Dermatology News

Nine days after the independent laboratory Valisure petitioned the Food and Drug Administration (FDA) to recall acne products with benzoyl peroxide (BP) because of the lab’s findings of extremely high levels of the carcinogen benzene, it published another report in Environmental Health Perspectives (EHP), on March 14, also warning about BP acne products.

The bottom line was the same: The laboratory, based in New Haven, Connecticut, said its analyses raise substantial concerns about the safety of BP-containing acne products currently on the market.

The lab’s results showed that the products can form over 800 times the conditionally restricted FDA concentration limit of 2 parts per million (ppm) of benzene, with both prescription and over-the-counter products affected.

“This is a problem of degradation, not contamination,” David Light, CEO and founder of Valisure, said in a telephone interview. BP can decompose into benzene, and exposure to benzene has been linked with a higher risk for leukemia and other blood cancers, according to the American Cancer Society.

In the wake of the findings, however, debate has erupted over the method and approach used by Valisure to test these products, with critics and companies contending that more “real-world” use data are needed. And the US Pharmacopeia (USP) is asking for full transparency about the testing methods.

In a March 8 statement, USP said the petition indicated that modified USP methods were used in the study, noting that “if changes are made to a USP method, complete validation data is necessary to demonstrate that a product meets USP standards.”

However, Valisure contended that drug products need to demonstrate stability over the entire life cycle, from shipment to continued use, emphasizing that constitutes the best “real-world” approach. It also defended the methodology it used.

The reports have led to a state of uncertainty about the use of BP products.

“Right now, we have more unknowns than anything else,” John Barbieri, MD, MBA, assistant professor of dermatology at Harvard Medical School and director of the Advanced Acne Therapeutics Clinic at Brigham and Women’s Hospital, Boston, said in a video posted on X and YouTube, summarizing the findings released by Valisure on March 6 and 14. He was not involved in the Valisure research.

Brigham and Women's Hospital

In a telephone interview, Dr. Barbieri said the report “needs to be taken seriously,” but he also believed the Valisure report is lacking information about testing under “real-world” conditions. He is calling for more information and more transparency about the data. What’s clear, Dr. Barbieri told this news organization, is that the findings about high benzene levels are not a manufacturing error. “It’s something to do with the molecule itself.”
 

Valisure’s Analyses

Valisure performed an initial analysis, using a method called gas chromatography-mass spectrometry, which is the FDA-preferred method for detecting benzene, Mr. Light said. It tested 175 acne products, 99 containing BP and 76 with other ingredients, such as salicylic acid. All the products without BP had no detectable benzene or values below 2 ppm, the FDA concentration limit for benzene.

Of the 99 BP products, 94 contained benzene without any elevated temperature incubation, according to Valisure. Using 50 °C (122 °F, the accepted pharmaceutical stability testing temperature) on 66 products, Valisure detected over 1500 ppm of benzene in two products, over 100 ppm in 17 products, and over 10 ppm in 42 products over an 18-day period.

The analysis confirmed, Valisure said in a press release and the petition, that a substantial amount of benzene can form in a BP product and leak outside the packaging into surrounding air.

The EHP paper, which includes authors from Valisure, reported that researchers took single lots of seven branded BP products, namely, Equate Beauty 2.5% BP cleansers, Neutrogena 10% BP cleanser, CVS Health 10% BP face wash, Walgreens 10% BP cream, Clean & Clear 10% cleanser, Equate Beauty 10% BP acne wash, and Proactiv 2.5% BP cleanser.

Using testing that involved gas chromatography-mass spectrometry, benzene was detected in all the BP products samples tested, and levels increased during incubation at body and shelf-life performance temperatures to more than 2 ppm. The authors concluded that the study “raises substantial concerns” about the safety of BP products currently on the market.
 

Methodology Debates

Two days after Valisure released its analysis on March 6, the USP reviewed the citizen’s petition filed by Valisure and called for more transparency around the testing methods.

“The petition referenced USP and indicated that modified USP methods and procedures were used in the study. The presence of unsafe levels of benzene should be taken seriously,” the statement said. The USP statement also noted that the Valisure analysis used modified USP methods and said that “if changes are made to a USP method, complete validation data is necessary to demonstrate that a product meets USP standards.”

In its statement, USP took issue with a practice known as accelerated thermal degradation, which it said Valisure used. USP said the approach involves raising the storage temperature of a product to higher than the temperature indicated on the label for the purpose of simulating degradation over a longer period. While the approach may be acceptable, USP said, the temperatures chosen may not be what is expected to happen to the products.

In response, Mr. Light of Valisure referenced guidance issued in August, 2020, from the FDA, stating that the method it used in the BP analysis can be used to detect impurities in hand sanitizers, including benzene. (In 2021, Valisure detected high levels of benzene in some hand sanitizers and asked the FDA to take action.)
 

Company Response

Among the companies that took issue with the report was Reckitt, which makes Clearasil, which contains BP. In a statement, the company said, in part: “The products and their ingredients are stable over the storage conditions described on their packaging which represent all reasonable and foreseeable conditions.” It said the findings presented by Valisure reflect “unrealistic scenarios rather than real-world conditions.”

The Personal Care Products Council, a national trade association that represents cosmetic and personal care product manufacturers, also took issue with the findings and the approach used to evaluate the products.
 

FDA and the Citizen’s Petition

The FDA accepted the petition, Mr. Light said, and gave it a docket number. “We’ll hopefully hear more soon” because the FDA is required to respond to a citizen’s petition within 180 days, he said.

“We generally don’t comment on pending citizens’ petitions,” an FDA spokesperson said in an email. “When we respond, we will respond directly to the petitioner and post the response in the designated agency public docket.”
 

Valisure’s Patent Application

Mr. Light and others have applied for a patent on methods of producing shelf-stable formulations to prevent degradation of BP to benzene.

“We saw the problem long before we had any sort of application,” Mr. Light said. The issue has been “known for decades.”
 

Role of BP Products for Acne

In the midst of uncertainty, “the first discussion is, do we want to use it?” Dr. Barbieri said in the interview. Some patients may want to avoid it altogether, until more data are available, including more verification of the findings, while others may be comfortable accepting the potential risk, he said.

“Benzoyl peroxide is one of our foundational acne treatments,” Dr. Barbieri said. In the American Academy of Dermatology updated guidelines on acne, published in January, 2024, strong recommendations were made for BP products, as well as topical retinoids, topical antibiotics, and oral doxycycline.

“When you take away BP, there’s no substitute for it,” Dr. Barbieri said. And if patients don’t get improvement with topicals, oral medications might be needed, and “these all have their own risks.”
 

In the Interim

Until more information is available, Dr. Barbieri is advising patients not to store the products at high temperatures or for a long time. Don’t keep the products past their expiration date, and perhaps keep products for a shorter time, “something like a month,” he said.

Those living in a hot climate might consider storing the products in the refrigerator, he said.

“We need more data from Valisure, from other groups that confirm their findings, and we need to hear from the FDA,” Dr. Barbieri said. “There’s a lot of uncertainty right now. But it’s important not to overreact.”

Dr. Barbieri had no relevant disclosures.


 

A version of this article appeared on Medscape.com.

Nine days after the independent laboratory Valisure petitioned the Food and Drug Administration (FDA) to recall acne products with benzoyl peroxide (BP) because of the lab’s findings of extremely high levels of the carcinogen benzene, it published another report in Environmental Health Perspectives (EHP), on March 14, also warning about BP acne products.

The bottom line was the same: The laboratory, based in New Haven, Connecticut, said its analyses raise substantial concerns about the safety of BP-containing acne products currently on the market.

The lab’s results showed that the products can form over 800 times the conditionally restricted FDA concentration limit of 2 parts per million (ppm) of benzene, with both prescription and over-the-counter products affected.

“This is a problem of degradation, not contamination,” David Light, CEO and founder of Valisure, said in a telephone interview. BP can decompose into benzene, and exposure to benzene has been linked with a higher risk for leukemia and other blood cancers, according to the American Cancer Society.

