Dermatology News

The lifetime cost of the new topical gene therapy Vyjuvek (beremagene geperpavec, formerly known as B-VEC) could be as much as $15-$22 million per patient, a figure that may give payers, especially federal programs like Medicaid, pause, according to the authors of a new study.

The US Food and Drug Administration (FDA) approved Vyjuvek (Krystal Biotech) in May 2023 for the treatment of wounds in patients ages 6 months and older with dystrophic epidermolysis bullosa (DEB), which includes two types, the most severe form (autosomal recessive, or RDEB) and the autosomal dominant form of DEB (DDEB), which tends to be milder.

CMS Launching Gene Therapy Program

The Biden administration recently announced that it was launching a program aimed at increasing access, curbing costs, and ensuring value of gene therapies, starting with sickle cell disease. The program will begin in early 2025. Among other aspects, the federal government will negotiate the price of the product with the manufacturer.

“The goal of the Cell and Gene Therapy Access Model is to increase access to innovative cell and gene therapies for people with Medicaid by making it easier for states to pay for these therapies,” said Liz Fowler, CMS Deputy Administrator and Director of the CMS Innovation Center, in a statement announcing the program.

Whether the new program takes a look at Vyjuvek – and when – is not clear.

But the authors of the study noted that the lifetime costs of treating a patient with Vyjuvek “exceed the costs of all other one-time gene therapies for other diseases.” And they wrote, even at the most conservative estimates, Vyjuvek “will be the most expensive gene therapy currently marketed in the US.”

The study was funded by a grant from Arnold Ventures, grants from the Kaiser Permanente Institute for Health Policy, the Commonwealth Fund, and the National Heart, Lung, and Blood Institute. Dr. Raymakers and co-authors reported no financial relationships relevant to the work.

The lifetime cost of the new topical gene therapy Vyjuvek (beremagene geperpavec, formerly known as B-VEC) could be as much as $15-$22 million per patient, a figure that may give payers, especially federal programs like Medicaid, pause, according to the authors of a new study.

The US Food and Drug Administration (FDA) approved Vyjuvek (Krystal Biotech) in May 2023 for the treatment of wounds in patients ages 6 months and older with dystrophic epidermolysis bullosa (DEB), which includes two types, the most severe form (autosomal recessive, or RDEB) and the autosomal dominant form of DEB (DDEB), which tends to be milder.

CMS Launching Gene Therapy Program

The Biden administration recently announced that it was launching a program aimed at increasing access, curbing costs, and ensuring value of gene therapies, starting with sickle cell disease. The program will begin in early 2025. Among other aspects, the federal government will negotiate the price of the product with the manufacturer.

“The goal of the Cell and Gene Therapy Access Model is to increase access to innovative cell and gene therapies for people with Medicaid by making it easier for states to pay for these therapies,” said Liz Fowler, CMS Deputy Administrator and Director of the CMS Innovation Center, in a statement announcing the program.

Whether the new program takes a look at Vyjuvek – and when – is not clear.

But the authors of the study noted that the lifetime costs of treating a patient with Vyjuvek “exceed the costs of all other one-time gene therapies for other diseases.” And they wrote, even at the most conservative estimates, Vyjuvek “will be the most expensive gene therapy currently marketed in the US.”

The study was funded by a grant from Arnold Ventures, grants from the Kaiser Permanente Institute for Health Policy, the Commonwealth Fund, and the National Heart, Lung, and Blood Institute. Dr. Raymakers and co-authors reported no financial relationships relevant to the work.

The lifetime cost of the new topical gene therapy Vyjuvek (beremagene geperpavec, formerly known as B-VEC) could be as much as $15-$22 million per patient, a figure that may give payers, especially federal programs like Medicaid, pause, according to the authors of a new study.

The US Food and Drug Administration (FDA) approved Vyjuvek (Krystal Biotech) in May 2023 for the treatment of wounds in patients ages 6 months and older with dystrophic epidermolysis bullosa (DEB), which includes two types, the most severe form (autosomal recessive, or RDEB) and the autosomal dominant form of DEB (DDEB), which tends to be milder.

CMS Launching Gene Therapy Program

The Biden administration recently announced that it was launching a program aimed at increasing access, curbing costs, and ensuring value of gene therapies, starting with sickle cell disease. The program will begin in early 2025. Among other aspects, the federal government will negotiate the price of the product with the manufacturer.

“The goal of the Cell and Gene Therapy Access Model is to increase access to innovative cell and gene therapies for people with Medicaid by making it easier for states to pay for these therapies,” said Liz Fowler, CMS Deputy Administrator and Director of the CMS Innovation Center, in a statement announcing the program.

Whether the new program takes a look at Vyjuvek – and when – is not clear.

But the authors of the study noted that the lifetime costs of treating a patient with Vyjuvek “exceed the costs of all other one-time gene therapies for other diseases.” And they wrote, even at the most conservative estimates, Vyjuvek “will be the most expensive gene therapy currently marketed in the US.”

The study was funded by a grant from Arnold Ventures, grants from the Kaiser Permanente Institute for Health Policy, the Commonwealth Fund, and the National Heart, Lung, and Blood Institute. Dr. Raymakers and co-authors reported no financial relationships relevant to the work.

TOPLINE:

Dupilumab improved the signs and symptoms and quality of life in adults and adolescents with moderate to severe atopic hand and foot dermatitis compared with placebo.

METHODOLOGY:

• The multinational phase 3 LIBERTY-AD-HAFT trial of adults and adolescents with moderate to severe chronic atopic dermatitis (AD) of the hands, feet, or both included 67 participants at 48 sites randomized to dupilumab monotherapy and 66 to placebo.
• The primary endpoint was the proportion of patients scoring 0 or 1 on Hand and Foot Investigator’s Global Assessment (HF-IGA) at week 16.
• Secondary endpoints were severity and extent of signs, symptom intensity (itch and pain), sleep, and quality of life.

TAKEAWAY:

• At week 16, 27 patients receiving dupilumab vs 11 receiving placebo achieved an HF-IGA score of 0 or 1 (40.3% vs 16.7%; P = .003).
• At week 16, 35 participants receiving dupilumab vs nine receiving placebo improved at least four points in the weekly average of daily HF-Peak Pruritus Numeric Rating Scale (52.2% vs 13.6%; P < .0001).
• At week 16, Quality of Life Hand Eczema Questionnaire results improved in the dupilumab group compared with controls (P < .0001), and weekly average of daily Sleep Numeric Rating Scale results improved in the dupilumab group compared with controls (P < .05).
• The safety profile was similar to the known profile in adults and adolescents with moderate to severe AD.

IN PRACTICE:

The results of the study “support dupilumab” as an “efficacious systemic therapy for moderate to severe H/F AD,” the authors wrote.

SOURCE:

The study, led by Eric L. Simpson, MD, MCR, professor of dermatology at the Oregon Health & Science University in Portland, was published on January 29, 2024, in the Journal of the American Academy of Dermatology.

LIMITATIONS:

The short duration of the study and the large proportion of patients with positive patch tests (31 of 133) suggested that some participants may have had concurrent AD and allergic contact dermatitis, so the effect of dupilumab on those patients needs further evaluation.

DISCLOSURES:

The study was sponsored by Sanofi and Regeneron. All but one author had financial relationships with Sanofi, Regeneron, or both. Several authors were employees of, and may hold stocks or stock options in, Sanofi or Regeneron.

TOPLINE:

Dupilumab improved the signs and symptoms and quality of life in adults and adolescents with moderate to severe atopic hand and foot dermatitis compared with placebo.

METHODOLOGY:

• The multinational phase 3 LIBERTY-AD-HAFT trial of adults and adolescents with moderate to severe chronic atopic dermatitis (AD) of the hands, feet, or both included 67 participants at 48 sites randomized to dupilumab monotherapy and 66 to placebo.
• The primary endpoint was the proportion of patients scoring 0 or 1 on Hand and Foot Investigator’s Global Assessment (HF-IGA) at week 16.
• Secondary endpoints were severity and extent of signs, symptom intensity (itch and pain), sleep, and quality of life.

TAKEAWAY:

• At week 16, 27 patients receiving dupilumab vs 11 receiving placebo achieved an HF-IGA score of 0 or 1 (40.3% vs 16.7%; P = .003).
• At week 16, 35 participants receiving dupilumab vs nine receiving placebo improved at least four points in the weekly average of daily HF-Peak Pruritus Numeric Rating Scale (52.2% vs 13.6%; P < .0001).
• At week 16, Quality of Life Hand Eczema Questionnaire results improved in the dupilumab group compared with controls (P < .0001), and weekly average of daily Sleep Numeric Rating Scale results improved in the dupilumab group compared with controls (P < .05).
• The safety profile was similar to the known profile in adults and adolescents with moderate to severe AD.

IN PRACTICE:

The results of the study “support dupilumab” as an “efficacious systemic therapy for moderate to severe H/F AD,” the authors wrote.

SOURCE:

The study, led by Eric L. Simpson, MD, MCR, professor of dermatology at the Oregon Health & Science University in Portland, was published on January 29, 2024, in the Journal of the American Academy of Dermatology.

LIMITATIONS:

The short duration of the study and the large proportion of patients with positive patch tests (31 of 133) suggested that some participants may have had concurrent AD and allergic contact dermatitis, so the effect of dupilumab on those patients needs further evaluation.

DISCLOSURES:

The study was sponsored by Sanofi and Regeneron. All but one author had financial relationships with Sanofi, Regeneron, or both. Several authors were employees of, and may hold stocks or stock options in, Sanofi or Regeneron.

TOPLINE:

Dupilumab improved the signs and symptoms and quality of life in adults and adolescents with moderate to severe atopic hand and foot dermatitis compared with placebo.

METHODOLOGY:

• The multinational phase 3 LIBERTY-AD-HAFT trial of adults and adolescents with moderate to severe chronic atopic dermatitis (AD) of the hands, feet, or both included 67 participants at 48 sites randomized to dupilumab monotherapy and 66 to placebo.
• The primary endpoint was the proportion of patients scoring 0 or 1 on Hand and Foot Investigator’s Global Assessment (HF-IGA) at week 16.
• Secondary endpoints were severity and extent of signs, symptom intensity (itch and pain), sleep, and quality of life.

TAKEAWAY:

• At week 16, 27 patients receiving dupilumab vs 11 receiving placebo achieved an HF-IGA score of 0 or 1 (40.3% vs 16.7%; P = .003).
• At week 16, 35 participants receiving dupilumab vs nine receiving placebo improved at least four points in the weekly average of daily HF-Peak Pruritus Numeric Rating Scale (52.2% vs 13.6%; P < .0001).
• At week 16, Quality of Life Hand Eczema Questionnaire results improved in the dupilumab group compared with controls (P < .0001), and weekly average of daily Sleep Numeric Rating Scale results improved in the dupilumab group compared with controls (P < .05).
• The safety profile was similar to the known profile in adults and adolescents with moderate to severe AD.

IN PRACTICE:

The results of the study “support dupilumab” as an “efficacious systemic therapy for moderate to severe H/F AD,” the authors wrote.

SOURCE:

The study, led by Eric L. Simpson, MD, MCR, professor of dermatology at the Oregon Health & Science University in Portland, was published on January 29, 2024, in the Journal of the American Academy of Dermatology.

