Among the potential uses envisioned for artificial intelligence (AI) in healthcare is decreasing provider burden by using the technology to help respond to patients’ questions submitted through portals.

Easing the burden on providers of responding to each question is a target ripe for solutions as during the COVID pandemic, such messages increased 157% from prepandemic levels, say authors of a paper published online in JAMA Network Open. Each additional message added 2.3 minutes to time spent on the electronic health record (EHR) per day.

Researchers at Stanford Health Care, led by Patricia Garcia, MD, with the department of medicine, conducted a 5-week, prospective, single-group quality improvement study from July 10 through August 13, 2023, at Stanford to test an AI response system.
 

Large Language Model Used

All attending physicians, advanced practice providers, clinic nurses, and clinical pharmacists from the divisions of primary care and gastroenterology and hepatology were enrolled in a pilot program that offered the option to answer patients’ questions with drafts that were generated by a Health Insurance Portability and Accountability Act–compliant large language model integrated into EHRs. Drafts were then reviewed by the provider.

The study primarily tested whether providers (162 were included) would use the AI-generated drafts. Secondary outcomes included whether using such a system saved time or improved the clinician experience.

Participants received survey emails before and after the pilot period and answered questions on areas including task load, EHR burden, usability, work exhaustion, burnout, and satisfaction.

Researchers found that the overall average utilization rate per clinician was 20% but there were significant between-group differences. For example, in gastroenterology and hepatology, nurses used the AI tool the most at 29% and physicians/APPs had a 24% usage rate, whereas clinical pharmacists had the highest use rate for primary care at 44% compared with physician use at 15%.
 

Burden Improved, But Didn’t Save Time

AI did not appear to save time but did improve task load scores and work exhaustion scores. The report states that there was no change in reply action time, write time, or read time between the prepilot and pilot periods. However, there were significant reductions in the physician task load score derivative (mean [SD], 61.31 [17.23] pre survey vs 47.26 [17.11] post survey; paired difference, −13.87; 95% CI, −17.38 to −9.50; P < .001) and work exhaustion scores decreased by a third (mean [SD], 1.95 [0.79] pre survey vs 1.62 [0.68] post survey; paired difference, −0.33; 95% CI, −0.50 to −0.17; P < .001)

The authors wrote that improvements in task load and emotional exhaustion scores suggest that generated replies have the potential to lessen cognitive burden and burnout. Though the AI tool didn’t save time, editing responses may be less cognitively taxing than writing responses for providers, the authors suggest.
 

Quality of AI Responses

Comments about AI response message voice and/or tone were the most common and had the highest absolute number of negative comments (10 positive, 2 neutral, and 14 negative). The most negative comments were about length (too long or too short) of the draft message (1 positive, 2 neutral, and 8 negative).

Comments on accuracy of the draft response were fairly even ­— 4 positive and 5 negative — but there were no adverse safety signals, the authors report.

The providers had high expectations about use and quality of the tool that “were either met or exceeded at the end of the pilot,” Dr. Garcia and coauthors write. “Given the evidence that burnout is associated with turnover, reductions in clinical activity, and quality, even a modest improvement may have a substantial impact.”

One coauthor reported grants from Google, Omada Health, and PredictaMed outside the submitted work. Another coauthor reported having a patent for Well-being Index Instruments and Mayo Leadership Impact Index, with royalties paid from Mayo Clinic, and receiving honoraria for presenting grand rounds, keynote lectures, and advising health care organizations on clinician well-being. No other disclosures were reported. 

Among the potential uses envisioned for artificial intelligence (AI) in healthcare is decreasing provider burden by using the technology to help respond to patients’ questions submitted through portals.

Easing the burden on providers of responding to each question is a target ripe for solutions as during the COVID pandemic, such messages increased 157% from prepandemic levels, say authors of a paper published online in JAMA Network Open. Each additional message added 2.3 minutes to time spent on the electronic health record (EHR) per day.

Researchers at Stanford Health Care, led by Patricia Garcia, MD, with the department of medicine, conducted a 5-week, prospective, single-group quality improvement study from July 10 through August 13, 2023, at Stanford to test an AI response system.
 

Large Language Model Used

All attending physicians, advanced practice providers, clinic nurses, and clinical pharmacists from the divisions of primary care and gastroenterology and hepatology were enrolled in a pilot program that offered the option to answer patients’ questions with drafts that were generated by a Health Insurance Portability and Accountability Act–compliant large language model integrated into EHRs. Drafts were then reviewed by the provider.

The study primarily tested whether providers (162 were included) would use the AI-generated drafts. Secondary outcomes included whether using such a system saved time or improved the clinician experience.

Participants received survey emails before and after the pilot period and answered questions on areas including task load, EHR burden, usability, work exhaustion, burnout, and satisfaction.

Researchers found that the overall average utilization rate per clinician was 20% but there were significant between-group differences. For example, in gastroenterology and hepatology, nurses used the AI tool the most at 29% and physicians/APPs had a 24% usage rate, whereas clinical pharmacists had the highest use rate for primary care at 44% compared with physician use at 15%.
 

Burden Improved, But Didn’t Save Time

AI did not appear to save time but did improve task load scores and work exhaustion scores. The report states that there was no change in reply action time, write time, or read time between the prepilot and pilot periods. However, there were significant reductions in the physician task load score derivative (mean [SD], 61.31 [17.23] pre survey vs 47.26 [17.11] post survey; paired difference, −13.87; 95% CI, −17.38 to −9.50; P < .001) and work exhaustion scores decreased by a third (mean [SD], 1.95 [0.79] pre survey vs 1.62 [0.68] post survey; paired difference, −0.33; 95% CI, −0.50 to −0.17; P < .001)

The authors wrote that improvements in task load and emotional exhaustion scores suggest that generated replies have the potential to lessen cognitive burden and burnout. Though the AI tool didn’t save time, editing responses may be less cognitively taxing than writing responses for providers, the authors suggest.
 

Quality of AI Responses

Comments about AI response message voice and/or tone were the most common and had the highest absolute number of negative comments (10 positive, 2 neutral, and 14 negative). The most negative comments were about length (too long or too short) of the draft message (1 positive, 2 neutral, and 8 negative).

Comments on accuracy of the draft response were fairly even ­— 4 positive and 5 negative — but there were no adverse safety signals, the authors report.

The providers had high expectations about use and quality of the tool that “were either met or exceeded at the end of the pilot,” Dr. Garcia and coauthors write. “Given the evidence that burnout is associated with turnover, reductions in clinical activity, and quality, even a modest improvement may have a substantial impact.”

One coauthor reported grants from Google, Omada Health, and PredictaMed outside the submitted work. Another coauthor reported having a patent for Well-being Index Instruments and Mayo Leadership Impact Index, with royalties paid from Mayo Clinic, and receiving honoraria for presenting grand rounds, keynote lectures, and advising health care organizations on clinician well-being. No other disclosures were reported. 

Among the potential uses envisioned for artificial intelligence (AI) in healthcare is decreasing provider burden by using the technology to help respond to patients’ questions submitted through portals.

Easing the burden on providers of responding to each question is a target ripe for solutions as during the COVID pandemic, such messages increased 157% from prepandemic levels, say authors of a paper published online in JAMA Network Open. Each additional message added 2.3 minutes to time spent on the electronic health record (EHR) per day.

Researchers at Stanford Health Care, led by Patricia Garcia, MD, with the department of medicine, conducted a 5-week, prospective, single-group quality improvement study from July 10 through August 13, 2023, at Stanford to test an AI response system.
 

Large Language Model Used

All attending physicians, advanced practice providers, clinic nurses, and clinical pharmacists from the divisions of primary care and gastroenterology and hepatology were enrolled in a pilot program that offered the option to answer patients’ questions with drafts that were generated by a Health Insurance Portability and Accountability Act–compliant large language model integrated into EHRs. Drafts were then reviewed by the provider.

The study primarily tested whether providers (162 were included) would use the AI-generated drafts. Secondary outcomes included whether using such a system saved time or improved the clinician experience.

Participants received survey emails before and after the pilot period and answered questions on areas including task load, EHR burden, usability, work exhaustion, burnout, and satisfaction.

Researchers found that the overall average utilization rate per clinician was 20% but there were significant between-group differences. For example, in gastroenterology and hepatology, nurses used the AI tool the most at 29% and physicians/APPs had a 24% usage rate, whereas clinical pharmacists had the highest use rate for primary care at 44% compared with physician use at 15%.
 

Burden Improved, But Didn’t Save Time

AI did not appear to save time but did improve task load scores and work exhaustion scores. The report states that there was no change in reply action time, write time, or read time between the prepilot and pilot periods. However, there were significant reductions in the physician task load score derivative (mean [SD], 61.31 [17.23] pre survey vs 47.26 [17.11] post survey; paired difference, −13.87; 95% CI, −17.38 to −9.50; P < .001) and work exhaustion scores decreased by a third (mean [SD], 1.95 [0.79] pre survey vs 1.62 [0.68] post survey; paired difference, −0.33; 95% CI, −0.50 to −0.17; P < .001)

The authors wrote that improvements in task load and emotional exhaustion scores suggest that generated replies have the potential to lessen cognitive burden and burnout. Though the AI tool didn’t save time, editing responses may be less cognitively taxing than writing responses for providers, the authors suggest.
 

Quality of AI Responses

Comments about AI response message voice and/or tone were the most common and had the highest absolute number of negative comments (10 positive, 2 neutral, and 14 negative). The most negative comments were about length (too long or too short) of the draft message (1 positive, 2 neutral, and 8 negative).

Comments on accuracy of the draft response were fairly even ­— 4 positive and 5 negative — but there were no adverse safety signals, the authors report.

The providers had high expectations about use and quality of the tool that “were either met or exceeded at the end of the pilot,” Dr. Garcia and coauthors write. “Given the evidence that burnout is associated with turnover, reductions in clinical activity, and quality, even a modest improvement may have a substantial impact.”

One coauthor reported grants from Google, Omada Health, and PredictaMed outside the submitted work. Another coauthor reported having a patent for Well-being Index Instruments and Mayo Leadership Impact Index, with royalties paid from Mayo Clinic, and receiving honoraria for presenting grand rounds, keynote lectures, and advising health care organizations on clinician well-being. No other disclosures were reported. 

SAN DIEGO — Among patients with skin of color and moderate to severe atopic dermatitis (AD) who underwent 16 weeks of treatment with lebrikizumab, 68% achieved a 75% reduction in the Eczema Area and Severity Index (EASI-75), interim results from a novel phase 3b trial showed.

Lebrikizumab, a novel monoclonal antibody being developed by Eli Lilly and Co, binds with high affinity to interleukin (IL)–13, thereby blocking the downstream effects of IL-13 with high potency, one of the study investigators, Jill S. Waibel, MD, a dermatologist in Miami, said at the annual meeting of the American Academy of Dermatology. Though the efficacy and safety of lebrikizumab to treat moderate to severe AD have been established in phase 3 studies, including subset analyses by race and ethnicity, “there is a paucity of data to guide the treatment of moderate-to-severe AD in populations traditionally under-represented in clinical trials, including patients with skin of color,” she said.

During a late-breaking abstract session, Dr. Waibel presented interim 16-week results from ADmirable, a phase 3b, open-label, 24-week study, was the first study to evaluate the safety and efficacy of lebrikizumab in adult and adolescents with skin of color and moderate to severe AD. At baseline and at 2 weeks, patients received a 500-mg loading dose of lebrikizumab. Through week 16, they received a 250-mg dose every 2 weeks. The study’s primary endpoint was the proportion of patients who achieved a 75% reduction in EASI-75 at week 16. “If they achieved the primary endpoint at week 16, they went to a 250-mg dose every 4 weeks,” Dr. Waibel said. “If they did not achieve that [primary endpoint] they stayed on the 250-mg dose every 2 weeks.”

The analysis included 50 patients with skin types IV, V, and VI who self-reported their race as Black or African American, American Indian or Alaska Native, Asian, and Native Hawaiian or Other Pacific Islander. They had chronic AD for at least 1 year, moderate to severe disease at baseline, a history of an inadequate response to topical medications, and were naive to biologics indicated for the treatment of AD.

Week 16 outcomes of interest were the EASI, the Investigator’s Global Assessment (IGA) of 0 or 1, the Pruritus Numerical Rating Scale (NRS), and PDCA-Derm, a scale developed by Eli Lilly and Co that was used to compare postinflammatory lesions to unaffected adjacent normal skin. All data for statistical analyses were summarized as observed.

At baseline, the mean age of the 50 patients was 42 years, 46% were women, their mean body mass index was 30.2, and the mean age at AD onset was 23 years. Most study participants (80%) were Black or African American, 14% were Asian, and 6% were American Indian or Alaska Native; 78% were not Hispanic or Latino and 22% were Hispanic or Latino. The mean EASI score was 28.1, the mean body surface area affected was 41.7%, and the mean Pruritus NRS score was 7.2 out of 11. According to the PDCA-Derm scale, 18% of patients had hypopigmented lesions, and 54% had hyperpigmented lesions.

After 16 weeks of treatment, 68% of patients achieved an EASI-75 response, whereas 46% achieved an EASI-90 response, Dr. Waibel reported at the meeting. In addition, 39% of patients achieved an IGA score of 0 or 1, 56% achieved a ≥ 4-point improvement on the Pruritus NRS, and 66% achieved a ≥ 3-point improvement on the Pruritus NRS. The PDCA-Derm score identified improvement in postinflammatory hyperpigmented lesions in 12 of 21 patients and improvement to normal skin tone in six of 21 patients.

“I have a large population [with skin of color in my practice],” Dr. Waibel said. “I usually tell my [patients with postinflammatory hyperpigmentation] that it takes 6 months to see improvement. In this study, we saw patients achieve improvement in skin tone in a 4-month time frame. PIH is sometimes more distressing than a primary condition, whether it’s acne or atopic dermatitis. In this case, it was surprisingly improved with lebrikizumab.”

No new safety signals or serious adverse events were observed. “This is very exciting because it’s the first time there has been a trial focusing on [patients with skin of color] with moderate to severe eczema in skin types IV-VI,” Dr. Waibel said.