In the wake of the findings, however, debate has erupted over the method and approach used by Valisure to test these products, with critics and companies contending that more “real-world” use data are needed. And the US Pharmacopeia (USP) is asking for full transparency about the testing methods.

In a March 8 statement, USP said the petition indicated that modified USP methods were used in the study, noting that “if changes are made to a USP method, complete validation data is necessary to demonstrate that a product meets USP standards.”

However, Valisure contended that drug products need to demonstrate stability over the entire life cycle, from shipment to continued use, emphasizing that constitutes the best “real-world” approach. It also defended the methodology it used.

The reports have led to a state of uncertainty about the use of BP products.

“Right now, we have more unknowns than anything else,” John Barbieri, MD, MBA, assistant professor of dermatology at Harvard Medical School and director of the Advanced Acne Therapeutics Clinic at Brigham and Women’s Hospital, Boston, said in a video posted on X and YouTube, summarizing the findings released by Valisure on March 6 and 14. He was not involved in the Valisure research.

Brigham and Women's Hospital

In a telephone interview, Dr. Barbieri said the report “needs to be taken seriously,” but he also believed the Valisure report is lacking information about testing under “real-world” conditions. He is calling for more information and more transparency about the data. What’s clear, Dr. Barbieri told this news organization, is that the findings about high benzene levels are not a manufacturing error. “It’s something to do with the molecule itself.”
 

Valisure’s Analyses

Valisure performed an initial analysis, using a method called gas chromatography-mass spectrometry, which is the FDA-preferred method for detecting benzene, Mr. Light said. It tested 175 acne products, 99 containing BP and 76 with other ingredients, such as salicylic acid. All the products without BP had no detectable benzene or values below 2 ppm, the FDA concentration limit for benzene.

Of the 99 BP products, 94 contained benzene without any elevated temperature incubation, according to Valisure. Using 50 °C (122 °F, the accepted pharmaceutical stability testing temperature) on 66 products, Valisure detected over 1500 ppm of benzene in two products, over 100 ppm in 17 products, and over 10 ppm in 42 products over an 18-day period.

The analysis confirmed, Valisure said in a press release and the petition, that a substantial amount of benzene can form in a BP product and leak outside the packaging into surrounding air.

The EHP paper, which includes authors from Valisure, reported that researchers took single lots of seven branded BP products, namely, Equate Beauty 2.5% BP cleansers, Neutrogena 10% BP cleanser, CVS Health 10% BP face wash, Walgreens 10% BP cream, Clean & Clear 10% cleanser, Equate Beauty 10% BP acne wash, and Proactiv 2.5% BP cleanser.

Using testing that involved gas chromatography-mass spectrometry, benzene was detected in all the BP products samples tested, and levels increased during incubation at body and shelf-life performance temperatures to more than 2 ppm. The authors concluded that the study “raises substantial concerns” about the safety of BP products currently on the market.
 

Methodology Debates

Two days after Valisure released its analysis on March 6, the USP reviewed the citizen’s petition filed by Valisure and called for more transparency around the testing methods.

“The petition referenced USP and indicated that modified USP methods and procedures were used in the study. The presence of unsafe levels of benzene should be taken seriously,” the statement said. The USP statement also noted that the Valisure analysis used modified USP methods and said that “if changes are made to a USP method, complete validation data is necessary to demonstrate that a product meets USP standards.”

In its statement, USP took issue with a practice known as accelerated thermal degradation, which it said Valisure used. USP said the approach involves raising the storage temperature of a product to higher than the temperature indicated on the label for the purpose of simulating degradation over a longer period. While the approach may be acceptable, USP said, the temperatures chosen may not be what is expected to happen to the products.

In response, Mr. Light of Valisure referenced guidance issued in August, 2020, from the FDA, stating that the method it used in the BP analysis can be used to detect impurities in hand sanitizers, including benzene. (In 2021, Valisure detected high levels of benzene in some hand sanitizers and asked the FDA to take action.)
 

Company Response

Among the companies that took issue with the report was Reckitt, which makes Clearasil, which contains BP. In a statement, the company said, in part: “The products and their ingredients are stable over the storage conditions described on their packaging which represent all reasonable and foreseeable conditions.” It said the findings presented by Valisure reflect “unrealistic scenarios rather than real-world conditions.”

The Personal Care Products Council, a national trade association that represents cosmetic and personal care product manufacturers, also took issue with the findings and the approach used to evaluate the products.
 

FDA and the Citizen’s Petition

The FDA accepted the petition, Mr. Light said, and gave it a docket number. “We’ll hopefully hear more soon” because the FDA is required to respond to a citizen’s petition within 180 days, he said.

“We generally don’t comment on pending citizens’ petitions,” an FDA spokesperson said in an email. “When we respond, we will respond directly to the petitioner and post the response in the designated agency public docket.”
 

Valisure’s Patent Application

Mr. Light and others have applied for a patent on methods of producing shelf-stable formulations to prevent degradation of BP to benzene.

“We saw the problem long before we had any sort of application,” Mr. Light said. The issue has been “known for decades.”
 

Role of BP Products for Acne

In the midst of uncertainty, “the first discussion is, do we want to use it?” Dr. Barbieri said in the interview. Some patients may want to avoid it altogether, until more data are available, including more verification of the findings, while others may be comfortable accepting the potential risk, he said.

“Benzoyl peroxide is one of our foundational acne treatments,” Dr. Barbieri said. In the American Academy of Dermatology updated guidelines on acne, published in January, 2024, strong recommendations were made for BP products, as well as topical retinoids, topical antibiotics, and oral doxycycline.

“When you take away BP, there’s no substitute for it,” Dr. Barbieri said. And if patients don’t get improvement with topicals, oral medications might be needed, and “these all have their own risks.”
 

In the Interim

Until more information is available, Dr. Barbieri is advising patients not to store the products at high temperatures or for a long time. Don’t keep the products past their expiration date, and perhaps keep products for a shorter time, “something like a month,” he said.

Those living in a hot climate might consider storing the products in the refrigerator, he said.

“We need more data from Valisure, from other groups that confirm their findings, and we need to hear from the FDA,” Dr. Barbieri said. “There’s a lot of uncertainty right now. But it’s important not to overreact.”

Dr. Barbieri had no relevant disclosures.


 

A version of this article appeared on Medscape.com.

Nine days after the independent laboratory Valisure petitioned the Food and Drug Administration (FDA) to recall acne products with benzoyl peroxide (BP) because of the lab’s findings of extremely high levels of the carcinogen benzene, it published another report in Environmental Health Perspectives (EHP), on March 14, also warning about BP acne products.

The bottom line was the same: The laboratory, based in New Haven, Connecticut, said its analyses raise substantial concerns about the safety of BP-containing acne products currently on the market.

The lab’s results showed that the products can form over 800 times the conditionally restricted FDA concentration limit of 2 parts per million (ppm) of benzene, with both prescription and over-the-counter products affected.

“This is a problem of degradation, not contamination,” David Light, CEO and founder of Valisure, said in a telephone interview. BP can decompose into benzene, and exposure to benzene has been linked with a higher risk for leukemia and other blood cancers, according to the American Cancer Society.

In the wake of the findings, however, debate has erupted over the method and approach used by Valisure to test these products, with critics and companies contending that more “real-world” use data are needed. And the US Pharmacopeia (USP) is asking for full transparency about the testing methods.

In a March 8 statement, USP said the petition indicated that modified USP methods were used in the study, noting that “if changes are made to a USP method, complete validation data is necessary to demonstrate that a product meets USP standards.”

However, Valisure contended that drug products need to demonstrate stability over the entire life cycle, from shipment to continued use, emphasizing that constitutes the best “real-world” approach. It also defended the methodology it used.

The reports have led to a state of uncertainty about the use of BP products.

“Right now, we have more unknowns than anything else,” John Barbieri, MD, MBA, assistant professor of dermatology at Harvard Medical School and director of the Advanced Acne Therapeutics Clinic at Brigham and Women’s Hospital, Boston, said in a video posted on X and YouTube, summarizing the findings released by Valisure on March 6 and 14. He was not involved in the Valisure research.