LIMITATIONS:

The short duration of the study and the large proportion of patients with positive patch tests (31 of 133) suggested that some participants may have had concurrent AD and allergic contact dermatitis, so the effect of dupilumab on those patients needs further evaluation.

DISCLOSURES:

The study was sponsored by Sanofi and Regeneron. All but one author had financial relationships with Sanofi, Regeneron, or both. Several authors were employees of, and may hold stocks or stock options in, Sanofi or Regeneron.

Less than half of the dermatology residents surveyed reported specific training on management of sensitive skin, according to a survey of approximately 200 residents.

Although sensitive skin affects an estimated 40%-70% of the population, knowledge of the pathophysiology of sensitive skin is incomplete, and consensus is lacking as to the best diagnosis and treatment strategies, and the inclusion of sensitive skin education in dermatology curricula has not been examined, according to Erika T. McCormick, BS, and Adam Friedman, MD, of George Washington University, Washington, DC.

For the study, published in the Journal of Drugs in Dermatology, they developed a 26-question survey for dermatology residents that asked about sensitive skin in dermatology residency training. Participants came from the Orlando Dermatology, Aesthetic, and Surgical Conference email list.

Survey respondents included 214 residents at various levels of training at programs across the United States; 67.1% were female, 92.1% were aged 25-34 years, and 85.5% were in academic or university programs.

Overall, 99% of respondents believed that sensitive skin issues should be part of their residency training to some extent, and 84% reported experiences with patients for whom the chief presenting complaint was sensitive skin.

However, fewer than half (48%) of the residents reported specific resident education in sensitive skin, while 51% reported nonspecific education about sensitive skin education in the context of other skin diseases, and 1% reported no education about sensitive skin.

Less than one-quarter of the respondents who received any sensitive skin education reported feeling comfortable in their ability to diagnose, evaluate, and manage sensitive skin, while those with sensitive skin–specific education were significantly more likely to describe themselves as “very knowledgeable.”

As for treatment approaches, residents with specific sensitive skin education were more likely than were those without sensitive skin–specific training to ask patients about allergies and past reactions to skin products, and to counsel them about environmental triggers.

Notably, 96% of the respondents were not familiar with the Sensitive Skin (SS) Scale–10, a validated measure of sensitive skin severity.

The most common challenges in care of patients with sensitive skin were assessing improvement over time, reported by 25% of respondents, recommending products (23%), and prescribing/medical management (22%). The topics residents expressed most interest in learning about were product recommendations (78%), patient counseling (77%), reviewing research on sensitive skin (70%), diagnosing sensitive skin (67%), using the SS-10 (48%), and clinical research updates (40%).

The findings were limited by several factors including the reliance on self-reports, the researchers noted. However, the results highlight the lack of consensus in treatment of sensitive skin and the need to address this knowledge gap at the residency level, they said.
 

Improving Tools for Practice

“Many practice patterns and approaches are forged in the fires of training,” corresponding author Dr. Friedman, professor and chair of dermatology and residency program director at George Washington University, said in an interview. “Identifying gaps, especially for heavily prevalent issues, questions, and concerns such as sensitive skin that residents will encounter in practice is important to ensure an educated workforce,” he said.

Education on sensitive skin is lacking because, until recently, research and clinical guidance have been lacking, Dr. Friedman said. The root of the problem is that sensitive skin is mainly considered a symptom, rather than an independent condition, he explained. “Depending on the study, the prevalence of sensitive skin has been reported as high as 70%, with roughly 40% of these patients having no primary skin condition,” he said. This means sensitive skin can be both a symptom and a condition, which causes confusion for clinicians and patients, he added.

“Therefore, in order to overcome this gap, the condition itself at a minimum needs a standard definition and a way to diagnosis, which we fortunately have in the validated research tool known as the SS-10,” said Dr. Friedman.

Almost all residents surveyed in the current study had never heard of the SS-10, but more than half found it to be useful after learning of it through the study survey, he noted.

Looking ahead, greater elucidation of the pathophysiology of sensitive skin is needed to effectively pursue studies of products and treatments for these patients, but the SS-10 can be used to define and monitor the condition to evaluate improvement, he added.

The study was funded by an independent fellowship grant from Galderma. Ms. McCormick is supported by an unrestricted fellowship grant funded by Galderma. Dr. Friedman has served as a consultant for Galderma.

Less than half of the dermatology residents surveyed reported specific training on management of sensitive skin, according to a survey of approximately 200 residents.

Although sensitive skin affects an estimated 40%-70% of the population, knowledge of the pathophysiology of sensitive skin is incomplete, and consensus is lacking as to the best diagnosis and treatment strategies, and the inclusion of sensitive skin education in dermatology curricula has not been examined, according to Erika T. McCormick, BS, and Adam Friedman, MD, of George Washington University, Washington, DC.

For the study, published in the Journal of Drugs in Dermatology, they developed a 26-question survey for dermatology residents that asked about sensitive skin in dermatology residency training. Participants came from the Orlando Dermatology, Aesthetic, and Surgical Conference email list.

Survey respondents included 214 residents at various levels of training at programs across the United States; 67.1% were female, 92.1% were aged 25-34 years, and 85.5% were in academic or university programs.

Overall, 99% of respondents believed that sensitive skin issues should be part of their residency training to some extent, and 84% reported experiences with patients for whom the chief presenting complaint was sensitive skin.

However, fewer than half (48%) of the residents reported specific resident education in sensitive skin, while 51% reported nonspecific education about sensitive skin education in the context of other skin diseases, and 1% reported no education about sensitive skin.

Less than one-quarter of the respondents who received any sensitive skin education reported feeling comfortable in their ability to diagnose, evaluate, and manage sensitive skin, while those with sensitive skin–specific education were significantly more likely to describe themselves as “very knowledgeable.”

As for treatment approaches, residents with specific sensitive skin education were more likely than were those without sensitive skin–specific training to ask patients about allergies and past reactions to skin products, and to counsel them about environmental triggers.

Notably, 96% of the respondents were not familiar with the Sensitive Skin (SS) Scale–10, a validated measure of sensitive skin severity.

The most common challenges in care of patients with sensitive skin were assessing improvement over time, reported by 25% of respondents, recommending products (23%), and prescribing/medical management (22%). The topics residents expressed most interest in learning about were product recommendations (78%), patient counseling (77%), reviewing research on sensitive skin (70%), diagnosing sensitive skin (67%), using the SS-10 (48%), and clinical research updates (40%).

The findings were limited by several factors including the reliance on self-reports, the researchers noted. However, the results highlight the lack of consensus in treatment of sensitive skin and the need to address this knowledge gap at the residency level, they said.
 

Improving Tools for Practice

“Many practice patterns and approaches are forged in the fires of training,” corresponding author Dr. Friedman, professor and chair of dermatology and residency program director at George Washington University, said in an interview. “Identifying gaps, especially for heavily prevalent issues, questions, and concerns such as sensitive skin that residents will encounter in practice is important to ensure an educated workforce,” he said.

Education on sensitive skin is lacking because, until recently, research and clinical guidance have been lacking, Dr. Friedman said. The root of the problem is that sensitive skin is mainly considered a symptom, rather than an independent condition, he explained. “Depending on the study, the prevalence of sensitive skin has been reported as high as 70%, with roughly 40% of these patients having no primary skin condition,” he said. This means sensitive skin can be both a symptom and a condition, which causes confusion for clinicians and patients, he added.

“Therefore, in order to overcome this gap, the condition itself at a minimum needs a standard definition and a way to diagnosis, which we fortunately have in the validated research tool known as the SS-10,” said Dr. Friedman.

Almost all residents surveyed in the current study had never heard of the SS-10, but more than half found it to be useful after learning of it through the study survey, he noted.

Looking ahead, greater elucidation of the pathophysiology of sensitive skin is needed to effectively pursue studies of products and treatments for these patients, but the SS-10 can be used to define and monitor the condition to evaluate improvement, he added.

The study was funded by an independent fellowship grant from Galderma. Ms. McCormick is supported by an unrestricted fellowship grant funded by Galderma. Dr. Friedman has served as a consultant for Galderma.

Less than half of the dermatology residents surveyed reported specific training on management of sensitive skin, according to a survey of approximately 200 residents.

Although sensitive skin affects an estimated 40%-70% of the population, knowledge of the pathophysiology of sensitive skin is incomplete, and consensus is lacking as to the best diagnosis and treatment strategies, and the inclusion of sensitive skin education in dermatology curricula has not been examined, according to Erika T. McCormick, BS, and Adam Friedman, MD, of George Washington University, Washington, DC.

For the study, published in the Journal of Drugs in Dermatology, they developed a 26-question survey for dermatology residents that asked about sensitive skin in dermatology residency training. Participants came from the Orlando Dermatology, Aesthetic, and Surgical Conference email list.

Survey respondents included 214 residents at various levels of training at programs across the United States; 67.1% were female, 92.1% were aged 25-34 years, and 85.5% were in academic or university programs.

Overall, 99% of respondents believed that sensitive skin issues should be part of their residency training to some extent, and 84% reported experiences with patients for whom the chief presenting complaint was sensitive skin.

However, fewer than half (48%) of the residents reported specific resident education in sensitive skin, while 51% reported nonspecific education about sensitive skin education in the context of other skin diseases, and 1% reported no education about sensitive skin.

Less than one-quarter of the respondents who received any sensitive skin education reported feeling comfortable in their ability to diagnose, evaluate, and manage sensitive skin, while those with sensitive skin–specific education were significantly more likely to describe themselves as “very knowledgeable.”

As for treatment approaches, residents with specific sensitive skin education were more likely than were those without sensitive skin–specific training to ask patients about allergies and past reactions to skin products, and to counsel them about environmental triggers.

Notably, 96% of the respondents were not familiar with the Sensitive Skin (SS) Scale–10, a validated measure of sensitive skin severity.

The most common challenges in care of patients with sensitive skin were assessing improvement over time, reported by 25% of respondents, recommending products (23%), and prescribing/medical management (22%). The topics residents expressed most interest in learning about were product recommendations (78%), patient counseling (77%), reviewing research on sensitive skin (70%), diagnosing sensitive skin (67%), using the SS-10 (48%), and clinical research updates (40%).

The findings were limited by several factors including the reliance on self-reports, the researchers noted. However, the results highlight the lack of consensus in treatment of sensitive skin and the need to address this knowledge gap at the residency level, they said.
 

Improving Tools for Practice

“Many practice patterns and approaches are forged in the fires of training,” corresponding author Dr. Friedman, professor and chair of dermatology and residency program director at George Washington University, said in an interview. “Identifying gaps, especially for heavily prevalent issues, questions, and concerns such as sensitive skin that residents will encounter in practice is important to ensure an educated workforce,” he said.

Education on sensitive skin is lacking because, until recently, research and clinical guidance have been lacking, Dr. Friedman said. The root of the problem is that sensitive skin is mainly considered a symptom, rather than an independent condition, he explained. “Depending on the study, the prevalence of sensitive skin has been reported as high as 70%, with roughly 40% of these patients having no primary skin condition,” he said. This means sensitive skin can be both a symptom and a condition, which causes confusion for clinicians and patients, he added.