In an interview, the study’s lead investigator, Andrew Alexis, MD, MPH, vice chair for diversity and inclusion in the department of dermatology and professor of clinical dermatology at Weill Cornell Medicine, New York City, said that the interim results from this study “ add valuable, clinically relevant data on the treatment of moderate to severe AD in patient populations with skin of color.”

“An interesting finding,” he continued, “was that improvement in postinflammatory hyperpigmented lesions was seen in 12 of 21 patients and improvement to normal skin tone was observed in six of 21 patients at week 16. This is particularly relevant to patients with skin of color who frequently suffer from pigmentary changes in association with their AD.”

Lebrikizumab was approved in November 2023 in Europe for the treatment of moderate to severe AD in people aged 12 years or older and is currently under review by the Food and Drug Administration for treatment of AD. 

Both Dr. Waibel and Dr. Alexis disclosed numerous conflicts of interest from various pharmaceutical companies, including serving as a consultant and/or advisor to Eli Lilly and Co.
 

A version of this article appeared on Medscape.com.
 

SAN DIEGO — Among patients with skin of color and moderate to severe atopic dermatitis (AD) who underwent 16 weeks of treatment with lebrikizumab, 68% achieved a 75% reduction in the Eczema Area and Severity Index (EASI-75), interim results from a novel phase 3b trial showed.

Lebrikizumab, a novel monoclonal antibody being developed by Eli Lilly and Co, binds with high affinity to interleukin (IL)–13, thereby blocking the downstream effects of IL-13 with high potency, one of the study investigators, Jill S. Waibel, MD, a dermatologist in Miami, said at the annual meeting of the American Academy of Dermatology. Though the efficacy and safety of lebrikizumab to treat moderate to severe AD have been established in phase 3 studies, including subset analyses by race and ethnicity, “there is a paucity of data to guide the treatment of moderate-to-severe AD in populations traditionally under-represented in clinical trials, including patients with skin of color,” she said.

During a late-breaking abstract session, Dr. Waibel presented interim 16-week results from ADmirable, a phase 3b, open-label, 24-week study, was the first study to evaluate the safety and efficacy of lebrikizumab in adult and adolescents with skin of color and moderate to severe AD. At baseline and at 2 weeks, patients received a 500-mg loading dose of lebrikizumab. Through week 16, they received a 250-mg dose every 2 weeks. The study’s primary endpoint was the proportion of patients who achieved a 75% reduction in EASI-75 at week 16. “If they achieved the primary endpoint at week 16, they went to a 250-mg dose every 4 weeks,” Dr. Waibel said. “If they did not achieve that [primary endpoint] they stayed on the 250-mg dose every 2 weeks.”

The analysis included 50 patients with skin types IV, V, and VI who self-reported their race as Black or African American, American Indian or Alaska Native, Asian, and Native Hawaiian or Other Pacific Islander. They had chronic AD for at least 1 year, moderate to severe disease at baseline, a history of an inadequate response to topical medications, and were naive to biologics indicated for the treatment of AD.

Week 16 outcomes of interest were the EASI, the Investigator’s Global Assessment (IGA) of 0 or 1, the Pruritus Numerical Rating Scale (NRS), and PDCA-Derm, a scale developed by Eli Lilly and Co that was used to compare postinflammatory lesions to unaffected adjacent normal skin. All data for statistical analyses were summarized as observed.

At baseline, the mean age of the 50 patients was 42 years, 46% were women, their mean body mass index was 30.2, and the mean age at AD onset was 23 years. Most study participants (80%) were Black or African American, 14% were Asian, and 6% were American Indian or Alaska Native; 78% were not Hispanic or Latino and 22% were Hispanic or Latino. The mean EASI score was 28.1, the mean body surface area affected was 41.7%, and the mean Pruritus NRS score was 7.2 out of 11. According to the PDCA-Derm scale, 18% of patients had hypopigmented lesions, and 54% had hyperpigmented lesions.

After 16 weeks of treatment, 68% of patients achieved an EASI-75 response, whereas 46% achieved an EASI-90 response, Dr. Waibel reported at the meeting. In addition, 39% of patients achieved an IGA score of 0 or 1, 56% achieved a ≥ 4-point improvement on the Pruritus NRS, and 66% achieved a ≥ 3-point improvement on the Pruritus NRS. The PDCA-Derm score identified improvement in postinflammatory hyperpigmented lesions in 12 of 21 patients and improvement to normal skin tone in six of 21 patients.

“I have a large population [with skin of color in my practice],” Dr. Waibel said. “I usually tell my [patients with postinflammatory hyperpigmentation] that it takes 6 months to see improvement. In this study, we saw patients achieve improvement in skin tone in a 4-month time frame. PIH is sometimes more distressing than a primary condition, whether it’s acne or atopic dermatitis. In this case, it was surprisingly improved with lebrikizumab.”

No new safety signals or serious adverse events were observed. “This is very exciting because it’s the first time there has been a trial focusing on [patients with skin of color] with moderate to severe eczema in skin types IV-VI,” Dr. Waibel said.

In an interview, the study’s lead investigator, Andrew Alexis, MD, MPH, vice chair for diversity and inclusion in the department of dermatology and professor of clinical dermatology at Weill Cornell Medicine, New York City, said that the interim results from this study “ add valuable, clinically relevant data on the treatment of moderate to severe AD in patient populations with skin of color.”

“An interesting finding,” he continued, “was that improvement in postinflammatory hyperpigmented lesions was seen in 12 of 21 patients and improvement to normal skin tone was observed in six of 21 patients at week 16. This is particularly relevant to patients with skin of color who frequently suffer from pigmentary changes in association with their AD.”

Lebrikizumab was approved in November 2023 in Europe for the treatment of moderate to severe AD in people aged 12 years or older and is currently under review by the Food and Drug Administration for treatment of AD. 

Both Dr. Waibel and Dr. Alexis disclosed numerous conflicts of interest from various pharmaceutical companies, including serving as a consultant and/or advisor to Eli Lilly and Co.
 

A version of this article appeared on Medscape.com.
 

SAN DIEGO — Among patients with skin of color and moderate to severe atopic dermatitis (AD) who underwent 16 weeks of treatment with lebrikizumab, 68% achieved a 75% reduction in the Eczema Area and Severity Index (EASI-75), interim results from a novel phase 3b trial showed.

Lebrikizumab, a novel monoclonal antibody being developed by Eli Lilly and Co, binds with high affinity to interleukin (IL)–13, thereby blocking the downstream effects of IL-13 with high potency, one of the study investigators, Jill S. Waibel, MD, a dermatologist in Miami, said at the annual meeting of the American Academy of Dermatology. Though the efficacy and safety of lebrikizumab to treat moderate to severe AD have been established in phase 3 studies, including subset analyses by race and ethnicity, “there is a paucity of data to guide the treatment of moderate-to-severe AD in populations traditionally under-represented in clinical trials, including patients with skin of color,” she said.

During a late-breaking abstract session, Dr. Waibel presented interim 16-week results from ADmirable, a phase 3b, open-label, 24-week study, was the first study to evaluate the safety and efficacy of lebrikizumab in adult and adolescents with skin of color and moderate to severe AD. At baseline and at 2 weeks, patients received a 500-mg loading dose of lebrikizumab. Through week 16, they received a 250-mg dose every 2 weeks. The study’s primary endpoint was the proportion of patients who achieved a 75% reduction in EASI-75 at week 16. “If they achieved the primary endpoint at week 16, they went to a 250-mg dose every 4 weeks,” Dr. Waibel said. “If they did not achieve that [primary endpoint] they stayed on the 250-mg dose every 2 weeks.”

The analysis included 50 patients with skin types IV, V, and VI who self-reported their race as Black or African American, American Indian or Alaska Native, Asian, and Native Hawaiian or Other Pacific Islander. They had chronic AD for at least 1 year, moderate to severe disease at baseline, a history of an inadequate response to topical medications, and were naive to biologics indicated for the treatment of AD.

Week 16 outcomes of interest were the EASI, the Investigator’s Global Assessment (IGA) of 0 or 1, the Pruritus Numerical Rating Scale (NRS), and PDCA-Derm, a scale developed by Eli Lilly and Co that was used to compare postinflammatory lesions to unaffected adjacent normal skin. All data for statistical analyses were summarized as observed.

At baseline, the mean age of the 50 patients was 42 years, 46% were women, their mean body mass index was 30.2, and the mean age at AD onset was 23 years. Most study participants (80%) were Black or African American, 14% were Asian, and 6% were American Indian or Alaska Native; 78% were not Hispanic or Latino and 22% were Hispanic or Latino. The mean EASI score was 28.1, the mean body surface area affected was 41.7%, and the mean Pruritus NRS score was 7.2 out of 11. According to the PDCA-Derm scale, 18% of patients had hypopigmented lesions, and 54% had hyperpigmented lesions.

After 16 weeks of treatment, 68% of patients achieved an EASI-75 response, whereas 46% achieved an EASI-90 response, Dr. Waibel reported at the meeting. In addition, 39% of patients achieved an IGA score of 0 or 1, 56% achieved a ≥ 4-point improvement on the Pruritus NRS, and 66% achieved a ≥ 3-point improvement on the Pruritus NRS. The PDCA-Derm score identified improvement in postinflammatory hyperpigmented lesions in 12 of 21 patients and improvement to normal skin tone in six of 21 patients.

“I have a large population [with skin of color in my practice],” Dr. Waibel said. “I usually tell my [patients with postinflammatory hyperpigmentation] that it takes 6 months to see improvement. In this study, we saw patients achieve improvement in skin tone in a 4-month time frame. PIH is sometimes more distressing than a primary condition, whether it’s acne or atopic dermatitis. In this case, it was surprisingly improved with lebrikizumab.”

No new safety signals or serious adverse events were observed. “This is very exciting because it’s the first time there has been a trial focusing on [patients with skin of color] with moderate to severe eczema in skin types IV-VI,” Dr. Waibel said.

In an interview, the study’s lead investigator, Andrew Alexis, MD, MPH, vice chair for diversity and inclusion in the department of dermatology and professor of clinical dermatology at Weill Cornell Medicine, New York City, said that the interim results from this study “ add valuable, clinically relevant data on the treatment of moderate to severe AD in patient populations with skin of color.”

“An interesting finding,” he continued, “was that improvement in postinflammatory hyperpigmented lesions was seen in 12 of 21 patients and improvement to normal skin tone was observed in six of 21 patients at week 16. This is particularly relevant to patients with skin of color who frequently suffer from pigmentary changes in association with their AD.”

Lebrikizumab was approved in November 2023 in Europe for the treatment of moderate to severe AD in people aged 12 years or older and is currently under review by the Food and Drug Administration for treatment of AD. 

Both Dr. Waibel and Dr. Alexis disclosed numerous conflicts of interest from various pharmaceutical companies, including serving as a consultant and/or advisor to Eli Lilly and Co.
 

A version of this article appeared on Medscape.com.
 

SAN DIEGO — Home-based phototherapy is non-inferior to office-based phototherapy for the treatment of plaque and guttate psoriasis across all skin types and was associated with improved Physician’s Global Assessment (PGA) and Dermatology Life Quality Index (DLQI) scores, results from a pragmatic, multicenter study showed.

“In 2024, we have a lot of ways to treat moderate-to-severe psoriasis, and phototherapy remains relevant,” lead investigator Joel M. Gelfand, MD, professor of dermatology and epidemiology at the University of Pennsylvania in Philadelphia, told attendees of a late-breaking abstract session at the annual meeting of the American Academy of Dermatology. 

Courtesy Dr. Gelfand

“Office phototherapy is 10 to 100 times less expensive than biologics for psoriasis, and in head-to-head trials, it’s about as effective as adalimumab and achieves better patient-reported outcomes. It may have some cardiovascular benefits by lowering IL-6 and improving HDL-P,” he said. “And, compared to secukinumab, it has no risk of infection.”

Although phototherapy is a preferred as a treatment by patients with psoriasis, he continued, inconvenience of traveling to a clinician’s office for the treatment and lack of coverage by health insurance plans remain major barriers to this option. According to Dr. Gelfand, office-based phototherapy is not available in 90% of counties in the United States, “and a lack of US data has resulted in many insurance companies not covering home phototherapy. As a result, many providers are uncertain about prescribing it.”
 

LITE Study Data

In 2019, Dr. Gelfand and colleagues Light Treatment Effectiveness (LITE) study, a patient-centered study that tested the hypothesis that narrowband UVB phototherapy of psoriasis at home is non-inferior to office treatment, based on outcomes that matter to patients, clinicians, and payers. The co-primary outcomes were a PGA score of 0/1 (clear, almost clear) and a 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. New or established patients to the practices were accepted into the trial, while those treated with phototherapy within 14 days before the baseline visit were not. These entry criteria “are highly pragmatic and reflect routine clinical practice,” he said.

The researchers evenly stratified patients by skin types I and II, III and IV, and V and VI. They collected data from medical records or from an app on the patient’s cell phone, which captured the DLQI data. Study participants were randomly assigned 1:1 to office- or home-based phototherapy for 12 weeks at doses recommended in the 2019 AAD-National Psoriasis Foundation guidelines. This was followed by a 12-week observation period, which ended at 24 weeks. 

At baseline, the mean DLQI score of patients was 12.2, the mean PGA score was 3, and their mean body surface area affected was 12.5%. “These patients had pretty severe disease, long-standing disease, and about 12% were on biologics or nonbiologic systemic therapy during the study,” said Dr. Gelfand, also the director of the Psoriasis and Phototherapy Treatment Center at Penn. In addition, he said, “the average round-trip to receive phototherapy in the office was about 60 minutes.”
 

An Improvement in Health Equity

Following treatment at 12 weeks, 25.6% of patients in the office-based phototherapy group achieved a PGA of 0/1, compared with 32.8% of patients in the home-based phototherapy group (P >.0001 for non-inferiority). Similarly, 33.6% of patients in the office-based phototherapy group achieved a score of 5 or less on the DLQI, compared with 52.4% of patients in the home-based phototherapy group (P >.0001 for non-inferiority).