Brigham and Women's Hospital

In a telephone interview, Dr. Barbieri said the report “needs to be taken seriously,” but he also believed the Valisure report is lacking information about testing under “real-world” conditions. He is calling for more information and more transparency about the data. What’s clear, Dr. Barbieri told this news organization, is that the findings about high benzene levels are not a manufacturing error. “It’s something to do with the molecule itself.”
 

Valisure’s Analyses

Valisure performed an initial analysis, using a method called gas chromatography-mass spectrometry, which is the FDA-preferred method for detecting benzene, Mr. Light said. It tested 175 acne products, 99 containing BP and 76 with other ingredients, such as salicylic acid. All the products without BP had no detectable benzene or values below 2 ppm, the FDA concentration limit for benzene.

Of the 99 BP products, 94 contained benzene without any elevated temperature incubation, according to Valisure. Using 50 °C (122 °F, the accepted pharmaceutical stability testing temperature) on 66 products, Valisure detected over 1500 ppm of benzene in two products, over 100 ppm in 17 products, and over 10 ppm in 42 products over an 18-day period.

The analysis confirmed, Valisure said in a press release and the petition, that a substantial amount of benzene can form in a BP product and leak outside the packaging into surrounding air.

The EHP paper, which includes authors from Valisure, reported that researchers took single lots of seven branded BP products, namely, Equate Beauty 2.5% BP cleansers, Neutrogena 10% BP cleanser, CVS Health 10% BP face wash, Walgreens 10% BP cream, Clean & Clear 10% cleanser, Equate Beauty 10% BP acne wash, and Proactiv 2.5% BP cleanser.

Using testing that involved gas chromatography-mass spectrometry, benzene was detected in all the BP products samples tested, and levels increased during incubation at body and shelf-life performance temperatures to more than 2 ppm. The authors concluded that the study “raises substantial concerns” about the safety of BP products currently on the market.
 

Methodology Debates

Two days after Valisure released its analysis on March 6, the USP reviewed the citizen’s petition filed by Valisure and called for more transparency around the testing methods.

“The petition referenced USP and indicated that modified USP methods and procedures were used in the study. The presence of unsafe levels of benzene should be taken seriously,” the statement said. The USP statement also noted that the Valisure analysis used modified USP methods and said that “if changes are made to a USP method, complete validation data is necessary to demonstrate that a product meets USP standards.”

In its statement, USP took issue with a practice known as accelerated thermal degradation, which it said Valisure used. USP said the approach involves raising the storage temperature of a product to higher than the temperature indicated on the label for the purpose of simulating degradation over a longer period. While the approach may be acceptable, USP said, the temperatures chosen may not be what is expected to happen to the products.

In response, Mr. Light of Valisure referenced guidance issued in August, 2020, from the FDA, stating that the method it used in the BP analysis can be used to detect impurities in hand sanitizers, including benzene. (In 2021, Valisure detected high levels of benzene in some hand sanitizers and asked the FDA to take action.)
 

Company Response

Among the companies that took issue with the report was Reckitt, which makes Clearasil, which contains BP. In a statement, the company said, in part: “The products and their ingredients are stable over the storage conditions described on their packaging which represent all reasonable and foreseeable conditions.” It said the findings presented by Valisure reflect “unrealistic scenarios rather than real-world conditions.”

The Personal Care Products Council, a national trade association that represents cosmetic and personal care product manufacturers, also took issue with the findings and the approach used to evaluate the products.
 

FDA and the Citizen’s Petition

The FDA accepted the petition, Mr. Light said, and gave it a docket number. “We’ll hopefully hear more soon” because the FDA is required to respond to a citizen’s petition within 180 days, he said.

“We generally don’t comment on pending citizens’ petitions,” an FDA spokesperson said in an email. “When we respond, we will respond directly to the petitioner and post the response in the designated agency public docket.”
 

Valisure’s Patent Application

Mr. Light and others have applied for a patent on methods of producing shelf-stable formulations to prevent degradation of BP to benzene.

“We saw the problem long before we had any sort of application,” Mr. Light said. The issue has been “known for decades.”
 

Role of BP Products for Acne

In the midst of uncertainty, “the first discussion is, do we want to use it?” Dr. Barbieri said in the interview. Some patients may want to avoid it altogether, until more data are available, including more verification of the findings, while others may be comfortable accepting the potential risk, he said.

“Benzoyl peroxide is one of our foundational acne treatments,” Dr. Barbieri said. In the American Academy of Dermatology updated guidelines on acne, published in January, 2024, strong recommendations were made for BP products, as well as topical retinoids, topical antibiotics, and oral doxycycline.

“When you take away BP, there’s no substitute for it,” Dr. Barbieri said. And if patients don’t get improvement with topicals, oral medications might be needed, and “these all have their own risks.”
 

In the Interim

Until more information is available, Dr. Barbieri is advising patients not to store the products at high temperatures or for a long time. Don’t keep the products past their expiration date, and perhaps keep products for a shorter time, “something like a month,” he said.

Those living in a hot climate might consider storing the products in the refrigerator, he said.

“We need more data from Valisure, from other groups that confirm their findings, and we need to hear from the FDA,” Dr. Barbieri said. “There’s a lot of uncertainty right now. But it’s important not to overreact.”

Dr. Barbieri had no relevant disclosures.


 

A version of this article appeared on Medscape.com.

SAN DIEGO — Just a day before the annual meeting of the American Academy of Dermatology (AAD) began, a study was published online in JAMA Dermatology, cautioning that most downloadable mobile apps driven by artificial intelligence (AI) for use in monitoring dermatologic conditions lack validation.

Not least of the problems among the 41 apps evaluated, the majority offered no supporting evidence, no information about whether the app performance had been validated, and no information about how user privacy would be managed, reported Shannon Wongvibulsin, MD, PhD, a resident in the dermatology program at the University of California, Los Angeles, and her coauthors.

The findings from this report were also summarized in a poster at the AAD meeting, and the major themes were reiterated in several AAD symposia devoted to AI at the meeting. Veronica Rotemberg, MD, PhD, a dermatologist at Memorial Sloan Kettering Cancer Center, New York City, was one of those who weighed in on the future of AI. Although she was the senior author of the report, she did not address the report or poster directly, but her presentation on the practical aspects of incorporating AI into dermatology practice revisited several of its themes. 

Of the different themes, perhaps the most important were the concept that the source of AI data matters and the point that practicing clinicians should be familiar with the data source.

To date, “there is not much transparency in what data AI models are using,” Dr. Rotemberg said at the meeting. Based on the expectation that dermatologists will be purchasing rather than developing their own AI-based systems, she reiterated more than once that “transparency of data is critical,” even if vendors are often reluctant to reveal how their proprietary systems have been developed.

Few Dermatology Apps Are Vetted for Accuracy

In the poster and in the more detailed JAMA Dermatology paper, Dr. Wongvibulsin and her coinvestigators evaluated direct-to-consumer downloadable apps that claim to help with the assessment and management of skin conditions. Very few provided any supporting evidence of accuracy or even information about how they functioned.

The 41 apps were drawn from more than 300 apps; the others were excluded for failing to meet such criteria as failing to employ AI, not being available in English, or not addressing clinical management of dermatologic diseases. Dr. Wongvibulsin pointed out that none of the apps had been granted regulatory approval even though only two provided a disclaimer to that effect.

In all, just 5 of the 41 provided supporting evidence from a peer-reviewed journal, and less than 40% were created with any input from a dermatologist, Dr. Wongvibulsin reported. The result is that the utility and accuracy of these apps were, for the most part, difficult to judge.

“At a minimum, app developers should provide details on what AI algorithms are used, what data sets were used for training, testing, and validation, whether there was any clinician input, whether there are any supporting publications, how user-submitted images are used, and if there are any measures used to ensure data privacy,” Dr. Wongvibulsin wrote in the poster.