“Therefore, in order to overcome this gap, the condition itself at a minimum needs a standard definition and a way to diagnosis, which we fortunately have in the validated research tool known as the SS-10,” said Dr. Friedman.

Almost all residents surveyed in the current study had never heard of the SS-10, but more than half found it to be useful after learning of it through the study survey, he noted.

Looking ahead, greater elucidation of the pathophysiology of sensitive skin is needed to effectively pursue studies of products and treatments for these patients, but the SS-10 can be used to define and monitor the condition to evaluate improvement, he added.

The study was funded by an independent fellowship grant from Galderma. Ms. McCormick is supported by an unrestricted fellowship grant funded by Galderma. Dr. Friedman has served as a consultant for Galderma.

Patients with quiescent systemic lupus erythematosus (SLE) who are on maintenance therapy with mycophenolate mofetil (MMF) may be able to be safely weaned off the drug with the understanding that disease flare may occur and may require restarting immunosuppressive therapy.

That’s the conclusion of investigators in a multicenter randomized trial conducted at 19 US centers and published in The Lancet Rheumatology. They found that among 100 patients with stable SLE who were on MMF for at least 2 years for renal indications or at least 1 year for nonrenal indications, MMF withdrawal was not significantly inferior to MMF maintenance in terms of clinically significant disease reactivation within at least 1 year.

Oklahoma Medical Research Foundation

“Our findings suggest that mycophenolate mofetil could be safely withdrawn in patients with stable SLE. However, larger studies with a longer follow-up are still needed,” wrote Eliza F. Chakravarty, MD, MS, from the University of Oklahoma College of Medicine in Oklahoma City, and colleagues.

“Our study was only for 60 weeks, so we don’t have long-term data on what happens when patients taper off, but my recommendation — and I think the data support this — is that even if you do have a history of lupus nephritis, if you had stable disease or very little to no activity for a year or 2, then I think it’s worth stopping the medication and following for any signs of disease flare,” Dr. Chakravarty said in an interview with this news organization. 

She added that “in clinical practice, we would follow patients regularly no matter what they’re on, even if they’re in remission, looking for clinical signs or laboratory evidence of flare, and then if they look like they might be having flare, treat them accordingly.”
 

Toxicities a Concern

Although MMF is effective for inducing prolonged disease quiescence, it is a known teratogen and has significant toxicities, and it’s desirable to wean patients off the drug if it can be done safely, Dr. Chakravarty said.

The optimal duration of maintenance therapy with MMF is not known, however, which prompted the researchers to conduct the open-label study.

Patients aged 18-70 years who met the American College of Rheumatology (ACR) 1997 SLE criteria and had a clinical SLE Disease Activity Index (SLEDAI) score ≤ 4 at screening and who also had been on stable or tapering MMF therapy for 2 or more years for renal indications or 1 or more year for nonrenal indications were eligible. All patients were on a background regimen of hydroxychloroquine.

Patients were randomly assigned on an equal basis to either withdrawal with a 12-week taper or to continued maintenance at their baseline dose, ranging from 1 to 3 g/day for 60 weeks. 

The investigators used an adaptive random-allocation strategy to ensure that the groups were balanced for study site, renal vs nonrenal disease, and baseline MMF dose (≥ 2 g/day vs < 2 g/day).

A total of 100 patients with an average age of 42 years were included in a modified intention-to-treat analysis: 49 were randomly assigned to maintenance and 51 to withdrawal.

Overall, 84% of patients were women, 40% were White, and 41% were Black. Most patients, 76%, had a history of lupus nephritis. 

Significant disease reactivation, the primary endpoints, was defined as the need to increase prednisone to ≥ 15 mg/day for 4 weeks, the need for two or more short steroid bursts, or the need to resume MMF or start patients on another immunosuppressive therapy.

By week 60, 18% of patients in the withdrawal group had clinically significant disease reactivation compared with 10% of patients in the maintenance group.

“Although the differences were not significant, this study used an estimation-based design to determine estimated increases in clinically significant disease reactivation risk with 75%, 85%, and 95% confidence limits to assist clinicians and patients in making informed treatment decisions. We found a 6%-8% increase with upper 85% confidence limits of 11%-19% in clinically significant disease reactivation and flare risk following mycophenolate mofetil withdrawal,” the investigators wrote.

Rates of adverse events were similar between the groups, occurring in 90% of patients in the maintenance arm and 88% of those in the withdrawal arm. Infections occurred more frequently among patients in the maintenance group, at 64% vs 46%.
 

Encouraging Data

In an accompanying editorial, Noémie Jourde-Chiche, MD, PhD, from Aix-Marseille University in Marseille, France, and Laurent Chiche, MD, from Hopital Europeen de Marseille, wrote that the study data “were clearly encouraging.” They noted that the results show that it’s feasible to wean select patients off immunosuppressive therapy and keep SLE in check and that the quantified risk assessment strategy will allow shared decision-making for each patient.

“Overall, the prospect of a time-limited (versus lifelong) treatment may favor compliance, as observed in other disease fields, which might consolidate remission and reduce the risk of subsequent relapse, using sequentially treat-to-target and think-to-untreat strategies for a win-wean era in SLE,” they wrote.

“We’ve been awaiting the results of this trial for quite a while, and so it is nice to see it out,” commented Karen H. Costenbader, MD, MPH, professor of medicine at Harvard Medical School, and chair of the division of rheumatology and director of the Lupus Program at Brigham and Women’s Hospital in Boston, Massachusetts.

“It does provide some data to address a question that comes up in discussions with patients all the time: A person with lupus has been doing really well, in what we call low disease activity state or remission, but on mycophenolate, possibly for several years,” she said in a reply to a request for objective commentary.

“The question is how and when to taper and can MMF be safely discontinued,” she said. “Personally, I always review the severity of the underlying disease and indication for the MMF in the first place. Really active SLE with rapidly progressing kidney or other organ damage has to be treated with tremendous respect and no one wants to go back there. I also think about how long it has been, which other medications are still being taken (hydroxychloroquine, belimumab [Benlysta], etc.) and whether the labs and symptoms have really returned to completely normal. Then I have discussions about all this with my patient and we often try a long, slow, gingerly taper with a lot of interim monitoring.”

The study was funded by the National Institute of Allergy and Infectious Diseases and the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Chakravarty and Dr. Costenbader report no relevant financial relationships. Dr. Jourde-Chiche declares personal consulting fees from Otsuka and AstraZeneca, personal speaking fees from GlaxoSmithKline and Otsuka, and personal payment for expert testimony from Otsuka. Dr. Chiche declares research grants paid to his institution from AstraZeneca and GlaxoSmithKline, personal consulting fees from Novartis and AstraZeneca, and personal speaking fees from GlaxoSmithKline and Novartis.

A version of this article appeared on Medscape.com . 

Patients with quiescent systemic lupus erythematosus (SLE) who are on maintenance therapy with mycophenolate mofetil (MMF) may be able to be safely weaned off the drug with the understanding that disease flare may occur and may require restarting immunosuppressive therapy.

That’s the conclusion of investigators in a multicenter randomized trial conducted at 19 US centers and published in The Lancet Rheumatology. They found that among 100 patients with stable SLE who were on MMF for at least 2 years for renal indications or at least 1 year for nonrenal indications, MMF withdrawal was not significantly inferior to MMF maintenance in terms of clinically significant disease reactivation within at least 1 year.

Oklahoma Medical Research Foundation

“Our findings suggest that mycophenolate mofetil could be safely withdrawn in patients with stable SLE. However, larger studies with a longer follow-up are still needed,” wrote Eliza F. Chakravarty, MD, MS, from the University of Oklahoma College of Medicine in Oklahoma City, and colleagues.

“Our study was only for 60 weeks, so we don’t have long-term data on what happens when patients taper off, but my recommendation — and I think the data support this — is that even if you do have a history of lupus nephritis, if you had stable disease or very little to no activity for a year or 2, then I think it’s worth stopping the medication and following for any signs of disease flare,” Dr. Chakravarty said in an interview with this news organization. 

She added that “in clinical practice, we would follow patients regularly no matter what they’re on, even if they’re in remission, looking for clinical signs or laboratory evidence of flare, and then if they look like they might be having flare, treat them accordingly.”
 

Toxicities a Concern

Although MMF is effective for inducing prolonged disease quiescence, it is a known teratogen and has significant toxicities, and it’s desirable to wean patients off the drug if it can be done safely, Dr. Chakravarty said.

The optimal duration of maintenance therapy with MMF is not known, however, which prompted the researchers to conduct the open-label study.

Patients aged 18-70 years who met the American College of Rheumatology (ACR) 1997 SLE criteria and had a clinical SLE Disease Activity Index (SLEDAI) score ≤ 4 at screening and who also had been on stable or tapering MMF therapy for 2 or more years for renal indications or 1 or more year for nonrenal indications were eligible. All patients were on a background regimen of hydroxychloroquine.

Patients were randomly assigned on an equal basis to either withdrawal with a 12-week taper or to continued maintenance at their baseline dose, ranging from 1 to 3 g/day for 60 weeks. 

The investigators used an adaptive random-allocation strategy to ensure that the groups were balanced for study site, renal vs nonrenal disease, and baseline MMF dose (≥ 2 g/day vs < 2 g/day).

A total of 100 patients with an average age of 42 years were included in a modified intention-to-treat analysis: 49 were randomly assigned to maintenance and 51 to withdrawal.

Overall, 84% of patients were women, 40% were White, and 41% were Black. Most patients, 76%, had a history of lupus nephritis. 

Significant disease reactivation, the primary endpoints, was defined as the need to increase prednisone to ≥ 15 mg/day for 4 weeks, the need for two or more short steroid bursts, or the need to resume MMF or start patients on another immunosuppressive therapy.

By week 60, 18% of patients in the withdrawal group had clinically significant disease reactivation compared with 10% of patients in the maintenance group.

“Although the differences were not significant, this study used an estimation-based design to determine estimated increases in clinically significant disease reactivation risk with 75%, 85%, and 95% confidence limits to assist clinicians and patients in making informed treatment decisions. We found a 6%-8% increase with upper 85% confidence limits of 11%-19% in clinically significant disease reactivation and flare risk following mycophenolate mofetil withdrawal,” the investigators wrote.

Rates of adverse events were similar between the groups, occurring in 90% of patients in the maintenance arm and 88% of those in the withdrawal arm. Infections occurred more frequently among patients in the maintenance group, at 64% vs 46%.
 

Encouraging Data

In an accompanying editorial, Noémie Jourde-Chiche, MD, PhD, from Aix-Marseille University in Marseille, France, and Laurent Chiche, MD, from Hopital Europeen de Marseille, wrote that the study data “were clearly encouraging.” They noted that the results show that it’s feasible to wean select patients off immunosuppressive therapy and keep SLE in check and that the quantified risk assessment strategy will allow shared decision-making for each patient.

“Overall, the prospect of a time-limited (versus lifelong) treatment may favor compliance, as observed in other disease fields, which might consolidate remission and reduce the risk of subsequent relapse, using sequentially treat-to-target and think-to-untreat strategies for a win-wean era in SLE,” they wrote.