In subgroup analyses, patients with darkly pigmented skin did especially well on home phototherapy relative to office treatment. “This finding is an example of how the LITE study was specifically designed to improve health equity through an intentionally inclusive approach,” Dr. Gelfand said. Perhaps not surprisingly, patients in the home-based phototherapy arm were more adherent to treatment compared with those in the office-based arm (a mean of 26.8 sessions during the study period, compared with a mean of 17.9, respectively; P < .0001). “They also had higher cumulative doses of phototherapy and therefore higher episodes of treatments with erythema,” he noted.

Among patients who reported “itchy, sore, painful, or stinging” skin in the previous week, 63% characterized the degree of discomfort as “not at all or a little,” while 28% said “a lot,” and 9% said “very much.” No patients withdrew or stopped phototherapy during the trial because of treatment-related side effects, “so it’s very well tolerated,” Dr. Gelfand said.

“If a patient never had phototherapy before, they did just as well at home as they did in the office. This suggests that there’s no reason to insist that a patient use office-based phototherapy before using home phototherapy.”

The researchers studied the efficacy of narrow-band UVB in patients who had at least two treatments per week for 12 weeks. In this subgroup of patients, 60% achieved clear or almost clear skin and nearly 50% achieved the equivalent of a Psoriasis Area and Severity Index (PASI) 90 score.

“Home phototherapy is clearly non-inferior to office-based phototherapy across all skin types and both primary outcomes, PGA and DLQI, and both have excellent effectiveness and safety in real-world settings,” Dr. Gelfand concluded. “These data support the use of home phototherapy as a first-line treatment option for psoriasis, including those with no prior phototherapy experience.”

LITE Study Described as “Groundbreaking”

One of the session moderators, dermatologist Andrew Blauvelt, MD, MBA, of the Oregon Medical Research Center, Portland, asked about the impact that lockdowns during the early phase of the COVID-19 pandemic had on the trial. “The study shut down for a couple weeks during the initial lockdown, but we got back up and running pretty quickly,” Dr. Gelfand responded. “We didn’t study that specific period of time, but the study was going on well before COVID and well after COVID restrictions were lifted. We’ll have to analyze that period of time you question but I suspect that it’s not driving the results we see.”

Asked to comment, Henry W. Lim, MD, a dermatologist with Henry Ford Health in Detroit, characterized the findings of the study as “groundbreaking, because it looked at a real-life situation in the use of phototherapy at home vs in the office, showing that the home phototherapy is not inferior to office-based phototherapy.”

A version of this article appeared on Medscape.com.

SAN DIEGO — Home-based phototherapy is non-inferior to office-based phototherapy for the treatment of plaque and guttate psoriasis across all skin types and was associated with improved Physician’s Global Assessment (PGA) and Dermatology Life Quality Index (DLQI) scores, results from a pragmatic, multicenter study showed.

“In 2024, we have a lot of ways to treat moderate-to-severe psoriasis, and phototherapy remains relevant,” lead investigator Joel M. Gelfand, MD, professor of dermatology and epidemiology at the University of Pennsylvania in Philadelphia, told attendees of a late-breaking abstract session at the annual meeting of the American Academy of Dermatology. 

Courtesy Dr. Gelfand

“Office phototherapy is 10 to 100 times less expensive than biologics for psoriasis, and in head-to-head trials, it’s about as effective as adalimumab and achieves better patient-reported outcomes. It may have some cardiovascular benefits by lowering IL-6 and improving HDL-P,” he said. “And, compared to secukinumab, it has no risk of infection.”

Although phototherapy is a preferred as a treatment by patients with psoriasis, he continued, inconvenience of traveling to a clinician’s office for the treatment and lack of coverage by health insurance plans remain major barriers to this option. According to Dr. Gelfand, office-based phototherapy is not available in 90% of counties in the United States, “and a lack of US data has resulted in many insurance companies not covering home phototherapy. As a result, many providers are uncertain about prescribing it.”
 

LITE Study Data

In 2019, Dr. Gelfand and colleagues Light Treatment Effectiveness (LITE) study, a patient-centered study that tested the hypothesis that narrowband UVB phototherapy of psoriasis at home is non-inferior to office treatment, based on outcomes that matter to patients, clinicians, and payers. The co-primary outcomes were a PGA score of 0/1 (clear, almost clear) and a 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. New or established patients to the practices were accepted into the trial, while those treated with phototherapy within 14 days before the baseline visit were not. These entry criteria “are highly pragmatic and reflect routine clinical practice,” he said.

The researchers evenly stratified patients by skin types I and II, III and IV, and V and VI. They collected data from medical records or from an app on the patient’s cell phone, which captured the DLQI data. Study participants were randomly assigned 1:1 to office- or home-based phototherapy for 12 weeks at doses recommended in the 2019 AAD-National Psoriasis Foundation guidelines. This was followed by a 12-week observation period, which ended at 24 weeks. 

At baseline, the mean DLQI score of patients was 12.2, the mean PGA score was 3, and their mean body surface area affected was 12.5%. “These patients had pretty severe disease, long-standing disease, and about 12% were on biologics or nonbiologic systemic therapy during the study,” said Dr. Gelfand, also the director of the Psoriasis and Phototherapy Treatment Center at Penn. In addition, he said, “the average round-trip to receive phototherapy in the office was about 60 minutes.”
 

An Improvement in Health Equity

Following treatment at 12 weeks, 25.6% of patients in the office-based phototherapy group achieved a PGA of 0/1, compared with 32.8% of patients in the home-based phototherapy group (P >.0001 for non-inferiority). Similarly, 33.6% of patients in the office-based phototherapy group achieved a score of 5 or less on the DLQI, compared with 52.4% of patients in the home-based phototherapy group (P >.0001 for non-inferiority).

In subgroup analyses, patients with darkly pigmented skin did especially well on home phototherapy relative to office treatment. “This finding is an example of how the LITE study was specifically designed to improve health equity through an intentionally inclusive approach,” Dr. Gelfand said. Perhaps not surprisingly, patients in the home-based phototherapy arm were more adherent to treatment compared with those in the office-based arm (a mean of 26.8 sessions during the study period, compared with a mean of 17.9, respectively; P < .0001). “They also had higher cumulative doses of phototherapy and therefore higher episodes of treatments with erythema,” he noted.

Among patients who reported “itchy, sore, painful, or stinging” skin in the previous week, 63% characterized the degree of discomfort as “not at all or a little,” while 28% said “a lot,” and 9% said “very much.” No patients withdrew or stopped phototherapy during the trial because of treatment-related side effects, “so it’s very well tolerated,” Dr. Gelfand said.

“If a patient never had phototherapy before, they did just as well at home as they did in the office. This suggests that there’s no reason to insist that a patient use office-based phototherapy before using home phototherapy.”

The researchers studied the efficacy of narrow-band UVB in patients who had at least two treatments per week for 12 weeks. In this subgroup of patients, 60% achieved clear or almost clear skin and nearly 50% achieved the equivalent of a Psoriasis Area and Severity Index (PASI) 90 score.

“Home phototherapy is clearly non-inferior to office-based phototherapy across all skin types and both primary outcomes, PGA and DLQI, and both have excellent effectiveness and safety in real-world settings,” Dr. Gelfand concluded. “These data support the use of home phototherapy as a first-line treatment option for psoriasis, including those with no prior phototherapy experience.”

LITE Study Described as “Groundbreaking”

One of the session moderators, dermatologist Andrew Blauvelt, MD, MBA, of the Oregon Medical Research Center, Portland, asked about the impact that lockdowns during the early phase of the COVID-19 pandemic had on the trial. “The study shut down for a couple weeks during the initial lockdown, but we got back up and running pretty quickly,” Dr. Gelfand responded. “We didn’t study that specific period of time, but the study was going on well before COVID and well after COVID restrictions were lifted. We’ll have to analyze that period of time you question but I suspect that it’s not driving the results we see.”

Asked to comment, Henry W. Lim, MD, a dermatologist with Henry Ford Health in Detroit, characterized the findings of the study as “groundbreaking, because it looked at a real-life situation in the use of phototherapy at home vs in the office, showing that the home phototherapy is not inferior to office-based phototherapy.”

A version of this article appeared on Medscape.com.

SAN DIEGO — Home-based phototherapy is non-inferior to office-based phototherapy for the treatment of plaque and guttate psoriasis across all skin types and was associated with improved Physician’s Global Assessment (PGA) and Dermatology Life Quality Index (DLQI) scores, results from a pragmatic, multicenter study showed.

“In 2024, we have a lot of ways to treat moderate-to-severe psoriasis, and phototherapy remains relevant,” lead investigator Joel M. Gelfand, MD, professor of dermatology and epidemiology at the University of Pennsylvania in Philadelphia, told attendees of a late-breaking abstract session at the annual meeting of the American Academy of Dermatology. 

Courtesy Dr. Gelfand

“Office phototherapy is 10 to 100 times less expensive than biologics for psoriasis, and in head-to-head trials, it’s about as effective as adalimumab and achieves better patient-reported outcomes. It may have some cardiovascular benefits by lowering IL-6 and improving HDL-P,” he said. “And, compared to secukinumab, it has no risk of infection.”

Although phototherapy is a preferred as a treatment by patients with psoriasis, he continued, inconvenience of traveling to a clinician’s office for the treatment and lack of coverage by health insurance plans remain major barriers to this option. According to Dr. Gelfand, office-based phototherapy is not available in 90% of counties in the United States, “and a lack of US data has resulted in many insurance companies not covering home phototherapy. As a result, many providers are uncertain about prescribing it.”
 

LITE Study Data

In 2019, Dr. Gelfand and colleagues Light Treatment Effectiveness (LITE) study, a patient-centered study that tested the hypothesis that narrowband UVB phototherapy of psoriasis at home is non-inferior to office treatment, based on outcomes that matter to patients, clinicians, and payers. The co-primary outcomes were a PGA score of 0/1 (clear, almost clear) and a 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. New or established patients to the practices were accepted into the trial, while those treated with phototherapy within 14 days before the baseline visit were not. These entry criteria “are highly pragmatic and reflect routine clinical practice,” he said.

The researchers evenly stratified patients by skin types I and II, III and IV, and V and VI. They collected data from medical records or from an app on the patient’s cell phone, which captured the DLQI data. Study participants were randomly assigned 1:1 to office- or home-based phototherapy for 12 weeks at doses recommended in the 2019 AAD-National Psoriasis Foundation guidelines. This was followed by a 12-week observation period, which ended at 24 weeks. 

At baseline, the mean DLQI score of patients was 12.2, the mean PGA score was 3, and their mean body surface area affected was 12.5%. “These patients had pretty severe disease, long-standing disease, and about 12% were on biologics or nonbiologic systemic therapy during the study,” said Dr. Gelfand, also the director of the Psoriasis and Phototherapy Treatment Center at Penn. In addition, he said, “the average round-trip to receive phototherapy in the office was about 60 minutes.”
 

An Improvement in Health Equity

Following treatment at 12 weeks, 25.6% of patients in the office-based phototherapy group achieved a PGA of 0/1, compared with 32.8% of patients in the home-based phototherapy group (P >.0001 for non-inferiority). Similarly, 33.6% of patients in the office-based phototherapy group achieved a score of 5 or less on the DLQI, compared with 52.4% of patients in the home-based phototherapy group (P >.0001 for non-inferiority).

In subgroup analyses, patients with darkly pigmented skin did especially well on home phototherapy relative to office treatment. “This finding is an example of how the LITE study was specifically designed to improve health equity through an intentionally inclusive approach,” Dr. Gelfand said. Perhaps not surprisingly, patients in the home-based phototherapy arm were more adherent to treatment compared with those in the office-based arm (a mean of 26.8 sessions during the study period, compared with a mean of 17.9, respectively; P < .0001). “They also had higher cumulative doses of phototherapy and therefore higher episodes of treatments with erythema,” he noted.

Among patients who reported “itchy, sore, painful, or stinging” skin in the previous week, 63% characterized the degree of discomfort as “not at all or a little,” while 28% said “a lot,” and 9% said “very much.” No patients withdrew or stopped phototherapy during the trial because of treatment-related side effects, “so it’s very well tolerated,” Dr. Gelfand said.

“If a patient never had phototherapy before, they did just as well at home as they did in the office. This suggests that there’s no reason to insist that a patient use office-based phototherapy before using home phototherapy.”

The researchers studied the efficacy of narrow-band UVB in patients who had at least two treatments per week for 12 weeks. In this subgroup of patients, 60% achieved clear or almost clear skin and nearly 50% achieved the equivalent of a Psoriasis Area and Severity Index (PASI) 90 score.

“Home phototherapy is clearly non-inferior to office-based phototherapy across all skin types and both primary outcomes, PGA and DLQI, and both have excellent effectiveness and safety in real-world settings,” Dr. Gelfand concluded. “These data support the use of home phototherapy as a first-line treatment option for psoriasis, including those with no prior phototherapy experience.”

LITE Study Described as “Groundbreaking”

One of the session moderators, dermatologist Andrew Blauvelt, MD, MBA, of the Oregon Medical Research Center, Portland, asked about the impact that lockdowns during the early phase of the COVID-19 pandemic had on the trial. “The study shut down for a couple weeks during the initial lockdown, but we got back up and running pretty quickly,” Dr. Gelfand responded. “We didn’t study that specific period of time, but the study was going on well before COVID and well after COVID restrictions were lifted. We’ll have to analyze that period of time you question but I suspect that it’s not driving the results we see.”

Asked to comment, Henry W. Lim, MD, a dermatologist with Henry Ford Health in Detroit, characterized the findings of the study as “groundbreaking, because it looked at a real-life situation in the use of phototherapy at home vs in the office, showing that the home phototherapy is not inferior to office-based phototherapy.”

A version of this article appeared on Medscape.com.

Medical schools with diversity, equity, and inclusion (DEI) initiatives could lose federal funding under a new bill proposed this week in the US House of Representatives. 

The Embracing Anti-Discrimination, Unbiased Curricula, and Advancing Truth in Education (EDUCATE) Act was introduced March 19 by North Carolina Rep. Greg Murphy (R-NC3). It aims to ban what the bill describes as “race-based mandates” at medical schools. 