For AI-based apps or systems designed for use by dermatologists, Dr. Rotemberg made similar assertions in her overview of what clinicians should be considering for proprietary AI systems, whether to help with diagnosis or improve office efficiency.
 

Only One Dermatology App Cleared By the FDA

Currently, the only FDA-cleared app for dermatologic use is the DermaSensor, an AI-driven device. It was cleared for use in January 2024 for the evaluation of skin lesions “suggestive” of melanoma, basal cell carcinoma, and/or squamous cell carcinoma in patients aged ≥ 40 years “to assist health care providers in determining whether to refer a patient to a dermatologist,” according to an FDA announcement.

Using elastic scattering spectroscopy to analyze light reflecting off the skin to detect malignancy, the manufacturer’s promotional material claims a 96% sensitivity and a 97% specificity. 

While Dr. Rotemberg did not comment on these claims, she cautioned that AI models differ with regards to how they were trained and the relative heterogeneity of the training dataset defined by types of patients, types of skin, and types of AI learning processes. All of these variables are relevant in whether the AI will perform in a given clinical setting at the level it performed during development.

“The most accurate models employ narrow datasets, but these do not necessarily mimic what we see in practice,” she said.

In addition, even when an AI-based system is working for a given task, it must be monitored over time. Dr. Rotemberg warned about the potential for “data drift,” which describes the slow evolution in how diseases present, their prevalence by age, or other factors that might affect AI performance. She explained that repeated validation is needed to ensure that the AI-based models remain as accurate over time as they were when first used.

Many of these concepts were explored in a consensus statement from the International Skin Imaging Collaboration AI Working Group, published in JAMA Dermatology in December 2021. The statement, of which Dr. Rotemberg was a coauthor, provided recommendations for the principles of AI algorithm development specific to dermatologic considerations.

At the AAD symposium, Dr. Rotemberg asked the audience for suggestions about the needs they hoped AI might address for in office care or efficiency. Their responses included generating prior authorizations for prescriptions, triaging email for importance, and helping to improve efficiency for common front desk tasks. She liked all of these suggestions, but she warned that as powerful as it can be, AI is not likely to provide technology that will fit seamlessly into workflows without adjustment.

“Our current systems do not allow human integration of AI models,” Dr. Rotemberg said. Rather than counting on AI to adapt to current practices, she cautioned that “we may have to redesign our entire structure to actually be able to accommodate AI-based” systems. The risk for users is tasks that become more challenging before they become easier. 

AI Should Not Be a Black Box

AI is promising, but it is not magic, according to other investigators, including Tofunmi A. Omiye, PhD, a postdoctoral scholar in dermatology at Stanford University, California. First author of a recent review of AI in dermatology published in Frontiers in Medicine, Dr. Omiye agreed that clinicians who want to employ AI should be able to understand basic principles if they want the technology to perform as expected.

“I totally agree that physicians should at least have a basic understanding of the data sources for training AI models as we have found that to be important to the performance of these models in the clinical setting,” he told this news organization.

“Beyond understanding the data sources, I believe physicians can also try to have a comprehensive understanding of what AI means, its training process, and evaluation as this will help them to evaluate its utility in their practice,” he added. He also reinforced the relevance of data drift.

“Concepts like distribution shift — where models perform less well over time due to changes in the patient population — are also important to keep in mind,” Dr. Omiye said.

Dr. Wongvibulsin, Dr. Rotemberg, and Dr. Omiye reported no potential financial conflicts of interest relevant to this topic. 

A version of this article appeared on Medscape.com .

SAN DIEGO — Just a day before the annual meeting of the American Academy of Dermatology (AAD) began, a study was published online in JAMA Dermatology, cautioning that most downloadable mobile apps driven by artificial intelligence (AI) for use in monitoring dermatologic conditions lack validation.

Not least of the problems among the 41 apps evaluated, the majority offered no supporting evidence, no information about whether the app performance had been validated, and no information about how user privacy would be managed, reported Shannon Wongvibulsin, MD, PhD, a resident in the dermatology program at the University of California, Los Angeles, and her coauthors.

The findings from this report were also summarized in a poster at the AAD meeting, and the major themes were reiterated in several AAD symposia devoted to AI at the meeting. Veronica Rotemberg, MD, PhD, a dermatologist at Memorial Sloan Kettering Cancer Center, New York City, was one of those who weighed in on the future of AI. Although she was the senior author of the report, she did not address the report or poster directly, but her presentation on the practical aspects of incorporating AI into dermatology practice revisited several of its themes. 

Of the different themes, perhaps the most important were the concept that the source of AI data matters and the point that practicing clinicians should be familiar with the data source.

To date, “there is not much transparency in what data AI models are using,” Dr. Rotemberg said at the meeting. Based on the expectation that dermatologists will be purchasing rather than developing their own AI-based systems, she reiterated more than once that “transparency of data is critical,” even if vendors are often reluctant to reveal how their proprietary systems have been developed.

Few Dermatology Apps Are Vetted for Accuracy

In the poster and in the more detailed JAMA Dermatology paper, Dr. Wongvibulsin and her coinvestigators evaluated direct-to-consumer downloadable apps that claim to help with the assessment and management of skin conditions. Very few provided any supporting evidence of accuracy or even information about how they functioned.

The 41 apps were drawn from more than 300 apps; the others were excluded for failing to meet such criteria as failing to employ AI, not being available in English, or not addressing clinical management of dermatologic diseases. Dr. Wongvibulsin pointed out that none of the apps had been granted regulatory approval even though only two provided a disclaimer to that effect.

In all, just 5 of the 41 provided supporting evidence from a peer-reviewed journal, and less than 40% were created with any input from a dermatologist, Dr. Wongvibulsin reported. The result is that the utility and accuracy of these apps were, for the most part, difficult to judge.

“At a minimum, app developers should provide details on what AI algorithms are used, what data sets were used for training, testing, and validation, whether there was any clinician input, whether there are any supporting publications, how user-submitted images are used, and if there are any measures used to ensure data privacy,” Dr. Wongvibulsin wrote in the poster.

For AI-based apps or systems designed for use by dermatologists, Dr. Rotemberg made similar assertions in her overview of what clinicians should be considering for proprietary AI systems, whether to help with diagnosis or improve office efficiency.
 

Only One Dermatology App Cleared By the FDA

Currently, the only FDA-cleared app for dermatologic use is the DermaSensor, an AI-driven device. It was cleared for use in January 2024 for the evaluation of skin lesions “suggestive” of melanoma, basal cell carcinoma, and/or squamous cell carcinoma in patients aged ≥ 40 years “to assist health care providers in determining whether to refer a patient to a dermatologist,” according to an FDA announcement.

Using elastic scattering spectroscopy to analyze light reflecting off the skin to detect malignancy, the manufacturer’s promotional material claims a 96% sensitivity and a 97% specificity. 

While Dr. Rotemberg did not comment on these claims, she cautioned that AI models differ with regards to how they were trained and the relative heterogeneity of the training dataset defined by types of patients, types of skin, and types of AI learning processes. All of these variables are relevant in whether the AI will perform in a given clinical setting at the level it performed during development.

“The most accurate models employ narrow datasets, but these do not necessarily mimic what we see in practice,” she said.

In addition, even when an AI-based system is working for a given task, it must be monitored over time. Dr. Rotemberg warned about the potential for “data drift,” which describes the slow evolution in how diseases present, their prevalence by age, or other factors that might affect AI performance. She explained that repeated validation is needed to ensure that the AI-based models remain as accurate over time as they were when first used.

Many of these concepts were explored in a consensus statement from the International Skin Imaging Collaboration AI Working Group, published in JAMA Dermatology in December 2021. The statement, of which Dr. Rotemberg was a coauthor, provided recommendations for the principles of AI algorithm development specific to dermatologic considerations.

At the AAD symposium, Dr. Rotemberg asked the audience for suggestions about the needs they hoped AI might address for in office care or efficiency. Their responses included generating prior authorizations for prescriptions, triaging email for importance, and helping to improve efficiency for common front desk tasks. She liked all of these suggestions, but she warned that as powerful as it can be, AI is not likely to provide technology that will fit seamlessly into workflows without adjustment.