“We’ve been awaiting the results of this trial for quite a while, and so it is nice to see it out,” commented Karen H. Costenbader, MD, MPH, professor of medicine at Harvard Medical School, and chair of the division of rheumatology and director of the Lupus Program at Brigham and Women’s Hospital in Boston, Massachusetts.

“It does provide some data to address a question that comes up in discussions with patients all the time: A person with lupus has been doing really well, in what we call low disease activity state or remission, but on mycophenolate, possibly for several years,” she said in a reply to a request for objective commentary.

“The question is how and when to taper and can MMF be safely discontinued,” she said. “Personally, I always review the severity of the underlying disease and indication for the MMF in the first place. Really active SLE with rapidly progressing kidney or other organ damage has to be treated with tremendous respect and no one wants to go back there. I also think about how long it has been, which other medications are still being taken (hydroxychloroquine, belimumab [Benlysta], etc.) and whether the labs and symptoms have really returned to completely normal. Then I have discussions about all this with my patient and we often try a long, slow, gingerly taper with a lot of interim monitoring.”

The study was funded by the National Institute of Allergy and Infectious Diseases and the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Chakravarty and Dr. Costenbader report no relevant financial relationships. Dr. Jourde-Chiche declares personal consulting fees from Otsuka and AstraZeneca, personal speaking fees from GlaxoSmithKline and Otsuka, and personal payment for expert testimony from Otsuka. Dr. Chiche declares research grants paid to his institution from AstraZeneca and GlaxoSmithKline, personal consulting fees from Novartis and AstraZeneca, and personal speaking fees from GlaxoSmithKline and Novartis.

A version of this article appeared on Medscape.com . 

Patients with quiescent systemic lupus erythematosus (SLE) who are on maintenance therapy with mycophenolate mofetil (MMF) may be able to be safely weaned off the drug with the understanding that disease flare may occur and may require restarting immunosuppressive therapy.

That’s the conclusion of investigators in a multicenter randomized trial conducted at 19 US centers and published in The Lancet Rheumatology. They found that among 100 patients with stable SLE who were on MMF for at least 2 years for renal indications or at least 1 year for nonrenal indications, MMF withdrawal was not significantly inferior to MMF maintenance in terms of clinically significant disease reactivation within at least 1 year.

Oklahoma Medical Research Foundation

“Our findings suggest that mycophenolate mofetil could be safely withdrawn in patients with stable SLE. However, larger studies with a longer follow-up are still needed,” wrote Eliza F. Chakravarty, MD, MS, from the University of Oklahoma College of Medicine in Oklahoma City, and colleagues.

“Our study was only for 60 weeks, so we don’t have long-term data on what happens when patients taper off, but my recommendation — and I think the data support this — is that even if you do have a history of lupus nephritis, if you had stable disease or very little to no activity for a year or 2, then I think it’s worth stopping the medication and following for any signs of disease flare,” Dr. Chakravarty said in an interview with this news organization. 

She added that “in clinical practice, we would follow patients regularly no matter what they’re on, even if they’re in remission, looking for clinical signs or laboratory evidence of flare, and then if they look like they might be having flare, treat them accordingly.”
 

Toxicities a Concern

Although MMF is effective for inducing prolonged disease quiescence, it is a known teratogen and has significant toxicities, and it’s desirable to wean patients off the drug if it can be done safely, Dr. Chakravarty said.

The optimal duration of maintenance therapy with MMF is not known, however, which prompted the researchers to conduct the open-label study.

Patients aged 18-70 years who met the American College of Rheumatology (ACR) 1997 SLE criteria and had a clinical SLE Disease Activity Index (SLEDAI) score ≤ 4 at screening and who also had been on stable or tapering MMF therapy for 2 or more years for renal indications or 1 or more year for nonrenal indications were eligible. All patients were on a background regimen of hydroxychloroquine.

Patients were randomly assigned on an equal basis to either withdrawal with a 12-week taper or to continued maintenance at their baseline dose, ranging from 1 to 3 g/day for 60 weeks. 

The investigators used an adaptive random-allocation strategy to ensure that the groups were balanced for study site, renal vs nonrenal disease, and baseline MMF dose (≥ 2 g/day vs < 2 g/day).

A total of 100 patients with an average age of 42 years were included in a modified intention-to-treat analysis: 49 were randomly assigned to maintenance and 51 to withdrawal.

Overall, 84% of patients were women, 40% were White, and 41% were Black. Most patients, 76%, had a history of lupus nephritis. 

Significant disease reactivation, the primary endpoints, was defined as the need to increase prednisone to ≥ 15 mg/day for 4 weeks, the need for two or more short steroid bursts, or the need to resume MMF or start patients on another immunosuppressive therapy.

By week 60, 18% of patients in the withdrawal group had clinically significant disease reactivation compared with 10% of patients in the maintenance group.

“Although the differences were not significant, this study used an estimation-based design to determine estimated increases in clinically significant disease reactivation risk with 75%, 85%, and 95% confidence limits to assist clinicians and patients in making informed treatment decisions. We found a 6%-8% increase with upper 85% confidence limits of 11%-19% in clinically significant disease reactivation and flare risk following mycophenolate mofetil withdrawal,” the investigators wrote.

Rates of adverse events were similar between the groups, occurring in 90% of patients in the maintenance arm and 88% of those in the withdrawal arm. Infections occurred more frequently among patients in the maintenance group, at 64% vs 46%.
 

Encouraging Data

In an accompanying editorial, Noémie Jourde-Chiche, MD, PhD, from Aix-Marseille University in Marseille, France, and Laurent Chiche, MD, from Hopital Europeen de Marseille, wrote that the study data “were clearly encouraging.” They noted that the results show that it’s feasible to wean select patients off immunosuppressive therapy and keep SLE in check and that the quantified risk assessment strategy will allow shared decision-making for each patient.

“Overall, the prospect of a time-limited (versus lifelong) treatment may favor compliance, as observed in other disease fields, which might consolidate remission and reduce the risk of subsequent relapse, using sequentially treat-to-target and think-to-untreat strategies for a win-wean era in SLE,” they wrote.

“We’ve been awaiting the results of this trial for quite a while, and so it is nice to see it out,” commented Karen H. Costenbader, MD, MPH, professor of medicine at Harvard Medical School, and chair of the division of rheumatology and director of the Lupus Program at Brigham and Women’s Hospital in Boston, Massachusetts.

“It does provide some data to address a question that comes up in discussions with patients all the time: A person with lupus has been doing really well, in what we call low disease activity state or remission, but on mycophenolate, possibly for several years,” she said in a reply to a request for objective commentary.

“The question is how and when to taper and can MMF be safely discontinued,” she said. “Personally, I always review the severity of the underlying disease and indication for the MMF in the first place. Really active SLE with rapidly progressing kidney or other organ damage has to be treated with tremendous respect and no one wants to go back there. I also think about how long it has been, which other medications are still being taken (hydroxychloroquine, belimumab [Benlysta], etc.) and whether the labs and symptoms have really returned to completely normal. Then I have discussions about all this with my patient and we often try a long, slow, gingerly taper with a lot of interim monitoring.”

The study was funded by the National Institute of Allergy and Infectious Diseases and the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Chakravarty and Dr. Costenbader report no relevant financial relationships. Dr. Jourde-Chiche declares personal consulting fees from Otsuka and AstraZeneca, personal speaking fees from GlaxoSmithKline and Otsuka, and personal payment for expert testimony from Otsuka. Dr. Chiche declares research grants paid to his institution from AstraZeneca and GlaxoSmithKline, personal consulting fees from Novartis and AstraZeneca, and personal speaking fees from GlaxoSmithKline and Novartis.

A version of this article appeared on Medscape.com . 

Using a new system for classifying established prognostic features of lymph nodes may lead to better staging of oral cavity squamous cell cancer (OSCC) than the TNM staging system, experts say.

The TNM staging system is used by most facilities for cancer reporting, as defined by the National Cancer Institute. This system combines the size and extent of the primary tumor (T), the number of neighboring lymph nodes with cancer and subcategories (N), and whether or not metastasis has occurred (M).

In a new study published in the journal Cancer, the researchers created a novel classification system to better account for extranodal extension (ENE). The study population included 1460 adults with OSCC (696 with no lymph node involvement and 764 with positive lymph nodes), who underwent surgical resections at four centers.

“Our findings build on the growing evidence base that historical factors do not improve staging performance and that their omission results in improved N‐classification [i.e., the nodal status or lymph node involvement in cancer staging] performance,” John R. de Almeida, MD, of the University of Toronto, and colleagues, wrote in their new paper.

For patients with OSCC, this system, known as the 8th edition of American Joint Committee on Cancer/International Union Against Cancer TNM N‐classification (TNM‐8‐N), has several limitations, the researchers explained. These limitations include redundancy in the rare N3a category (i.e., having single or multiple lymph nodes greater than 6 cm or 3-7 lymph nodes without ENE) and the impact of ENE as a new prognostic feature, they said.

“Recent studies have shown that major ENE is associated with a significantly worse outcome than minor ENE, suggesting that these two subgroups should be considered as separate entities,” the authors wrote.
 

Study Methods and Results

The researchers created N-classifications based on adjusted hazard ratios and statistical analysis (recursive partitioning) with a focus on lymph node (LN) size and number and the extent of ENE. They compared their classifications of OSCC cases to those of the TNM-8-N’s classifications of the same cases.

Using the new classification system, lymph node number and size and the extent of ENE were associated with overall survival. The adjusted hazard ratios for LN counts of 1 vs. zero and greater than 1 vs. 0 were 1.92 and 3.21, respectively. The adjusted hazard ratios (aHRs) for LN size of greater than 3 cm vs. 3 cm or less, and for major vs. minor ENE were 1.88 and 1.40, respectively.

The use of an aHR improved cancer staging compared to the TNM-8-N by eliminating the N2c and 6-cm threshold, stratifying the extent of ENE, and stratifying N2b by 3-cm threshold, the researchers wrote.

The researchers compared their new system to the TNM-8 and also two other classification systems and their own recursive partitioning analysis (another statistical model).

The aHR-based system ranked first out of five in terms of correctly staging cancer, while the TNM-8 was fifth in the discovery cohort and fifth in the validation cohorts.

Outcome predictions (percentage variance explained) were 19.81 with the aHR vs. 18.95 in theTNM-8 in the discovery cohort, and similarly were 11.72 vs. 10.13, respectively, in the validation cohort.

“Overall, 25 patients staged as IVa in TNM‐8 were upstaged to IVb in the aHR proposal, and one patient staged as IVb was downstaged to IVa. Otherwise, overall stage between TNM‐8 and aHR remained the same,” the authors wrote.

“Our proposed N-classification based on aHR challenges previous tenets such as the importance of the 6-cm threshold and the importance of contralateral nodes,” the researchers wrote in their discussion.

The results from the new classification system were limited by the relatively small sample sizes and may not generalize to nonsquamous oral cancers, the researchers noted.

Further validation is needed before this system may be routinely applied in practice, but the results support evidence in favor of eliminating historical factors from staging, they said.
 