The legislation highlights a larger national backlash, largely led by conservatives, against considering race and ethnicity in higher education after the Supreme Court overturned affirmative action last summer. 

According to the bill’s text, medical schools must not “establish, maintain, or contract with a [DEI] office, or any other functional equivalent.” They must also agree that they will not force students or faculty to acknowledge that “America is an oppressive nation” or that “individuals should be adversely treated on the basis of their sex, race, ethnicity, religion, color, or national origin.” 

If H.R. 7725 passes, noncompliant medical schools would no longer receive federal funding or be eligible to participate in guaranteed student loan programs. 

Advocating for colorblind medical school admissions overlooks the racism that still exists in society, said Vanessa Grubbs, MD, MPH, nephrologist and cofounder of the nonprofit Black Doc Village. She told this news organization that bills like H.R. 7725 distract from the real work of diversifying the physician workforce to achieve equitable care for all. 

“There’s a huge body of literature that shows when there is racial or cultural concordance, people have better satisfaction and health outcomes,” said Dr. Grubbs. “It’s really telling that the first thing the people dreaming up these bills say is that by having a diverse workforce, it automatically means that you have a less qualified workforce or that you’re lowering standards.”

The bill joins dozens of state legislative actions seeking to ban DEI principles in healthcare.

This week, Alabama legislators passed a bill prohibiting public universities from establishing DEI programs or using state money to sponsor events involving “divisive concepts.” If signed by the governor, the bill would go into effect on October 1, 2024, joining states like Tennessee and Utah with similar laws already on the books.

Industry groups are also grappling with anti-DEI sentiment. Earlier this month, the American Academy of Dermatology’s annual meeting took an unexpected turn when a member physician and 92 colleagues petitioned the academy to end its DEI programs, including scholarships and mentoring. A committee hearing the petition declined to send it to the Academy’s board.

Rep. Murphy, a urology surgeon who wrote a related editorial in the Wall Street Journal, argued that DEI ideology violates freedom of speech and allows medical schools to reject candidates for not being progressive enough. In the opinion piece, he and coauthor nephrologist Stanley Goldfarb, MD, referred to DEI efforts as “quackery” and a form of discrimination. 

Dr. Goldfarb is the chairman of Do No Harm, a Virginia-based advocacy group that has pushed to eradicate “identity politics” in medical education and clinical practice. The group was instrumental in suing the Louisiana governor for a law requiring that minority candidates fill some state medical board positions. It also filed a complaint against the Medical Board of California on behalf of two physicians, claiming the state’s mandated implicit bias training for healthcare professionals violates their First Amendment rights.

Following the Supreme Court’s ruling overturning affirmative action, the American Medical Association (AMA) adopted a policy advising medical schools to consider race as a factor in admissions alongside other criteria such as test scores, grades, and interviews. The policy provides a “necessary safeguard” to diversify the physician workforce and advance health equity, the AMA said at the time. 

The Association of American Medical Colleges supports DEI principles in medical education while advocating for race-neutral admissions practices like holistic review. This method considers the whole applicant, including their experiences, attributes, academic achievements, and the value they bring to the learning environment. 

H.R. 7725 has 35 cosponsors, many of whom are physicians. Podiatrist and Ohio Rep. Brad Wenstrup (R) said in a statement that medical education should be “free of discrimination” and that the bill would prevent physicians from “being forced to pledge, affirm, or adopt tenets that have infiltrated higher education.”

A version of this article appeared on Medscape.com .

Medical schools with diversity, equity, and inclusion (DEI) initiatives could lose federal funding under a new bill proposed this week in the US House of Representatives. 

The Embracing Anti-Discrimination, Unbiased Curricula, and Advancing Truth in Education (EDUCATE) Act was introduced March 19 by North Carolina Rep. Greg Murphy (R-NC3). It aims to ban what the bill describes as “race-based mandates” at medical schools. 

The legislation highlights a larger national backlash, largely led by conservatives, against considering race and ethnicity in higher education after the Supreme Court overturned affirmative action last summer. 

According to the bill’s text, medical schools must not “establish, maintain, or contract with a [DEI] office, or any other functional equivalent.” They must also agree that they will not force students or faculty to acknowledge that “America is an oppressive nation” or that “individuals should be adversely treated on the basis of their sex, race, ethnicity, religion, color, or national origin.” 

If H.R. 7725 passes, noncompliant medical schools would no longer receive federal funding or be eligible to participate in guaranteed student loan programs. 

Advocating for colorblind medical school admissions overlooks the racism that still exists in society, said Vanessa Grubbs, MD, MPH, nephrologist and cofounder of the nonprofit Black Doc Village. She told this news organization that bills like H.R. 7725 distract from the real work of diversifying the physician workforce to achieve equitable care for all. 

“There’s a huge body of literature that shows when there is racial or cultural concordance, people have better satisfaction and health outcomes,” said Dr. Grubbs. “It’s really telling that the first thing the people dreaming up these bills say is that by having a diverse workforce, it automatically means that you have a less qualified workforce or that you’re lowering standards.”

The bill joins dozens of state legislative actions seeking to ban DEI principles in healthcare.

This week, Alabama legislators passed a bill prohibiting public universities from establishing DEI programs or using state money to sponsor events involving “divisive concepts.” If signed by the governor, the bill would go into effect on October 1, 2024, joining states like Tennessee and Utah with similar laws already on the books.

Industry groups are also grappling with anti-DEI sentiment. Earlier this month, the American Academy of Dermatology’s annual meeting took an unexpected turn when a member physician and 92 colleagues petitioned the academy to end its DEI programs, including scholarships and mentoring. A committee hearing the petition declined to send it to the Academy’s board.

Rep. Murphy, a urology surgeon who wrote a related editorial in the Wall Street Journal, argued that DEI ideology violates freedom of speech and allows medical schools to reject candidates for not being progressive enough. In the opinion piece, he and coauthor nephrologist Stanley Goldfarb, MD, referred to DEI efforts as “quackery” and a form of discrimination. 

Dr. Goldfarb is the chairman of Do No Harm, a Virginia-based advocacy group that has pushed to eradicate “identity politics” in medical education and clinical practice. The group was instrumental in suing the Louisiana governor for a law requiring that minority candidates fill some state medical board positions. It also filed a complaint against the Medical Board of California on behalf of two physicians, claiming the state’s mandated implicit bias training for healthcare professionals violates their First Amendment rights.

Following the Supreme Court’s ruling overturning affirmative action, the American Medical Association (AMA) adopted a policy advising medical schools to consider race as a factor in admissions alongside other criteria such as test scores, grades, and interviews. The policy provides a “necessary safeguard” to diversify the physician workforce and advance health equity, the AMA said at the time. 

The Association of American Medical Colleges supports DEI principles in medical education while advocating for race-neutral admissions practices like holistic review. This method considers the whole applicant, including their experiences, attributes, academic achievements, and the value they bring to the learning environment. 

H.R. 7725 has 35 cosponsors, many of whom are physicians. Podiatrist and Ohio Rep. Brad Wenstrup (R) said in a statement that medical education should be “free of discrimination” and that the bill would prevent physicians from “being forced to pledge, affirm, or adopt tenets that have infiltrated higher education.”

A version of this article appeared on Medscape.com .

Medical schools with diversity, equity, and inclusion (DEI) initiatives could lose federal funding under a new bill proposed this week in the US House of Representatives. 

The Embracing Anti-Discrimination, Unbiased Curricula, and Advancing Truth in Education (EDUCATE) Act was introduced March 19 by North Carolina Rep. Greg Murphy (R-NC3). It aims to ban what the bill describes as “race-based mandates” at medical schools. 

The legislation highlights a larger national backlash, largely led by conservatives, against considering race and ethnicity in higher education after the Supreme Court overturned affirmative action last summer. 

According to the bill’s text, medical schools must not “establish, maintain, or contract with a [DEI] office, or any other functional equivalent.” They must also agree that they will not force students or faculty to acknowledge that “America is an oppressive nation” or that “individuals should be adversely treated on the basis of their sex, race, ethnicity, religion, color, or national origin.” 

If H.R. 7725 passes, noncompliant medical schools would no longer receive federal funding or be eligible to participate in guaranteed student loan programs. 

Advocating for colorblind medical school admissions overlooks the racism that still exists in society, said Vanessa Grubbs, MD, MPH, nephrologist and cofounder of the nonprofit Black Doc Village. She told this news organization that bills like H.R. 7725 distract from the real work of diversifying the physician workforce to achieve equitable care for all. 

“There’s a huge body of literature that shows when there is racial or cultural concordance, people have better satisfaction and health outcomes,” said Dr. Grubbs. “It’s really telling that the first thing the people dreaming up these bills say is that by having a diverse workforce, it automatically means that you have a less qualified workforce or that you’re lowering standards.”

The bill joins dozens of state legislative actions seeking to ban DEI principles in healthcare.

This week, Alabama legislators passed a bill prohibiting public universities from establishing DEI programs or using state money to sponsor events involving “divisive concepts.” If signed by the governor, the bill would go into effect on October 1, 2024, joining states like Tennessee and Utah with similar laws already on the books.

Industry groups are also grappling with anti-DEI sentiment. Earlier this month, the American Academy of Dermatology’s annual meeting took an unexpected turn when a member physician and 92 colleagues petitioned the academy to end its DEI programs, including scholarships and mentoring. A committee hearing the petition declined to send it to the Academy’s board.

Rep. Murphy, a urology surgeon who wrote a related editorial in the Wall Street Journal, argued that DEI ideology violates freedom of speech and allows medical schools to reject candidates for not being progressive enough. In the opinion piece, he and coauthor nephrologist Stanley Goldfarb, MD, referred to DEI efforts as “quackery” and a form of discrimination. 

Dr. Goldfarb is the chairman of Do No Harm, a Virginia-based advocacy group that has pushed to eradicate “identity politics” in medical education and clinical practice. The group was instrumental in suing the Louisiana governor for a law requiring that minority candidates fill some state medical board positions. It also filed a complaint against the Medical Board of California on behalf of two physicians, claiming the state’s mandated implicit bias training for healthcare professionals violates their First Amendment rights.

Following the Supreme Court’s ruling overturning affirmative action, the American Medical Association (AMA) adopted a policy advising medical schools to consider race as a factor in admissions alongside other criteria such as test scores, grades, and interviews. The policy provides a “necessary safeguard” to diversify the physician workforce and advance health equity, the AMA said at the time. 

The Association of American Medical Colleges supports DEI principles in medical education while advocating for race-neutral admissions practices like holistic review. This method considers the whole applicant, including their experiences, attributes, academic achievements, and the value they bring to the learning environment. 

H.R. 7725 has 35 cosponsors, many of whom are physicians. Podiatrist and Ohio Rep. Brad Wenstrup (R) said in a statement that medical education should be “free of discrimination” and that the bill would prevent physicians from “being forced to pledge, affirm, or adopt tenets that have infiltrated higher education.”

A version of this article appeared on Medscape.com .

About 7% of US adults report having or having had symptoms of long COVID such as fatigue, heart palpitations and/or dizziness. These are 3 of the 12 symptoms identified as part of the National Institute of Health’s RECOVER initiative that can be reliably used to classify someone as having long COVID.

While there is no standard federally approved treatment for long COVID, physicians can recommend several strategies to their patients to help them recover.

The good news is that many people experience improvements in their symptoms over time by adopting these strategies, said Andrew Schamess, MD, an internal medicine physician at the Ohio State University Wexner Medical Center and director of its Post-COVID Recovery Program. 

1. Pace yourself.

Fatigue and postexertional malaise are 2 of the 12 symptoms used to classify someone as having long COVID. 

“There’s mental, or cognitive, fatigue, where people become exhausted after any span of time trying to do complicated cognitive tasks,” said Dr. Schamess. “There’s also general fatigue, or sleepiness, where after a few hours you feel like you could go right back to sleep.” 

The third category, he added, is postexertional malaise, where patients are exhausted by exercise, either immediately or up to 24-48 hours later.

That’s where a technique known as “pacing” can help. Pacing is an energy-conservation technique often used among people with other disabling conditions, such as chronic fatigue syndrome, said Ravindra Ganesh, MD, an internal medicine physician at the Mayo Clinic in Minnesota who specializes in long COVID.

“I tell patients that they have to figure out what their energy envelope is, which is the fixed amount of energy that they can use every day without crashing,” he said. 

You may be able to handle a daily 30-minute walk, for example, but if you pair it with something cognitively difficult, such as doing your taxes, your fatigue symptoms may flare up. 

“It’s hard advice for my patients to follow, as most are real go-getters,” he said. “But I point out to them that if they aim to minimize crashes, it will help them make slow progress.”

Over time, he said, their energy levels should gradually rise so that they can engage in more and more activity.

2. Follow a plant-based, anti-inflammatory diet.

There’s no research to suggest that following a certain eating pattern will help to reverse long COVID, said Dr. Ganesh. But in general, he said his patients anecdotally report that they feel better when they limit refined sugar and follow a plant-based diet that can help to lower inflammation in the body. 

“It makes sense, because it prevents dramatic blood glucose changes that can cause their body to crash,” he said. He generally recommends an anti-inflammatory diet like the Mediterranean diet, which is rich in fruits, vegetables, whole grains, and mono-unsaturated fat.

Many people with long COVID take an array of supplements, Dr. Ganesh said, although there’s little research to suggest that they may help. He does encourage patients to take about 2 g of an omega-3 supplement, such as fish oil, as it may help to reduce inflammation associated with long COVID. 

He also recommends fisetin, a dietary flavonoid found in fruits such as strawberries and kiwis. Preliminary research suggests that it may help to combat some of the neurologic damage associated with long COVID. 

“It appears to maintain mitochondrial function and has anti-inflammatory activities,” said Dr. Ganesh.

3. Modify exercise. 

Most of the time, exercise boosts health and reduces risk for certain diseases. But this strategy may not work for people who have certain symptoms from long COVID, such as postexertional malaise or postural orthostatic tachycardia syndrome (POTS), a condition that causes symptoms such as a fast heart rate, dizziness, and fatigue when transitioning from lying down to standing up. 