“Our current systems do not allow human integration of AI models,” Dr. Rotemberg said. Rather than counting on AI to adapt to current practices, she cautioned that “we may have to redesign our entire structure to actually be able to accommodate AI-based” systems. The risk for users is tasks that become more challenging before they become easier. 

AI Should Not Be a Black Box

AI is promising, but it is not magic, according to other investigators, including Tofunmi A. Omiye, PhD, a postdoctoral scholar in dermatology at Stanford University, California. First author of a recent review of AI in dermatology published in Frontiers in Medicine, Dr. Omiye agreed that clinicians who want to employ AI should be able to understand basic principles if they want the technology to perform as expected.

“I totally agree that physicians should at least have a basic understanding of the data sources for training AI models as we have found that to be important to the performance of these models in the clinical setting,” he told this news organization.

“Beyond understanding the data sources, I believe physicians can also try to have a comprehensive understanding of what AI means, its training process, and evaluation as this will help them to evaluate its utility in their practice,” he added. He also reinforced the relevance of data drift.

“Concepts like distribution shift — where models perform less well over time due to changes in the patient population — are also important to keep in mind,” Dr. Omiye said.

Dr. Wongvibulsin, Dr. Rotemberg, and Dr. Omiye reported no potential financial conflicts of interest relevant to this topic. 

A version of this article appeared on Medscape.com .

SAN DIEGO — Just a day before the annual meeting of the American Academy of Dermatology (AAD) began, a study was published online in JAMA Dermatology, cautioning that most downloadable mobile apps driven by artificial intelligence (AI) for use in monitoring dermatologic conditions lack validation.

Not least of the problems among the 41 apps evaluated, the majority offered no supporting evidence, no information about whether the app performance had been validated, and no information about how user privacy would be managed, reported Shannon Wongvibulsin, MD, PhD, a resident in the dermatology program at the University of California, Los Angeles, and her coauthors.

The findings from this report were also summarized in a poster at the AAD meeting, and the major themes were reiterated in several AAD symposia devoted to AI at the meeting. Veronica Rotemberg, MD, PhD, a dermatologist at Memorial Sloan Kettering Cancer Center, New York City, was one of those who weighed in on the future of AI. Although she was the senior author of the report, she did not address the report or poster directly, but her presentation on the practical aspects of incorporating AI into dermatology practice revisited several of its themes. 

Of the different themes, perhaps the most important were the concept that the source of AI data matters and the point that practicing clinicians should be familiar with the data source.

To date, “there is not much transparency in what data AI models are using,” Dr. Rotemberg said at the meeting. Based on the expectation that dermatologists will be purchasing rather than developing their own AI-based systems, she reiterated more than once that “transparency of data is critical,” even if vendors are often reluctant to reveal how their proprietary systems have been developed.

Few Dermatology Apps Are Vetted for Accuracy

In the poster and in the more detailed JAMA Dermatology paper, Dr. Wongvibulsin and her coinvestigators evaluated direct-to-consumer downloadable apps that claim to help with the assessment and management of skin conditions. Very few provided any supporting evidence of accuracy or even information about how they functioned.

The 41 apps were drawn from more than 300 apps; the others were excluded for failing to meet such criteria as failing to employ AI, not being available in English, or not addressing clinical management of dermatologic diseases. Dr. Wongvibulsin pointed out that none of the apps had been granted regulatory approval even though only two provided a disclaimer to that effect.

In all, just 5 of the 41 provided supporting evidence from a peer-reviewed journal, and less than 40% were created with any input from a dermatologist, Dr. Wongvibulsin reported. The result is that the utility and accuracy of these apps were, for the most part, difficult to judge.

“At a minimum, app developers should provide details on what AI algorithms are used, what data sets were used for training, testing, and validation, whether there was any clinician input, whether there are any supporting publications, how user-submitted images are used, and if there are any measures used to ensure data privacy,” Dr. Wongvibulsin wrote in the poster.

For AI-based apps or systems designed for use by dermatologists, Dr. Rotemberg made similar assertions in her overview of what clinicians should be considering for proprietary AI systems, whether to help with diagnosis or improve office efficiency.
 

Only One Dermatology App Cleared By the FDA

Currently, the only FDA-cleared app for dermatologic use is the DermaSensor, an AI-driven device. It was cleared for use in January 2024 for the evaluation of skin lesions “suggestive” of melanoma, basal cell carcinoma, and/or squamous cell carcinoma in patients aged ≥ 40 years “to assist health care providers in determining whether to refer a patient to a dermatologist,” according to an FDA announcement.

Using elastic scattering spectroscopy to analyze light reflecting off the skin to detect malignancy, the manufacturer’s promotional material claims a 96% sensitivity and a 97% specificity. 

While Dr. Rotemberg did not comment on these claims, she cautioned that AI models differ with regards to how they were trained and the relative heterogeneity of the training dataset defined by types of patients, types of skin, and types of AI learning processes. All of these variables are relevant in whether the AI will perform in a given clinical setting at the level it performed during development.

“The most accurate models employ narrow datasets, but these do not necessarily mimic what we see in practice,” she said.

In addition, even when an AI-based system is working for a given task, it must be monitored over time. Dr. Rotemberg warned about the potential for “data drift,” which describes the slow evolution in how diseases present, their prevalence by age, or other factors that might affect AI performance. She explained that repeated validation is needed to ensure that the AI-based models remain as accurate over time as they were when first used.

Many of these concepts were explored in a consensus statement from the International Skin Imaging Collaboration AI Working Group, published in JAMA Dermatology in December 2021. The statement, of which Dr. Rotemberg was a coauthor, provided recommendations for the principles of AI algorithm development specific to dermatologic considerations.

At the AAD symposium, Dr. Rotemberg asked the audience for suggestions about the needs they hoped AI might address for in office care or efficiency. Their responses included generating prior authorizations for prescriptions, triaging email for importance, and helping to improve efficiency for common front desk tasks. She liked all of these suggestions, but she warned that as powerful as it can be, AI is not likely to provide technology that will fit seamlessly into workflows without adjustment.

“Our current systems do not allow human integration of AI models,” Dr. Rotemberg said. Rather than counting on AI to adapt to current practices, she cautioned that “we may have to redesign our entire structure to actually be able to accommodate AI-based” systems. The risk for users is tasks that become more challenging before they become easier. 

AI Should Not Be a Black Box

AI is promising, but it is not magic, according to other investigators, including Tofunmi A. Omiye, PhD, a postdoctoral scholar in dermatology at Stanford University, California. First author of a recent review of AI in dermatology published in Frontiers in Medicine, Dr. Omiye agreed that clinicians who want to employ AI should be able to understand basic principles if they want the technology to perform as expected.

“I totally agree that physicians should at least have a basic understanding of the data sources for training AI models as we have found that to be important to the performance of these models in the clinical setting,” he told this news organization.

“Beyond understanding the data sources, I believe physicians can also try to have a comprehensive understanding of what AI means, its training process, and evaluation as this will help them to evaluate its utility in their practice,” he added. He also reinforced the relevance of data drift.

“Concepts like distribution shift — where models perform less well over time due to changes in the patient population — are also important to keep in mind,” Dr. Omiye said.

Dr. Wongvibulsin, Dr. Rotemberg, and Dr. Omiye reported no potential financial conflicts of interest relevant to this topic. 

A version of this article appeared on Medscape.com .

SAN DIEGO — Nemolizumab, the first-in-class inhibitor of interleukin-31 (IL-31), a neuroimmune cytokine linked to the promotion of pruritus and inflammation, continues to show good efficacy and safety for prurigo nodularis in an open-label follow-up pivotal trial following patients out to 52 weeks.

The OLYMPIA 2 trial, published just a few months ago, was positive for the primary endpoint of itch, and the 52-week data show “on-going improvement” not just in this key symptom but in the resolution of skin lesions, according to Shawn Kwatra, MD, director of the itch center and associate professor of dermatology, Johns Hopkins School of Medicine, Baltimore, Maryland.