Experts Tout Advantages of Proposed Classification System

Cancer staging must be as accurate as possible and reviewed frequently, Shawn Li, MD, an otolaryngologist at University Hospitals, Cleveland, said in an interview. “This study aims to optimize nodal staging in oral cavity cancer. The current staging system doesn’t reflect updated data, and may not be specific enough to oral cavity cancers.”

This study notes the importance of stratifying extranodal extension (ENE) by micro (less than 2 mm) and macro (greater than 2 mm),” he said. It also points out that metastatic disease greater than 6 cm without ENE is infrequent enough not to require its own subcategory, he said.

Finally, in the new classification, proposed in this paper, “N2c was removed, because, statistically, it doesn’t seem to be a worse prognosis in cancers of the oral cavity,” he said.

“The data [described in this new paper] suggests that certain traditional criteria used in nodal staging for oral cavity cancer, such as [involving] very large lymph nodes greater than 6 cm in size and contralateral nodal involvement, may be less important than criteria that have not as of yet been incorporated into head and neck staging,” Wesley Talcott, MD, said in an interview. “The current study provides evidence that in oral cavity cancer, the prognostic accuracy of staging may improve by dropping these older criteria and incorporating degree of extranodal extension.”

This evidence is apparent in the ranking of the new aHR classification as first of the five strategies compared in the study, said Dr. Talcott, who was not involved in the study.

Highlighting the importance of microscopic vs. macroscopic extension may lead to doctors improving their identification of patients at highest risk for recurrence and refining treatment strategies, suggested Dr. Talcott, MD, a radiation oncologist at Northwell Health, New York, NY. However, a larger dataset is needed to validate the diagnostic accuracy of the authors’ proposed staging system, he said.

The TNM‐8‐N was updated in 2017, Dr. Li noted. “Since this system is widely referenced, it will likely need to be updated again before the changes in this study are widely adopted,” he said.

The study was supported by the National Institutes of Health and the National Cancer Institute. The researchers, Dr. Li, and Dr. Talcott had no financial conflicts to disclose.

Using a new system for classifying established prognostic features of lymph nodes may lead to better staging of oral cavity squamous cell cancer (OSCC) than the TNM staging system, experts say.

The TNM staging system is used by most facilities for cancer reporting, as defined by the National Cancer Institute. This system combines the size and extent of the primary tumor (T), the number of neighboring lymph nodes with cancer and subcategories (N), and whether or not metastasis has occurred (M).

In a new study published in the journal Cancer, the researchers created a novel classification system to better account for extranodal extension (ENE). The study population included 1460 adults with OSCC (696 with no lymph node involvement and 764 with positive lymph nodes), who underwent surgical resections at four centers.

“Our findings build on the growing evidence base that historical factors do not improve staging performance and that their omission results in improved N‐classification [i.e., the nodal status or lymph node involvement in cancer staging] performance,” John R. de Almeida, MD, of the University of Toronto, and colleagues, wrote in their new paper.

For patients with OSCC, this system, known as the 8th edition of American Joint Committee on Cancer/International Union Against Cancer TNM N‐classification (TNM‐8‐N), has several limitations, the researchers explained. These limitations include redundancy in the rare N3a category (i.e., having single or multiple lymph nodes greater than 6 cm or 3-7 lymph nodes without ENE) and the impact of ENE as a new prognostic feature, they said.

“Recent studies have shown that major ENE is associated with a significantly worse outcome than minor ENE, suggesting that these two subgroups should be considered as separate entities,” the authors wrote.
 

Study Methods and Results

The researchers created N-classifications based on adjusted hazard ratios and statistical analysis (recursive partitioning) with a focus on lymph node (LN) size and number and the extent of ENE. They compared their classifications of OSCC cases to those of the TNM-8-N’s classifications of the same cases.

Using the new classification system, lymph node number and size and the extent of ENE were associated with overall survival. The adjusted hazard ratios for LN counts of 1 vs. zero and greater than 1 vs. 0 were 1.92 and 3.21, respectively. The adjusted hazard ratios (aHRs) for LN size of greater than 3 cm vs. 3 cm or less, and for major vs. minor ENE were 1.88 and 1.40, respectively.

The use of an aHR improved cancer staging compared to the TNM-8-N by eliminating the N2c and 6-cm threshold, stratifying the extent of ENE, and stratifying N2b by 3-cm threshold, the researchers wrote.

The researchers compared their new system to the TNM-8 and also two other classification systems and their own recursive partitioning analysis (another statistical model).

The aHR-based system ranked first out of five in terms of correctly staging cancer, while the TNM-8 was fifth in the discovery cohort and fifth in the validation cohorts.

Outcome predictions (percentage variance explained) were 19.81 with the aHR vs. 18.95 in theTNM-8 in the discovery cohort, and similarly were 11.72 vs. 10.13, respectively, in the validation cohort.

“Overall, 25 patients staged as IVa in TNM‐8 were upstaged to IVb in the aHR proposal, and one patient staged as IVb was downstaged to IVa. Otherwise, overall stage between TNM‐8 and aHR remained the same,” the authors wrote.

“Our proposed N-classification based on aHR challenges previous tenets such as the importance of the 6-cm threshold and the importance of contralateral nodes,” the researchers wrote in their discussion.

The results from the new classification system were limited by the relatively small sample sizes and may not generalize to nonsquamous oral cancers, the researchers noted.

Further validation is needed before this system may be routinely applied in practice, but the results support evidence in favor of eliminating historical factors from staging, they said.
 

Experts Tout Advantages of Proposed Classification System

Cancer staging must be as accurate as possible and reviewed frequently, Shawn Li, MD, an otolaryngologist at University Hospitals, Cleveland, said in an interview. “This study aims to optimize nodal staging in oral cavity cancer. The current staging system doesn’t reflect updated data, and may not be specific enough to oral cavity cancers.”

This study notes the importance of stratifying extranodal extension (ENE) by micro (less than 2 mm) and macro (greater than 2 mm),” he said. It also points out that metastatic disease greater than 6 cm without ENE is infrequent enough not to require its own subcategory, he said.

Finally, in the new classification, proposed in this paper, “N2c was removed, because, statistically, it doesn’t seem to be a worse prognosis in cancers of the oral cavity,” he said.

“The data [described in this new paper] suggests that certain traditional criteria used in nodal staging for oral cavity cancer, such as [involving] very large lymph nodes greater than 6 cm in size and contralateral nodal involvement, may be less important than criteria that have not as of yet been incorporated into head and neck staging,” Wesley Talcott, MD, said in an interview. “The current study provides evidence that in oral cavity cancer, the prognostic accuracy of staging may improve by dropping these older criteria and incorporating degree of extranodal extension.”

This evidence is apparent in the ranking of the new aHR classification as first of the five strategies compared in the study, said Dr. Talcott, who was not involved in the study.

Highlighting the importance of microscopic vs. macroscopic extension may lead to doctors improving their identification of patients at highest risk for recurrence and refining treatment strategies, suggested Dr. Talcott, MD, a radiation oncologist at Northwell Health, New York, NY. However, a larger dataset is needed to validate the diagnostic accuracy of the authors’ proposed staging system, he said.

The TNM‐8‐N was updated in 2017, Dr. Li noted. “Since this system is widely referenced, it will likely need to be updated again before the changes in this study are widely adopted,” he said.

The study was supported by the National Institutes of Health and the National Cancer Institute. The researchers, Dr. Li, and Dr. Talcott had no financial conflicts to disclose.

Using a new system for classifying established prognostic features of lymph nodes may lead to better staging of oral cavity squamous cell cancer (OSCC) than the TNM staging system, experts say.

The TNM staging system is used by most facilities for cancer reporting, as defined by the National Cancer Institute. This system combines the size and extent of the primary tumor (T), the number of neighboring lymph nodes with cancer and subcategories (N), and whether or not metastasis has occurred (M).

In a new study published in the journal Cancer, the researchers created a novel classification system to better account for extranodal extension (ENE). The study population included 1460 adults with OSCC (696 with no lymph node involvement and 764 with positive lymph nodes), who underwent surgical resections at four centers.

“Our findings build on the growing evidence base that historical factors do not improve staging performance and that their omission results in improved N‐classification [i.e., the nodal status or lymph node involvement in cancer staging] performance,” John R. de Almeida, MD, of the University of Toronto, and colleagues, wrote in their new paper.

For patients with OSCC, this system, known as the 8th edition of American Joint Committee on Cancer/International Union Against Cancer TNM N‐classification (TNM‐8‐N), has several limitations, the researchers explained. These limitations include redundancy in the rare N3a category (i.e., having single or multiple lymph nodes greater than 6 cm or 3-7 lymph nodes without ENE) and the impact of ENE as a new prognostic feature, they said.

“Recent studies have shown that major ENE is associated with a significantly worse outcome than minor ENE, suggesting that these two subgroups should be considered as separate entities,” the authors wrote.
 

Study Methods and Results

The researchers created N-classifications based on adjusted hazard ratios and statistical analysis (recursive partitioning) with a focus on lymph node (LN) size and number and the extent of ENE. They compared their classifications of OSCC cases to those of the TNM-8-N’s classifications of the same cases.

Using the new classification system, lymph node number and size and the extent of ENE were associated with overall survival. The adjusted hazard ratios for LN counts of 1 vs. zero and greater than 1 vs. 0 were 1.92 and 3.21, respectively. The adjusted hazard ratios (aHRs) for LN size of greater than 3 cm vs. 3 cm or less, and for major vs. minor ENE were 1.88 and 1.40, respectively.

The use of an aHR improved cancer staging compared to the TNM-8-N by eliminating the N2c and 6-cm threshold, stratifying the extent of ENE, and stratifying N2b by 3-cm threshold, the researchers wrote.

The researchers compared their new system to the TNM-8 and also two other classification systems and their own recursive partitioning analysis (another statistical model).

The aHR-based system ranked first out of five in terms of correctly staging cancer, while the TNM-8 was fifth in the discovery cohort and fifth in the validation cohorts.

Outcome predictions (percentage variance explained) were 19.81 with the aHR vs. 18.95 in theTNM-8 in the discovery cohort, and similarly were 11.72 vs. 10.13, respectively, in the validation cohort.

“Overall, 25 patients staged as IVa in TNM‐8 were upstaged to IVb in the aHR proposal, and one patient staged as IVb was downstaged to IVa. Otherwise, overall stage between TNM‐8 and aHR remained the same,” the authors wrote.

“Our proposed N-classification based on aHR challenges previous tenets such as the importance of the 6-cm threshold and the importance of contralateral nodes,” the researchers wrote in their discussion.

The results from the new classification system were limited by the relatively small sample sizes and may not generalize to nonsquamous oral cancers, the researchers noted.

Further validation is needed before this system may be routinely applied in practice, but the results support evidence in favor of eliminating historical factors from staging, they said.
 

Experts Tout Advantages of Proposed Classification System

Cancer staging must be as accurate as possible and reviewed frequently, Shawn Li, MD, an otolaryngologist at University Hospitals, Cleveland, said in an interview. “This study aims to optimize nodal staging in oral cavity cancer. The current staging system doesn’t reflect updated data, and may not be specific enough to oral cavity cancers.”

This study notes the importance of stratifying extranodal extension (ENE) by micro (less than 2 mm) and macro (greater than 2 mm),” he said. It also points out that metastatic disease greater than 6 cm without ENE is infrequent enough not to require its own subcategory, he said.