“With long-COVID patients, it often has to be symptom-titrated exercise,” said Dr. Schamess. This means physical activity needs to be constantly monitored and adjusted on the basis of a patient’s symptoms. “We need to figure out what they can do that doesn’t provoke their symptoms,” he explained. 

Dr. Schamess often recommends that patients with long COVID, at least initially, focus on exercises in which they are sitting (such as cycling) or prone. 

“The key thing is most people with long COVID can do a lot more exercise in a sitting or lying position than a standing position,” he said. “It’s baffling to them that they can’t walk two blocks but can bike 10 miles.” 

For symptoms like fatigue or postexertional malaise, Dr. Schamess often refers patients to physical therapy to develop an individualized exercise program. A 2022 study published in Scandinavian Journal of Medicine & Science in Sports found that when long-COVID patients completed an 8-week program of three exercise sessions per week, they experienced significant improvements in quality of life, fatigue, muscle strength, and overall fitness compared with a control group. 

“It’s important to make sure that workouts are supervised, so that they can be modified as necessary” said Dr. Schamess. 

4. Take steps to improve sleep quality.

A 2023 study published in the Journal of General Internal Medicine found that about 40% of people with long COVID report sleep issues such as insomnia or not feeling refreshed in the morning. 

“Sleep may become challenging, which can be frustrating for a patient with long COVID who desperately needs rest,” said Lawrence Purpura, MD, an infectious disease specialist and director of the long COVID clinic at Columbia University Medical Center in New York City.

Some of the simplest ways to improve sleep are common sense; however, these issues never affected the person pre-COVID, so they have to become new habits.

“A lot of my patients with long COVID find that they are more sensitive to caffeine, so they really can’t have it anymore later in the day,” he said. “The same goes for bright screens” such as those on cell phones, tablets, and e-book readers, he said. “They may find that it’s harder for them to fall and stay asleep if they’re on their iPhone right before bed. These are all things that may not have been issues before they were diagnosed with long COVID.”

Dr. Purpura also said that he encourages his patients to practice mindfulness or relaxation exercises before bed, such as deep breathing. One technique he recommends is called box breathing, where the patient inhales for 4 seconds, holds his or her breath for 4 seconds, exhales for 4 seconds, then holds his or her breath again for 4 seconds. Some research suggests that this paced breathing technique, when done for 20 minutes before bed, helps to improve symptoms of insomnia. 

While sleep medications such as zolpidem (Ambien) are often used as short-term relief for insomnia, Dr. Schamess said he has not found them particularly helpful for sleep issues that stem from long COVID. 

“They help patients fall asleep but not necessarily stay asleep, which can be an issue for people with long COVID,” he said.

5. Consider medications.

No standard drugs or treatments have yet been approved to treat long COVID (although some, such as Paxlovid, are in clinical trials). But some medications may help to relieve symptoms, said Dr. Ganesh. These include:

• Blood pressure drugs such as beta-blockers now used to treat POTS symptoms
• Nerve-pain medications such as gabapentin or pregabalin. “These can also help with sleep, since patients don’t have pain to distract them,” said Dr. Ganesh.
• Low-dose naltrexone to help with fatigue

“There’s not a one-size-fits-all approach to treat long-COVID symptoms,” said Dr. Ganesh. “You really need to work with the patient and possibly even cycle through several different medications before you find one that helps.”

A version of this article appeared on Medscape.com.

About 7% of US adults report having or having had symptoms of long COVID such as fatigue, heart palpitations and/or dizziness. These are 3 of the 12 symptoms identified as part of the National Institute of Health’s RECOVER initiative that can be reliably used to classify someone as having long COVID.

While there is no standard federally approved treatment for long COVID, physicians can recommend several strategies to their patients to help them recover.

The good news is that many people experience improvements in their symptoms over time by adopting these strategies, said Andrew Schamess, MD, an internal medicine physician at the Ohio State University Wexner Medical Center and director of its Post-COVID Recovery Program. 

1. Pace yourself.

Fatigue and postexertional malaise are 2 of the 12 symptoms used to classify someone as having long COVID. 

“There’s mental, or cognitive, fatigue, where people become exhausted after any span of time trying to do complicated cognitive tasks,” said Dr. Schamess. “There’s also general fatigue, or sleepiness, where after a few hours you feel like you could go right back to sleep.” 

The third category, he added, is postexertional malaise, where patients are exhausted by exercise, either immediately or up to 24-48 hours later.

That’s where a technique known as “pacing” can help. Pacing is an energy-conservation technique often used among people with other disabling conditions, such as chronic fatigue syndrome, said Ravindra Ganesh, MD, an internal medicine physician at the Mayo Clinic in Minnesota who specializes in long COVID.

“I tell patients that they have to figure out what their energy envelope is, which is the fixed amount of energy that they can use every day without crashing,” he said. 

You may be able to handle a daily 30-minute walk, for example, but if you pair it with something cognitively difficult, such as doing your taxes, your fatigue symptoms may flare up. 

“It’s hard advice for my patients to follow, as most are real go-getters,” he said. “But I point out to them that if they aim to minimize crashes, it will help them make slow progress.”

Over time, he said, their energy levels should gradually rise so that they can engage in more and more activity.

2. Follow a plant-based, anti-inflammatory diet.

There’s no research to suggest that following a certain eating pattern will help to reverse long COVID, said Dr. Ganesh. But in general, he said his patients anecdotally report that they feel better when they limit refined sugar and follow a plant-based diet that can help to lower inflammation in the body. 

“It makes sense, because it prevents dramatic blood glucose changes that can cause their body to crash,” he said. He generally recommends an anti-inflammatory diet like the Mediterranean diet, which is rich in fruits, vegetables, whole grains, and mono-unsaturated fat.

Many people with long COVID take an array of supplements, Dr. Ganesh said, although there’s little research to suggest that they may help. He does encourage patients to take about 2 g of an omega-3 supplement, such as fish oil, as it may help to reduce inflammation associated with long COVID. 

He also recommends fisetin, a dietary flavonoid found in fruits such as strawberries and kiwis. Preliminary research suggests that it may help to combat some of the neurologic damage associated with long COVID. 

“It appears to maintain mitochondrial function and has anti-inflammatory activities,” said Dr. Ganesh.

3. Modify exercise. 

Most of the time, exercise boosts health and reduces risk for certain diseases. But this strategy may not work for people who have certain symptoms from long COVID, such as postexertional malaise or postural orthostatic tachycardia syndrome (POTS), a condition that causes symptoms such as a fast heart rate, dizziness, and fatigue when transitioning from lying down to standing up. 

“With long-COVID patients, it often has to be symptom-titrated exercise,” said Dr. Schamess. This means physical activity needs to be constantly monitored and adjusted on the basis of a patient’s symptoms. “We need to figure out what they can do that doesn’t provoke their symptoms,” he explained. 

Dr. Schamess often recommends that patients with long COVID, at least initially, focus on exercises in which they are sitting (such as cycling) or prone. 

“The key thing is most people with long COVID can do a lot more exercise in a sitting or lying position than a standing position,” he said. “It’s baffling to them that they can’t walk two blocks but can bike 10 miles.” 

For symptoms like fatigue or postexertional malaise, Dr. Schamess often refers patients to physical therapy to develop an individualized exercise program. A 2022 study published in Scandinavian Journal of Medicine & Science in Sports found that when long-COVID patients completed an 8-week program of three exercise sessions per week, they experienced significant improvements in quality of life, fatigue, muscle strength, and overall fitness compared with a control group. 

“It’s important to make sure that workouts are supervised, so that they can be modified as necessary” said Dr. Schamess. 

4. Take steps to improve sleep quality.

A 2023 study published in the Journal of General Internal Medicine found that about 40% of people with long COVID report sleep issues such as insomnia or not feeling refreshed in the morning. 

“Sleep may become challenging, which can be frustrating for a patient with long COVID who desperately needs rest,” said Lawrence Purpura, MD, an infectious disease specialist and director of the long COVID clinic at Columbia University Medical Center in New York City.

Some of the simplest ways to improve sleep are common sense; however, these issues never affected the person pre-COVID, so they have to become new habits.

“A lot of my patients with long COVID find that they are more sensitive to caffeine, so they really can’t have it anymore later in the day,” he said. “The same goes for bright screens” such as those on cell phones, tablets, and e-book readers, he said. “They may find that it’s harder for them to fall and stay asleep if they’re on their iPhone right before bed. These are all things that may not have been issues before they were diagnosed with long COVID.”

Dr. Purpura also said that he encourages his patients to practice mindfulness or relaxation exercises before bed, such as deep breathing. One technique he recommends is called box breathing, where the patient inhales for 4 seconds, holds his or her breath for 4 seconds, exhales for 4 seconds, then holds his or her breath again for 4 seconds. Some research suggests that this paced breathing technique, when done for 20 minutes before bed, helps to improve symptoms of insomnia. 

While sleep medications such as zolpidem (Ambien) are often used as short-term relief for insomnia, Dr. Schamess said he has not found them particularly helpful for sleep issues that stem from long COVID. 

“They help patients fall asleep but not necessarily stay asleep, which can be an issue for people with long COVID,” he said.

5. Consider medications.

No standard drugs or treatments have yet been approved to treat long COVID (although some, such as Paxlovid, are in clinical trials). But some medications may help to relieve symptoms, said Dr. Ganesh. These include:

• Blood pressure drugs such as beta-blockers now used to treat POTS symptoms
• Nerve-pain medications such as gabapentin or pregabalin. “These can also help with sleep, since patients don’t have pain to distract them,” said Dr. Ganesh.
• Low-dose naltrexone to help with fatigue

“There’s not a one-size-fits-all approach to treat long-COVID symptoms,” said Dr. Ganesh. “You really need to work with the patient and possibly even cycle through several different medications before you find one that helps.”

A version of this article appeared on Medscape.com.

About 7% of US adults report having or having had symptoms of long COVID such as fatigue, heart palpitations and/or dizziness. These are 3 of the 12 symptoms identified as part of the National Institute of Health’s RECOVER initiative that can be reliably used to classify someone as having long COVID.

While there is no standard federally approved treatment for long COVID, physicians can recommend several strategies to their patients to help them recover.

The good news is that many people experience improvements in their symptoms over time by adopting these strategies, said Andrew Schamess, MD, an internal medicine physician at the Ohio State University Wexner Medical Center and director of its Post-COVID Recovery Program. 

1. Pace yourself.

Fatigue and postexertional malaise are 2 of the 12 symptoms used to classify someone as having long COVID. 

“There’s mental, or cognitive, fatigue, where people become exhausted after any span of time trying to do complicated cognitive tasks,” said Dr. Schamess. “There’s also general fatigue, or sleepiness, where after a few hours you feel like you could go right back to sleep.” 

The third category, he added, is postexertional malaise, where patients are exhausted by exercise, either immediately or up to 24-48 hours later.

That’s where a technique known as “pacing” can help. Pacing is an energy-conservation technique often used among people with other disabling conditions, such as chronic fatigue syndrome, said Ravindra Ganesh, MD, an internal medicine physician at the Mayo Clinic in Minnesota who specializes in long COVID.

“I tell patients that they have to figure out what their energy envelope is, which is the fixed amount of energy that they can use every day without crashing,” he said. 

You may be able to handle a daily 30-minute walk, for example, but if you pair it with something cognitively difficult, such as doing your taxes, your fatigue symptoms may flare up. 

“It’s hard advice for my patients to follow, as most are real go-getters,” he said. “But I point out to them that if they aim to minimize crashes, it will help them make slow progress.”

Over time, he said, their energy levels should gradually rise so that they can engage in more and more activity.

2. Follow a plant-based, anti-inflammatory diet.

There’s no research to suggest that following a certain eating pattern will help to reverse long COVID, said Dr. Ganesh. But in general, he said his patients anecdotally report that they feel better when they limit refined sugar and follow a plant-based diet that can help to lower inflammation in the body. 

“It makes sense, because it prevents dramatic blood glucose changes that can cause their body to crash,” he said. He generally recommends an anti-inflammatory diet like the Mediterranean diet, which is rich in fruits, vegetables, whole grains, and mono-unsaturated fat.

Many people with long COVID take an array of supplements, Dr. Ganesh said, although there’s little research to suggest that they may help. He does encourage patients to take about 2 g of an omega-3 supplement, such as fish oil, as it may help to reduce inflammation associated with long COVID. 

He also recommends fisetin, a dietary flavonoid found in fruits such as strawberries and kiwis. Preliminary research suggests that it may help to combat some of the neurologic damage associated with long COVID. 

“It appears to maintain mitochondrial function and has anti-inflammatory activities,” said Dr. Ganesh.

3. Modify exercise. 

Most of the time, exercise boosts health and reduces risk for certain diseases. But this strategy may not work for people who have certain symptoms from long COVID, such as postexertional malaise or postural orthostatic tachycardia syndrome (POTS), a condition that causes symptoms such as a fast heart rate, dizziness, and fatigue when transitioning from lying down to standing up. 

“With long-COVID patients, it often has to be symptom-titrated exercise,” said Dr. Schamess. This means physical activity needs to be constantly monitored and adjusted on the basis of a patient’s symptoms. “We need to figure out what they can do that doesn’t provoke their symptoms,” he explained. 

Dr. Schamess often recommends that patients with long COVID, at least initially, focus on exercises in which they are sitting (such as cycling) or prone. 

“The key thing is most people with long COVID can do a lot more exercise in a sitting or lying position than a standing position,” he said. “It’s baffling to them that they can’t walk two blocks but can bike 10 miles.” 

For symptoms like fatigue or postexertional malaise, Dr. Schamess often refers patients to physical therapy to develop an individualized exercise program. A 2022 study published in Scandinavian Journal of Medicine & Science in Sports found that when long-COVID patients completed an 8-week program of three exercise sessions per week, they experienced significant improvements in quality of life, fatigue, muscle strength, and overall fitness compared with a control group. 

“It’s important to make sure that workouts are supervised, so that they can be modified as necessary” said Dr. Schamess. 

