satellite/in-transit, and distant), DSD, and “major poor outcomes” (defined as metastasis and DSD combined).

About 30% of the immunosuppressed patients were organ transplant recipients (OTR) and 10% had chronic lymphocytic leukemia (CLL). Half of the immunocompetent patients (50.3%) underwent Mohs surgery as the primary treatment, as did 58.2% of the immunosuppressed patients.

On multivariable analysis, significant predictors of “major poor outcomes” included immunosuppression (subdistribution hazard ratio [SHR], 1.3; P = .04), Brigham and Women’s Hospital tumor stage (SHR 6.7 for T2a, 18.1 for T2b, and 37.2 for T3; P < .001 for all), location on the head/neck (SHR, 2.1; P < .001), and adjuvant radiation (SHR, 1.6; P < .001).

But when metastasis and DSD were evaluated separately, immunosuppression was only predictive of DSD (SHR, 1.7; P = .008) but not metastasis (SHR, 1.2; P = .21). Dr. Klein explained that they also conducted a separate subanalysis limited to OTR and patients with CLL, which demonstrated that immunosuppression was no longer a significant predictor of “major poor outcomes” (SHR, 0.9; P = .66 for OTR; SHR, 1.4; P = .25 for CLL).

“Organ transplant status and CLL were not independent risk factors for major poor outcomes,” he said. “But in summary, we may be tipping the scale to immunosuppression being a risk factor.”

Asked to comment on the findings, Naissan O. Wesley, MD, director of Mohs surgery, Skin Care and Laser Physicians of Beverly Hills, Los Angeles, California, stated that “this larger scale study presented at this meeting was important to further confirm what we see in everyday practice, that immunosuppression may lead to poorer outcomes in patients with cutaneous squamous cell carcinoma.”

Also weighing in on the data, Jesse M. Lewin, MD, chief of Mohs micrographic and dermatologic surgery, at the Icahn School of Medicine at Mount Sinai, New York City, noted that the treatment of cSCC in high-risk patients has been challenging because of the historical lack of data and large studies to guide management.

“The authors provide a large cohort to help stratify which patients are most at risk for poor outcomes, which can inform our decision to refer for neoadjuvant or adjuvant treatment and multi-disciplinary management,” he said. “This is the first step in being able to optimize cure in these patients.”

The study was independently supported. Dr. Klein, Dr. Lewin, and Dr. Wesley reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

PHOENIX — Immunosuppression is an independent risk factor for poorer outcomes in patients with cutaneous squamous cell carcinoma (cSCC), according to new research that was presented at the American College of Mohs Surgery (ACMS) 2024 annual meeting.

Even though immunosuppression is strongly associated with an increased risk for cSCC, studies to date have generally not shown it to be an independent risk factor for metastasis and disease-specific death (DSD), after accounting for primary tumor stage.

“Solid organ transplant puts patients at risk for developing cutaneous squamous cell carcinoma, and it’s more likely to have aggressive features,” said study author Jason Klein, MD, PhD, a dermatology resident at University of Texas Southwestern Medical Center, Dallas. “But it’s still not known if immunosuppression is an independent risk factor.”

Other groups “have tried to tackle this, but they have all primarily been single-institution data,” he noted, adding that “results so far have been tipping the scale towards immunosuppression not being an independent risk factor” for worse outcomes.

Immunosuppressed individuals face a greater risk for cSCC than the general population and often present with more aggressive, multifocal disease. However, Dr. Klein explained that a previous retrospective study comprising a cohort of approximately 7600 tumors from two centers reported that immunosuppression was not an independent risk factor for both tumor metastasis and cancer-specific death after adjusting for tumor characteristics.

Tipped the Scale

Therefore, the goal of the current study was to repeat this analysis but in a much larger retrospective cohort. Dr. Klein and his colleagues pooled cSCC data from 12 dermatology centers (11 academic and one private) that were located in the United States, Spain, and Brazil. The cohort included 4392 patients (3769 immunocompetent patients and 623 immunosuppressed patients) with 19,237 tumors (15,191 immunocompetent and 4046 immunosuppressed). Study endpoints included local recurrence, metastasis (nodal, satellite/in-transit, and distant), DSD, and “major poor outcomes” (defined as metastasis and DSD combined).

About 30% of the immunosuppressed patients were organ transplant recipients (OTR) and 10% had chronic lymphocytic leukemia (CLL). Half of the immunocompetent patients (50.3%) underwent Mohs surgery as the primary treatment, as did 58.2% of the immunosuppressed patients.

On multivariable analysis, significant predictors of “major poor outcomes” included immunosuppression (subdistribution hazard ratio [SHR], 1.3; P = .04), Brigham and Women’s Hospital tumor stage (SHR 6.7 for T2a, 18.1 for T2b, and 37.2 for T3; P < .001 for all), location on the head/neck (SHR, 2.1; P < .001), and adjuvant radiation (SHR, 1.6; P < .001).

But when metastasis and DSD were evaluated separately, immunosuppression was only predictive of DSD (SHR, 1.7; P = .008) but not metastasis (SHR, 1.2; P = .21). Dr. Klein explained that they also conducted a separate subanalysis limited to OTR and patients with CLL, which demonstrated that immunosuppression was no longer a significant predictor of “major poor outcomes” (SHR, 0.9; P = .66 for OTR; SHR, 1.4; P = .25 for CLL).

“Organ transplant status and CLL were not independent risk factors for major poor outcomes,” he said. “But in summary, we may be tipping the scale to immunosuppression being a risk factor.”

Asked to comment on the findings, Naissan O. Wesley, MD, director of Mohs surgery, Skin Care and Laser Physicians of Beverly Hills, Los Angeles, California, stated that “this larger scale study presented at this meeting was important to further confirm what we see in everyday practice, that immunosuppression may lead to poorer outcomes in patients with cutaneous squamous cell carcinoma.”

Also weighing in on the data, Jesse M. Lewin, MD, chief of Mohs micrographic and dermatologic surgery, at the Icahn School of Medicine at Mount Sinai, New York City, noted that the treatment of cSCC in high-risk patients has been challenging because of the historical lack of data and large studies to guide management.

“The authors provide a large cohort to help stratify which patients are most at risk for poor outcomes, which can inform our decision to refer for neoadjuvant or adjuvant treatment and multi-disciplinary management,” he said. “This is the first step in being able to optimize cure in these patients.”

The study was independently supported. Dr. Klein, Dr. Lewin, and Dr. Wesley reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

PHOENIX — Immunosuppression is an independent risk factor for poorer outcomes in patients with cutaneous squamous cell carcinoma (cSCC), according to new research that was presented at the American College of Mohs Surgery (ACMS) 2024 annual meeting.

Even though immunosuppression is strongly associated with an increased risk for cSCC, studies to date have generally not shown it to be an independent risk factor for metastasis and disease-specific death (DSD), after accounting for primary tumor stage.

“Solid organ transplant puts patients at risk for developing cutaneous squamous cell carcinoma, and it’s more likely to have aggressive features,” said study author Jason Klein, MD, PhD, a dermatology resident at University of Texas Southwestern Medical Center, Dallas. “But it’s still not known if immunosuppression is an independent risk factor.”

Other groups “have tried to tackle this, but they have all primarily been single-institution data,” he noted, adding that “results so far have been tipping the scale towards immunosuppression not being an independent risk factor” for worse outcomes.

Immunosuppressed individuals face a greater risk for cSCC than the general population and often present with more aggressive, multifocal disease. However, Dr. Klein explained that a previous retrospective study comprising a cohort of approximately 7600 tumors from two centers reported that immunosuppression was not an independent risk factor for both tumor metastasis and cancer-specific death after adjusting for tumor characteristics.

Tipped the Scale

Therefore, the goal of the current study was to repeat this analysis but in a much larger retrospective cohort. Dr. Klein and his colleagues pooled cSCC data from 12 dermatology centers (11 academic and one private) that were located in the United States, Spain, and Brazil. The cohort included 4392 patients (3769 immunocompetent patients and 623 immunosuppressed patients) with 19,237 tumors (15,191 immunocompetent and 4046 immunosuppressed). Study endpoints included local recurrence, metastasis (nodal, satellite/in-transit, and distant), DSD, and “major poor outcomes” (defined as metastasis and DSD combined).

About 30% of the immunosuppressed patients were organ transplant recipients (OTR) and 10% had chronic lymphocytic leukemia (CLL). Half of the immunocompetent patients (50.3%) underwent Mohs surgery as the primary treatment, as did 58.2% of the immunosuppressed patients.

On multivariable analysis, significant predictors of “major poor outcomes” included immunosuppression (subdistribution hazard ratio [SHR], 1.3; P = .04), Brigham and Women’s Hospital tumor stage (SHR 6.7 for T2a, 18.1 for T2b, and 37.2 for T3; P < .001 for all), location on the head/neck (SHR, 2.1; P < .001), and adjuvant radiation (SHR, 1.6; P < .001).

But when metastasis and DSD were evaluated separately, immunosuppression was only predictive of DSD (SHR, 1.7; P = .008) but not metastasis (SHR, 1.2; P = .21). Dr. Klein explained that they also conducted a separate subanalysis limited to OTR and patients with CLL, which demonstrated that immunosuppression was no longer a significant predictor of “major poor outcomes” (SHR, 0.9; P = .66 for OTR; SHR, 1.4; P = .25 for CLL).

“Organ transplant status and CLL were not independent risk factors for major poor outcomes,” he said. “But in summary, we may be tipping the scale to immunosuppression being a risk factor.”

Asked to comment on the findings, Naissan O. Wesley, MD, director of Mohs surgery, Skin Care and Laser Physicians of Beverly Hills, Los Angeles, California, stated that “this larger scale study presented at this meeting was important to further confirm what we see in everyday practice, that immunosuppression may lead to poorer outcomes in patients with cutaneous squamous cell carcinoma.”

Also weighing in on the data, Jesse M. Lewin, MD, chief of Mohs micrographic and dermatologic surgery, at the Icahn School of Medicine at Mount Sinai, New York City, noted that the treatment of cSCC in high-risk patients has been challenging because of the historical lack of data and large studies to guide management.

“The authors provide a large cohort to help stratify which patients are most at risk for poor outcomes, which can inform our decision to refer for neoadjuvant or adjuvant treatment and multi-disciplinary management,” he said. “This is the first step in being able to optimize cure in these patients.”

The study was independently supported. Dr. Klein, Dr. Lewin, and Dr. Wesley reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

PHOENIX — There is a high prevalence of emotional and physical burden associated with being a Mohs surgeon, particularly among women and younger surgeons, according to new findings. In addition, most surgeons did not feel prepared to manage or prevent these symptoms.

“Our study highlights the need to implement ergonomic training and emotion-focused coping skills, as part of fellowship training and the continuing medical education curriculum, to alleviate and prevent emotional burnout,” said lead author Eduardo A. Michelen-Gómez, MD, a dermatology resident at the University of Puerto Rico School of Medicine, San Juano. “This interaction also must be designed to cater to generation and sex specific needs.”

Dr. Michelen-Gómez presented the findings at the annual meeting of the American College of Mohs Surgery.

Mohs is a demanding procedure that involves repetitive motion, strict attention to detail, and high practice efficiency, all of which must be balanced with the need to prioritize patient safety and well-being. “All of these factors predispose Mohs surgeons to be at an increased risk of physical and emotional stress,” he said.

Despite these concerns, however, the literature is limited concerning work-associated stressors among Mohs surgeons. To further explore this issue, Dr. Michelen-Gómez and colleagues conducted a survey study of ACMS members to investigate not only the prevalence of emotional and physical stressors associated with being a Mohs surgeon but also what specific actions physicians were taking to prevent and/or treat these stressors.

They designed a 21-question cross-sectional electronic survey that was sent to all active ACMS members in 2023. Outcomes evaluated were gender, years of practice, concern for and prevalence of occupational musculoskeletal disorders, emotional stress and burnout, and surgeon’s knowledge and training to manage these symptoms. A total of 473 Mohs surgeons responded.
 

High Prevalence of Injury and Burnout

“Almost 90% of respondents reported moderate to severe concern for occupational musculoskeletal injuries,” said Dr. Michelen-Gómez. “The prevalence of these injuries was 68%, with neck injuries being the most common complaint. Of the entire cohort, 67% have adopted ergonomic practices patterns.”

Female surgeons had a higher prevalence of musculoskeletal injuries than men, and there was no correlation between years of practice and prevalence of these injuries.

Their results also showed that 70% of respondents reported experiencing psychological and emotional stress or burnout associated with being a Mohs surgeon. The cause of emotional stress differed between men and women. “In males, the most common cause was patient care–related anxiety, while in females, it was finding an adequate work-life balance,” he said.

Surgeons with fewer years of experience were more likely to experience emotional stress (P = .01), and female surgeons had a higher prevalence of burnout and musculoskeletal disorders (71.0% and 71.4%, respectively) than male surgeons (67.7% and 65.2%, respectively).

To prevent or manage musculoskeletal injury, respondents reported using interventions such as physical therapy, yoga/stretching/Pilates, massage therapy, cupping, and using a physical trainer. Specific actions for preventing or managing emotional stress and burnout included engaging with a therapist, working with a life coach, practicing meditation or mindfulness, journaling, relying on religion or spirituality, and exercise.

However, among those who reported musculoskeletal disorders or emotional stress, only 40.56% and 46.67%, respectively, felt they had sufficient knowledge and the resources to manage them appropriately.

“In addition, we found a positive correlation between the development of psychological stress and physical issues,” said Dr. Michelen-Gómez. Future studies can include determining the most effective methods to address the emotional and physical stressors of practicing Mohs Surgery.”

Asked to comment on the study findings, Jesse M. Lewin, MD, chief of Mohs micrographic and dermatologic surgery and vice chair of surgical operations at the Icahn School of Medicine at Mount Sinai, New York City, said that the real-world take-home messages from this study are twofold.

“It is important to focus on physician wellness and prevention of burnout and physical injury to protect our physician workforce, and two, we should equip physicians-in-training with tools to protect their physical and emotional health,” he said.

Dr. Michelen-Gómez and Dr. Lewin, who was not involved with the study, had no relevant disclosures.
 

A version of this article appeared on Medscape.com.

PHOENIX — There is a high prevalence of emotional and physical burden associated with being a Mohs surgeon, particularly among women and younger surgeons, according to new findings. In addition, most surgeons did not feel prepared to manage or prevent these symptoms.