The drug, which was found well tolerated in the double-blind OLYMPIA 2 study at 16 weeks, has not been associated with any new adverse events (AEs) in follow-up so far, according to Dr. Kwatra, who presented these findings in a late-breaker session at the annual meeting of the American Academy of Dermatology (AAD).

The promise of an anti-IL-31 drug for sustained control of itch and inflammation was further supported by a separate late breaker on long-term maintenance data on nemolizumab for moderate to severe atopic dermatitis (AD).
 

New Prurigo Nodularis Therapies Needed

For prurigo nodularis, excitement about a new therapy is particularly warranted, according to Dr. Kwatra. Current treatment options, such as steroids and antihistamines, are neither well-tolerated nor particularly effective in most patients. He indicated that the very positive interim 52-week data from the ongoing open-label extension suggests that nemolizumab might be an important step forward for patients with this disease.

The interim 52-week analysis included 307 patients on continuous nemolizumab and 174 patients randomized previously to placebo and were nemolizumab-naive when they entered the open-label extension. Participants were drawn from the phase 3 trial as well as an earlier phase 2 study. Nemolizumab in all patients was delivered at a subcutaneous dose of 45 mg every 4 weeks.

Pointing out that the 2024 AAD annual meeting, with more than 19,000 attendees, “was the largest dermatology conference in the history of the world,” he added that his late-breaker results represent “the largest prurigo nodularis clinical study in the history of the world.”

At 52 weeks, 89.9% and 83.3% of those on continuous nemolizumab and those switched to nemolizumab, respectively, had achieved at least a 4-point reduction from baseline on the Peak Pruritus Numerical Rating Scale (NRS), which has a range from 0 to 10.

Approximately two thirds of patients (67.8% and 64.4%, respectively) had a weekly average peak NRS of ≤ 2, meaning they were free or almost free of itch. The improvement in a sleep index and in quality of life as measured with the Dermatology Life Quality Index closely followed the relief of itch with the large gains achieved within weeks of initiating treatment continuing on an upward slope at 52 weeks.

Over this time, lesions were also resolving. By week 52, healing of more than 75% of lesions had been achieved by 79.1% in both those on continuous nemolizumab and those who had been switched to nemolizumab. The rate of response was again about two thirds for those with lesion resolution considered clear or almost clear by the Investigator’s Global Assessment (IGA) response.
 

No Serious AEs Over Extended Follow-Up

With a mean duration of 388 days follow-up, there were no serious AEs that were clearly treatment related, but Dr. Kwatra did report that some patients developed mild eczematous lesions that typically responded to topical therapy. He also reported that asthma, particularly worsening asthma in patients already diagnosed with this disease, was seen in a small proportion of patients. Both were considered manageable, and no patients discontinued therapy because of these events, Dr. Kwatra said.

While further follow-up is planned, “we have never seen data in a prurigo nodularis [treatment trial] past 6 months,” he pointed out. For a challenging disease with a major adverse effect on quality of life, nemolizumab, if approved, will offer an important option for a difficult disease, he added.

Itch Improves in Patients with AD

Further support for the long-term safety of nemolizumab and its efficacy against itch was provided by another phase 3 extension study conducted in the treatment of AD. These long-term extension results were also presented in a late breaker session at the AAD meeting.

Evaluating maintenance data from responders, defined as a 75% reduction lesions on the Eczema Area and Severity Index (EASI-75) or as clear or almost clear skin on IGA at the end of the randomized ARCADIA 1 and 2 trials, there were 169 patients on every 4-week nemolizumab, 169 patients on every 8-week nemolizumab, and 169 patients on every 4-week placebo.

For pruritus, a ≥ 4 point NRS reduction was achieved at week 48 in 76.2% of those on the every 4-week dose, 59.7% of those on the every 8-week dose, and 41% on those on placebo, reported Jonathan Silverberg, MD, PhD, director of clinical research, Department of Dermatology, George Washington School of Medicine, Washington.

These not only represented sustained responses over the course of 48 weeks, but there was a gradual rise in this rate of success from baseline in the higher dose group. For a NRS score of ≤ 2, meaning no itch or almost no itch, the proportions were 64.9%, 52.9%, and 31.3%, respectively. These were accompanied by sustained responses in IGA and EASI-75 scores.

Overall, there was a “nice durability of response” over the maintenance period, with no new or dose-related safety signals, according to Dr. Silverberg. He pointed out that the every 8-week dose response was lower than every 4-week dose response, but “it looks very good” in regard to response and duration of response, “suggesting that this might be an option for a large subset of patients.”

Andrew Blauvelt, MD, an investigator with Oregon Medical Research Center, Portland, Oregon, cautioned that despite the promise, dermatologists “might need help” in understanding this new agent and using it appropriately. He pointed out that it employs a new mechanism of action, and it has “a couple of new twists that we have not seen with other drugs,” including its association with worsening asthma.

Noting that asthma exacerbation has been reported in a proportion of treated patients approaching 4%, he expressed concern “that this is not rare.” He also expressed concern about reports of peripheral edema and asked Dr. Kwatra specifically how this should be handled in the routine clinical setting.

Pointing out that the 1% of new cases of asthma in the nemolizumab arm was, in fact, lower than the rate of new cases in the placebo arm, Dr. Kwatra said that there have been cases of increased asthma symptoms in patients with existing disease. However, he added that this and the reports of peripheral edema, some of which appear to be simply associated with prurigo nodularis, typically resolve with routine interventions. He said, however, that these side effects represent legitimate concerns that clinicians should consider, but he indicated that they do not appear to be a threat to the benefit-to-risk ratio of this agent.

In February 2024, the Food and Drug Administration and the European Medicines Agency accepted submissions for nemolizumab for the treatment of prurigo nodularis and AD, according to Galderma, the company developing nemolizumab.

Dr. Kwatra reported a financial relationship with more than 15 pharmaceutical companies, including Galderma, which sponsored the nemolizumab trials. Dr. Silverberg reported financial relationships with more than 35 pharmaceutical companies, including Galderma. Dr. Blauvelt reported financial relationships with more than 20 pharmaceutical companies, including Galderma.

A version of this article appeared on Medscape.com.

SAN DIEGO — Nemolizumab, the first-in-class inhibitor of interleukin-31 (IL-31), a neuroimmune cytokine linked to the promotion of pruritus and inflammation, continues to show good efficacy and safety for prurigo nodularis in an open-label follow-up pivotal trial following patients out to 52 weeks.

The OLYMPIA 2 trial, published just a few months ago, was positive for the primary endpoint of itch, and the 52-week data show “on-going improvement” not just in this key symptom but in the resolution of skin lesions, according to Shawn Kwatra, MD, director of the itch center and associate professor of dermatology, Johns Hopkins School of Medicine, Baltimore, Maryland.

The drug, which was found well tolerated in the double-blind OLYMPIA 2 study at 16 weeks, has not been associated with any new adverse events (AEs) in follow-up so far, according to Dr. Kwatra, who presented these findings in a late-breaker session at the annual meeting of the American Academy of Dermatology (AAD).

The promise of an anti-IL-31 drug for sustained control of itch and inflammation was further supported by a separate late breaker on long-term maintenance data on nemolizumab for moderate to severe atopic dermatitis (AD).
 

New Prurigo Nodularis Therapies Needed

For prurigo nodularis, excitement about a new therapy is particularly warranted, according to Dr. Kwatra. Current treatment options, such as steroids and antihistamines, are neither well-tolerated nor particularly effective in most patients. He indicated that the very positive interim 52-week data from the ongoing open-label extension suggests that nemolizumab might be an important step forward for patients with this disease.

The interim 52-week analysis included 307 patients on continuous nemolizumab and 174 patients randomized previously to placebo and were nemolizumab-naive when they entered the open-label extension. Participants were drawn from the phase 3 trial as well as an earlier phase 2 study. Nemolizumab in all patients was delivered at a subcutaneous dose of 45 mg every 4 weeks.