Finally, in the new classification, proposed in this paper, “N2c was removed, because, statistically, it doesn’t seem to be a worse prognosis in cancers of the oral cavity,” he said.

“The data [described in this new paper] suggests that certain traditional criteria used in nodal staging for oral cavity cancer, such as [involving] very large lymph nodes greater than 6 cm in size and contralateral nodal involvement, may be less important than criteria that have not as of yet been incorporated into head and neck staging,” Wesley Talcott, MD, said in an interview. “The current study provides evidence that in oral cavity cancer, the prognostic accuracy of staging may improve by dropping these older criteria and incorporating degree of extranodal extension.”

This evidence is apparent in the ranking of the new aHR classification as first of the five strategies compared in the study, said Dr. Talcott, who was not involved in the study.

Highlighting the importance of microscopic vs. macroscopic extension may lead to doctors improving their identification of patients at highest risk for recurrence and refining treatment strategies, suggested Dr. Talcott, MD, a radiation oncologist at Northwell Health, New York, NY. However, a larger dataset is needed to validate the diagnostic accuracy of the authors’ proposed staging system, he said.

The TNM‐8‐N was updated in 2017, Dr. Li noted. “Since this system is widely referenced, it will likely need to be updated again before the changes in this study are widely adopted,” he said.

The study was supported by the National Institutes of Health and the National Cancer Institute. The researchers, Dr. Li, and Dr. Talcott had no financial conflicts to disclose.

Healthcare workers have been at an increased risk for SARS-CoV-2 infection and mental distress such as anxiety and depression during the pandemic, according to new research.

In an analysis of administrative health records for about 3000 healthcare workers in Alberta, Canada, the workers were as much as twice as likely to become infected with SARS-CoV-2 compared with the overall population. The risk for infection was higher among healthcare workers in the first two waves of the pandemic and again during the fifth wave.

“Previous publications, including ours, suggested that the main problem was in the early weeks and months of the pandemic, but this paper shows that it continued until the later stages,” senior author Nicola Cherry, MD, an occupational epidemiologist at the University of Alberta in Edmonton, Canada, told this news organization.

The findings were published in the Canadian Journal of Public Health.
 

Wave Upon Wave

In the current study, the investigators sought to compare the risk for SARS-CoV-2 infection and mental distress among healthcare workers and among community referents (CRs). They examined the following waves of the COVID-19 pandemic:

• Wave 1: From March to June 2020 (4 months).
• Wave 2: From July 2020 to February 2021 (8 months).
• Wave 3: From March to June 2021 (4 months).
• Wave 4: From July to October 2021 (4 months).
• Wave 5 (Omicron): From November 2021 to March 2022 (5 months).

Healthcare workers in Alberta were asked at recruitment for consent to match their individual records to the Alberta Administrative Health Database. As the pandemic progressed, participants were also asked for consent to be linked to COVID-19 immunization records maintained by the provinces, as well as for the results of all polymerase chain reaction (PCR) testing for the SARS-CoV-2 virus.

The investigators matched 2959 healthcare workers to 14,546 CRs according to their age, sex, geographic location in Alberta, and number of physician claims from April 1, 2019, to March 31, 2020.

Incident SARS-CoV-2 infection was examined using PCR testing and the first date of a physician consultation at which the code for SARS-CoV-2 infection had been recorded. Mental health disorders were identified from physician records. They included anxiety disorders, stress and adjustment reactions, and depressive disorders.

Most (79.5%) of the healthcare workers were registered nurses, followed by physicians (16.1%), healthcare aides (2.4%), and licensed practical nurses (2.0%). Most participants (87.5%) were female. The median age at recruitment was 44 years.

Healthcare workers were at a greater risk for COVID-19 overall, with the first SARS-CoV-2 infection defined from either PCR tests (odds ratio [OR], 1.96) or from physician records (OR, 1.33). They were also at an increased risk for anxiety (adjusted OR, 1.25; P < .001), stress/adjustment reaction (adjusted OR, 1.52; P < .001), and depressive condition (adjusted OR, 1.39; P < .001). Moreover, the excess risks for stress/adjustment reactions and depressive conditions increased with successive waves during the pandemic, peaking in the fourth wave and continuing in the fifth wave.

“Although the increase was less in the middle of the phases of the pandemic, it came back with a vengeance during the last phase, which was the Omicron phase,” said Dr. Cherry.

“Employers of healthcare workers can’t assume that everything is now under control, that they know what they’re doing, and that there is no risk. We are now having some increases in COVID. It’s going to go on. The pandemic is not over in that sense, and infection control continues to be major,” she added.

The finding that mental health worsened among healthcare workers was not surprising, Dr. Cherry said. Even before the pandemic, studies had shown that healthcare workers were at a greater risk for depression than the population overall.

“There is a lot of need for care in mental health support of healthcare workers, whether during a pandemic or not,” said Dr. Cherry.
 

Nurses Are Suffering

Commenting on the research for this news organization, Farinaz Havaei, PhD, RN, assistant professor of nursing at the University of British Columbia in Vancouver, Canada, said, “This is a very important and timely study that draws on objective clinical and administrative data, as opposed to healthcare workers’ subjective reports.” Dr. Havaei did not participate in the research.

Overall, the findings are consistent with previous research that drew upon healthcare workers’ reports. They speak to the chronic and cumulative impact of COVID-19 and its associated stressors on the mental health and well-being of healthcare workers, said Dr. Havaei.

“The likelihood of stress/adjustment reaction and depression showed a relatively steady increase with increasing COVID-19 waves. This increase can likely be explained by healthcare workers’ depleting emotional reserves for coping with chronic workplace stressors such as concerns about exposure to COVID-19, inadequate staffing, and work overload,” she said. Witnessing the suffering and trauma of patients and their families likely added to this risk.

Dr. Havaei also pointed out that most of the study participants were nurses. The findings are consistent with prepandemic research that showed that the suboptimal conditions that nurses increasingly faced resulted in high levels of exhaustion and burnout.

“While I agree with the authors’ call for more mental health support for healthcare workers, I think prevention efforts that address the root cause of the problem should be prioritized,” she said.
 

From Heroes to Zeros

The same phenomena have been observed in the United States, said John Q. Young, MD, MPP, PhD, professor and chair of psychiatry at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell in Hempstead, New York. In various studies, Dr. Young and his colleagues have reported a strong association between exposure to the stressors of the pandemic and subsequent development of depression, anxiety, and posttraumatic stress disorder (PTSD) among healthcare workers.

“The findings from Alberta are remarkably consistent. In the beginning of the pandemic, there was a lot of acknowledgment of the work healthcare workers were doing. The fire department clapping as you leave work at night, being called heroes, even though a lot of healthcare workers feel uncomfortable with the hero language because they don’t feel like heroes. Yes, they’re afraid, but they are going to do what they need to do and help,” he said.

But as the pandemic continued, public sentiment changed, Dr. Young said. “They’ve gone from heroes to zeros. Now we are seeing the accumulated, chronic effects over months and years, and these are significant. Our healthcare workforce is vulnerable now. The reserves are low. There are serious shortages in nursing, with more retirements and more people leaving the field,” he said.

As part of a campaign to help healthcare workers cope, psychiatrists at Northwell Health have started a program called Stress First Aid at their Center for Traumatic Stress Response Resilience, where they train nurses, physicians, and other healthcare staff to use basic tools to recognize and respond to stress and distress in themselves and in their colleagues, said Dr. Young.

“For those healthcare workers who find that they are struggling and need more support, there is resilience coaching, which is one-on-one support. For those who need more clinical attention, there is a clinical program where our healthcare workers can meet with a psychologist, psychiatrist, or a therapist, to work through depression, PTSD, and anxiety. We didn’t have this before the pandemic, but it is now a big focus for our workforce,” he said. “We are trying to build resilience. The trauma is real.”

The study was supported by the College of Physicians and Surgeons of Alberta, the Canadian Institutes of Health Research, and the Canadian Immunology Task Force. Dr. Cherry and Dr. Havaei reported no relevant financial relationships. Dr. Young reported that he is senior vice president of behavioral health at Northwell.

A version of this article appeared on Medscape.com.

Healthcare workers have been at an increased risk for SARS-CoV-2 infection and mental distress such as anxiety and depression during the pandemic, according to new research.

In an analysis of administrative health records for about 3000 healthcare workers in Alberta, Canada, the workers were as much as twice as likely to become infected with SARS-CoV-2 compared with the overall population. The risk for infection was higher among healthcare workers in the first two waves of the pandemic and again during the fifth wave.

“Previous publications, including ours, suggested that the main problem was in the early weeks and months of the pandemic, but this paper shows that it continued until the later stages,” senior author Nicola Cherry, MD, an occupational epidemiologist at the University of Alberta in Edmonton, Canada, told this news organization.

The findings were published in the Canadian Journal of Public Health.
 

Wave Upon Wave

In the current study, the investigators sought to compare the risk for SARS-CoV-2 infection and mental distress among healthcare workers and among community referents (CRs). They examined the following waves of the COVID-19 pandemic:

• Wave 1: From March to June 2020 (4 months).
• Wave 2: From July 2020 to February 2021 (8 months).
• Wave 3: From March to June 2021 (4 months).
• Wave 4: From July to October 2021 (4 months).
• Wave 5 (Omicron): From November 2021 to March 2022 (5 months).

Healthcare workers in Alberta were asked at recruitment for consent to match their individual records to the Alberta Administrative Health Database. As the pandemic progressed, participants were also asked for consent to be linked to COVID-19 immunization records maintained by the provinces, as well as for the results of all polymerase chain reaction (PCR) testing for the SARS-CoV-2 virus.

The investigators matched 2959 healthcare workers to 14,546 CRs according to their age, sex, geographic location in Alberta, and number of physician claims from April 1, 2019, to March 31, 2020.

Incident SARS-CoV-2 infection was examined using PCR testing and the first date of a physician consultation at which the code for SARS-CoV-2 infection had been recorded. Mental health disorders were identified from physician records. They included anxiety disorders, stress and adjustment reactions, and depressive disorders.

Most (79.5%) of the healthcare workers were registered nurses, followed by physicians (16.1%), healthcare aides (2.4%), and licensed practical nurses (2.0%). Most participants (87.5%) were female. The median age at recruitment was 44 years.

Healthcare workers were at a greater risk for COVID-19 overall, with the first SARS-CoV-2 infection defined from either PCR tests (odds ratio [OR], 1.96) or from physician records (OR, 1.33). They were also at an increased risk for anxiety (adjusted OR, 1.25; P < .001), stress/adjustment reaction (adjusted OR, 1.52; P < .001), and depressive condition (adjusted OR, 1.39; P < .001). Moreover, the excess risks for stress/adjustment reactions and depressive conditions increased with successive waves during the pandemic, peaking in the fourth wave and continuing in the fifth wave.

“Although the increase was less in the middle of the phases of the pandemic, it came back with a vengeance during the last phase, which was the Omicron phase,” said Dr. Cherry.

“Employers of healthcare workers can’t assume that everything is now under control, that they know what they’re doing, and that there is no risk. We are now having some increases in COVID. It’s going to go on. The pandemic is not over in that sense, and infection control continues to be major,” she added.