“Our study highlights the need to implement ergonomic training and emotion-focused coping skills, as part of fellowship training and the continuing medical education curriculum, to alleviate and prevent emotional burnout,” said lead author Eduardo A. Michelen-Gómez, MD, a dermatology resident at the University of Puerto Rico School of Medicine, San Juano. “This interaction also must be designed to cater to generation and sex specific needs.”

Dr. Michelen-Gómez presented the findings at the annual meeting of the American College of Mohs Surgery.

Mohs is a demanding procedure that involves repetitive motion, strict attention to detail, and high practice efficiency, all of which must be balanced with the need to prioritize patient safety and well-being. “All of these factors predispose Mohs surgeons to be at an increased risk of physical and emotional stress,” he said.

Despite these concerns, however, the literature is limited concerning work-associated stressors among Mohs surgeons. To further explore this issue, Dr. Michelen-Gómez and colleagues conducted a survey study of ACMS members to investigate not only the prevalence of emotional and physical stressors associated with being a Mohs surgeon but also what specific actions physicians were taking to prevent and/or treat these stressors.

They designed a 21-question cross-sectional electronic survey that was sent to all active ACMS members in 2023. Outcomes evaluated were gender, years of practice, concern for and prevalence of occupational musculoskeletal disorders, emotional stress and burnout, and surgeon’s knowledge and training to manage these symptoms. A total of 473 Mohs surgeons responded.
 

High Prevalence of Injury and Burnout

“Almost 90% of respondents reported moderate to severe concern for occupational musculoskeletal injuries,” said Dr. Michelen-Gómez. “The prevalence of these injuries was 68%, with neck injuries being the most common complaint. Of the entire cohort, 67% have adopted ergonomic practices patterns.”

Female surgeons had a higher prevalence of musculoskeletal injuries than men, and there was no correlation between years of practice and prevalence of these injuries.

Their results also showed that 70% of respondents reported experiencing psychological and emotional stress or burnout associated with being a Mohs surgeon. The cause of emotional stress differed between men and women. “In males, the most common cause was patient care–related anxiety, while in females, it was finding an adequate work-life balance,” he said.

Surgeons with fewer years of experience were more likely to experience emotional stress (P = .01), and female surgeons had a higher prevalence of burnout and musculoskeletal disorders (71.0% and 71.4%, respectively) than male surgeons (67.7% and 65.2%, respectively).

To prevent or manage musculoskeletal injury, respondents reported using interventions such as physical therapy, yoga/stretching/Pilates, massage therapy, cupping, and using a physical trainer. Specific actions for preventing or managing emotional stress and burnout included engaging with a therapist, working with a life coach, practicing meditation or mindfulness, journaling, relying on religion or spirituality, and exercise.

However, among those who reported musculoskeletal disorders or emotional stress, only 40.56% and 46.67%, respectively, felt they had sufficient knowledge and the resources to manage them appropriately.

“In addition, we found a positive correlation between the development of psychological stress and physical issues,” said Dr. Michelen-Gómez. Future studies can include determining the most effective methods to address the emotional and physical stressors of practicing Mohs Surgery.”

Asked to comment on the study findings, Jesse M. Lewin, MD, chief of Mohs micrographic and dermatologic surgery and vice chair of surgical operations at the Icahn School of Medicine at Mount Sinai, New York City, said that the real-world take-home messages from this study are twofold.

“It is important to focus on physician wellness and prevention of burnout and physical injury to protect our physician workforce, and two, we should equip physicians-in-training with tools to protect their physical and emotional health,” he said.

Dr. Michelen-Gómez and Dr. Lewin, who was not involved with the study, had no relevant disclosures.
 

A version of this article appeared on Medscape.com.

PHOENIX — There is a high prevalence of emotional and physical burden associated with being a Mohs surgeon, particularly among women and younger surgeons, according to new findings. In addition, most surgeons did not feel prepared to manage or prevent these symptoms.

“Our study highlights the need to implement ergonomic training and emotion-focused coping skills, as part of fellowship training and the continuing medical education curriculum, to alleviate and prevent emotional burnout,” said lead author Eduardo A. Michelen-Gómez, MD, a dermatology resident at the University of Puerto Rico School of Medicine, San Juano. “This interaction also must be designed to cater to generation and sex specific needs.”

Dr. Michelen-Gómez presented the findings at the annual meeting of the American College of Mohs Surgery.

Mohs is a demanding procedure that involves repetitive motion, strict attention to detail, and high practice efficiency, all of which must be balanced with the need to prioritize patient safety and well-being. “All of these factors predispose Mohs surgeons to be at an increased risk of physical and emotional stress,” he said.

Despite these concerns, however, the literature is limited concerning work-associated stressors among Mohs surgeons. To further explore this issue, Dr. Michelen-Gómez and colleagues conducted a survey study of ACMS members to investigate not only the prevalence of emotional and physical stressors associated with being a Mohs surgeon but also what specific actions physicians were taking to prevent and/or treat these stressors.

They designed a 21-question cross-sectional electronic survey that was sent to all active ACMS members in 2023. Outcomes evaluated were gender, years of practice, concern for and prevalence of occupational musculoskeletal disorders, emotional stress and burnout, and surgeon’s knowledge and training to manage these symptoms. A total of 473 Mohs surgeons responded.
 

High Prevalence of Injury and Burnout

“Almost 90% of respondents reported moderate to severe concern for occupational musculoskeletal injuries,” said Dr. Michelen-Gómez. “The prevalence of these injuries was 68%, with neck injuries being the most common complaint. Of the entire cohort, 67% have adopted ergonomic practices patterns.”

Female surgeons had a higher prevalence of musculoskeletal injuries than men, and there was no correlation between years of practice and prevalence of these injuries.

Their results also showed that 70% of respondents reported experiencing psychological and emotional stress or burnout associated with being a Mohs surgeon. The cause of emotional stress differed between men and women. “In males, the most common cause was patient care–related anxiety, while in females, it was finding an adequate work-life balance,” he said.

Surgeons with fewer years of experience were more likely to experience emotional stress (P = .01), and female surgeons had a higher prevalence of burnout and musculoskeletal disorders (71.0% and 71.4%, respectively) than male surgeons (67.7% and 65.2%, respectively).

To prevent or manage musculoskeletal injury, respondents reported using interventions such as physical therapy, yoga/stretching/Pilates, massage therapy, cupping, and using a physical trainer. Specific actions for preventing or managing emotional stress and burnout included engaging with a therapist, working with a life coach, practicing meditation or mindfulness, journaling, relying on religion or spirituality, and exercise.

However, among those who reported musculoskeletal disorders or emotional stress, only 40.56% and 46.67%, respectively, felt they had sufficient knowledge and the resources to manage them appropriately.

“In addition, we found a positive correlation between the development of psychological stress and physical issues,” said Dr. Michelen-Gómez. Future studies can include determining the most effective methods to address the emotional and physical stressors of practicing Mohs Surgery.”

Asked to comment on the study findings, Jesse M. Lewin, MD, chief of Mohs micrographic and dermatologic surgery and vice chair of surgical operations at the Icahn School of Medicine at Mount Sinai, New York City, said that the real-world take-home messages from this study are twofold.

“It is important to focus on physician wellness and prevention of burnout and physical injury to protect our physician workforce, and two, we should equip physicians-in-training with tools to protect their physical and emotional health,” he said.

Dr. Michelen-Gómez and Dr. Lewin, who was not involved with the study, had no relevant disclosures.
 

A version of this article appeared on Medscape.com.

Each month I set out on an expedition to find a topic for this column. I came across a new book Rebel Health by Susannah Fox that I thought might be a good one. It’s both a treatise on the shortcomings of healthcare and a Baedeker for patients on how to find their way to being better served. Her argument is that many patients’ needs are unmet and their conditions are often invisible to us in mainstream healthcare. We fail to find solutions to help them. Patients would benefit from more open access to their records and more resources to take control of their own health, she argues. A few chapters in, I thought, “Oh, here we go, another diatribe on doctors and how we care most about how to keep patients in their rightful, subordinate place.” The “Rebel” title is provocative and implies patients need to overthrow the status quo. Well, I am part of the establishment. I stopped reading. This book doesn’t apply to me, I thought.

After all, I’m a healthcare progressive, right? My notes and results have been open for years. I encourage shared decision-making and try to empower patients as much as treat them. The idea that I or my colleagues are unwilling to do whatever is necessary to meet our patients’ needs was maddening. We dedicate our lives to it. My young daughter often greets me in the morning by asking if I’ll be working tonight. Most nights, I am — answering patient messages, collaborating with colleagues to help patients, keeping up with medical knowledge. I was angry at what felt like unjust criticism, especially that we’d neglect patients because their problems are not obvious or worse, there is not enough money to be made helping them. Harrumph.

Kaiser Permanente

That’s when I realized the best thing for me was to read the entire book and digest the arguments. I pride myself on being well-read, but I fall into a common trap: the podcasts I listen to, news I consume, and books I read mostly affirm my beliefs. It is a healthy choice to seek dispositive data and contrasting stories rather than always feeding our personal opinions.

Rebel Health was not written by Robespierre. It was penned by a thoughtful, articulate patient advocate with over 20 years experience. She has far more bona fides than I could achieve in two lifetimes. In the book, she reminds us that scientific advances in the last 100 years have made medicine more effective but also disintermediated caregivers, family, and patients. Patients and caregivers can not only help but also offer innovative and customized solutions to their problems. She describes four patient archetypes: seekers, networkers, solvers, and champions, and offers a four-quadrant model to visualize how some patients are unhelped by our current healthcare system. She advocates for frictionless, open access to health data and tries to inspire patients to connect, innovate, and create to fill the voids that exist in healthcare. We have come a long way from the immured system of a decade ago; much of that is the result of patient advocates. But healthcare is still too costly, too fragmented and too many patients unhelped. “Community is a superpower,” she writes. I agree, we should assemble all the heroes in the universe for this challenge.

Fox also tells stories of patients who solved diagnostic dilemmas through their own research and advocacy. I thought of my own contrasting experiences of patients whose DIY care was based on misinformation and how their false confidence led to poorer outcomes for them. I want to share with her readers how physicians feel hurt when patients question our competence or place the opinion of an adversarial Redditor over ours. Physicians are sometimes wrong and often in doubt. Most of us care deeply about our patients regardless of how visible their diagnosis or how easy they are to appease.

We don’t have time to engage back-and-forth on an insignificantly abnormal test they find in their open chart or why B12 and hormone testing would not be helpful for their disease. It’s also not the patients’ fault. Having unfettered access to their data might add work, but it also adds value. They are trying to learn and be active in their care. Physicians are frustrated mostly because we don’t have time to meet these unmet needs. Everyone is trying their best and we all want the same thing: patients to be satisfied and well.

As for learning the skill of being open-minded, an excellent reference is Adam Grant’s Think Again. It’s inspiring and instructive of how we can all be more open, including how to have productive arguments rather than fruitless fights. We live in divisive times. Perhaps if we all put in effort to be open-minded, push down righteous indignation, and advance more honest humility we’d all be a bit better off.

Patients are the primary audience for the Rebel Health book. Yet, as we care about them and we all want to make healthcare better, it is worth reading in its entirety. I told my daughter I don’t have to work tonight because I’ve written my article this month. When she’s a little older, I’ll tell her all about it. To be successful, she’ll have to be as open-minded as she is smart. She can learn both.

I have no conflict of interest in the book.

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 Twitter. Write to him at [email protected].

Each month I set out on an expedition to find a topic for this column. I came across a new book Rebel Health by Susannah Fox that I thought might be a good one. It’s both a treatise on the shortcomings of healthcare and a Baedeker for patients on how to find their way to being better served. Her argument is that many patients’ needs are unmet and their conditions are often invisible to us in mainstream healthcare. We fail to find solutions to help them. Patients would benefit from more open access to their records and more resources to take control of their own health, she argues. A few chapters in, I thought, “Oh, here we go, another diatribe on doctors and how we care most about how to keep patients in their rightful, subordinate place.” The “Rebel” title is provocative and implies patients need to overthrow the status quo. Well, I am part of the establishment. I stopped reading. This book doesn’t apply to me, I thought.

After all, I’m a healthcare progressive, right? My notes and results have been open for years. I encourage shared decision-making and try to empower patients as much as treat them. The idea that I or my colleagues are unwilling to do whatever is necessary to meet our patients’ needs was maddening. We dedicate our lives to it. My young daughter often greets me in the morning by asking if I’ll be working tonight. Most nights, I am — answering patient messages, collaborating with colleagues to help patients, keeping up with medical knowledge. I was angry at what felt like unjust criticism, especially that we’d neglect patients because their problems are not obvious or worse, there is not enough money to be made helping them. Harrumph.

Kaiser Permanente

That’s when I realized the best thing for me was to read the entire book and digest the arguments. I pride myself on being well-read, but I fall into a common trap: the podcasts I listen to, news I consume, and books I read mostly affirm my beliefs. It is a healthy choice to seek dispositive data and contrasting stories rather than always feeding our personal opinions.

Rebel Health was not written by Robespierre. It was penned by a thoughtful, articulate patient advocate with over 20 years experience. She has far more bona fides than I could achieve in two lifetimes. In the book, she reminds us that scientific advances in the last 100 years have made medicine more effective but also disintermediated caregivers, family, and patients. Patients and caregivers can not only help but also offer innovative and customized solutions to their problems. She describes four patient archetypes: seekers, networkers, solvers, and champions, and offers a four-quadrant model to visualize how some patients are unhelped by our current healthcare system. She advocates for frictionless, open access to health data and tries to inspire patients to connect, innovate, and create to fill the voids that exist in healthcare. We have come a long way from the immured system of a decade ago; much of that is the result of patient advocates. But healthcare is still too costly, too fragmented and too many patients unhelped. “Community is a superpower,” she writes. I agree, we should assemble all the heroes in the universe for this challenge.

Fox also tells stories of patients who solved diagnostic dilemmas through their own research and advocacy. I thought of my own contrasting experiences of patients whose DIY care was based on misinformation and how their false confidence led to poorer outcomes for them. I want to share with her readers how physicians feel hurt when patients question our competence or place the opinion of an adversarial Redditor over ours. Physicians are sometimes wrong and often in doubt. Most of us care deeply about our patients regardless of how visible their diagnosis or how easy they are to appease.