Pointing out that the 2024 AAD annual meeting, with more than 19,000 attendees, “was the largest dermatology conference in the history of the world,” he added that his late-breaker results represent “the largest prurigo nodularis clinical study in the history of the world.”

At 52 weeks, 89.9% and 83.3% of those on continuous nemolizumab and those switched to nemolizumab, respectively, had achieved at least a 4-point reduction from baseline on the Peak Pruritus Numerical Rating Scale (NRS), which has a range from 0 to 10.

Approximately two thirds of patients (67.8% and 64.4%, respectively) had a weekly average peak NRS of ≤ 2, meaning they were free or almost free of itch. The improvement in a sleep index and in quality of life as measured with the Dermatology Life Quality Index closely followed the relief of itch with the large gains achieved within weeks of initiating treatment continuing on an upward slope at 52 weeks.

Over this time, lesions were also resolving. By week 52, healing of more than 75% of lesions had been achieved by 79.1% in both those on continuous nemolizumab and those who had been switched to nemolizumab. The rate of response was again about two thirds for those with lesion resolution considered clear or almost clear by the Investigator’s Global Assessment (IGA) response.
 

No Serious AEs Over Extended Follow-Up

With a mean duration of 388 days follow-up, there were no serious AEs that were clearly treatment related, but Dr. Kwatra did report that some patients developed mild eczematous lesions that typically responded to topical therapy. He also reported that asthma, particularly worsening asthma in patients already diagnosed with this disease, was seen in a small proportion of patients. Both were considered manageable, and no patients discontinued therapy because of these events, Dr. Kwatra said.

While further follow-up is planned, “we have never seen data in a prurigo nodularis [treatment trial] past 6 months,” he pointed out. For a challenging disease with a major adverse effect on quality of life, nemolizumab, if approved, will offer an important option for a difficult disease, he added.

Itch Improves in Patients with AD

Further support for the long-term safety of nemolizumab and its efficacy against itch was provided by another phase 3 extension study conducted in the treatment of AD. These long-term extension results were also presented in a late breaker session at the AAD meeting.

Evaluating maintenance data from responders, defined as a 75% reduction lesions on the Eczema Area and Severity Index (EASI-75) or as clear or almost clear skin on IGA at the end of the randomized ARCADIA 1 and 2 trials, there were 169 patients on every 4-week nemolizumab, 169 patients on every 8-week nemolizumab, and 169 patients on every 4-week placebo.

For pruritus, a ≥ 4 point NRS reduction was achieved at week 48 in 76.2% of those on the every 4-week dose, 59.7% of those on the every 8-week dose, and 41% on those on placebo, reported Jonathan Silverberg, MD, PhD, director of clinical research, Department of Dermatology, George Washington School of Medicine, Washington.

These not only represented sustained responses over the course of 48 weeks, but there was a gradual rise in this rate of success from baseline in the higher dose group. For a NRS score of ≤ 2, meaning no itch or almost no itch, the proportions were 64.9%, 52.9%, and 31.3%, respectively. These were accompanied by sustained responses in IGA and EASI-75 scores.

Overall, there was a “nice durability of response” over the maintenance period, with no new or dose-related safety signals, according to Dr. Silverberg. He pointed out that the every 8-week dose response was lower than every 4-week dose response, but “it looks very good” in regard to response and duration of response, “suggesting that this might be an option for a large subset of patients.”

Andrew Blauvelt, MD, an investigator with Oregon Medical Research Center, Portland, Oregon, cautioned that despite the promise, dermatologists “might need help” in understanding this new agent and using it appropriately. He pointed out that it employs a new mechanism of action, and it has “a couple of new twists that we have not seen with other drugs,” including its association with worsening asthma.

Noting that asthma exacerbation has been reported in a proportion of treated patients approaching 4%, he expressed concern “that this is not rare.” He also expressed concern about reports of peripheral edema and asked Dr. Kwatra specifically how this should be handled in the routine clinical setting.

Pointing out that the 1% of new cases of asthma in the nemolizumab arm was, in fact, lower than the rate of new cases in the placebo arm, Dr. Kwatra said that there have been cases of increased asthma symptoms in patients with existing disease. However, he added that this and the reports of peripheral edema, some of which appear to be simply associated with prurigo nodularis, typically resolve with routine interventions. He said, however, that these side effects represent legitimate concerns that clinicians should consider, but he indicated that they do not appear to be a threat to the benefit-to-risk ratio of this agent.

In February 2024, the Food and Drug Administration and the European Medicines Agency accepted submissions for nemolizumab for the treatment of prurigo nodularis and AD, according to Galderma, the company developing nemolizumab.

Dr. Kwatra reported a financial relationship with more than 15 pharmaceutical companies, including Galderma, which sponsored the nemolizumab trials. Dr. Silverberg reported financial relationships with more than 35 pharmaceutical companies, including Galderma. Dr. Blauvelt reported financial relationships with more than 20 pharmaceutical companies, including Galderma.

A version of this article appeared on Medscape.com.

SAN DIEGO — Nemolizumab, the first-in-class inhibitor of interleukin-31 (IL-31), a neuroimmune cytokine linked to the promotion of pruritus and inflammation, continues to show good efficacy and safety for prurigo nodularis in an open-label follow-up pivotal trial following patients out to 52 weeks.

The OLYMPIA 2 trial, published just a few months ago, was positive for the primary endpoint of itch, and the 52-week data show “on-going improvement” not just in this key symptom but in the resolution of skin lesions, according to Shawn Kwatra, MD, director of the itch center and associate professor of dermatology, Johns Hopkins School of Medicine, Baltimore, Maryland.

The drug, which was found well tolerated in the double-blind OLYMPIA 2 study at 16 weeks, has not been associated with any new adverse events (AEs) in follow-up so far, according to Dr. Kwatra, who presented these findings in a late-breaker session at the annual meeting of the American Academy of Dermatology (AAD).

The promise of an anti-IL-31 drug for sustained control of itch and inflammation was further supported by a separate late breaker on long-term maintenance data on nemolizumab for moderate to severe atopic dermatitis (AD).
 

New Prurigo Nodularis Therapies Needed

For prurigo nodularis, excitement about a new therapy is particularly warranted, according to Dr. Kwatra. Current treatment options, such as steroids and antihistamines, are neither well-tolerated nor particularly effective in most patients. He indicated that the very positive interim 52-week data from the ongoing open-label extension suggests that nemolizumab might be an important step forward for patients with this disease.

The interim 52-week analysis included 307 patients on continuous nemolizumab and 174 patients randomized previously to placebo and were nemolizumab-naive when they entered the open-label extension. Participants were drawn from the phase 3 trial as well as an earlier phase 2 study. Nemolizumab in all patients was delivered at a subcutaneous dose of 45 mg every 4 weeks.

Pointing out that the 2024 AAD annual meeting, with more than 19,000 attendees, “was the largest dermatology conference in the history of the world,” he added that his late-breaker results represent “the largest prurigo nodularis clinical study in the history of the world.”

At 52 weeks, 89.9% and 83.3% of those on continuous nemolizumab and those switched to nemolizumab, respectively, had achieved at least a 4-point reduction from baseline on the Peak Pruritus Numerical Rating Scale (NRS), which has a range from 0 to 10.

Approximately two thirds of patients (67.8% and 64.4%, respectively) had a weekly average peak NRS of ≤ 2, meaning they were free or almost free of itch. The improvement in a sleep index and in quality of life as measured with the Dermatology Life Quality Index closely followed the relief of itch with the large gains achieved within weeks of initiating treatment continuing on an upward slope at 52 weeks.

Over this time, lesions were also resolving. By week 52, healing of more than 75% of lesions had been achieved by 79.1% in both those on continuous nemolizumab and those who had been switched to nemolizumab. The rate of response was again about two thirds for those with lesion resolution considered clear or almost clear by the Investigator’s Global Assessment (IGA) response.
 