4. Take steps to improve sleep quality.

A 2023 study published in the Journal of General Internal Medicine found that about 40% of people with long COVID report sleep issues such as insomnia or not feeling refreshed in the morning. 

“Sleep may become challenging, which can be frustrating for a patient with long COVID who desperately needs rest,” said Lawrence Purpura, MD, an infectious disease specialist and director of the long COVID clinic at Columbia University Medical Center in New York City.

Some of the simplest ways to improve sleep are common sense; however, these issues never affected the person pre-COVID, so they have to become new habits.

“A lot of my patients with long COVID find that they are more sensitive to caffeine, so they really can’t have it anymore later in the day,” he said. “The same goes for bright screens” such as those on cell phones, tablets, and e-book readers, he said. “They may find that it’s harder for them to fall and stay asleep if they’re on their iPhone right before bed. These are all things that may not have been issues before they were diagnosed with long COVID.”

Dr. Purpura also said that he encourages his patients to practice mindfulness or relaxation exercises before bed, such as deep breathing. One technique he recommends is called box breathing, where the patient inhales for 4 seconds, holds his or her breath for 4 seconds, exhales for 4 seconds, then holds his or her breath again for 4 seconds. Some research suggests that this paced breathing technique, when done for 20 minutes before bed, helps to improve symptoms of insomnia. 

While sleep medications such as zolpidem (Ambien) are often used as short-term relief for insomnia, Dr. Schamess said he has not found them particularly helpful for sleep issues that stem from long COVID. 

“They help patients fall asleep but not necessarily stay asleep, which can be an issue for people with long COVID,” he said.

5. Consider medications.

No standard drugs or treatments have yet been approved to treat long COVID (although some, such as Paxlovid, are in clinical trials). But some medications may help to relieve symptoms, said Dr. Ganesh. These include:

• Blood pressure drugs such as beta-blockers now used to treat POTS symptoms
• Nerve-pain medications such as gabapentin or pregabalin. “These can also help with sleep, since patients don’t have pain to distract them,” said Dr. Ganesh.
• Low-dose naltrexone to help with fatigue

“There’s not a one-size-fits-all approach to treat long-COVID symptoms,” said Dr. Ganesh. “You really need to work with the patient and possibly even cycle through several different medications before you find one that helps.”

A version of this article appeared on Medscape.com.

SAN DIEGO — The investigative oral Bruton’s tyrosine kinase (BTK) inhibitor remibrutinib shows promise in patients with moderate to severe hidradenitis suppurativa (HS), results from a randomized 16-week phase 2 trial showed.

“Research shows that the TNF-alpha and IL-17 signaling pathways have important roles in HS,” lead investigator Alexa B. Kimball, MD, MPH, from the Clinical Laboratory for Epidemiology and Applied Research in Skin at Beth Israel Deaconess Medical Center, Boston, said at the annual meeting of the American Academy of Dermatology. “However, several additional pathways are thought to contribute to disease pathogenesis.”

“We will see if phase 3 trials with more balanced demographics across remibrutinib and placebo arms will reproduce these outcomes,” she continued, “It is exciting to see this potential new medication for HS under continued investigation, especially in light of the current gap in oral therapeutic options for the HS patient community.” Dr. Hsiao was not involved with the study.

Dr. Kimball disclosed numerous conflicts of interest from various pharmaceutical companies, including the receipt of research grants and consulting fees from Novartis. Dr. Hsiao disclosed that she is a member of the board of directors for the Hidradenitis Suppurativa Foundation. She has also served as a consultant for AbbVie, Aclaris, Boehringer Ingelheim, Incyte, Novartis, and UCB; as a speaker for AbbVie, Novartis, and UCB; and as an investigator for Amgen, Boehringer Ingelheim, and Incyte.

A version of this article appeared on Medscape.com.

SAN DIEGO — The investigative oral Bruton’s tyrosine kinase (BTK) inhibitor remibrutinib shows promise in patients with moderate to severe hidradenitis suppurativa (HS), results from a randomized 16-week phase 2 trial showed.

“Research shows that the TNF-alpha and IL-17 signaling pathways have important roles in HS,” lead investigator Alexa B. Kimball, MD, MPH, from the Clinical Laboratory for Epidemiology and Applied Research in Skin at Beth Israel Deaconess Medical Center, Boston, said at the annual meeting of the American Academy of Dermatology. “However, several additional pathways are thought to contribute to disease pathogenesis.”

“We will see if phase 3 trials with more balanced demographics across remibrutinib and placebo arms will reproduce these outcomes,” she continued, “It is exciting to see this potential new medication for HS under continued investigation, especially in light of the current gap in oral therapeutic options for the HS patient community.” Dr. Hsiao was not involved with the study.

Dr. Kimball disclosed numerous conflicts of interest from various pharmaceutical companies, including the receipt of research grants and consulting fees from Novartis. Dr. Hsiao disclosed that she is a member of the board of directors for the Hidradenitis Suppurativa Foundation. She has also served as a consultant for AbbVie, Aclaris, Boehringer Ingelheim, Incyte, Novartis, and UCB; as a speaker for AbbVie, Novartis, and UCB; and as an investigator for Amgen, Boehringer Ingelheim, and Incyte.

A version of this article appeared on Medscape.com.

SAN DIEGO — The investigative oral Bruton’s tyrosine kinase (BTK) inhibitor remibrutinib shows promise in patients with moderate to severe hidradenitis suppurativa (HS), results from a randomized 16-week phase 2 trial showed.

“Research shows that the TNF-alpha and IL-17 signaling pathways have important roles in HS,” lead investigator Alexa B. Kimball, MD, MPH, from the Clinical Laboratory for Epidemiology and Applied Research in Skin at Beth Israel Deaconess Medical Center, Boston, said at the annual meeting of the American Academy of Dermatology. “However, several additional pathways are thought to contribute to disease pathogenesis.”

“We will see if phase 3 trials with more balanced demographics across remibrutinib and placebo arms will reproduce these outcomes,” she continued, “It is exciting to see this potential new medication for HS under continued investigation, especially in light of the current gap in oral therapeutic options for the HS patient community.” Dr. Hsiao was not involved with the study.

Dr. Kimball disclosed numerous conflicts of interest from various pharmaceutical companies, including the receipt of research grants and consulting fees from Novartis. Dr. Hsiao disclosed that she is a member of the board of directors for the Hidradenitis Suppurativa Foundation. She has also served as a consultant for AbbVie, Aclaris, Boehringer Ingelheim, Incyte, Novartis, and UCB; as a speaker for AbbVie, Novartis, and UCB; and as an investigator for Amgen, Boehringer Ingelheim, and Incyte.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved resmetirom (Rezdiffra, Madrigal Pharmaceuticals), the first drug to treat patients with metabolic dysfunction–associated steatohepatitis (MASH) and moderate to advanced liver fibrosis (consistent with stage F2 and F3 disease), along with diet and exercise. 

Resmetirom is a once-daily, oral thyroid hormone receptor beta-selective agonist. The FDA granted the drug breakthrough therapy designation and priority review.

The approval is based on the phase 3 MAESTRO-NASH trial, in which resmetirom was superior to placebo at achieving resolution of nonalcoholic steatohepatitis (NASH) and improving liver fibrosis in both 80-mg and 100-mg doses. 

The trial used the earlier nomenclature of NASH and nonalcoholic fatty liver disease (NAFLD). An international consensus group has since changed these terms to MASH and metabolic dysfunction–associated steatotic liver disease (MASLD), respectively. (Note that the terms NASH and NAFLD will be used to discuss the trial results in this article to align with the trial’s original language.) 

The results were published online February 6 in The New England Journal of Medicine. 

“The approval of the first medication for NASH is a true game-changer for healthcare providers, the research community and, most importantly, patients living with this serious liver condition,” lead MAESTRO-NASH investigator Stephen Harrison, MD, gastroenterologist, hepatologist, and chairman of Pinnacle Clinical Research and Summit Clinical Research, San Antonio, Texas, said in a news release. 

“Based on the robust efficacy and safety data generated in two large Phase 3 MAESTRO studies, I believe Rezdiffra will become the foundational therapy for patients with NASH with moderate to advanced liver fibrosis. Importantly, we continue to study Rezdiffra to determine if the positive results observed in the MAESTRO studies will lead to reduced risk of progression to cirrhosis, liver failure, need for liver transplant and premature mortality,” Dr. Harrison added.

 

Addressing an Unmet Need 

MASH is a progressive liver disease and the leading cause of liver-related mortality. The disease affects an estimated 1.5 million adults in the United States, of which, roughly 525,000 have MASH with significant fibrosis. Until now, there was no FDA-approved medication. 

In the ongoing MAESTRO-NASH, 996 adults with biopsy-confirmed NASH and significant stage 2-3 fibrosis were randomly assigned to receive oral once-daily resmetirom (80 mg or 100 mg) or placebo. 

Patients were followed for 52 weeks, at which point, they were assessed for the dual primary endpoints of NASH resolution (including a reduction in the NAFLD activity score by ≥ 2 points) with no worsening of fibrosis and an improvement (reduction) in fibrosis by at least one stage with no worsening of the NAFLD activity score.

Patients receiving resmetirom had a significant improvement across both doses and both primary endpoints. 

At 52 weeks, NASH resolution with no worsening of fibrosis was achieved in 25.9% and 29.9% of the patients in the 80-mg and 100-mg groups, respectively, compared with 9.7% on placebo.

Fibrosis improved by at least one stage with no worsening of the NAFLD activity score in 24.2% and 25.9% of patients in the 80-mg and 100-mg groups, respectively, compared with 14.2% on placebo. 

The trial also met multiple secondary endpoints, including statistically significant reduction from baseline in liver enzymes (alanine transaminase, aspartate aminotransferase, and gamma-glutamyl transferase) and low-density lipoprotein cholesterol with resmetirom compared with placebo. 

Improvement in fibrosis biomarkers and relevant imaging tests were also observed in resmetirom treatment groups compared with placebo. 

The most common adverse events included diarrhea and nausea, which typically began early in treatment and were mild to moderate in severity. Pruritus, abdominal pain, vomiting, constipation, and dizziness were also reported.

Resmetirom is expected to be available to patients in the United States in April and will be distributed through a limited specialty pharmacy network.

Full prescribing information is available online. Prescribing information does not include a liver biopsy requirement for diagnosis.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved resmetirom (Rezdiffra, Madrigal Pharmaceuticals), the first drug to treat patients with metabolic dysfunction–associated steatohepatitis (MASH) and moderate to advanced liver fibrosis (consistent with stage F2 and F3 disease), along with diet and exercise. 

Resmetirom is a once-daily, oral thyroid hormone receptor beta-selective agonist. The FDA granted the drug breakthrough therapy designation and priority review.

The approval is based on the phase 3 MAESTRO-NASH trial, in which resmetirom was superior to placebo at achieving resolution of nonalcoholic steatohepatitis (NASH) and improving liver fibrosis in both 80-mg and 100-mg doses. 

The trial used the earlier nomenclature of NASH and nonalcoholic fatty liver disease (NAFLD). An international consensus group has since changed these terms to MASH and metabolic dysfunction–associated steatotic liver disease (MASLD), respectively. (Note that the terms NASH and NAFLD will be used to discuss the trial results in this article to align with the trial’s original language.) 

The results were published online February 6 in The New England Journal of Medicine. 

“The approval of the first medication for NASH is a true game-changer for healthcare providers, the research community and, most importantly, patients living with this serious liver condition,” lead MAESTRO-NASH investigator Stephen Harrison, MD, gastroenterologist, hepatologist, and chairman of Pinnacle Clinical Research and Summit Clinical Research, San Antonio, Texas, said in a news release. 

“Based on the robust efficacy and safety data generated in two large Phase 3 MAESTRO studies, I believe Rezdiffra will become the foundational therapy for patients with NASH with moderate to advanced liver fibrosis. Importantly, we continue to study Rezdiffra to determine if the positive results observed in the MAESTRO studies will lead to reduced risk of progression to cirrhosis, liver failure, need for liver transplant and premature mortality,” Dr. Harrison added.

 

Addressing an Unmet Need 

MASH is a progressive liver disease and the leading cause of liver-related mortality. The disease affects an estimated 1.5 million adults in the United States, of which, roughly 525,000 have MASH with significant fibrosis. Until now, there was no FDA-approved medication. 

In the ongoing MAESTRO-NASH, 996 adults with biopsy-confirmed NASH and significant stage 2-3 fibrosis were randomly assigned to receive oral once-daily resmetirom (80 mg or 100 mg) or placebo. 

Patients were followed for 52 weeks, at which point, they were assessed for the dual primary endpoints of NASH resolution (including a reduction in the NAFLD activity score by ≥ 2 points) with no worsening of fibrosis and an improvement (reduction) in fibrosis by at least one stage with no worsening of the NAFLD activity score.

Patients receiving resmetirom had a significant improvement across both doses and both primary endpoints. 

At 52 weeks, NASH resolution with no worsening of fibrosis was achieved in 25.9% and 29.9% of the patients in the 80-mg and 100-mg groups, respectively, compared with 9.7% on placebo.

Fibrosis improved by at least one stage with no worsening of the NAFLD activity score in 24.2% and 25.9% of patients in the 80-mg and 100-mg groups, respectively, compared with 14.2% on placebo. 

The trial also met multiple secondary endpoints, including statistically significant reduction from baseline in liver enzymes (alanine transaminase, aspartate aminotransferase, and gamma-glutamyl transferase) and low-density lipoprotein cholesterol with resmetirom compared with placebo. 

Improvement in fibrosis biomarkers and relevant imaging tests were also observed in resmetirom treatment groups compared with placebo. 

The most common adverse events included diarrhea and nausea, which typically began early in treatment and were mild to moderate in severity. Pruritus, abdominal pain, vomiting, constipation, and dizziness were also reported.

Resmetirom is expected to be available to patients in the United States in April and will be distributed through a limited specialty pharmacy network.