We don’t have time to engage back-and-forth on an insignificantly abnormal test they find in their open chart or why B12 and hormone testing would not be helpful for their disease. It’s also not the patients’ fault. Having unfettered access to their data might add work, but it also adds value. They are trying to learn and be active in their care. Physicians are frustrated mostly because we don’t have time to meet these unmet needs. Everyone is trying their best and we all want the same thing: patients to be satisfied and well.

As for learning the skill of being open-minded, an excellent reference is Adam Grant’s Think Again. It’s inspiring and instructive of how we can all be more open, including how to have productive arguments rather than fruitless fights. We live in divisive times. Perhaps if we all put in effort to be open-minded, push down righteous indignation, and advance more honest humility we’d all be a bit better off.

Patients are the primary audience for the Rebel Health book. Yet, as we care about them and we all want to make healthcare better, it is worth reading in its entirety. I told my daughter I don’t have to work tonight because I’ve written my article this month. When she’s a little older, I’ll tell her all about it. To be successful, she’ll have to be as open-minded as she is smart. She can learn both.

I have no conflict of interest in the book.

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 Twitter. Write to him at [email protected].

Each month I set out on an expedition to find a topic for this column. I came across a new book Rebel Health by Susannah Fox that I thought might be a good one. It’s both a treatise on the shortcomings of healthcare and a Baedeker for patients on how to find their way to being better served. Her argument is that many patients’ needs are unmet and their conditions are often invisible to us in mainstream healthcare. We fail to find solutions to help them. Patients would benefit from more open access to their records and more resources to take control of their own health, she argues. A few chapters in, I thought, “Oh, here we go, another diatribe on doctors and how we care most about how to keep patients in their rightful, subordinate place.” The “Rebel” title is provocative and implies patients need to overthrow the status quo. Well, I am part of the establishment. I stopped reading. This book doesn’t apply to me, I thought.

After all, I’m a healthcare progressive, right? My notes and results have been open for years. I encourage shared decision-making and try to empower patients as much as treat them. The idea that I or my colleagues are unwilling to do whatever is necessary to meet our patients’ needs was maddening. We dedicate our lives to it. My young daughter often greets me in the morning by asking if I’ll be working tonight. Most nights, I am — answering patient messages, collaborating with colleagues to help patients, keeping up with medical knowledge. I was angry at what felt like unjust criticism, especially that we’d neglect patients because their problems are not obvious or worse, there is not enough money to be made helping them. Harrumph.

Kaiser Permanente

That’s when I realized the best thing for me was to read the entire book and digest the arguments. I pride myself on being well-read, but I fall into a common trap: the podcasts I listen to, news I consume, and books I read mostly affirm my beliefs. It is a healthy choice to seek dispositive data and contrasting stories rather than always feeding our personal opinions.

Rebel Health was not written by Robespierre. It was penned by a thoughtful, articulate patient advocate with over 20 years experience. She has far more bona fides than I could achieve in two lifetimes. In the book, she reminds us that scientific advances in the last 100 years have made medicine more effective but also disintermediated caregivers, family, and patients. Patients and caregivers can not only help but also offer innovative and customized solutions to their problems. She describes four patient archetypes: seekers, networkers, solvers, and champions, and offers a four-quadrant model to visualize how some patients are unhelped by our current healthcare system. She advocates for frictionless, open access to health data and tries to inspire patients to connect, innovate, and create to fill the voids that exist in healthcare. We have come a long way from the immured system of a decade ago; much of that is the result of patient advocates. But healthcare is still too costly, too fragmented and too many patients unhelped. “Community is a superpower,” she writes. I agree, we should assemble all the heroes in the universe for this challenge.

Fox also tells stories of patients who solved diagnostic dilemmas through their own research and advocacy. I thought of my own contrasting experiences of patients whose DIY care was based on misinformation and how their false confidence led to poorer outcomes for them. I want to share with her readers how physicians feel hurt when patients question our competence or place the opinion of an adversarial Redditor over ours. Physicians are sometimes wrong and often in doubt. Most of us care deeply about our patients regardless of how visible their diagnosis or how easy they are to appease.

We don’t have time to engage back-and-forth on an insignificantly abnormal test they find in their open chart or why B12 and hormone testing would not be helpful for their disease. It’s also not the patients’ fault. Having unfettered access to their data might add work, but it also adds value. They are trying to learn and be active in their care. Physicians are frustrated mostly because we don’t have time to meet these unmet needs. Everyone is trying their best and we all want the same thing: patients to be satisfied and well.

As for learning the skill of being open-minded, an excellent reference is Adam Grant’s Think Again. It’s inspiring and instructive of how we can all be more open, including how to have productive arguments rather than fruitless fights. We live in divisive times. Perhaps if we all put in effort to be open-minded, push down righteous indignation, and advance more honest humility we’d all be a bit better off.

Patients are the primary audience for the Rebel Health book. Yet, as we care about them and we all want to make healthcare better, it is worth reading in its entirety. I told my daughter I don’t have to work tonight because I’ve written my article this month. When she’s a little older, I’ll tell her all about it. To be successful, she’ll have to be as open-minded as she is smart. She can learn both.

I have no conflict of interest in the book.

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 Twitter. Write to him at [email protected].

PHOENIX — Reimbursement for dermatologic procedures has not maintained a parallel increase with the cost of healthcare delivery, according to new study findings. Medicare cuts, which are expected to continue, have exacerbated this issue even further.

“This ongoing downward trend in inflation-adjusted reimbursement may lead to delayed patient access to quality dermatology surgical care,” said lead study author Lily Park, DO, a resident in the Department of Dermatology, Larkin Community Hospital, Miami. “This trend will lead to reduced access.”

Dr. Park emphasized that reimbursement for Mohs surgery has also been further affected by the multiple surgery reduction rule, which is where Medicare pays less for the second and subsequent procedures performed during the same patient encounter. Reductions may be calculated in several ways, depending on what kind of procedure or service is involved.

“The Mohs surgery community needs to be aware of this financial trend and actively engage with healthcare policymakers to ensure the establishment of a sustainable payment infrastructure,” she said.

Dr. Park presented the study results at the annual meeting of the American College of Mohs Surgery.

The landscape of healthcare economics continues to evolve and has been further complicated by rising inflation. In addition, a 2% cut to the Medicare payment conversion factor was implemented in 2023, followed by a further 3.37% cut in early 2024 — which was cut by half in March 2024, with an additional cut expected this year, she noted. “This has presented more challenges for dermatologic surgeons who are already dealing with the rising healthcare costs.”

However, despite these financial challenges, there is a lack of research on physician reimbursement for dermatologic procedures, including surgery.

Decreased Reimbursement for All Procedures

Dr. Park and colleagues analyzed trends in Medicare reimbursement rates for Mohs micrographic surgery and several other common dermatologic procedures. Beginning with 2007, they calculated the inflation-adjusted values for each year’s non-facility prices for all codes except Current Procedural Terminology (CPT) codes 11102 and 11104. For those two codes, inflation-adjusted prices were based on the prices in 2019, the year when the codes were first introduced. The authors estimated the inflation adjusted value for each year based on the non-facility price for 2007, and the difference between the rate of inflation and the change in physician reimbursement over time was calculated.

The six most commonly performed procedures in 2023, ranked in descending order of frequency, were identified as CPT 17000, used for the removal of actinic keratosis; CPT 11102, used for biopsy of skin; CPT 17110, used for the destruction of benign lesions such as seborrheic keratoses and warts; CPT 17311, used for the destruction of malignant lesions (including Mohs surgery); CPT 11104, which is also related to biopsy of skin; and CPT 10060, used for incision and drainage of abscess.

Their analysis showed that all CPT codes experienced a decline when compared with their inflation-adjusted values. Both Mohs surgery (17311) and benign destruction of premalignant lesions (17000) showed a decrease of 46% in reimbursement during an inflation-adjusted 18-year time span between 2007 and 2024.

When adjusted for inflation, Dr. Park noted, reimbursement for CPT 17311 and 17000 should actually be increased by 42% and 41% in 2024, respectively. The greatest declines in reimbursement were seen during the last 4 years.

“Future legislation, such as H.R.2474, a bill proposing inflation-based updates to physician pay, would aid us in the future if implemented,” said Dr. Park.
 

Dangerous Trend

The finding that payments have declined for many common dermatologic procedures since 2007 “is particularly important given the rising cost of healthcare delivery,” said Jesse M. Lewin, MD, who was asked to comment on the study results. “The administrative burden of electronic medical records, filing, and following up insurance claims has necessitated the employment of more non-physician staff to support these tasks,” he told this news organization.

“Declining reimbursement for Mohs surgery and other cancer-related procedures is a dangerous trend, as the ultimate impact will be the effect it has on quality and accessibility of skin cancer care for patients,” added Dr. Lewin, chief of Mohs micrographic and dermatologic surgery and vice chair of surgical operations at the Icahn School of Medicine at Mount Sinai, New York City. “This is an important study that reinforces physician engagement in healthcare policy and legislation to advocate for our specialty and patients.”

The study was independently supported. Dr. Park and Dr. Lewin, who was not involved with the study, reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

PHOENIX — Reimbursement for dermatologic procedures has not maintained a parallel increase with the cost of healthcare delivery, according to new study findings. Medicare cuts, which are expected to continue, have exacerbated this issue even further.

“This ongoing downward trend in inflation-adjusted reimbursement may lead to delayed patient access to quality dermatology surgical care,” said lead study author Lily Park, DO, a resident in the Department of Dermatology, Larkin Community Hospital, Miami. “This trend will lead to reduced access.”

Dr. Park emphasized that reimbursement for Mohs surgery has also been further affected by the multiple surgery reduction rule, which is where Medicare pays less for the second and subsequent procedures performed during the same patient encounter. Reductions may be calculated in several ways, depending on what kind of procedure or service is involved.

“The Mohs surgery community needs to be aware of this financial trend and actively engage with healthcare policymakers to ensure the establishment of a sustainable payment infrastructure,” she said.

Dr. Park presented the study results at the annual meeting of the American College of Mohs Surgery.

The landscape of healthcare economics continues to evolve and has been further complicated by rising inflation. In addition, a 2% cut to the Medicare payment conversion factor was implemented in 2023, followed by a further 3.37% cut in early 2024 — which was cut by half in March 2024, with an additional cut expected this year, she noted. “This has presented more challenges for dermatologic surgeons who are already dealing with the rising healthcare costs.”

However, despite these financial challenges, there is a lack of research on physician reimbursement for dermatologic procedures, including surgery.

Decreased Reimbursement for All Procedures

Dr. Park and colleagues analyzed trends in Medicare reimbursement rates for Mohs micrographic surgery and several other common dermatologic procedures. Beginning with 2007, they calculated the inflation-adjusted values for each year’s non-facility prices for all codes except Current Procedural Terminology (CPT) codes 11102 and 11104. For those two codes, inflation-adjusted prices were based on the prices in 2019, the year when the codes were first introduced. The authors estimated the inflation adjusted value for each year based on the non-facility price for 2007, and the difference between the rate of inflation and the change in physician reimbursement over time was calculated.

The six most commonly performed procedures in 2023, ranked in descending order of frequency, were identified as CPT 17000, used for the removal of actinic keratosis; CPT 11102, used for biopsy of skin; CPT 17110, used for the destruction of benign lesions such as seborrheic keratoses and warts; CPT 17311, used for the destruction of malignant lesions (including Mohs surgery); CPT 11104, which is also related to biopsy of skin; and CPT 10060, used for incision and drainage of abscess.

Their analysis showed that all CPT codes experienced a decline when compared with their inflation-adjusted values. Both Mohs surgery (17311) and benign destruction of premalignant lesions (17000) showed a decrease of 46% in reimbursement during an inflation-adjusted 18-year time span between 2007 and 2024.

When adjusted for inflation, Dr. Park noted, reimbursement for CPT 17311 and 17000 should actually be increased by 42% and 41% in 2024, respectively. The greatest declines in reimbursement were seen during the last 4 years.

“Future legislation, such as H.R.2474, a bill proposing inflation-based updates to physician pay, would aid us in the future if implemented,” said Dr. Park.
 

Dangerous Trend

The finding that payments have declined for many common dermatologic procedures since 2007 “is particularly important given the rising cost of healthcare delivery,” said Jesse M. Lewin, MD, who was asked to comment on the study results. “The administrative burden of electronic medical records, filing, and following up insurance claims has necessitated the employment of more non-physician staff to support these tasks,” he told this news organization.

“Declining reimbursement for Mohs surgery and other cancer-related procedures is a dangerous trend, as the ultimate impact will be the effect it has on quality and accessibility of skin cancer care for patients,” added Dr. Lewin, chief of Mohs micrographic and dermatologic surgery and vice chair of surgical operations at the Icahn School of Medicine at Mount Sinai, New York City. “This is an important study that reinforces physician engagement in healthcare policy and legislation to advocate for our specialty and patients.”

The study was independently supported. Dr. Park and Dr. Lewin, who was not involved with the study, reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

PHOENIX — Reimbursement for dermatologic procedures has not maintained a parallel increase with the cost of healthcare delivery, according to new study findings. Medicare cuts, which are expected to continue, have exacerbated this issue even further.

“This ongoing downward trend in inflation-adjusted reimbursement may lead to delayed patient access to quality dermatology surgical care,” said lead study author Lily Park, DO, a resident in the Department of Dermatology, Larkin Community Hospital, Miami. “This trend will lead to reduced access.”

Dr. Park emphasized that reimbursement for Mohs surgery has also been further affected by the multiple surgery reduction rule, which is where Medicare pays less for the second and subsequent procedures performed during the same patient encounter. Reductions may be calculated in several ways, depending on what kind of procedure or service is involved.

“The Mohs surgery community needs to be aware of this financial trend and actively engage with healthcare policymakers to ensure the establishment of a sustainable payment infrastructure,” she said.

Dr. Park presented the study results at the annual meeting of the American College of Mohs Surgery.

The landscape of healthcare economics continues to evolve and has been further complicated by rising inflation. In addition, a 2% cut to the Medicare payment conversion factor was implemented in 2023, followed by a further 3.37% cut in early 2024 — which was cut by half in March 2024, with an additional cut expected this year, she noted. “This has presented more challenges for dermatologic surgeons who are already dealing with the rising healthcare costs.”

However, despite these financial challenges, there is a lack of research on physician reimbursement for dermatologic procedures, including surgery.