No Serious AEs Over Extended Follow-Up

With a mean duration of 388 days follow-up, there were no serious AEs that were clearly treatment related, but Dr. Kwatra did report that some patients developed mild eczematous lesions that typically responded to topical therapy. He also reported that asthma, particularly worsening asthma in patients already diagnosed with this disease, was seen in a small proportion of patients. Both were considered manageable, and no patients discontinued therapy because of these events, Dr. Kwatra said.

While further follow-up is planned, “we have never seen data in a prurigo nodularis [treatment trial] past 6 months,” he pointed out. For a challenging disease with a major adverse effect on quality of life, nemolizumab, if approved, will offer an important option for a difficult disease, he added.

Itch Improves in Patients with AD

Further support for the long-term safety of nemolizumab and its efficacy against itch was provided by another phase 3 extension study conducted in the treatment of AD. These long-term extension results were also presented in a late breaker session at the AAD meeting.

Evaluating maintenance data from responders, defined as a 75% reduction lesions on the Eczema Area and Severity Index (EASI-75) or as clear or almost clear skin on IGA at the end of the randomized ARCADIA 1 and 2 trials, there were 169 patients on every 4-week nemolizumab, 169 patients on every 8-week nemolizumab, and 169 patients on every 4-week placebo.

For pruritus, a ≥ 4 point NRS reduction was achieved at week 48 in 76.2% of those on the every 4-week dose, 59.7% of those on the every 8-week dose, and 41% on those on placebo, reported Jonathan Silverberg, MD, PhD, director of clinical research, Department of Dermatology, George Washington School of Medicine, Washington.

These not only represented sustained responses over the course of 48 weeks, but there was a gradual rise in this rate of success from baseline in the higher dose group. For a NRS score of ≤ 2, meaning no itch or almost no itch, the proportions were 64.9%, 52.9%, and 31.3%, respectively. These were accompanied by sustained responses in IGA and EASI-75 scores.

Overall, there was a “nice durability of response” over the maintenance period, with no new or dose-related safety signals, according to Dr. Silverberg. He pointed out that the every 8-week dose response was lower than every 4-week dose response, but “it looks very good” in regard to response and duration of response, “suggesting that this might be an option for a large subset of patients.”

Andrew Blauvelt, MD, an investigator with Oregon Medical Research Center, Portland, Oregon, cautioned that despite the promise, dermatologists “might need help” in understanding this new agent and using it appropriately. He pointed out that it employs a new mechanism of action, and it has “a couple of new twists that we have not seen with other drugs,” including its association with worsening asthma.

Noting that asthma exacerbation has been reported in a proportion of treated patients approaching 4%, he expressed concern “that this is not rare.” He also expressed concern about reports of peripheral edema and asked Dr. Kwatra specifically how this should be handled in the routine clinical setting.

Pointing out that the 1% of new cases of asthma in the nemolizumab arm was, in fact, lower than the rate of new cases in the placebo arm, Dr. Kwatra said that there have been cases of increased asthma symptoms in patients with existing disease. However, he added that this and the reports of peripheral edema, some of which appear to be simply associated with prurigo nodularis, typically resolve with routine interventions. He said, however, that these side effects represent legitimate concerns that clinicians should consider, but he indicated that they do not appear to be a threat to the benefit-to-risk ratio of this agent.

In February 2024, the Food and Drug Administration and the European Medicines Agency accepted submissions for nemolizumab for the treatment of prurigo nodularis and AD, according to Galderma, the company developing nemolizumab.

Dr. Kwatra reported a financial relationship with more than 15 pharmaceutical companies, including Galderma, which sponsored the nemolizumab trials. Dr. Silverberg reported financial relationships with more than 35 pharmaceutical companies, including Galderma. Dr. Blauvelt reported financial relationships with more than 20 pharmaceutical companies, including Galderma.

A version of this article appeared on Medscape.com.

The Food and Drug Administration (FDA) has approved spesolimab-sbzo, an interleukin (IL)-36 receptor antagonist, for the treatment of generalized pustular psoriasis (GPP) in adults and in pediatric patients aged ≥ 12 years who weigh ≥ 40 kg, according to an announcement from the manufacturer. 

This is an expanded indication for spesolimab-sbzo, first approved in September 2022 for treating GPP flares. Developed by Boehringer Ingelheim and marketed under the name Spevigo, the product is an injectable antibody that blocks the IL-36 receptor, a key part of the pathway shown to be involved in the cause of GPP, which is rare and is a potentially-life-threatening disease.

According to a press release from the company, the FDA’s approval of the expanded indication was based on the results of a 48-week clinical trial of 123 patients (Effisayil 2), which showed that individuals who received spesolimab experienced a significant 84% reduction in GPP flares compared with those who received placebo. Among 30 study participants who received a high treatment dose, no flares were observed after week 4. Among all patients who received spesolimab-sbzo, treatment was associated with an increased incidence (defined as ≥ 9 cases per 100 patient-years) of injection site reactions, urinary tract infections, arthralgia, and pruritus compared with placebo. 

Spesolimab-sbzo is currently available in 48 countries, according to the Boehringer Ingelheim release, which states that the approval makes it the first targeted therapy that is available for the acute and chronic treatment of patients with GPP.

A version of this article appeared on Medscape.com.

The Food and Drug Administration (FDA) has approved spesolimab-sbzo, an interleukin (IL)-36 receptor antagonist, for the treatment of generalized pustular psoriasis (GPP) in adults and in pediatric patients aged ≥ 12 years who weigh ≥ 40 kg, according to an announcement from the manufacturer. 

This is an expanded indication for spesolimab-sbzo, first approved in September 2022 for treating GPP flares. Developed by Boehringer Ingelheim and marketed under the name Spevigo, the product is an injectable antibody that blocks the IL-36 receptor, a key part of the pathway shown to be involved in the cause of GPP, which is rare and is a potentially-life-threatening disease.

According to a press release from the company, the FDA’s approval of the expanded indication was based on the results of a 48-week clinical trial of 123 patients (Effisayil 2), which showed that individuals who received spesolimab experienced a significant 84% reduction in GPP flares compared with those who received placebo. Among 30 study participants who received a high treatment dose, no flares were observed after week 4. Among all patients who received spesolimab-sbzo, treatment was associated with an increased incidence (defined as ≥ 9 cases per 100 patient-years) of injection site reactions, urinary tract infections, arthralgia, and pruritus compared with placebo. 

Spesolimab-sbzo is currently available in 48 countries, according to the Boehringer Ingelheim release, which states that the approval makes it the first targeted therapy that is available for the acute and chronic treatment of patients with GPP.

A version of this article appeared on Medscape.com.

The Food and Drug Administration (FDA) has approved spesolimab-sbzo, an interleukin (IL)-36 receptor antagonist, for the treatment of generalized pustular psoriasis (GPP) in adults and in pediatric patients aged ≥ 12 years who weigh ≥ 40 kg, according to an announcement from the manufacturer. 

This is an expanded indication for spesolimab-sbzo, first approved in September 2022 for treating GPP flares. Developed by Boehringer Ingelheim and marketed under the name Spevigo, the product is an injectable antibody that blocks the IL-36 receptor, a key part of the pathway shown to be involved in the cause of GPP, which is rare and is a potentially-life-threatening disease.

According to a press release from the company, the FDA’s approval of the expanded indication was based on the results of a 48-week clinical trial of 123 patients (Effisayil 2), which showed that individuals who received spesolimab experienced a significant 84% reduction in GPP flares compared with those who received placebo. Among 30 study participants who received a high treatment dose, no flares were observed after week 4. Among all patients who received spesolimab-sbzo, treatment was associated with an increased incidence (defined as ≥ 9 cases per 100 patient-years) of injection site reactions, urinary tract infections, arthralgia, and pruritus compared with placebo. 

Spesolimab-sbzo is currently available in 48 countries, according to the Boehringer Ingelheim release, which states that the approval makes it the first targeted therapy that is available for the acute and chronic treatment of patients with GPP.

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 — 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 .

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.

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.