Full prescribing information is available online. Prescribing information does not include a liver biopsy requirement for diagnosis.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved resmetirom (Rezdiffra, Madrigal Pharmaceuticals), the first drug to treat patients with metabolic dysfunction–associated steatohepatitis (MASH) and moderate to advanced liver fibrosis (consistent with stage F2 and F3 disease), along with diet and exercise. 

Resmetirom is a once-daily, oral thyroid hormone receptor beta-selective agonist. The FDA granted the drug breakthrough therapy designation and priority review.

The approval is based on the phase 3 MAESTRO-NASH trial, in which resmetirom was superior to placebo at achieving resolution of nonalcoholic steatohepatitis (NASH) and improving liver fibrosis in both 80-mg and 100-mg doses. 

The trial used the earlier nomenclature of NASH and nonalcoholic fatty liver disease (NAFLD). An international consensus group has since changed these terms to MASH and metabolic dysfunction–associated steatotic liver disease (MASLD), respectively. (Note that the terms NASH and NAFLD will be used to discuss the trial results in this article to align with the trial’s original language.) 

The results were published online February 6 in The New England Journal of Medicine. 

“The approval of the first medication for NASH is a true game-changer for healthcare providers, the research community and, most importantly, patients living with this serious liver condition,” lead MAESTRO-NASH investigator Stephen Harrison, MD, gastroenterologist, hepatologist, and chairman of Pinnacle Clinical Research and Summit Clinical Research, San Antonio, Texas, said in a news release. 

“Based on the robust efficacy and safety data generated in two large Phase 3 MAESTRO studies, I believe Rezdiffra will become the foundational therapy for patients with NASH with moderate to advanced liver fibrosis. Importantly, we continue to study Rezdiffra to determine if the positive results observed in the MAESTRO studies will lead to reduced risk of progression to cirrhosis, liver failure, need for liver transplant and premature mortality,” Dr. Harrison added.

 

Addressing an Unmet Need 

MASH is a progressive liver disease and the leading cause of liver-related mortality. The disease affects an estimated 1.5 million adults in the United States, of which, roughly 525,000 have MASH with significant fibrosis. Until now, there was no FDA-approved medication. 

In the ongoing MAESTRO-NASH, 996 adults with biopsy-confirmed NASH and significant stage 2-3 fibrosis were randomly assigned to receive oral once-daily resmetirom (80 mg or 100 mg) or placebo. 

Patients were followed for 52 weeks, at which point, they were assessed for the dual primary endpoints of NASH resolution (including a reduction in the NAFLD activity score by ≥ 2 points) with no worsening of fibrosis and an improvement (reduction) in fibrosis by at least one stage with no worsening of the NAFLD activity score.

Patients receiving resmetirom had a significant improvement across both doses and both primary endpoints. 

At 52 weeks, NASH resolution with no worsening of fibrosis was achieved in 25.9% and 29.9% of the patients in the 80-mg and 100-mg groups, respectively, compared with 9.7% on placebo.

Fibrosis improved by at least one stage with no worsening of the NAFLD activity score in 24.2% and 25.9% of patients in the 80-mg and 100-mg groups, respectively, compared with 14.2% on placebo. 

The trial also met multiple secondary endpoints, including statistically significant reduction from baseline in liver enzymes (alanine transaminase, aspartate aminotransferase, and gamma-glutamyl transferase) and low-density lipoprotein cholesterol with resmetirom compared with placebo. 

Improvement in fibrosis biomarkers and relevant imaging tests were also observed in resmetirom treatment groups compared with placebo. 

The most common adverse events included diarrhea and nausea, which typically began early in treatment and were mild to moderate in severity. Pruritus, abdominal pain, vomiting, constipation, and dizziness were also reported.

Resmetirom is expected to be available to patients in the United States in April and will be distributed through a limited specialty pharmacy network.

Full prescribing information is available online. Prescribing information does not include a liver biopsy requirement for diagnosis.

A version of this article appeared on Medscape.com.

TOPLINE: 

The results of a recent study suggest that biologics and small molecule inhibitors (SMIs) do not impair the protective effect of COVID-19 vaccine against hospitalization in patients with psoriasis and hidradenitis suppurativa (HS).

METHODOLOGY:

• It remains unknown whether immunomodulatory therapies impair COVID-19 vaccine efficacy and increase hospitalization rates linked to COVID-19 in patients with inflammatory skin conditions such as psoriasis or HS.
• Researchers conducted a cross-sectional study using data from the Epic Cosmos database from January 2020 to October 2023, identifying 30,845 patients with psoriasis or HS.
• Overall, 22,293 patients with documented completion of their primary COVID-19 vaccine series were included in the analysis.
• Of the vaccinated patients, they compared 7046 patients with psoriasis on SMIs and 2033 with psoriasis or HS on biologics with 13,214 patients who did not receive biologics or SMIs.
• The primary outcome was the COVID-19 hospitalization rate.
• Treatment with biologics did not increase COVID-19-related hospitalization rates in vaccinated patients with psoriasis or HS (hospitalization rate, 6.0% for both those taking and those not taking a biologic; P > .99).
• Similarly, hospitalization rates did not significantly differ between vaccinated patients who received SMIs vs those who did not (7.1% vs 6.0%; P = .0596).

IN PRACTICE:

These findings “encourage dermatologists to continue treating [psoriasis]/HS confidently despite the ongoing COVID-19 pandemic,” the authors concluded.

SOURCE:

The study led by Bella R. Lee from Ohio State University Wexner Medical Center, Columbus, was published online on March 13, 2024, in the Journal of the American Academy of Dermatology. 

LIMITATIONS:

Multivariable adjustments could not be performed in this study due to unavailability of individual-level data, and hospital admissions that occurred outside the Epic system were not captured.

DISCLOSURES:

The study did not receive any funding. All authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE: 

The results of a recent study suggest that biologics and small molecule inhibitors (SMIs) do not impair the protective effect of COVID-19 vaccine against hospitalization in patients with psoriasis and hidradenitis suppurativa (HS).

METHODOLOGY:

• It remains unknown whether immunomodulatory therapies impair COVID-19 vaccine efficacy and increase hospitalization rates linked to COVID-19 in patients with inflammatory skin conditions such as psoriasis or HS.
• Researchers conducted a cross-sectional study using data from the Epic Cosmos database from January 2020 to October 2023, identifying 30,845 patients with psoriasis or HS.
• Overall, 22,293 patients with documented completion of their primary COVID-19 vaccine series were included in the analysis.
• Of the vaccinated patients, they compared 7046 patients with psoriasis on SMIs and 2033 with psoriasis or HS on biologics with 13,214 patients who did not receive biologics or SMIs.
• The primary outcome was the COVID-19 hospitalization rate.
• Treatment with biologics did not increase COVID-19-related hospitalization rates in vaccinated patients with psoriasis or HS (hospitalization rate, 6.0% for both those taking and those not taking a biologic; P > .99).
• Similarly, hospitalization rates did not significantly differ between vaccinated patients who received SMIs vs those who did not (7.1% vs 6.0%; P = .0596).

IN PRACTICE:

These findings “encourage dermatologists to continue treating [psoriasis]/HS confidently despite the ongoing COVID-19 pandemic,” the authors concluded.

SOURCE:

The study led by Bella R. Lee from Ohio State University Wexner Medical Center, Columbus, was published online on March 13, 2024, in the Journal of the American Academy of Dermatology. 

LIMITATIONS:

Multivariable adjustments could not be performed in this study due to unavailability of individual-level data, and hospital admissions that occurred outside the Epic system were not captured.

DISCLOSURES:

The study did not receive any funding. All authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE: 

The results of a recent study suggest that biologics and small molecule inhibitors (SMIs) do not impair the protective effect of COVID-19 vaccine against hospitalization in patients with psoriasis and hidradenitis suppurativa (HS).

METHODOLOGY:

• It remains unknown whether immunomodulatory therapies impair COVID-19 vaccine efficacy and increase hospitalization rates linked to COVID-19 in patients with inflammatory skin conditions such as psoriasis or HS.
• Researchers conducted a cross-sectional study using data from the Epic Cosmos database from January 2020 to October 2023, identifying 30,845 patients with psoriasis or HS.
• Overall, 22,293 patients with documented completion of their primary COVID-19 vaccine series were included in the analysis.
• Of the vaccinated patients, they compared 7046 patients with psoriasis on SMIs and 2033 with psoriasis or HS on biologics with 13,214 patients who did not receive biologics or SMIs.
• The primary outcome was the COVID-19 hospitalization rate.
• Treatment with biologics did not increase COVID-19-related hospitalization rates in vaccinated patients with psoriasis or HS (hospitalization rate, 6.0% for both those taking and those not taking a biologic; P > .99).
• Similarly, hospitalization rates did not significantly differ between vaccinated patients who received SMIs vs those who did not (7.1% vs 6.0%; P = .0596).

IN PRACTICE:

These findings “encourage dermatologists to continue treating [psoriasis]/HS confidently despite the ongoing COVID-19 pandemic,” the authors concluded.

SOURCE:

The study led by Bella R. Lee from Ohio State University Wexner Medical Center, Columbus, was published online on March 13, 2024, in the Journal of the American Academy of Dermatology. 

LIMITATIONS:

Multivariable adjustments could not be performed in this study due to unavailability of individual-level data, and hospital admissions that occurred outside the Epic system were not captured.

DISCLOSURES:

The study did not receive any funding. All authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

SAN DIEGO — Maternal hidradenitis suppurativa (HS) is associated with an increased risk for adverse birth outcomes and childhood morbidities, including respiratory, metabolic, central nervous system, and other conditions.

Those are key findings from a longitudinal cohort study that was presented during a poster session at the annual meeting of the American Academy of Dermatology.

“HS is associated with morbidity in women of reproductive age and adverse pregnancy outcomes, [but] its effect on offspring outcomes remains unclear,” corresponding author Kaiyang Li, a third-year medical student at McGill University, Quebec, Canada, and coauthors wrote in their abstract.

To investigate the association between maternal HS and offspring outcomes at birth and with up to 16 years of follow-up, the researchers drew from a longitudinal cohort of 1,275,593 children born in Quebec between April 1, 2006 and March 31, 2022. They matched children with their mothers and used identification numbers to follow the children to note morbidities that led to hospital admissions before age 16 years. The exposure of interest was HS, and the main outcome measure was childhood hospitalizations for respiratory, cardiovascular, metabolic, and other morbidities prior to age 16 years. 

Next, they estimated hazard ratios (HR) and 95% CIs for the association of maternal HS with childhood morbidity in adjusted Cox proportional hazards regression models. “As prenatal exposure to hyperandrogenism may influence boys and girls differently, we carried out subgroup analyses stratified by child sex,” they wrote. 

The study population included 1283 children whose mothers had HS and 1,274,310 unexposed children. As for infant outcomes, compared with no exposure, maternal HS was associated with an increased risk for preterm birth (relative risk [RR], 1.29; 95% CI, 1,08-1.55), neonatal death (RR, 2.07; 95% CI, 1.03-14.13), birth defects (RR, 1.29; 95% CI, 1.07-1.56), congenital heart defects (RR, 1.57; 95% CI, 1.02-2.44), and orofacial defects (RR 4.29; 95% CI, 1.85-9.97).

As for long-term outcomes in the children, compared with those whose mothers did not have HS, maternal HS was associated with an increased risk for any childhood hospitalization (HR, 1.31; 95% CI, 1.19-1.44), respiratory hospitalization (HR, 1.21; 95% CI, 1.05-1.40), metabolic hospitalization (HR, 2.64; 95% CI, 1.67-4.20), gastrointestinal hospitalization (HR, 1.34; 95% CI, 1.03-1.74), and developmental hospitalization (HR, 1.92; 95% CI, 1.43-2.58).

Commenting on the results after the meeting, Ms. Li said that the findings support the need for timely management of HS in expectant mothers and people planning to conceive, and for “interdisciplinary care and follow up for both the mother and the baby, involving the dermatologist, the obstetrician, and the neonatologist or pediatrician if needed.”

“HS is a multidisciplinary disease, plain and simple,” Adam Friedman, MD, professor and chair of dermatology, George Washington University, Washington, who was asked to comment on the study, said in an interview. “This study highlights the importance of collaboration between dermatology and obstetrician-gynecologist given the potential negative pregnancy outcomes, but to me raising alarm bells given the known gaps and delays in diagnosis matched to disease onset,” said Dr. Friedman, who was not involved with the study. “We need to do better to ensure the safety of both patient and patient-to-be.”

The researchers reported having no financial disclosures. The abstract was selected as the second-place winner in the AAD’s poster competition. Dr. Friedman has no relevant disclosures.

A version of this article appeared on Medscape.com.

SAN DIEGO — Maternal hidradenitis suppurativa (HS) is associated with an increased risk for adverse birth outcomes and childhood morbidities, including respiratory, metabolic, central nervous system, and other conditions.

Those are key findings from a longitudinal cohort study that was presented during a poster session at the annual meeting of the American Academy of Dermatology.

“HS is associated with morbidity in women of reproductive age and adverse pregnancy outcomes, [but] its effect on offspring outcomes remains unclear,” corresponding author Kaiyang Li, a third-year medical student at McGill University, Quebec, Canada, and coauthors wrote in their abstract.

To investigate the association between maternal HS and offspring outcomes at birth and with up to 16 years of follow-up, the researchers drew from a longitudinal cohort of 1,275,593 children born in Quebec between April 1, 2006 and March 31, 2022. They matched children with their mothers and used identification numbers to follow the children to note morbidities that led to hospital admissions before age 16 years. The exposure of interest was HS, and the main outcome measure was childhood hospitalizations for respiratory, cardiovascular, metabolic, and other morbidities prior to age 16 years. 

Next, they estimated hazard ratios (HR) and 95% CIs for the association of maternal HS with childhood morbidity in adjusted Cox proportional hazards regression models. “As prenatal exposure to hyperandrogenism may influence boys and girls differently, we carried out subgroup analyses stratified by child sex,” they wrote. 