Decreased Reimbursement for All Procedures

Dr. Park and colleagues analyzed trends in Medicare reimbursement rates for Mohs micrographic surgery and several other common dermatologic procedures. Beginning with 2007, they calculated the inflation-adjusted values for each year’s non-facility prices for all codes except Current Procedural Terminology (CPT) codes 11102 and 11104. For those two codes, inflation-adjusted prices were based on the prices in 2019, the year when the codes were first introduced. The authors estimated the inflation adjusted value for each year based on the non-facility price for 2007, and the difference between the rate of inflation and the change in physician reimbursement over time was calculated.

The six most commonly performed procedures in 2023, ranked in descending order of frequency, were identified as CPT 17000, used for the removal of actinic keratosis; CPT 11102, used for biopsy of skin; CPT 17110, used for the destruction of benign lesions such as seborrheic keratoses and warts; CPT 17311, used for the destruction of malignant lesions (including Mohs surgery); CPT 11104, which is also related to biopsy of skin; and CPT 10060, used for incision and drainage of abscess.

Their analysis showed that all CPT codes experienced a decline when compared with their inflation-adjusted values. Both Mohs surgery (17311) and benign destruction of premalignant lesions (17000) showed a decrease of 46% in reimbursement during an inflation-adjusted 18-year time span between 2007 and 2024.

When adjusted for inflation, Dr. Park noted, reimbursement for CPT 17311 and 17000 should actually be increased by 42% and 41% in 2024, respectively. The greatest declines in reimbursement were seen during the last 4 years.

“Future legislation, such as H.R.2474, a bill proposing inflation-based updates to physician pay, would aid us in the future if implemented,” said Dr. Park.
 

Dangerous Trend

The finding that payments have declined for many common dermatologic procedures since 2007 “is particularly important given the rising cost of healthcare delivery,” said Jesse M. Lewin, MD, who was asked to comment on the study results. “The administrative burden of electronic medical records, filing, and following up insurance claims has necessitated the employment of more non-physician staff to support these tasks,” he told this news organization.

“Declining reimbursement for Mohs surgery and other cancer-related procedures is a dangerous trend, as the ultimate impact will be the effect it has on quality and accessibility of skin cancer care for patients,” added Dr. Lewin, chief of Mohs micrographic and dermatologic surgery and vice chair of surgical operations at the Icahn School of Medicine at Mount Sinai, New York City. “This is an important study that reinforces physician engagement in healthcare policy and legislation to advocate for our specialty and patients.”

The study was independently supported. Dr. Park and Dr. Lewin, who was not involved with the study, reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

In April, the Federal Trade Commission (FTC), by a vote of 3-2, opened a long-anticipated can of worms by approving its final rule that effectively bans employers’ use of all non-compete agreements (with very limited exceptions). The final rule will not go into effect until 120 days after its publication in the Federal Register, which took place on May 7, and numerous legal challenges appear to be on the horizon.

The principal components of the rule are as follows:

• After the effective date, most non-compete agreements (which prevent departing employees from signing with a new employer for a defined period within a specific geographic area) are banned nationwide.
• The rule exempts certain “senior executives,” ie individuals who earn more than $151,164 annually and serve in policy-making positions.
• There is another major exception for non-competes connected with a sale of a business.
• While not explicitly stated, the rule arguably exempts non-profits, tax-exempt hospitals, and other tax-exempt entities.
• Employers must provide verbal and written notice to employees regarding existing agreements, which would be voided under the rule.

The final rule is the latest skirmish in an ongoing, years-long debate. Twelve states have already put non-compete bans in place, according to a recent paper, and they may serve as a harbinger of things to come should the federal ban go into effect. Each state rule varies in its specifics as states respond to local market conditions. While some states ban all non-compete agreements outright, others limit them based on variables, such as income and employment circumstances. Of course, should the federal ban take effect, it will supersede whatever rules the individual states have in place.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

In April, the Federal Trade Commission (FTC), by a vote of 3-2, opened a long-anticipated can of worms by approving its final rule that effectively bans employers’ use of all non-compete agreements (with very limited exceptions). The final rule will not go into effect until 120 days after its publication in the Federal Register, which took place on May 7, and numerous legal challenges appear to be on the horizon.

The principal components of the rule are as follows:

• After the effective date, most non-compete agreements (which prevent departing employees from signing with a new employer for a defined period within a specific geographic area) are banned nationwide.
• The rule exempts certain “senior executives,” ie individuals who earn more than $151,164 annually and serve in policy-making positions.
• There is another major exception for non-competes connected with a sale of a business.
• While not explicitly stated, the rule arguably exempts non-profits, tax-exempt hospitals, and other tax-exempt entities.
• Employers must provide verbal and written notice to employees regarding existing agreements, which would be voided under the rule.

The final rule is the latest skirmish in an ongoing, years-long debate. Twelve states have already put non-compete bans in place, according to a recent paper, and they may serve as a harbinger of things to come should the federal ban go into effect. Each state rule varies in its specifics as states respond to local market conditions. While some states ban all non-compete agreements outright, others limit them based on variables, such as income and employment circumstances. Of course, should the federal ban take effect, it will supersede whatever rules the individual states have in place.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

In April, the Federal Trade Commission (FTC), by a vote of 3-2, opened a long-anticipated can of worms by approving its final rule that effectively bans employers’ use of all non-compete agreements (with very limited exceptions). The final rule will not go into effect until 120 days after its publication in the Federal Register, which took place on May 7, and numerous legal challenges appear to be on the horizon.

The principal components of the rule are as follows:

• After the effective date, most non-compete agreements (which prevent departing employees from signing with a new employer for a defined period within a specific geographic area) are banned nationwide.
• The rule exempts certain “senior executives,” ie individuals who earn more than $151,164 annually and serve in policy-making positions.
• There is another major exception for non-competes connected with a sale of a business.
• While not explicitly stated, the rule arguably exempts non-profits, tax-exempt hospitals, and other tax-exempt entities.
• Employers must provide verbal and written notice to employees regarding existing agreements, which would be voided under the rule.

The final rule is the latest skirmish in an ongoing, years-long debate. Twelve states have already put non-compete bans in place, according to a recent paper, and they may serve as a harbinger of things to come should the federal ban go into effect. Each state rule varies in its specifics as states respond to local market conditions. While some states ban all non-compete agreements outright, others limit them based on variables, such as income and employment circumstances. Of course, should the federal ban take effect, it will supersede whatever rules the individual states have in place.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

Supporters of home phototherapy for patients with plaque and guttate psoriasis had plenty to cheer about at the annual meeting of the American Academy of Dermatology (AAD) in March. There, Joel M. Gelfand, MD, professor of dermatology and epidemiology at the University of Pennsylvania in Philadelphia, presented results from the LITE study, a trial that tested the hypothesis that narrowband ultraviolet B phototherapy of psoriasis at home is noninferior to office treatment, based on outcomes that matter to patients, clinicians, and payers. While smaller studies have drawn similar conclusions, LITE was the largest trial of its kind to show what many dermatologists have suspected for years: Home phototherapy can be an effective first-line treatment for patients with moderate to severe psoriasis.

The co-primary outcomes in the LITE study were a Physician’s Global Assessment (PGA) score of 0/1 (clear, almost clear) and a Dermatology Life Quality Index (DLQI) score of 5 or less (small, no effect on health-related quality of life).

Dr. Gelfand and colleagues at 42 sites in the United States enrolled 783 patients aged 12 years and older who had plaque or guttate psoriasis and were candidates for phototherapy at home or in an office setting. Following 12 weeks of treatment, 25.6% of patients in the office-based phototherapy group achieved a PGA score of 0/1 compared with 32.8% of patients in the home-based phototherapy group (P > .0001 for noninferiority, non-response imputation for missing data). Similarly, 33.6% of patients in the office-based phototherapy group achieved a DLQI score of 5 or less compared with 52.4% of patients in the home-based phototherapy group (P > .0001 for noninferiority, non-response imputation for missing data).

Courtesy Dr. Gelfand

A Safe and Effective Option

“I think that it’s important for physicians, insurance companies, and patients with psoriasis to understand that this is a very safe and effective form of therapy,” Craig A. Elmets, MD, professor of dermatology at The University of Alabama at Birmingham, said in an interview. “For people who are not interested in systemic medications or who have contraindications to systemic medications, phototherapy would be ideal,” added Dr. Elmets, first author of the joint AAD–National Psoriasis Foundation (NPF) guidelines for the management and treatment of psoriasis with phototherapy, published in 2019.

Factors beyond efficacy support the role of home phototherapy, Dr. Gelfand said, including the fact that it costs 10-100 times less than biologics for psoriasis and that office-based phototherapy is not available in 90% of counties in the United States. However, insurance coverage of home phototherapy “is highly variable because until the LITE study, there was no large-scale US data to support its use,” he told this news organization.

“Also, insurance companies are broken up into two parts: Durable medical goods and the medical side such as pharmacy costs, and they are siloed. The durable medical goods side views phototherapy as expensive, while the pharmacy side views it as dirt cheap. This is part of the problem with our health system. A lot of things are siloed and don’t make any sense,” said Dr. Gelfand, director of the Psoriasis and Phototherapy Treatment Center at the University of Pennsylvania. By working with the NPF and payers, he added, “we’re hoping ... to transform the way insurance companies think about covering home phototherapy.”

In the meantime, he and Dr. Elmets shared practical ways to optimize access to home phototherapy for psoriasis patients:

Have the discussion. Patients “rarely bring this up as an option,” Dr. Elmets said, so the onus is on clinicians to talk about it. In his view, the ideal candidate “is averse to using systemic agents but whose disease is beyond the point where topical medicines alone will work. One of the advantages of phototherapy is that it doesn’t have immunosuppressive effects.”

Clinicians and patients can learn about the efficacy and safety of phototherapy for psoriasis, including home-based options, on the NPF’s web site and by reading the 2019 joint AAD-NPF guidelines.

Shared decision-making is key. “When a patient comes in, I’ll discuss what their treatment options are and [we] will decide upon a course of action based on their unique needs and preferences [and] if it’s medically appropriate, meaning they have the type of psoriasis likely to respond to phototherapy,” Dr. Gelfand said. A patient with psoriasis mainly on the fingernails or genitals “is not a good candidate for phototherapy. If it’s on the trunk or extremities, that patient would be a good candidate.”

Home phototherapy candidates also must be willing and able to operate a machine and have dedicated space in their dwelling for it (most units are about the size of a door). Patients also have to be reliable, follow directions, and come back in person for follow-up appointments “so we can assess their response to treatment and fine-tune things as necessary and make sure they’re not developing any skin damage,” Dr. Gelfand said.

Educate yourself about existing options. Home phototherapy units from manufacturers such as Daavlin, National Biological Corporation, and SolRx range between $1200 and $6000 in cost, Dr. Gelfand said. He and his colleagues used the Daavlin 7 series in the LITE study. That unit features an integrated dosimetry system that delivers the correct dose of energy based on parameters that the prescribing clinician recommends. Settings are based on the patient’s skin type and how much the prescriber wants to increase the dose for each treatment. “The machine does the rest,” he said. “It knows what dose to give, so they get the same dosing as they would in an office situation.”

Smaller home-based phototherapy units designed to treat the hands and feet are available. So are handheld units to treat the scalp. “These can be a nice option for patients who have a few spots, but if the disease is moderate to severe, then it’s going to be pretty laborious to [use them],” Dr. Elmets said.

Remember that phototherapy is not a cure-all. According to the joint AAD-NPF guidelines, most phototherapy regimens require treatments two to three times per week for 10-14 weeks. Once patients achieve their home phototherapy treatment goal, Dr. Elmets often recommends treatments one to two times per week for maintenance.

“Patients with psoriasis have a lifetime condition,” he noted. “There are certainly cases where people have gone on phototherapy, cleared, and then stopped for a period of time. If they flare up, they can always go back to phototherapy. Usually, people who are on phototherapy use some type of topical agents to touch up areas that are resistant.”

Expect pushback from insurers on coverage. While Medicare and some integrated health plans cover home phototherapy, expect to spend time writing letters or placing phone calls to insurance companies to convince them why they should cover home phototherapy for candidate psoriasis patients. “Usually there’s a lot of letter writing and a long delay in getting approval,” Dr. Elmets said.

Dr. Elmets and Dr. Gelfand reported no relevant financial relationships. The LITE study was funded by the Patient-Centered Outcomes Research Institute. Research partners included the National Psoriasis Foundation and Daavlin, which provided the home phototherapy machines and covered the cost of shipping the devices.

A version of this article appeared on Medscape.com.

Supporters of home phototherapy for patients with plaque and guttate psoriasis had plenty to cheer about at the annual meeting of the American Academy of Dermatology (AAD) in March. There, Joel M. Gelfand, MD, professor of dermatology and epidemiology at the University of Pennsylvania in Philadelphia, presented results from the LITE study, a trial that tested the hypothesis that narrowband ultraviolet B phototherapy of psoriasis at home is noninferior to office treatment, based on outcomes that matter to patients, clinicians, and payers. While smaller studies have drawn similar conclusions, LITE was the largest trial of its kind to show what many dermatologists have suspected for years: Home phototherapy can be an effective first-line treatment for patients with moderate to severe psoriasis.

The co-primary outcomes in the LITE study were a Physician’s Global Assessment (PGA) score of 0/1 (clear, almost clear) and a Dermatology Life Quality Index (DLQI) score of 5 or less (small, no effect on health-related quality of life).

Dr. Gelfand and colleagues at 42 sites in the United States enrolled 783 patients aged 12 years and older who had plaque or guttate psoriasis and were candidates for phototherapy at home or in an office setting. Following 12 weeks of treatment, 25.6% of patients in the office-based phototherapy group achieved a PGA score of 0/1 compared with 32.8% of patients in the home-based phototherapy group (P > .0001 for noninferiority, non-response imputation for missing data). Similarly, 33.6% of patients in the office-based phototherapy group achieved a DLQI score of 5 or less compared with 52.4% of patients in the home-based phototherapy group (P > .0001 for noninferiority, non-response imputation for missing data).