The finding that mental health worsened among healthcare workers was not surprising, Dr. Cherry said. Even before the pandemic, studies had shown that healthcare workers were at a greater risk for depression than the population overall.

“There is a lot of need for care in mental health support of healthcare workers, whether during a pandemic or not,” said Dr. Cherry.
 

Nurses Are Suffering

Commenting on the research for this news organization, Farinaz Havaei, PhD, RN, assistant professor of nursing at the University of British Columbia in Vancouver, Canada, said, “This is a very important and timely study that draws on objective clinical and administrative data, as opposed to healthcare workers’ subjective reports.” Dr. Havaei did not participate in the research.

Overall, the findings are consistent with previous research that drew upon healthcare workers’ reports. They speak to the chronic and cumulative impact of COVID-19 and its associated stressors on the mental health and well-being of healthcare workers, said Dr. Havaei.

“The likelihood of stress/adjustment reaction and depression showed a relatively steady increase with increasing COVID-19 waves. This increase can likely be explained by healthcare workers’ depleting emotional reserves for coping with chronic workplace stressors such as concerns about exposure to COVID-19, inadequate staffing, and work overload,” she said. Witnessing the suffering and trauma of patients and their families likely added to this risk.

Dr. Havaei also pointed out that most of the study participants were nurses. The findings are consistent with prepandemic research that showed that the suboptimal conditions that nurses increasingly faced resulted in high levels of exhaustion and burnout.

“While I agree with the authors’ call for more mental health support for healthcare workers, I think prevention efforts that address the root cause of the problem should be prioritized,” she said.
 

From Heroes to Zeros

The same phenomena have been observed in the United States, said John Q. Young, MD, MPP, PhD, professor and chair of psychiatry at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell in Hempstead, New York. In various studies, Dr. Young and his colleagues have reported a strong association between exposure to the stressors of the pandemic and subsequent development of depression, anxiety, and posttraumatic stress disorder (PTSD) among healthcare workers.

“The findings from Alberta are remarkably consistent. In the beginning of the pandemic, there was a lot of acknowledgment of the work healthcare workers were doing. The fire department clapping as you leave work at night, being called heroes, even though a lot of healthcare workers feel uncomfortable with the hero language because they don’t feel like heroes. Yes, they’re afraid, but they are going to do what they need to do and help,” he said.

But as the pandemic continued, public sentiment changed, Dr. Young said. “They’ve gone from heroes to zeros. Now we are seeing the accumulated, chronic effects over months and years, and these are significant. Our healthcare workforce is vulnerable now. The reserves are low. There are serious shortages in nursing, with more retirements and more people leaving the field,” he said.

As part of a campaign to help healthcare workers cope, psychiatrists at Northwell Health have started a program called Stress First Aid at their Center for Traumatic Stress Response Resilience, where they train nurses, physicians, and other healthcare staff to use basic tools to recognize and respond to stress and distress in themselves and in their colleagues, said Dr. Young.

“For those healthcare workers who find that they are struggling and need more support, there is resilience coaching, which is one-on-one support. For those who need more clinical attention, there is a clinical program where our healthcare workers can meet with a psychologist, psychiatrist, or a therapist, to work through depression, PTSD, and anxiety. We didn’t have this before the pandemic, but it is now a big focus for our workforce,” he said. “We are trying to build resilience. The trauma is real.”

The study was supported by the College of Physicians and Surgeons of Alberta, the Canadian Institutes of Health Research, and the Canadian Immunology Task Force. Dr. Cherry and Dr. Havaei reported no relevant financial relationships. Dr. Young reported that he is senior vice president of behavioral health at Northwell.

A version of this article appeared on Medscape.com.

Healthcare workers have been at an increased risk for SARS-CoV-2 infection and mental distress such as anxiety and depression during the pandemic, according to new research.

In an analysis of administrative health records for about 3000 healthcare workers in Alberta, Canada, the workers were as much as twice as likely to become infected with SARS-CoV-2 compared with the overall population. The risk for infection was higher among healthcare workers in the first two waves of the pandemic and again during the fifth wave.

“Previous publications, including ours, suggested that the main problem was in the early weeks and months of the pandemic, but this paper shows that it continued until the later stages,” senior author Nicola Cherry, MD, an occupational epidemiologist at the University of Alberta in Edmonton, Canada, told this news organization.

The findings were published in the Canadian Journal of Public Health.
 

Wave Upon Wave

In the current study, the investigators sought to compare the risk for SARS-CoV-2 infection and mental distress among healthcare workers and among community referents (CRs). They examined the following waves of the COVID-19 pandemic:

• Wave 1: From March to June 2020 (4 months).
• Wave 2: From July 2020 to February 2021 (8 months).
• Wave 3: From March to June 2021 (4 months).
• Wave 4: From July to October 2021 (4 months).
• Wave 5 (Omicron): From November 2021 to March 2022 (5 months).

Healthcare workers in Alberta were asked at recruitment for consent to match their individual records to the Alberta Administrative Health Database. As the pandemic progressed, participants were also asked for consent to be linked to COVID-19 immunization records maintained by the provinces, as well as for the results of all polymerase chain reaction (PCR) testing for the SARS-CoV-2 virus.

The investigators matched 2959 healthcare workers to 14,546 CRs according to their age, sex, geographic location in Alberta, and number of physician claims from April 1, 2019, to March 31, 2020.

Incident SARS-CoV-2 infection was examined using PCR testing and the first date of a physician consultation at which the code for SARS-CoV-2 infection had been recorded. Mental health disorders were identified from physician records. They included anxiety disorders, stress and adjustment reactions, and depressive disorders.

Most (79.5%) of the healthcare workers were registered nurses, followed by physicians (16.1%), healthcare aides (2.4%), and licensed practical nurses (2.0%). Most participants (87.5%) were female. The median age at recruitment was 44 years.

Healthcare workers were at a greater risk for COVID-19 overall, with the first SARS-CoV-2 infection defined from either PCR tests (odds ratio [OR], 1.96) or from physician records (OR, 1.33). They were also at an increased risk for anxiety (adjusted OR, 1.25; P < .001), stress/adjustment reaction (adjusted OR, 1.52; P < .001), and depressive condition (adjusted OR, 1.39; P < .001). Moreover, the excess risks for stress/adjustment reactions and depressive conditions increased with successive waves during the pandemic, peaking in the fourth wave and continuing in the fifth wave.

“Although the increase was less in the middle of the phases of the pandemic, it came back with a vengeance during the last phase, which was the Omicron phase,” said Dr. Cherry.

“Employers of healthcare workers can’t assume that everything is now under control, that they know what they’re doing, and that there is no risk. We are now having some increases in COVID. It’s going to go on. The pandemic is not over in that sense, and infection control continues to be major,” she added.

The finding that mental health worsened among healthcare workers was not surprising, Dr. Cherry said. Even before the pandemic, studies had shown that healthcare workers were at a greater risk for depression than the population overall.

“There is a lot of need for care in mental health support of healthcare workers, whether during a pandemic or not,” said Dr. Cherry.
 

Nurses Are Suffering

Commenting on the research for this news organization, Farinaz Havaei, PhD, RN, assistant professor of nursing at the University of British Columbia in Vancouver, Canada, said, “This is a very important and timely study that draws on objective clinical and administrative data, as opposed to healthcare workers’ subjective reports.” Dr. Havaei did not participate in the research.

Overall, the findings are consistent with previous research that drew upon healthcare workers’ reports. They speak to the chronic and cumulative impact of COVID-19 and its associated stressors on the mental health and well-being of healthcare workers, said Dr. Havaei.

“The likelihood of stress/adjustment reaction and depression showed a relatively steady increase with increasing COVID-19 waves. This increase can likely be explained by healthcare workers’ depleting emotional reserves for coping with chronic workplace stressors such as concerns about exposure to COVID-19, inadequate staffing, and work overload,” she said. Witnessing the suffering and trauma of patients and their families likely added to this risk.

Dr. Havaei also pointed out that most of the study participants were nurses. The findings are consistent with prepandemic research that showed that the suboptimal conditions that nurses increasingly faced resulted in high levels of exhaustion and burnout.

“While I agree with the authors’ call for more mental health support for healthcare workers, I think prevention efforts that address the root cause of the problem should be prioritized,” she said.
 

From Heroes to Zeros

The same phenomena have been observed in the United States, said John Q. Young, MD, MPP, PhD, professor and chair of psychiatry at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell in Hempstead, New York. In various studies, Dr. Young and his colleagues have reported a strong association between exposure to the stressors of the pandemic and subsequent development of depression, anxiety, and posttraumatic stress disorder (PTSD) among healthcare workers.

“The findings from Alberta are remarkably consistent. In the beginning of the pandemic, there was a lot of acknowledgment of the work healthcare workers were doing. The fire department clapping as you leave work at night, being called heroes, even though a lot of healthcare workers feel uncomfortable with the hero language because they don’t feel like heroes. Yes, they’re afraid, but they are going to do what they need to do and help,” he said.

But as the pandemic continued, public sentiment changed, Dr. Young said. “They’ve gone from heroes to zeros. Now we are seeing the accumulated, chronic effects over months and years, and these are significant. Our healthcare workforce is vulnerable now. The reserves are low. There are serious shortages in nursing, with more retirements and more people leaving the field,” he said.

As part of a campaign to help healthcare workers cope, psychiatrists at Northwell Health have started a program called Stress First Aid at their Center for Traumatic Stress Response Resilience, where they train nurses, physicians, and other healthcare staff to use basic tools to recognize and respond to stress and distress in themselves and in their colleagues, said Dr. Young.

“For those healthcare workers who find that they are struggling and need more support, there is resilience coaching, which is one-on-one support. For those who need more clinical attention, there is a clinical program where our healthcare workers can meet with a psychologist, psychiatrist, or a therapist, to work through depression, PTSD, and anxiety. We didn’t have this before the pandemic, but it is now a big focus for our workforce,” he said. “We are trying to build resilience. The trauma is real.”

The study was supported by the College of Physicians and Surgeons of Alberta, the Canadian Institutes of Health Research, and the Canadian Immunology Task Force. Dr. Cherry and Dr. Havaei reported no relevant financial relationships. Dr. Young reported that he is senior vice president of behavioral health at Northwell.

A version of this article appeared on Medscape.com.

When clinicians in a large-scale study viewed a series of digital images that showed skin diseases across skin tones and were asked to make a diagnosis, the accuracy was 38% among dermatologists and 19% among primary care physicians (PCPs). But when decision support from a deep learning system (DLS) was introduced, diagnostic accuracy increased by 33% among dermatologists and 69% among PCPs, results from a multicenter study showed.

However, the researchers found that across all images, diseases in dark skin (Fitzpatrick skin types 5 and 6) were diagnosed less accurately than diseases in light skin (Fitzpatrick skin types 1-4).

“These results contribute to an emerging literature on diagnostic accuracy disparities across patient skin tones and present evidence that the diagnostic accuracy of medical professionals on images of dark skin is lower than on images of light skin,” researchers led by Matthew Groh, PhD, of Northwestern University’s Kellogg School of Management, wrote in their study, published online in Nature Medicine.