The study population included 1283 children whose mothers had HS and 1,274,310 unexposed children. As for infant outcomes, compared with no exposure, maternal HS was associated with an increased risk for preterm birth (relative risk [RR], 1.29; 95% CI, 1,08-1.55), neonatal death (RR, 2.07; 95% CI, 1.03-14.13), birth defects (RR, 1.29; 95% CI, 1.07-1.56), congenital heart defects (RR, 1.57; 95% CI, 1.02-2.44), and orofacial defects (RR 4.29; 95% CI, 1.85-9.97).

As for long-term outcomes in the children, compared with those whose mothers did not have HS, maternal HS was associated with an increased risk for any childhood hospitalization (HR, 1.31; 95% CI, 1.19-1.44), respiratory hospitalization (HR, 1.21; 95% CI, 1.05-1.40), metabolic hospitalization (HR, 2.64; 95% CI, 1.67-4.20), gastrointestinal hospitalization (HR, 1.34; 95% CI, 1.03-1.74), and developmental hospitalization (HR, 1.92; 95% CI, 1.43-2.58).

Commenting on the results after the meeting, Ms. Li said that the findings support the need for timely management of HS in expectant mothers and people planning to conceive, and for “interdisciplinary care and follow up for both the mother and the baby, involving the dermatologist, the obstetrician, and the neonatologist or pediatrician if needed.”

“HS is a multidisciplinary disease, plain and simple,” Adam Friedman, MD, professor and chair of dermatology, George Washington University, Washington, who was asked to comment on the study, said in an interview. “This study highlights the importance of collaboration between dermatology and obstetrician-gynecologist given the potential negative pregnancy outcomes, but to me raising alarm bells given the known gaps and delays in diagnosis matched to disease onset,” said Dr. Friedman, who was not involved with the study. “We need to do better to ensure the safety of both patient and patient-to-be.”

The researchers reported having no financial disclosures. The abstract was selected as the second-place winner in the AAD’s poster competition. Dr. Friedman has no relevant disclosures.

A version of this article appeared on Medscape.com.

SAN DIEGO — Maternal hidradenitis suppurativa (HS) is associated with an increased risk for adverse birth outcomes and childhood morbidities, including respiratory, metabolic, central nervous system, and other conditions.

Those are key findings from a longitudinal cohort study that was presented during a poster session at the annual meeting of the American Academy of Dermatology.

“HS is associated with morbidity in women of reproductive age and adverse pregnancy outcomes, [but] its effect on offspring outcomes remains unclear,” corresponding author Kaiyang Li, a third-year medical student at McGill University, Quebec, Canada, and coauthors wrote in their abstract.

To investigate the association between maternal HS and offspring outcomes at birth and with up to 16 years of follow-up, the researchers drew from a longitudinal cohort of 1,275,593 children born in Quebec between April 1, 2006 and March 31, 2022. They matched children with their mothers and used identification numbers to follow the children to note morbidities that led to hospital admissions before age 16 years. The exposure of interest was HS, and the main outcome measure was childhood hospitalizations for respiratory, cardiovascular, metabolic, and other morbidities prior to age 16 years. 

Next, they estimated hazard ratios (HR) and 95% CIs for the association of maternal HS with childhood morbidity in adjusted Cox proportional hazards regression models. “As prenatal exposure to hyperandrogenism may influence boys and girls differently, we carried out subgroup analyses stratified by child sex,” they wrote. 

The study population included 1283 children whose mothers had HS and 1,274,310 unexposed children. As for infant outcomes, compared with no exposure, maternal HS was associated with an increased risk for preterm birth (relative risk [RR], 1.29; 95% CI, 1,08-1.55), neonatal death (RR, 2.07; 95% CI, 1.03-14.13), birth defects (RR, 1.29; 95% CI, 1.07-1.56), congenital heart defects (RR, 1.57; 95% CI, 1.02-2.44), and orofacial defects (RR 4.29; 95% CI, 1.85-9.97).

As for long-term outcomes in the children, compared with those whose mothers did not have HS, maternal HS was associated with an increased risk for any childhood hospitalization (HR, 1.31; 95% CI, 1.19-1.44), respiratory hospitalization (HR, 1.21; 95% CI, 1.05-1.40), metabolic hospitalization (HR, 2.64; 95% CI, 1.67-4.20), gastrointestinal hospitalization (HR, 1.34; 95% CI, 1.03-1.74), and developmental hospitalization (HR, 1.92; 95% CI, 1.43-2.58).

Commenting on the results after the meeting, Ms. Li said that the findings support the need for timely management of HS in expectant mothers and people planning to conceive, and for “interdisciplinary care and follow up for both the mother and the baby, involving the dermatologist, the obstetrician, and the neonatologist or pediatrician if needed.”

“HS is a multidisciplinary disease, plain and simple,” Adam Friedman, MD, professor and chair of dermatology, George Washington University, Washington, who was asked to comment on the study, said in an interview. “This study highlights the importance of collaboration between dermatology and obstetrician-gynecologist given the potential negative pregnancy outcomes, but to me raising alarm bells given the known gaps and delays in diagnosis matched to disease onset,” said Dr. Friedman, who was not involved with the study. “We need to do better to ensure the safety of both patient and patient-to-be.”

The researchers reported having no financial disclosures. The abstract was selected as the second-place winner in the AAD’s poster competition. Dr. Friedman has no relevant disclosures.

A version of this article appeared on Medscape.com.

Most major cancer trial centers in the United States are located closer to populations with higher proportions of White, affluent individuals, a new study finds.

This inequity may be potentiating the underrepresentation of racially minoritized and socioeconomically disadvantaged populations in clinical trials, suggesting that employment of satellite hospitals is needed to expand access to investigational therapies, reported lead author Hassal Lee, MD, PhD, of Cold Spring Harbor Laboratory, Cold Spring Harbor, New York, and colleagues.

“Minoritized and socioeconomically disadvantaged populations are underrepresented in clinical trials,” the investigators wrote in JAMA Oncology. “This may reduce the generalizability of trial results and propagate health disparities. Contributors to inequitable trial participation include individual-level factors and structural factors.”

Specifically, travel time to trial centers, as well as socioeconomic deprivation, can reduce likelihood of trial participation.

“Data on these parameters and population data on self-identified race exist, but their interrelation with clinical research facilities has not been systematically analyzed,” they wrote.

To try to draw comparisons between the distribution of patients of different races and socioeconomic statuses and the locations of clinical research facilities, Dr. Lee and colleagues aggregated data from the US Census, National Trial registry, Nature Index of Cancer Research Health Institutions, OpenStreetMap, National Cancer Institute–designated Cancer Centers list, and National Homeland Infrastructure Foundation. They then characterized catchment population demographics within 30-, 60-, and 120-minute driving commute times of all US hospitals, along with a more focused look at centers capable of conducting phase 1, phase 2, and phase 3 trials.

These efforts revealed broad geographic inequity.The 78 major centers that conduct 94% of all US cancer trials are located within 30 minutes of populations that have a 10.1% higher proportion of self-identified White individuals than the average US county, and a median income $18,900 higher than average (unpaired mean differences).

The publication also includes several maps characterizing racial and socioeconomic demographics within various catchment areas. For example, centers in New York City, Houston, and Chicago have the most diverse catchment populations within a 30-minute commute. Maps of all cities in the United States with populations greater than 500,000 are available in a supplementary index.

“This study indicates that geographical population distributions may present barriers to equitable clinical trial access and that data are available to proactively strategize about reduction of such barriers,” Dr. Lee and colleagues wrote.

The findings call attention to modifiable socioeconomic factors associated with trial participation, they added, like financial toxicity and affordable transportation, noting that ethnic and racial groups consent to trials at similar rates after controlling for income.

In addition, Dr. Lee and colleagues advised clinical trial designers to enlist satellite hospitals to increase participant diversity, since long commutes exacerbate “socioeconomic burdens associated with clinical trial participation,” with trial participation decreasing as commute time increases.

“Existing clinical trial centers may build collaborative efforts with nearby hospitals closer to underrepresented populations or set up community centers to support new collaborative networks to improve geographical access equity,” they wrote. “Methodologically, our approach is transferable to any country, region, or global effort with sufficient source data and can inform decision-making along the continuum of cancer care, from screening to implementing specialist care.”

A coauthor disclosed relationships with Flagship Therapeutics, Leidos Holding Ltd, Pershing Square Foundation, and others.

Most major cancer trial centers in the United States are located closer to populations with higher proportions of White, affluent individuals, a new study finds.

This inequity may be potentiating the underrepresentation of racially minoritized and socioeconomically disadvantaged populations in clinical trials, suggesting that employment of satellite hospitals is needed to expand access to investigational therapies, reported lead author Hassal Lee, MD, PhD, of Cold Spring Harbor Laboratory, Cold Spring Harbor, New York, and colleagues.

“Minoritized and socioeconomically disadvantaged populations are underrepresented in clinical trials,” the investigators wrote in JAMA Oncology. “This may reduce the generalizability of trial results and propagate health disparities. Contributors to inequitable trial participation include individual-level factors and structural factors.”

Specifically, travel time to trial centers, as well as socioeconomic deprivation, can reduce likelihood of trial participation.

“Data on these parameters and population data on self-identified race exist, but their interrelation with clinical research facilities has not been systematically analyzed,” they wrote.

To try to draw comparisons between the distribution of patients of different races and socioeconomic statuses and the locations of clinical research facilities, Dr. Lee and colleagues aggregated data from the US Census, National Trial registry, Nature Index of Cancer Research Health Institutions, OpenStreetMap, National Cancer Institute–designated Cancer Centers list, and National Homeland Infrastructure Foundation. They then characterized catchment population demographics within 30-, 60-, and 120-minute driving commute times of all US hospitals, along with a more focused look at centers capable of conducting phase 1, phase 2, and phase 3 trials.

These efforts revealed broad geographic inequity.The 78 major centers that conduct 94% of all US cancer trials are located within 30 minutes of populations that have a 10.1% higher proportion of self-identified White individuals than the average US county, and a median income $18,900 higher than average (unpaired mean differences).

The publication also includes several maps characterizing racial and socioeconomic demographics within various catchment areas. For example, centers in New York City, Houston, and Chicago have the most diverse catchment populations within a 30-minute commute. Maps of all cities in the United States with populations greater than 500,000 are available in a supplementary index.

“This study indicates that geographical population distributions may present barriers to equitable clinical trial access and that data are available to proactively strategize about reduction of such barriers,” Dr. Lee and colleagues wrote.

The findings call attention to modifiable socioeconomic factors associated with trial participation, they added, like financial toxicity and affordable transportation, noting that ethnic and racial groups consent to trials at similar rates after controlling for income.

In addition, Dr. Lee and colleagues advised clinical trial designers to enlist satellite hospitals to increase participant diversity, since long commutes exacerbate “socioeconomic burdens associated with clinical trial participation,” with trial participation decreasing as commute time increases.

“Existing clinical trial centers may build collaborative efforts with nearby hospitals closer to underrepresented populations or set up community centers to support new collaborative networks to improve geographical access equity,” they wrote. “Methodologically, our approach is transferable to any country, region, or global effort with sufficient source data and can inform decision-making along the continuum of cancer care, from screening to implementing specialist care.”

A coauthor disclosed relationships with Flagship Therapeutics, Leidos Holding Ltd, Pershing Square Foundation, and others.

Most major cancer trial centers in the United States are located closer to populations with higher proportions of White, affluent individuals, a new study finds.

This inequity may be potentiating the underrepresentation of racially minoritized and socioeconomically disadvantaged populations in clinical trials, suggesting that employment of satellite hospitals is needed to expand access to investigational therapies, reported lead author Hassal Lee, MD, PhD, of Cold Spring Harbor Laboratory, Cold Spring Harbor, New York, and colleagues.

“Minoritized and socioeconomically disadvantaged populations are underrepresented in clinical trials,” the investigators wrote in JAMA Oncology. “This may reduce the generalizability of trial results and propagate health disparities. Contributors to inequitable trial participation include individual-level factors and structural factors.”

Specifically, travel time to trial centers, as well as socioeconomic deprivation, can reduce likelihood of trial participation.

“Data on these parameters and population data on self-identified race exist, but their interrelation with clinical research facilities has not been systematically analyzed,” they wrote.

To try to draw comparisons between the distribution of patients of different races and socioeconomic statuses and the locations of clinical research facilities, Dr. Lee and colleagues aggregated data from the US Census, National Trial registry, Nature Index of Cancer Research Health Institutions, OpenStreetMap, National Cancer Institute–designated Cancer Centers list, and National Homeland Infrastructure Foundation. They then characterized catchment population demographics within 30-, 60-, and 120-minute driving commute times of all US hospitals, along with a more focused look at centers capable of conducting phase 1, phase 2, and phase 3 trials.

These efforts revealed broad geographic inequity.The 78 major centers that conduct 94% of all US cancer trials are located within 30 minutes of populations that have a 10.1% higher proportion of self-identified White individuals than the average US county, and a median income $18,900 higher than average (unpaired mean differences).

The publication also includes several maps characterizing racial and socioeconomic demographics within various catchment areas. For example, centers in New York City, Houston, and Chicago have the most diverse catchment populations within a 30-minute commute. Maps of all cities in the United States with populations greater than 500,000 are available in a supplementary index.

“This study indicates that geographical population distributions may present barriers to equitable clinical trial access and that data are available to proactively strategize about reduction of such barriers,” Dr. Lee and colleagues wrote.

The findings call attention to modifiable socioeconomic factors associated with trial participation, they added, like financial toxicity and affordable transportation, noting that ethnic and racial groups consent to trials at similar rates after controlling for income.

In addition, Dr. Lee and colleagues advised clinical trial designers to enlist satellite hospitals to increase participant diversity, since long commutes exacerbate “socioeconomic burdens associated with clinical trial participation,” with trial participation decreasing as commute time increases.

“Existing clinical trial centers may build collaborative efforts with nearby hospitals closer to underrepresented populations or set up community centers to support new collaborative networks to improve geographical access equity,” they wrote. “Methodologically, our approach is transferable to any country, region, or global effort with sufficient source data and can inform decision-making along the continuum of cancer care, from screening to implementing specialist care.”

A coauthor disclosed relationships with Flagship Therapeutics, Leidos Holding Ltd, Pershing Square Foundation, and others.