Courtesy Dr. Gelfand

A Safe and Effective Option

“I think that it’s important for physicians, insurance companies, and patients with psoriasis to understand that this is a very safe and effective form of therapy,” Craig A. Elmets, MD, professor of dermatology at The University of Alabama at Birmingham, said in an interview. “For people who are not interested in systemic medications or who have contraindications to systemic medications, phototherapy would be ideal,” added Dr. Elmets, first author of the joint AAD–National Psoriasis Foundation (NPF) guidelines for the management and treatment of psoriasis with phototherapy, published in 2019.

Factors beyond efficacy support the role of home phototherapy, Dr. Gelfand said, including the fact that it costs 10-100 times less than biologics for psoriasis and that office-based phototherapy is not available in 90% of counties in the United States. However, insurance coverage of home phototherapy “is highly variable because until the LITE study, there was no large-scale US data to support its use,” he told this news organization.

“Also, insurance companies are broken up into two parts: Durable medical goods and the medical side such as pharmacy costs, and they are siloed. The durable medical goods side views phototherapy as expensive, while the pharmacy side views it as dirt cheap. This is part of the problem with our health system. A lot of things are siloed and don’t make any sense,” said Dr. Gelfand, director of the Psoriasis and Phototherapy Treatment Center at the University of Pennsylvania. By working with the NPF and payers, he added, “we’re hoping ... to transform the way insurance companies think about covering home phototherapy.”

In the meantime, he and Dr. Elmets shared practical ways to optimize access to home phototherapy for psoriasis patients:

Have the discussion. Patients “rarely bring this up as an option,” Dr. Elmets said, so the onus is on clinicians to talk about it. In his view, the ideal candidate “is averse to using systemic agents but whose disease is beyond the point where topical medicines alone will work. One of the advantages of phototherapy is that it doesn’t have immunosuppressive effects.”

Clinicians and patients can learn about the efficacy and safety of phototherapy for psoriasis, including home-based options, on the NPF’s web site and by reading the 2019 joint AAD-NPF guidelines.

Shared decision-making is key. “When a patient comes in, I’ll discuss what their treatment options are and [we] will decide upon a course of action based on their unique needs and preferences [and] if it’s medically appropriate, meaning they have the type of psoriasis likely to respond to phototherapy,” Dr. Gelfand said. A patient with psoriasis mainly on the fingernails or genitals “is not a good candidate for phototherapy. If it’s on the trunk or extremities, that patient would be a good candidate.”

Home phototherapy candidates also must be willing and able to operate a machine and have dedicated space in their dwelling for it (most units are about the size of a door). Patients also have to be reliable, follow directions, and come back in person for follow-up appointments “so we can assess their response to treatment and fine-tune things as necessary and make sure they’re not developing any skin damage,” Dr. Gelfand said.

Educate yourself about existing options. Home phototherapy units from manufacturers such as Daavlin, National Biological Corporation, and SolRx range between $1200 and $6000 in cost, Dr. Gelfand said. He and his colleagues used the Daavlin 7 series in the LITE study. That unit features an integrated dosimetry system that delivers the correct dose of energy based on parameters that the prescribing clinician recommends. Settings are based on the patient’s skin type and how much the prescriber wants to increase the dose for each treatment. “The machine does the rest,” he said. “It knows what dose to give, so they get the same dosing as they would in an office situation.”

Smaller home-based phototherapy units designed to treat the hands and feet are available. So are handheld units to treat the scalp. “These can be a nice option for patients who have a few spots, but if the disease is moderate to severe, then it’s going to be pretty laborious to [use them],” Dr. Elmets said.

Remember that phototherapy is not a cure-all. According to the joint AAD-NPF guidelines, most phototherapy regimens require treatments two to three times per week for 10-14 weeks. Once patients achieve their home phototherapy treatment goal, Dr. Elmets often recommends treatments one to two times per week for maintenance.

“Patients with psoriasis have a lifetime condition,” he noted. “There are certainly cases where people have gone on phototherapy, cleared, and then stopped for a period of time. If they flare up, they can always go back to phototherapy. Usually, people who are on phototherapy use some type of topical agents to touch up areas that are resistant.”

Expect pushback from insurers on coverage. While Medicare and some integrated health plans cover home phototherapy, expect to spend time writing letters or placing phone calls to insurance companies to convince them why they should cover home phototherapy for candidate psoriasis patients. “Usually there’s a lot of letter writing and a long delay in getting approval,” Dr. Elmets said.

Dr. Elmets and Dr. Gelfand reported no relevant financial relationships. The LITE study was funded by the Patient-Centered Outcomes Research Institute. Research partners included the National Psoriasis Foundation and Daavlin, which provided the home phototherapy machines and covered the cost of shipping the devices.

A version of this article appeared on Medscape.com.

Supporters of home phototherapy for patients with plaque and guttate psoriasis had plenty to cheer about at the annual meeting of the American Academy of Dermatology (AAD) in March. There, Joel M. Gelfand, MD, professor of dermatology and epidemiology at the University of Pennsylvania in Philadelphia, presented results from the LITE study, a trial that tested the hypothesis that narrowband ultraviolet B phototherapy of psoriasis at home is noninferior to office treatment, based on outcomes that matter to patients, clinicians, and payers. While smaller studies have drawn similar conclusions, LITE was the largest trial of its kind to show what many dermatologists have suspected for years: Home phototherapy can be an effective first-line treatment for patients with moderate to severe psoriasis.

The co-primary outcomes in the LITE study were a Physician’s Global Assessment (PGA) score of 0/1 (clear, almost clear) and a Dermatology Life Quality Index (DLQI) score of 5 or less (small, no effect on health-related quality of life).

Dr. Gelfand and colleagues at 42 sites in the United States enrolled 783 patients aged 12 years and older who had plaque or guttate psoriasis and were candidates for phototherapy at home or in an office setting. Following 12 weeks of treatment, 25.6% of patients in the office-based phototherapy group achieved a PGA score of 0/1 compared with 32.8% of patients in the home-based phototherapy group (P > .0001 for noninferiority, non-response imputation for missing data). Similarly, 33.6% of patients in the office-based phototherapy group achieved a DLQI score of 5 or less compared with 52.4% of patients in the home-based phototherapy group (P > .0001 for noninferiority, non-response imputation for missing data).

Courtesy Dr. Gelfand

A Safe and Effective Option

“I think that it’s important for physicians, insurance companies, and patients with psoriasis to understand that this is a very safe and effective form of therapy,” Craig A. Elmets, MD, professor of dermatology at The University of Alabama at Birmingham, said in an interview. “For people who are not interested in systemic medications or who have contraindications to systemic medications, phototherapy would be ideal,” added Dr. Elmets, first author of the joint AAD–National Psoriasis Foundation (NPF) guidelines for the management and treatment of psoriasis with phototherapy, published in 2019.

Factors beyond efficacy support the role of home phototherapy, Dr. Gelfand said, including the fact that it costs 10-100 times less than biologics for psoriasis and that office-based phototherapy is not available in 90% of counties in the United States. However, insurance coverage of home phototherapy “is highly variable because until the LITE study, there was no large-scale US data to support its use,” he told this news organization.

“Also, insurance companies are broken up into two parts: Durable medical goods and the medical side such as pharmacy costs, and they are siloed. The durable medical goods side views phototherapy as expensive, while the pharmacy side views it as dirt cheap. This is part of the problem with our health system. A lot of things are siloed and don’t make any sense,” said Dr. Gelfand, director of the Psoriasis and Phototherapy Treatment Center at the University of Pennsylvania. By working with the NPF and payers, he added, “we’re hoping ... to transform the way insurance companies think about covering home phototherapy.”

In the meantime, he and Dr. Elmets shared practical ways to optimize access to home phototherapy for psoriasis patients:

Have the discussion. Patients “rarely bring this up as an option,” Dr. Elmets said, so the onus is on clinicians to talk about it. In his view, the ideal candidate “is averse to using systemic agents but whose disease is beyond the point where topical medicines alone will work. One of the advantages of phototherapy is that it doesn’t have immunosuppressive effects.”

Clinicians and patients can learn about the efficacy and safety of phototherapy for psoriasis, including home-based options, on the NPF’s web site and by reading the 2019 joint AAD-NPF guidelines.

Shared decision-making is key. “When a patient comes in, I’ll discuss what their treatment options are and [we] will decide upon a course of action based on their unique needs and preferences [and] if it’s medically appropriate, meaning they have the type of psoriasis likely to respond to phototherapy,” Dr. Gelfand said. A patient with psoriasis mainly on the fingernails or genitals “is not a good candidate for phototherapy. If it’s on the trunk or extremities, that patient would be a good candidate.”

Home phototherapy candidates also must be willing and able to operate a machine and have dedicated space in their dwelling for it (most units are about the size of a door). Patients also have to be reliable, follow directions, and come back in person for follow-up appointments “so we can assess their response to treatment and fine-tune things as necessary and make sure they’re not developing any skin damage,” Dr. Gelfand said.

Educate yourself about existing options. Home phototherapy units from manufacturers such as Daavlin, National Biological Corporation, and SolRx range between $1200 and $6000 in cost, Dr. Gelfand said. He and his colleagues used the Daavlin 7 series in the LITE study. That unit features an integrated dosimetry system that delivers the correct dose of energy based on parameters that the prescribing clinician recommends. Settings are based on the patient’s skin type and how much the prescriber wants to increase the dose for each treatment. “The machine does the rest,” he said. “It knows what dose to give, so they get the same dosing as they would in an office situation.”

Smaller home-based phototherapy units designed to treat the hands and feet are available. So are handheld units to treat the scalp. “These can be a nice option for patients who have a few spots, but if the disease is moderate to severe, then it’s going to be pretty laborious to [use them],” Dr. Elmets said.

Remember that phototherapy is not a cure-all. According to the joint AAD-NPF guidelines, most phototherapy regimens require treatments two to three times per week for 10-14 weeks. Once patients achieve their home phototherapy treatment goal, Dr. Elmets often recommends treatments one to two times per week for maintenance.

“Patients with psoriasis have a lifetime condition,” he noted. “There are certainly cases where people have gone on phototherapy, cleared, and then stopped for a period of time. If they flare up, they can always go back to phototherapy. Usually, people who are on phototherapy use some type of topical agents to touch up areas that are resistant.”

Expect pushback from insurers on coverage. While Medicare and some integrated health plans cover home phototherapy, expect to spend time writing letters or placing phone calls to insurance companies to convince them why they should cover home phototherapy for candidate psoriasis patients. “Usually there’s a lot of letter writing and a long delay in getting approval,” Dr. Elmets said.

Dr. Elmets and Dr. Gelfand reported no relevant financial relationships. The LITE study was funded by the Patient-Centered Outcomes Research Institute. Research partners included the National Psoriasis Foundation and Daavlin, which provided the home phototherapy machines and covered the cost of shipping the devices.

A version of this article appeared on Medscape.com.

Older patients prescribed hydroxychloroquine (HCQ) have a higher risk of developing retinal damage from taking the medication, according to a new analysis.

In addition to known risk factors such as a higher weight-based HCQ dose and higher cumulative dose, researchers also found that female sex, chronic kidney disease stage III, and tamoxifen use were associated with HCQ retinopathy.

The findings provide “evidence for other key risk factors for hydroxychloroquine retinopathy beyond hydroxychloroquine exposure itself,” wrote April M. Jorge, MD, of the Division of Rheumatology, Allergy, and Immunology at Massachusetts General Hospital, Boston, and colleagues.

Baylor College of Medicine

Study Details

Researchers identified patients in the Kaiser Permanente Northern California (KPNC), Oakland, California, health system who began taking HCQ between July 1, 1997, and December 14, 2014. To be included, patients needed to have at least 5 years of continuous enrollment in the KPNC system and at least one prescription for HCQ after more than 5 years of starting the drug. Patients were followed from HCQ initiation to their last retinopathy screening study, up to December 31, 2020.

The study was published May 9 in JAMA Network Open.

Of the 4677 users followed for the study, 83% were women, and the average age starting HCQ was 52. Most patients were White (58.1%), while 13.7% were Asian, 10.5% were Black, and 17.7% were Hispanic.

More than 60% of patients had an initial dose > 5 mg/kg/d, though the mean initial dose of HCQ was 4.4 mg/kg/d. After 5 years, only 34.4% of patients were using a daily dose over 5 mg/kg.

Of the entire cohort, 125 patients (2.7%) developed HCQ retinopathy. As expected, cumulative HCQ exposure was associated with a higher retinopathy risk: For every 100 g of HCQ cumulative exposure, risk rose by 64% (hazard ratio [HR], 1.64; 95% CI, 1.44-1.87).

Age was a significant risk factor for retinal damage from HCQ use. Individuals who began taking the drug at 65 years or older were nearly six times more likely to develop retinopathy than those who started HCQ when they were younger than 45. In people aged 55-64 years, this risk was nearly four times higher, and individuals aged 45-54 years when starting the drug were 2.5 times more likely to have retinal damage than those younger than 45.

Other risk factors were female sex (HR, 3.83; 95% CI, 1.86-7.89), chronic kidney disease stage III (HR, 1.95; 95% CI, 1.25-3.04), and tamoxifen use (HR, 3.43; 95% CI, 1.08-10.89), although only 17 patients were taking tamoxifen during the study.

Researchers also found that the type of HCQ retinopathy varied by race. Of the 125 cases in the cohort, 102 had a parafoveal pattern, and 23 had a pericentral pattern. Asian individuals were 15 times more likely, and Black individuals were more than 5 times more likely to develop this pericentral type than were White patients.

This association in Asian patients has also been found in previous studies, Dr. Weng said, and many eye practices now screen their Asian patients with a 30-2 Humphrey visual field — rather than the more commonly used 10-2 — to examine areas farther outside the center.

This study also found this association in Black patients, though only five Black patients developed HCQ retinopathy over the study period.

“More studies and larger studies will be very helpful in strengthening or dispelling some of the associations that have been seen here,” Dr. Weng said.
 

‘More Room for Personalized Medicine’

The team found a “relatively linear” relationship between HCQ dose and retinopathy risk, with higher daily doses correlating with higher incidence. While 2016 guidelines from the American Academy of Ophthalmology advise using < 5 mg/kg, “what we found is it’s not that straightforward [where there’s] just this one cutoff,” Dr. Jorge told this news organization. “It does seem like the higher the dose of medication per bodyweight and the longer duration of use, there is a higher risk of retinopathy.”

These findings leave “a bit more room for personalized medicine” with patients, she explained. “For an elderly female patient with CKD, aiming for a dose < 5 mg/kg might be more appropriate; however, a young male patient without any additional risk factors may be able to exceed 5 mg/kg and continue to have a low risk for HCQ retinopathy,” she said.

“For anyone, I think it really is more of an individual risk-benefit evaluation,” rather than strict cutoffs, she continued.

“Guidelines are just that: They’re guidelines,” added Dr. Weng, “and treatment plans should be tailored to each individual patient.”

As the study authors also discussed, “the goal is to treat the patient with the lowest dose that is still effective and also be mindful of the duration that a patient is left at higher doses,” Dr. Weng said. “But ultimately, we need to control these diseases, which can cause damage across multiple organ systems in the body. While it’s important to be aware of the potential retinopathy adverse events, we also don’t want physicians to feel restricted in their use of this very effective drug.”

The work of three coauthors on the current study was supported by a grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). Dr. Jorge’s work on the study was supported by an award from the Rheumatology Research Foundation and a grant from NIAMS. Dr. Jorge reported clinical trial agreements with Bristol Myers Squibb and Cabaletta Bio outside of this study. Dr. Weng has served as a consultant for Allergan/AbbVie, Alcon, Apellis Pharmaceuticals, Alimera Sciences, DORC, Novartis, Genentech, Regeneron, RegenxBio, Iveric Bio, and EyePoint Pharmaceuticals. Dr. Weng disclosed financial relationships with Springer Publishers (royalties) and DRCR Retina Network, Alimera Sciences, and Applied Genetic Technologies Corporation (research).

A version of this article appeared on Medscape.com.

Older patients prescribed hydroxychloroquine (HCQ) have a higher risk of developing retinal damage from taking the medication, according to a new analysis.

In addition to known risk factors such as a higher weight-based HCQ dose and higher cumulative dose, researchers also found that female sex, chronic kidney disease stage III, and tamoxifen use were associated with HCQ retinopathy.

The findings provide “evidence for other key risk factors for hydroxychloroquine retinopathy beyond hydroxychloroquine exposure itself,” wrote April M. Jorge, MD, of the Division of Rheumatology, Allergy, and Immunology at Massachusetts General Hospital, Boston, and colleagues.

Baylor College of Medicine

Study Details

Researchers identified patients in the Kaiser Permanente Northern California (KPNC), Oakland, California, health system who began taking HCQ between July 1, 1997, and December 14, 2014. To be included, patients needed to have at least 5 years of continuous enrollment in the KPNC system and at least one prescription for HCQ after more than 5 years of starting the drug. Patients were followed from HCQ initiation to their last retinopathy screening study, up to December 31, 2020.

The study was published May 9 in JAMA Network Open.

Of the 4677 users followed for the study, 83% were women, and the average age starting HCQ was 52. Most patients were White (58.1%), while 13.7% were Asian, 10.5% were Black, and 17.7% were Hispanic.

More than 60% of patients had an initial dose > 5 mg/kg/d, though the mean initial dose of HCQ was 4.4 mg/kg/d. After 5 years, only 34.4% of patients were using a daily dose over 5 mg/kg.

Of the entire cohort, 125 patients (2.7%) developed HCQ retinopathy. As expected, cumulative HCQ exposure was associated with a higher retinopathy risk: For every 100 g of HCQ cumulative exposure, risk rose by 64% (hazard ratio [HR], 1.64; 95% CI, 1.44-1.87).

Age was a significant risk factor for retinal damage from HCQ use. Individuals who began taking the drug at 65 years or older were nearly six times more likely to develop retinopathy than those who started HCQ when they were younger than 45. In people aged 55-64 years, this risk was nearly four times higher, and individuals aged 45-54 years when starting the drug were 2.5 times more likely to have retinal damage than those younger than 45.

Other risk factors were female sex (HR, 3.83; 95% CI, 1.86-7.89), chronic kidney disease stage III (HR, 1.95; 95% CI, 1.25-3.04), and tamoxifen use (HR, 3.43; 95% CI, 1.08-10.89), although only 17 patients were taking tamoxifen during the study.

Researchers also found that the type of HCQ retinopathy varied by race. Of the 125 cases in the cohort, 102 had a parafoveal pattern, and 23 had a pericentral pattern. Asian individuals were 15 times more likely, and Black individuals were more than 5 times more likely to develop this pericentral type than were White patients.

This association in Asian patients has also been found in previous studies, Dr. Weng said, and many eye practices now screen their Asian patients with a 30-2 Humphrey visual field — rather than the more commonly used 10-2 — to examine areas farther outside the center.

This study also found this association in Black patients, though only five Black patients developed HCQ retinopathy over the study period.

“More studies and larger studies will be very helpful in strengthening or dispelling some of the associations that have been seen here,” Dr. Weng said.
 

‘More Room for Personalized Medicine’

The team found a “relatively linear” relationship between HCQ dose and retinopathy risk, with higher daily doses correlating with higher incidence. While 2016 guidelines from the American Academy of Ophthalmology advise using < 5 mg/kg, “what we found is it’s not that straightforward [where there’s] just this one cutoff,” Dr. Jorge told this news organization. “It does seem like the higher the dose of medication per bodyweight and the longer duration of use, there is a higher risk of retinopathy.”

These findings leave “a bit more room for personalized medicine” with patients, she explained. “For an elderly female patient with CKD, aiming for a dose < 5 mg/kg might be more appropriate; however, a young male patient without any additional risk factors may be able to exceed 5 mg/kg and continue to have a low risk for HCQ retinopathy,” she said.

“For anyone, I think it really is more of an individual risk-benefit evaluation,” rather than strict cutoffs, she continued.

“Guidelines are just that: They’re guidelines,” added Dr. Weng, “and treatment plans should be tailored to each individual patient.”

As the study authors also discussed, “the goal is to treat the patient with the lowest dose that is still effective and also be mindful of the duration that a patient is left at higher doses,” Dr. Weng said. “But ultimately, we need to control these diseases, which can cause damage across multiple organ systems in the body. While it’s important to be aware of the potential retinopathy adverse events, we also don’t want physicians to feel restricted in their use of this very effective drug.”

The work of three coauthors on the current study was supported by a grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). Dr. Jorge’s work on the study was supported by an award from the Rheumatology Research Foundation and a grant from NIAMS. Dr. Jorge reported clinical trial agreements with Bristol Myers Squibb and Cabaletta Bio outside of this study. Dr. Weng has served as a consultant for Allergan/AbbVie, Alcon, Apellis Pharmaceuticals, Alimera Sciences, DORC, Novartis, Genentech, Regeneron, RegenxBio, Iveric Bio, and EyePoint Pharmaceuticals. Dr. Weng disclosed financial relationships with Springer Publishers (royalties) and DRCR Retina Network, Alimera Sciences, and Applied Genetic Technologies Corporation (research).

A version of this article appeared on Medscape.com.

Older patients prescribed hydroxychloroquine (HCQ) have a higher risk of developing retinal damage from taking the medication, according to a new analysis.

In addition to known risk factors such as a higher weight-based HCQ dose and higher cumulative dose, researchers also found that female sex, chronic kidney disease stage III, and tamoxifen use were associated with HCQ retinopathy.

The findings provide “evidence for other key risk factors for hydroxychloroquine retinopathy beyond hydroxychloroquine exposure itself,” wrote April M. Jorge, MD, of the Division of Rheumatology, Allergy, and Immunology at Massachusetts General Hospital, Boston, and colleagues.

Baylor College of Medicine

Study Details

Researchers identified patients in the Kaiser Permanente Northern California (KPNC), Oakland, California, health system who began taking HCQ between July 1, 1997, and December 14, 2014. To be included, patients needed to have at least 5 years of continuous enrollment in the KPNC system and at least one prescription for HCQ after more than 5 years of starting the drug. Patients were followed from HCQ initiation to their last retinopathy screening study, up to December 31, 2020.

The study was published May 9 in JAMA Network Open.

Of the 4677 users followed for the study, 83% were women, and the average age starting HCQ was 52. Most patients were White (58.1%), while 13.7% were Asian, 10.5% were Black, and 17.7% were Hispanic.

More than 60% of patients had an initial dose > 5 mg/kg/d, though the mean initial dose of HCQ was 4.4 mg/kg/d. After 5 years, only 34.4% of patients were using a daily dose over 5 mg/kg.

Of the entire cohort, 125 patients (2.7%) developed HCQ retinopathy. As expected, cumulative HCQ exposure was associated with a higher retinopathy risk: For every 100 g of HCQ cumulative exposure, risk rose by 64% (hazard ratio [HR], 1.64; 95% CI, 1.44-1.87).

Age was a significant risk factor for retinal damage from HCQ use. Individuals who began taking the drug at 65 years or older were nearly six times more likely to develop retinopathy than those who started HCQ when they were younger than 45. In people aged 55-64 years, this risk was nearly four times higher, and individuals aged 45-54 years when starting the drug were 2.5 times more likely to have retinal damage than those younger than 45.

Other risk factors were female sex (HR, 3.83; 95% CI, 1.86-7.89), chronic kidney disease stage III (HR, 1.95; 95% CI, 1.25-3.04), and tamoxifen use (HR, 3.43; 95% CI, 1.08-10.89), although only 17 patients were taking tamoxifen during the study.

Researchers also found that the type of HCQ retinopathy varied by race. Of the 125 cases in the cohort, 102 had a parafoveal pattern, and 23 had a pericentral pattern. Asian individuals were 15 times more likely, and Black individuals were more than 5 times more likely to develop this pericentral type than were White patients.

This association in Asian patients has also been found in previous studies, Dr. Weng said, and many eye practices now screen their Asian patients with a 30-2 Humphrey visual field — rather than the more commonly used 10-2 — to examine areas farther outside the center.

This study also found this association in Black patients, though only five Black patients developed HCQ retinopathy over the study period.

“More studies and larger studies will be very helpful in strengthening or dispelling some of the associations that have been seen here,” Dr. Weng said.
 

‘More Room for Personalized Medicine’

The team found a “relatively linear” relationship between HCQ dose and retinopathy risk, with higher daily doses correlating with higher incidence. While 2016 guidelines from the American Academy of Ophthalmology advise using < 5 mg/kg, “what we found is it’s not that straightforward [where there’s] just this one cutoff,” Dr. Jorge told this news organization. “It does seem like the higher the dose of medication per bodyweight and the longer duration of use, there is a higher risk of retinopathy.”

These findings leave “a bit more room for personalized medicine” with patients, she explained. “For an elderly female patient with CKD, aiming for a dose < 5 mg/kg might be more appropriate; however, a young male patient without any additional risk factors may be able to exceed 5 mg/kg and continue to have a low risk for HCQ retinopathy,” she said.

“For anyone, I think it really is more of an individual risk-benefit evaluation,” rather than strict cutoffs, she continued.

“Guidelines are just that: They’re guidelines,” added Dr. Weng, “and treatment plans should be tailored to each individual patient.”

As the study authors also discussed, “the goal is to treat the patient with the lowest dose that is still effective and also be mindful of the duration that a patient is left at higher doses,” Dr. Weng said. “But ultimately, we need to control these diseases, which can cause damage across multiple organ systems in the body. While it’s important to be aware of the potential retinopathy adverse events, we also don’t want physicians to feel restricted in their use of this very effective drug.”

The work of three coauthors on the current study was supported by a grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). Dr. Jorge’s work on the study was supported by an award from the Rheumatology Research Foundation and a grant from NIAMS. Dr. Jorge reported clinical trial agreements with Bristol Myers Squibb and Cabaletta Bio outside of this study. Dr. Weng has served as a consultant for Allergan/AbbVie, Alcon, Apellis Pharmaceuticals, Alimera Sciences, DORC, Novartis, Genentech, Regeneron, RegenxBio, Iveric Bio, and EyePoint Pharmaceuticals. Dr. Weng disclosed financial relationships with Springer Publishers (royalties) and DRCR Retina Network, Alimera Sciences, and Applied Genetic Technologies Corporation (research).

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved Benlysta (belimumab) autoinjector for patients aged 5 years or older with active systemic lupus erythematosus (SLE) on standard therapy. This is the first time that children with SLE can receive this treatment at home, according to a GSK press release.

Prior to this approval, pediatric patients aged 5 years or older could receive belimumab only intravenously via a 1-hour infusion in a hospital or clinic setting.

Wikimedia Commons/FitzColinGerald/Creative Commons License

“Going to the doctor’s office once every 4 weeks can be a logistical hurdle for some children and their caregivers, so having the option to administer Benlysta in the comfort of their home provides much-needed flexibility,” Mary Crimmings, the interim CEO and senior vice president for marketing and communications at the Lupus Foundation of America, said in a statement. 

An estimated 5000-10,000 children in the United States are living with SLE.

Belimumab is a B-lymphocyte stimulator–specific inhibitor approved for the treatment of active SLE and active lupus nephritis in patients aged 5 years or older receiving standard therapy. This approval of the subcutaneous administration of belimumab applies only to pediatric patients with SLE.

The 200-mg injection can be administered once every week for children who weigh ≥ 40 kg and should be given once every 2 weeks for children weighing between 15 and 40 kg. 

The autoinjector “will be available immediately” for caregivers, the company announcement said.

“Patients are our top priority, and we are always working to innovate solutions that can improve lives and address unmet needs,” Court Horncastle, senior vice president and head of US specialty at GSK, said in the press release. “This approval for an at-home treatment is the first and only of its kind for children with lupus and is a testament to our continued commitment to the lupus community.”

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved Benlysta (belimumab) autoinjector for patients aged 5 years or older with active systemic lupus erythematosus (SLE) on standard therapy. This is the first time that children with SLE can receive this treatment at home, according to a GSK press release.

Prior to this approval, pediatric patients aged 5 years or older could receive belimumab only intravenously via a 1-hour infusion in a hospital or clinic setting.

Wikimedia Commons/FitzColinGerald/Creative Commons License

“Going to the doctor’s office once every 4 weeks can be a logistical hurdle for some children and their caregivers, so having the option to administer Benlysta in the comfort of their home provides much-needed flexibility,” Mary Crimmings, the interim CEO and senior vice president for marketing and communications at the Lupus Foundation of America, said in a statement. 

An estimated 5000-10,000 children in the United States are living with SLE.

Belimumab is a B-lymphocyte stimulator–specific inhibitor approved for the treatment of active SLE and active lupus nephritis in patients aged 5 years or older receiving standard therapy. This approval of the subcutaneous administration of belimumab applies only to pediatric patients with SLE.

The 200-mg injection can be administered once every week for children who weigh ≥ 40 kg and should be given once every 2 weeks for children weighing between 15 and 40 kg. 

The autoinjector “will be available immediately” for caregivers, the company announcement said.

“Patients are our top priority, and we are always working to innovate solutions that can improve lives and address unmet needs,” Court Horncastle, senior vice president and head of US specialty at GSK, said in the press release. “This approval for an at-home treatment is the first and only of its kind for children with lupus and is a testament to our continued commitment to the lupus community.”

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved Benlysta (belimumab) autoinjector for patients aged 5 years or older with active systemic lupus erythematosus (SLE) on standard therapy. This is the first time that children with SLE can receive this treatment at home, according to a GSK press release.

Prior to this approval, pediatric patients aged 5 years or older could receive belimumab only intravenously via a 1-hour infusion in a hospital or clinic setting.

Wikimedia Commons/FitzColinGerald/Creative Commons License

“Going to the doctor’s office once every 4 weeks can be a logistical hurdle for some children and their caregivers, so having the option to administer Benlysta in the comfort of their home provides much-needed flexibility,” Mary Crimmings, the interim CEO and senior vice president for marketing and communications at the Lupus Foundation of America, said in a statement. 

An estimated 5000-10,000 children in the United States are living with SLE.

Belimumab is a B-lymphocyte stimulator–specific inhibitor approved for the treatment of active SLE and active lupus nephritis in patients aged 5 years or older receiving standard therapy. This approval of the subcutaneous administration of belimumab applies only to pediatric patients with SLE.

The 200-mg injection can be administered once every week for children who weigh ≥ 40 kg and should be given once every 2 weeks for children weighing between 15 and 40 kg. 

The autoinjector “will be available immediately” for caregivers, the company announcement said.

“Patients are our top priority, and we are always working to innovate solutions that can improve lives and address unmet needs,” Court Horncastle, senior vice president and head of US specialty at GSK, said in the press release. “This approval for an at-home treatment is the first and only of its kind for children with lupus and is a testament to our continued commitment to the lupus community.”

A version of this article appeared on Medscape.com.

Patients with metastatic or advanced cancer treated in practices that have high rates of giving systemic care in the last two weeks of life do not have longer survival rates than patients in practices that have low rates of such care.

This conclusion of a new study published online May 16 in JAMA Oncology may help reassure oncologists that giving systemic anticancer therapy (SACT) at the most advanced stages of cancer will not improve the patient’s life, the authors wrote. It also may encourage them to instead focus more on honest communication with patients about their choices, Maureen E. Canavan, PhD, at the Cancer and Outcomes, Public Policy and Effectiveness Research (COPPER) Center at the Yale School of Medicine in New Haven, Connecticut, and colleagues, wrote in their paper.
 

How Was the Study Conducted?

Researchers used Flatiron Health, a nationwide electronic health records database of academic and community practices throughout the United State. They identified 78,446 adults with advanced or metastatic stages of one of six common cancers (breast, colorectal, urothelial, non–small cell lung cancer [NSCLC], pancreatic and renal cell carcinoma) who were treated at healthcare practices from 2015 to 2019. They then stratified practices into quintiles based on how often the practices treated patients with any systemic therapy, including chemotherapy and immunotherapy, in their last 14 days of life. They compared whether patients in practices with greater use of systemic treatment at very advanced stages had longer overall survival.

What Were the Main Findings?

“We saw that there were absolutely no survival differences between the practices that used more systemic therapy for very advanced cancer than the practices that use less,” said senior author Kerin Adelson, MD, chief quality and value officer at MD Anderson Cancer Center in Houston, Texas. In some cancers, those in the lowest quintile (those with the lowest rates of systemic end-of-life care) lived fewer years compared with those in the highest quintiles. In other cancers, those in the lowest quintiles lived more years than those in the highest quintiles.

“What’s important is that none of those differences, after you control for other factors, was statistically significant,” Dr. Adelson said. “That was the same in every cancer type we looked at.”

An example is seen in advanced urothelial cancer. Those in the first quintile (lowest rates of systemic care at end of life) had an SACT rate range of 4.0-9.1. The SACT rate range in the highest quintile was 19.8-42.6. But the median overall survival (OS) rate for those in the lowest quintile was 12.7 months, not statistically different from the median OS in the highest quintile (11 months.)
 

How Does This Study Add to the Literature?

The American Society of Clinical Oncology (ASCO) and the National Quality Forum (NQF) developed a cancer quality metric to reduce SACT at the end of life. The NQF 0210 is a ratio of patients who get systemic treatment within 14 days of death over all patients who die of cancer. The quality metric has been widely adopted and used in value-based care reporting.

But the metric has been criticized because it focuses only on people who died and not people who lived longer because they benefited from the systemic therapy, the authors wrote.

Dr. Canavan’s team focused on all patients treated in the practice, not just those who died, Dr. Adelson said. This may put that criticism to rest, Dr. Adelson said.

“I personally believed the ASCO and NQF metric was appropriate and the criticisms were off base,” said Otis Brawley, MD, associate director of community outreach and engagement at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University School of Medicine in Baltimore. “Canavan’s study is evidence suggesting the metrics were appropriate.”

This study included not just chemotherapy, as some other studies have, but targeted therapies and immunotherapies as well. Dr. Adelson said some think that the newer drugs might change the prognosis at end of life. But this study shows “even those drugs are not helping patients to survive with very advanced cancer,” she said.

 

Could This Change Practice?

The authors noted that end-of life SACT has been linked with more acute care use, delays in conversations about care goals, late enrollment in hospice, higher costs, and potentially shorter and poorer quality life.

Dr. Adelson said she’s hoping that the knowledge that there’s no survival benefit for use of SACT for patients with advanced solid tumors who are nearing the end of life will lead instead to more conversations about prognosis with patients and transitions to palliative care.

“Palliative care has actually been shown to improve quality of life and, in some studies, even survival,” she said.

“I doubt it will change practice, but it should,” Dr. Brawley said. “The study suggests that doctors and patients have too much hope for chemotherapy as patients’ disease progresses. In the US especially, there is a tendency to believe we have better therapies than we truly do and we have difficulty accepting that the patient is dying. Many patients get third- and fourth-line chemotherapy that is highly likely to increase suffering without realistic hope of prolonging life and especially no hope of prolonging life with good quality.”

Dr. Adelson disclosed ties with AbbVie, Quantum Health, Gilead, ParetoHealth, and Carrum Health. Various coauthors disclosed ties with Roche, AbbVie, Johnson & Johnson, Genentech, the National Comprehensive Cancer Network, and AstraZeneca. The study was funded by Flatiron Health, an independent member of the Roche group. Dr. Brawley reports no relevant financial disclosures.

Patients with metastatic or advanced cancer treated in practices that have high rates of giving systemic care in the last two weeks of life do not have longer survival rates than patients in practices that have low rates of such care.

This conclusion of a new study published online May 16 in JAMA Oncology may help reassure oncologists that giving systemic anticancer therapy (SACT) at the most advanced stages of cancer will not improve the patient’s life, the authors wrote. It also may encourage them to instead focus more on honest communication with patients about their choices, Maureen E. Canavan, PhD, at the Cancer and Outcomes, Public Policy and Effectiveness Research (COPPER) Center at the Yale School of Medicine in New Haven, Connecticut, and colleagues, wrote in their paper.
 

How Was the Study Conducted?

Researchers used Flatiron Health, a nationwide electronic health records database of academic and community practices throughout the United State. They identified 78,446 adults with advanced or metastatic stages of one of six common cancers (breast, colorectal, urothelial, non–small cell lung cancer [NSCLC], pancreatic and renal cell carcinoma) who were treated at healthcare practices from 2015 to 2019. They then stratified practices into quintiles based on how often the practices treated patients with any systemic therapy, including chemotherapy and immunotherapy, in their last 14 days of life. They compared whether patients in practices with greater use of systemic treatment at very advanced stages had longer overall survival.

What Were the Main Findings?

“We saw that there were absolutely no survival differences between the practices that used more systemic therapy for very advanced cancer than the practices that use less,” said senior author Kerin Adelson, MD, chief quality and value officer at MD Anderson Cancer Center in Houston, Texas. In some cancers, those in the lowest quintile (those with the lowest rates of systemic end-of-life care) lived fewer years compared with those in the highest quintiles. In other cancers, those in the lowest quintiles lived more years than those in the highest quintiles.

“What’s important is that none of those differences, after you control for other factors, was statistically significant,” Dr. Adelson said. “That was the same in every cancer type we looked at.”

An example is seen in advanced urothelial cancer. Those in the first quintile (lowest rates of systemic care at end of life) had an SACT rate range of 4.0-9.1. The SACT rate range in the highest quintile was 19.8-42.6. But the median overall survival (OS) rate for those in the lowest quintile was 12.7 months, not statistically different from the median OS in the highest quintile (11 months.)
 

How Does This Study Add to the Literature?

The American Society of Clinical Oncology (ASCO) and the National Quality Forum (NQF) developed a cancer quality metric to reduce SACT at the end of life. The NQF 0210 is a ratio of patients who get systemic treatment within 14 days of death over all patients who die of cancer. The quality metric has been widely adopted and used in value-based care reporting.

But the metric has been criticized because it focuses only on people who died and not people who lived longer because they benefited from the systemic therapy, the authors wrote.

Dr. Canavan’s team focused on all patients treated in the practice, not just those who died, Dr. Adelson said. This may put that criticism to rest, Dr. Adelson said.

“I personally believed the ASCO and NQF metric was appropriate and the criticisms were off base,” said Otis Brawley, MD, associate director of community outreach and engagement at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University School of Medicine in Baltimore. “Canavan’s study is evidence suggesting the metrics were appropriate.”

This study included not just chemotherapy, as some other studies have, but targeted therapies and immunotherapies as well. Dr. Adelson said some think that the newer drugs might change the prognosis at end of life. But this study shows “even those drugs are not helping patients to survive with very advanced cancer,” she said.

 

Could This Change Practice?

The authors noted that end-of life SACT has been linked with more acute care use, delays in conversations about care goals, late enrollment in hospice, higher costs, and potentially shorter and poorer quality life.

Dr. Adelson said she’s hoping that the knowledge that there’s no survival benefit for use of SACT for patients with advanced solid tumors who are nearing the end of life will lead instead to more conversations about prognosis with patients and transitions to palliative care.

“Palliative care has actually been shown to improve quality of life and, in some studies, even survival,” she said.

“I doubt it will change practice, but it should,” Dr. Brawley said. “The study suggests that doctors and patients have too much hope for chemotherapy as patients’ disease progresses. In the US especially, there is a tendency to believe we have better therapies than we truly do and we have difficulty accepting that the patient is dying. Many patients get third- and fourth-line chemotherapy that is highly likely to increase suffering without realistic hope of prolonging life and especially no hope of prolonging life with good quality.”

Dr. Adelson disclosed ties with AbbVie, Quantum Health, Gilead, ParetoHealth, and Carrum Health. Various coauthors disclosed ties with Roche, AbbVie, Johnson & Johnson, Genentech, the National Comprehensive Cancer Network, and AstraZeneca. The study was funded by Flatiron Health, an independent member of the Roche group. Dr. Brawley reports no relevant financial disclosures.

Patients with metastatic or advanced cancer treated in practices that have high rates of giving systemic care in the last two weeks of life do not have longer survival rates than patients in practices that have low rates of such care.

This conclusion of a new study published online May 16 in JAMA Oncology may help reassure oncologists that giving systemic anticancer therapy (SACT) at the most advanced stages of cancer will not improve the patient’s life, the authors wrote. It also may encourage them to instead focus more on honest communication with patients about their choices, Maureen E. Canavan, PhD, at the Cancer and Outcomes, Public Policy and Effectiveness Research (COPPER) Center at the Yale School of Medicine in New Haven, Connecticut, and colleagues, wrote in their paper.
 

How Was the Study Conducted?

Researchers used Flatiron Health, a nationwide electronic health records database of academic and community practices throughout the United State. They identified 78,446 adults with advanced or metastatic stages of one of six common cancers (breast, colorectal, urothelial, non–small cell lung cancer [NSCLC], pancreatic and renal cell carcinoma) who were treated at healthcare practices from 2015 to 2019. They then stratified practices into quintiles based on how often the practices treated patients with any systemic therapy, including chemotherapy and immunotherapy, in their last 14 days of life. They compared whether patients in practices with greater use of systemic treatment at very advanced stages had longer overall survival.

What Were the Main Findings?

“We saw that there were absolutely no survival differences between the practices that used more systemic therapy for very advanced cancer than the practices that use less,” said senior author Kerin Adelson, MD, chief quality and value officer at MD Anderson Cancer Center in Houston, Texas. In some cancers, those in the lowest quintile (those with the lowest rates of systemic end-of-life care) lived fewer years compared with those in the highest quintiles. In other cancers, those in the lowest quintiles lived more years than those in the highest quintiles.

“What’s important is that none of those differences, after you control for other factors, was statistically significant,” Dr. Adelson said. “That was the same in every cancer type we looked at.”

An example is seen in advanced urothelial cancer. Those in the first quintile (lowest rates of systemic care at end of life) had an SACT rate range of 4.0-9.1. The SACT rate range in the highest quintile was 19.8-42.6. But the median overall survival (OS) rate for those in the lowest quintile was 12.7 months, not statistically different from the median OS in the highest quintile (11 months.)
 

How Does This Study Add to the Literature?

The American Society of Clinical Oncology (ASCO) and the National Quality Forum (NQF) developed a cancer quality metric to reduce SACT at the end of life. The NQF 0210 is a ratio of patients who get systemic treatment within 14 days of death over all patients who die of cancer. The quality metric has been widely adopted and used in value-based care reporting.

But the metric has been criticized because it focuses only on people who died and not people who lived longer because they benefited from the systemic therapy, the authors wrote.

Dr. Canavan’s team focused on all patients treated in the practice, not just those who died, Dr. Adelson said. This may put that criticism to rest, Dr. Adelson said.

“I personally believed the ASCO and NQF metric was appropriate and the criticisms were off base,” said Otis Brawley, MD, associate director of community outreach and engagement at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University School of Medicine in Baltimore. “Canavan’s study is evidence suggesting the metrics were appropriate.”

This study included not just chemotherapy, as some other studies have, but targeted therapies and immunotherapies as well. Dr. Adelson said some think that the newer drugs might change the prognosis at end of life. But this study shows “even those drugs are not helping patients to survive with very advanced cancer,” she said.

 

Could This Change Practice?

The authors noted that end-of life SACT has been linked with more acute care use, delays in conversations about care goals, late enrollment in hospice, higher costs, and potentially shorter and poorer quality life.

Dr. Adelson said she’s hoping that the knowledge that there’s no survival benefit for use of SACT for patients with advanced solid tumors who are nearing the end of life will lead instead to more conversations about prognosis with patients and transitions to palliative care.

“Palliative care has actually been shown to improve quality of life and, in some studies, even survival,” she said.

“I doubt it will change practice, but it should,” Dr. Brawley said. “The study suggests that doctors and patients have too much hope for chemotherapy as patients’ disease progresses. In the US especially, there is a tendency to believe we have better therapies than we truly do and we have difficulty accepting that the patient is dying. Many patients get third- and fourth-line chemotherapy that is highly likely to increase suffering without realistic hope of prolonging life and especially no hope of prolonging life with good quality.”

Dr. Adelson disclosed ties with AbbVie, Quantum Health, Gilead, ParetoHealth, and Carrum Health. Various coauthors disclosed ties with Roche, AbbVie, Johnson & Johnson, Genentech, the National Comprehensive Cancer Network, and AstraZeneca. The study was funded by Flatiron Health, an independent member of the Roche group. Dr. Brawley reports no relevant financial disclosures.

PHOENIX — Immunotherapy has revolutionized outcomes for patients with metastatic Merkel cell carcinoma (MCC). However, findings from a new study suggest that many patients who are eligible for immunotherapy are not receiving this treatment, despite guideline recommendations, and survival outcomes are better at high-volume centers.

The study has important implications, said study author Shayan Cheraghlou, MD, an incoming fellow in Mohs surgery at New York University, New York City. “We can see that in a real-world setting, these agents have an impact on survival,” he said. “We also found high-volume centers were significantly more likely to use the agents than low-volume centers.” He presented the findings at the annual meeting of the American College of Mohs Surgery.

MCC is a neuroendocrine skin cancer with a high rate of mortality, and even though it remains relatively rare, its incidence has been rising rapidly since the late 1990s and continues to increase. There were no approved treatments available until 2017, when the US Food and Drug Administration (FDA) approved the immunotherapy drug avelumab (Bavencio) to treat advanced MCC. Two years later, pembrolizumab (Keytruda) also received regulatory approval for MCC, and these two agents have revolutionized outcomes.

“In clinical trial settings, these agents led to significant and durable responses, and they are now the recommended treatments in guidelines for metastatic Merkel cell carcinoma,” said Dr. Cheraghlou. “However, we don’t have data as to how they are being used in the real-world setting and if survival outcomes are similar.”

Real World vs Clinical Trials

Real-world outcomes can differ from clinical trial data, and the adoption of novel therapeutics can be gradual. The goal of this study was to see if clinical trial data matched what was being observed in actual clinical use and if the agents were being used uniformly in centers across the United States.

The authors used data from the National Cancer Database that included patients diagnosed with cancer from 2004 to 2019 and identified 1017 adult cases of metastatic MCC. They then looked at the association of a variety of patient characteristics, tumors, and system factors with the likelihood of receiving systemic treatment for their disease.

“Our first finding was maybe the least surprising,” he said. “Patients who received these therapeutic agents had significantly improved survival compared to those who have not.”

Those who received immunotherapy had a 35% decrease in the risk for death per year compared with those who did not. The 1-, 3-, and 5-year survival rates were 47.2%, 21.8%, and 16.5%, respectively, for patients who did not receive immunotherapy compared with 62.7%, 34.4%, and 23.6%, respectively, for those who were treated with these agents.

Dr. Cheraghlou noted that they started to get some “surprising” findings when they looked at utilization data. “While it has been increasing over time, it is not as high as it should be,” he emphasized.

From 2017 to 2019, 54.2% of patients with metastatic MCC received immunotherapy. The data also showed an increase in use from 45.1% in 2017 to 63.0% in 2019. “This is an effective treatment for aggressive malignancy, so we have to ask why more patients aren’t getting them,” said Dr. Cheraghlou.

Their findings did suggest one possible reason, and that was that high-volume centers were significantly more likely to use the agents than low-volume centers. Centers that were in the top percentile for MCC case volume were three times as likely to use immunotherapy for MCC compared with other institutions. “So, if you have metastatic Merkel cell carcinoma and go to a low volume center, you may be less likely to get potential lifesaving treatment,” he noted.
 

Implications Going Forward

Dr. Cheraghlou concluded his presentation by pointing out that this study has important implications. The data showed that in a real-world setting, these agents have an impact on survival, but all eligible patients do not have access. “In other countries, there are established referral patterns for all patients with aggressive rare malignancies and really all cancers,” he added. “But in the US, cancer care is more decentralized. Studies like this and others show that high-volume centers have much better outcomes for aggressive rare malignancies, and we should be looking at why this is the case and mitigating these disparities and outcomes.”

Commenting on the study results, Jeffrey M. Farma, MD, co-director of the Melanoma and Skin Cancer Program and professor of surgical oncology at Fox Chase Cancer Center, Philadelphia, referred to the two immunotherapies that have been approved for MCC since 2017, which have demonstrated a survival benefit and improved outcomes in patients with metastatic MCC.

Fox Chase Cancer Center

“In their study, immunotherapy was associated with improved outcomes,” said Dr. Farma. “This study highlights the continued lag of implementation of guidelines when new therapies are approved, and that for rare cancers like Merkel cell carcinoma, being treated at high-volume centers and the regionalization of care can lead to improved outcomes for patients.”

Dr. Cheraghlou and Dr. Farma had no disclosures.

A version of this article appeared on Medscape.com.

PHOENIX — Immunotherapy has revolutionized outcomes for patients with metastatic Merkel cell carcinoma (MCC). However, findings from a new study suggest that many patients who are eligible for immunotherapy are not receiving this treatment, despite guideline recommendations, and survival outcomes are better at high-volume centers.

The study has important implications, said study author Shayan Cheraghlou, MD, an incoming fellow in Mohs surgery at New York University, New York City. “We can see that in a real-world setting, these agents have an impact on survival,” he said. “We also found high-volume centers were significantly more likely to use the agents than low-volume centers.” He presented the findings at the annual meeting of the American College of Mohs Surgery.

MCC is a neuroendocrine skin cancer with a high rate of mortality, and even though it remains relatively rare, its incidence has been rising rapidly since the late 1990s and continues to increase. There were no approved treatments available until 2017, when the US Food and Drug Administration (FDA) approved the immunotherapy drug avelumab (Bavencio) to treat advanced MCC. Two years later, pembrolizumab (Keytruda) also received regulatory approval for MCC, and these two agents have revolutionized outcomes.

“In clinical trial settings, these agents led to significant and durable responses, and they are now the recommended treatments in guidelines for metastatic Merkel cell carcinoma,” said Dr. Cheraghlou. “However, we don’t have data as to how they are being used in the real-world setting and if survival outcomes are similar.”

Real World vs Clinical Trials

Real-world outcomes can differ from clinical trial data, and the adoption of novel therapeutics can be gradual. The goal of this study was to see if clinical trial data matched what was being observed in actual clinical use and if the agents were being used uniformly in centers across the United States.

The authors used data from the National Cancer Database that included patients diagnosed with cancer from 2004 to 2019 and identified 1017 adult cases of metastatic MCC. They then looked at the association of a variety of patient characteristics, tumors, and system factors with the likelihood of receiving systemic treatment for their disease.

“Our first finding was maybe the least surprising,” he said. “Patients who received these therapeutic agents had significantly improved survival compared to those who have not.”

Those who received immunotherapy had a 35% decrease in the risk for death per year compared with those who did not. The 1-, 3-, and 5-year survival rates were 47.2%, 21.8%, and 16.5%, respectively, for patients who did not receive immunotherapy compared with 62.7%, 34.4%, and 23.6%, respectively, for those who were treated with these agents.

Dr. Cheraghlou noted that they started to get some “surprising” findings when they looked at utilization data. “While it has been increasing over time, it is not as high as it should be,” he emphasized.

From 2017 to 2019, 54.2% of patients with metastatic MCC received immunotherapy. The data also showed an increase in use from 45.1% in 2017 to 63.0% in 2019. “This is an effective treatment for aggressive malignancy, so we have to ask why more patients aren’t getting them,” said Dr. Cheraghlou.

Their findings did suggest one possible reason, and that was that high-volume centers were significantly more likely to use the agents than low-volume centers. Centers that were in the top percentile for MCC case volume were three times as likely to use immunotherapy for MCC compared with other institutions. “So, if you have metastatic Merkel cell carcinoma and go to a low volume center, you may be less likely to get potential lifesaving treatment,” he noted.
 

Implications Going Forward

Dr. Cheraghlou concluded his presentation by pointing out that this study has important implications. The data showed that in a real-world setting, these agents have an impact on survival, but all eligible patients do not have access. “In other countries, there are established referral patterns for all patients with aggressive rare malignancies and really all cancers,” he added. “But in the US, cancer care is more decentralized. Studies like this and others show that high-volume centers have much better outcomes for aggressive rare malignancies, and we should be looking at why this is the case and mitigating these disparities and outcomes.”

Commenting on the study results, Jeffrey M. Farma, MD, co-director of the Melanoma and Skin Cancer Program and professor of surgical oncology at Fox Chase Cancer Center, Philadelphia, referred to the two immunotherapies that have been approved for MCC since 2017, which have demonstrated a survival benefit and improved outcomes in patients with metastatic MCC.

Fox Chase Cancer Center

“In their study, immunotherapy was associated with improved outcomes,” said Dr. Farma. “This study highlights the continued lag of implementation of guidelines when new therapies are approved, and that for rare cancers like Merkel cell carcinoma, being treated at high-volume centers and the regionalization of care can lead to improved outcomes for patients.”

Dr. Cheraghlou and Dr. Farma had no disclosures.

A version of this article appeared on Medscape.com.

PHOENIX — Immunotherapy has revolutionized outcomes for patients with metastatic Merkel cell carcinoma (MCC). However, findings from a new study suggest that many patients who are eligible for immunotherapy are not receiving this treatment, despite guideline recommendations, and survival outcomes are better at high-volume centers.

The study has important implications, said study author Shayan Cheraghlou, MD, an incoming fellow in Mohs surgery at New York University, New York City. “We can see that in a real-world setting, these agents have an impact on survival,” he said. “We also found high-volume centers were significantly more likely to use the agents than low-volume centers.” He presented the findings at the annual meeting of the American College of Mohs Surgery.

MCC is a neuroendocrine skin cancer with a high rate of mortality, and even though it remains relatively rare, its incidence has been rising rapidly since the late 1990s and continues to increase. There were no approved treatments available until 2017, when the US Food and Drug Administration (FDA) approved the immunotherapy drug avelumab (Bavencio) to treat advanced MCC. Two years later, pembrolizumab (Keytruda) also received regulatory approval for MCC, and these two agents have revolutionized outcomes.

“In clinical trial settings, these agents led to significant and durable responses, and they are now the recommended treatments in guidelines for metastatic Merkel cell carcinoma,” said Dr. Cheraghlou. “However, we don’t have data as to how they are being used in the real-world setting and if survival outcomes are similar.”

Real World vs Clinical Trials

Real-world outcomes can differ from clinical trial data, and the adoption of novel therapeutics can be gradual. The goal of this study was to see if clinical trial data matched what was being observed in actual clinical use and if the agents were being used uniformly in centers across the United States.

The authors used data from the National Cancer Database that included patients diagnosed with cancer from 2004 to 2019 and identified 1017 adult cases of metastatic MCC. They then looked at the association of a variety of patient characteristics, tumors, and system factors with the likelihood of receiving systemic treatment for their disease.

“Our first finding was maybe the least surprising,” he said. “Patients who received these therapeutic agents had significantly improved survival compared to those who have not.”

Those who received immunotherapy had a 35% decrease in the risk for death per year compared with those who did not. The 1-, 3-, and 5-year survival rates were 47.2%, 21.8%, and 16.5%, respectively, for patients who did not receive immunotherapy compared with 62.7%, 34.4%, and 23.6%, respectively, for those who were treated with these agents.

Dr. Cheraghlou noted that they started to get some “surprising” findings when they looked at utilization data. “While it has been increasing over time, it is not as high as it should be,” he emphasized.

From 2017 to 2019, 54.2% of patients with metastatic MCC received immunotherapy. The data also showed an increase in use from 45.1% in 2017 to 63.0% in 2019. “This is an effective treatment for aggressive malignancy, so we have to ask why more patients aren’t getting them,” said Dr. Cheraghlou.

Their findings did suggest one possible reason, and that was that high-volume centers were significantly more likely to use the agents than low-volume centers. Centers that were in the top percentile for MCC case volume were three times as likely to use immunotherapy for MCC compared with other institutions. “So, if you have metastatic Merkel cell carcinoma and go to a low volume center, you may be less likely to get potential lifesaving treatment,” he noted.
 

Implications Going Forward

Dr. Cheraghlou concluded his presentation by pointing out that this study has important implications. The data showed that in a real-world setting, these agents have an impact on survival, but all eligible patients do not have access. “In other countries, there are established referral patterns for all patients with aggressive rare malignancies and really all cancers,” he added. “But in the US, cancer care is more decentralized. Studies like this and others show that high-volume centers have much better outcomes for aggressive rare malignancies, and we should be looking at why this is the case and mitigating these disparities and outcomes.”

Commenting on the study results, Jeffrey M. Farma, MD, co-director of the Melanoma and Skin Cancer Program and professor of surgical oncology at Fox Chase Cancer Center, Philadelphia, referred to the two immunotherapies that have been approved for MCC since 2017, which have demonstrated a survival benefit and improved outcomes in patients with metastatic MCC.

Fox Chase Cancer Center

“In their study, immunotherapy was associated with improved outcomes,” said Dr. Farma. “This study highlights the continued lag of implementation of guidelines when new therapies are approved, and that for rare cancers like Merkel cell carcinoma, being treated at high-volume centers and the regionalization of care can lead to improved outcomes for patients.”

Dr. Cheraghlou and Dr. Farma had no disclosures.

A version of this article appeared on Medscape.com.