For the study, 389 board-certified dermatologists and 450 PCPs in 39 countries were presented with 364 images to view spanning 46 skin diseases and asked to submit up to four differential diagnoses. Nearly 80% of the images were of 8 diseases: atopic dermatitis, cutaneous T-cell lymphoma (CTCL), dermatomyositis, lichen planus, Lyme disease, pityriasis rosea, pityriasis rubra pilaris, and secondary syphilis.

Dermatologists and PCPs achieved a diagnostic accuracy of 38% and 19%, respectively, but both groups of clinicians were 4 percentage points less accurate for diagnosis of images of dark skin as compared with light skin. With assistance from DLS decision support, diagnostic accuracy increased by 33% among dermatologists and 69% among primary care physicians. Among dermatologists, DLS support generally increased diagnostic accuracy evenly across skin tones. However, among PCPs, DLS support increased their diagnostic accuracy more in light skin tones than in dark ones.

In the survey component of the study, when the participants were asked, “Do you feel you received sufficient training for diagnosing skin diseases in patients with skin of color (non-white patients)?” 67% of all PCPs and 33% of all dermatologists responded no. “Furthermore, we have found differences in how often BCDs [board-certified dermatologists] and PCPs refer patients with light and dark skin for biopsy,” the authors wrote. “Specifically, for CTCL (a life-threatening disease), we found that both BCDs and PCPs report that they would refer patients for biopsy significantly more often in light skin than dark skin. Moreover, for the common skin diseases atopic dermatitis and pityriasis rosea, we found that BCDs report they would refer patients for biopsy more often in dark skin than light skin, which creates an unnecessary overburden on patients with dark skin.”

In a press release about the study, Dr. Groh emphasized that he and other scientists who investigate human-computer interaction “have to find a way to incorporate underrepresented demographics in our research. That way we will be ready to accurately implement these models in the real world and build AI systems that serve as tools that are designed to avoid the kind of systematic errors we know humans and machines are prone to. Then you can update curricula, you can change norms in different fields and hopefully everyone gets better.”

When clinicians in a large-scale study viewed a series of digital images that showed skin diseases across skin tones and were asked to make a diagnosis, the accuracy was 38% among dermatologists and 19% among primary care physicians (PCPs). But when decision support from a deep learning system (DLS) was introduced, diagnostic accuracy increased by 33% among dermatologists and 69% among PCPs, results from a multicenter study showed.

However, the researchers found that across all images, diseases in dark skin (Fitzpatrick skin types 5 and 6) were diagnosed less accurately than diseases in light skin (Fitzpatrick skin types 1-4).

“These results contribute to an emerging literature on diagnostic accuracy disparities across patient skin tones and present evidence that the diagnostic accuracy of medical professionals on images of dark skin is lower than on images of light skin,” researchers led by Matthew Groh, PhD, of Northwestern University’s Kellogg School of Management, wrote in their study, published online in Nature Medicine.

For the study, 389 board-certified dermatologists and 450 PCPs in 39 countries were presented with 364 images to view spanning 46 skin diseases and asked to submit up to four differential diagnoses. Nearly 80% of the images were of 8 diseases: atopic dermatitis, cutaneous T-cell lymphoma (CTCL), dermatomyositis, lichen planus, Lyme disease, pityriasis rosea, pityriasis rubra pilaris, and secondary syphilis.

Dermatologists and PCPs achieved a diagnostic accuracy of 38% and 19%, respectively, but both groups of clinicians were 4 percentage points less accurate for diagnosis of images of dark skin as compared with light skin. With assistance from DLS decision support, diagnostic accuracy increased by 33% among dermatologists and 69% among primary care physicians. Among dermatologists, DLS support generally increased diagnostic accuracy evenly across skin tones. However, among PCPs, DLS support increased their diagnostic accuracy more in light skin tones than in dark ones.

In the survey component of the study, when the participants were asked, “Do you feel you received sufficient training for diagnosing skin diseases in patients with skin of color (non-white patients)?” 67% of all PCPs and 33% of all dermatologists responded no. “Furthermore, we have found differences in how often BCDs [board-certified dermatologists] and PCPs refer patients with light and dark skin for biopsy,” the authors wrote. “Specifically, for CTCL (a life-threatening disease), we found that both BCDs and PCPs report that they would refer patients for biopsy significantly more often in light skin than dark skin. Moreover, for the common skin diseases atopic dermatitis and pityriasis rosea, we found that BCDs report they would refer patients for biopsy more often in dark skin than light skin, which creates an unnecessary overburden on patients with dark skin.”

In a press release about the study, Dr. Groh emphasized that he and other scientists who investigate human-computer interaction “have to find a way to incorporate underrepresented demographics in our research. That way we will be ready to accurately implement these models in the real world and build AI systems that serve as tools that are designed to avoid the kind of systematic errors we know humans and machines are prone to. Then you can update curricula, you can change norms in different fields and hopefully everyone gets better.”

When clinicians in a large-scale study viewed a series of digital images that showed skin diseases across skin tones and were asked to make a diagnosis, the accuracy was 38% among dermatologists and 19% among primary care physicians (PCPs). But when decision support from a deep learning system (DLS) was introduced, diagnostic accuracy increased by 33% among dermatologists and 69% among PCPs, results from a multicenter study showed.

However, the researchers found that across all images, diseases in dark skin (Fitzpatrick skin types 5 and 6) were diagnosed less accurately than diseases in light skin (Fitzpatrick skin types 1-4).

“These results contribute to an emerging literature on diagnostic accuracy disparities across patient skin tones and present evidence that the diagnostic accuracy of medical professionals on images of dark skin is lower than on images of light skin,” researchers led by Matthew Groh, PhD, of Northwestern University’s Kellogg School of Management, wrote in their study, published online in Nature Medicine.

For the study, 389 board-certified dermatologists and 450 PCPs in 39 countries were presented with 364 images to view spanning 46 skin diseases and asked to submit up to four differential diagnoses. Nearly 80% of the images were of 8 diseases: atopic dermatitis, cutaneous T-cell lymphoma (CTCL), dermatomyositis, lichen planus, Lyme disease, pityriasis rosea, pityriasis rubra pilaris, and secondary syphilis.

Dermatologists and PCPs achieved a diagnostic accuracy of 38% and 19%, respectively, but both groups of clinicians were 4 percentage points less accurate for diagnosis of images of dark skin as compared with light skin. With assistance from DLS decision support, diagnostic accuracy increased by 33% among dermatologists and 69% among primary care physicians. Among dermatologists, DLS support generally increased diagnostic accuracy evenly across skin tones. However, among PCPs, DLS support increased their diagnostic accuracy more in light skin tones than in dark ones.

In the survey component of the study, when the participants were asked, “Do you feel you received sufficient training for diagnosing skin diseases in patients with skin of color (non-white patients)?” 67% of all PCPs and 33% of all dermatologists responded no. “Furthermore, we have found differences in how often BCDs [board-certified dermatologists] and PCPs refer patients with light and dark skin for biopsy,” the authors wrote. “Specifically, for CTCL (a life-threatening disease), we found that both BCDs and PCPs report that they would refer patients for biopsy significantly more often in light skin than dark skin. Moreover, for the common skin diseases atopic dermatitis and pityriasis rosea, we found that BCDs report they would refer patients for biopsy more often in dark skin than light skin, which creates an unnecessary overburden on patients with dark skin.”

In a press release about the study, Dr. Groh emphasized that he and other scientists who investigate human-computer interaction “have to find a way to incorporate underrepresented demographics in our research. That way we will be ready to accurately implement these models in the real world and build AI systems that serve as tools that are designed to avoid the kind of systematic errors we know humans and machines are prone to. Then you can update curricula, you can change norms in different fields and hopefully everyone gets better.”

Comorbidities may play a large role in driving poor pregnancy outcomes in pregnant people with certain immune-mediated inflammatory diseases (IMIDs).

In a new study of 12 individual IMIDs, people with rheumatoid arthritis (RA) or inflammatory bowel disease (IBD) did not have signficantly increased risk for preterm birth (PTB) or low birth weight (LBW), compared with people who did not have an IMID, after adjusting for additional chronic conditions and other confounding factors.

The study was published online on February 1 in eClinicalMedicine.

While many studies have explored the relationships between pregnancy outcomes and IMIDs, “the impact of comorbidities on the relation between IMIDs and pregnancy course is insufficiently examined,” the authors wrote. These previous studies also tended to have a small sample size.
 

Pregnancy Outcome Risks Varied Between IMIDs

To remedy this, researchers used electronic health record data from Providence St Joseph Health — a multistate integrated healthcare system — to identify more than 365,000 pregnant people with live births between January 1, 2013, and December 31, 2022. The cohort included more than 5700 people with at least one of 12 IMIDs: Psoriasis, IBD, RA, spondyloarthritis (SpA), multiple sclerosis, systemic lupus erythematosus (SLE), psoriatic arthritis (PsA), antiphospholipid syndrome (APS), Sjögren syndrome (SjS), vasculitis, sarcoidosis, and systemic sclerosis. The study included only live births with a gestational age of 20 weeks or greater.

Researchers compared maternal-fetal health outcomes between the two groups, controlling for comorbidities including diabetes, cardiovascular disease, chronic kidney disease, obesity, and depression. They also accounted for confounding variables including race, age, smoking status, and socioeconomic status.

In total, 83% of people in the IMID group had no immunomodulatory medication prescriptions during their pregnancy. Of the 17% taking medication, 48%-70% continued taking their medication until delivery. Most patients were White, comprising 62.9% of the non-IMID group and 73.1% of the IMID group.

After adjusting for comorbidities, patients with any of the 12 IMIDs had a 10%-20% higher risk for PTB, LBW, small for gestation age (SGA), and cesarean section than did comparators.

But these risks varied between IMIDs. Patients with RA and IBD did not have an increased risk for PTB or LBW. However, when researchers did not control for comorbidities, pregnancy risks were higher and showed statistical significance in these two groups.

“This suggests that for RA and IBD, comorbidities may be a more important factor for adverse outcomes than the underlying autoimmune disease,” senior author Jennifer Hadlock, MD, an associate professor and director of medical data science at the Institute for Systems Biology in Seattle, Washington, said in a video accompanying a press release.

Overall, the analysis found that women with IMIDs were approximately two to three times more likely to have chronic comorbidities than the control group.

Like previous studies, there was a strong association between SLE and APS and poor pregnancy outcomes, even after controlling for confounding factors. Patients with SpA had a 50% increased risk for PTB, while those with SLE and APS had more than a twofold higher risk. Patients with SLE were 90% more likely than comparators to deliver babies with an SGA condition, while RA patients had a 30% higher risk. SLE was the only condition with an increased risk for LBW (relative risk, 3.5). IBD, RA, PsA, SpA, SLE, APS, and SjS were all associated with a higher likelihood of delivery via cesarean section.

“The findings of this study reveal that the associations between IMIDs and adverse pregnancy outcomes are influenced by the specific type of IMIDs and the presence of comorbidities,” the authors wrote.
 

A Large Study, But How Representative Is It?

Asked to comment on the study, Catherine Sims, MD, a rheumatologist at Duke University Medical Center in Durham, North Carolina, noted that the analysis was much larger than many reproductive rheumatology studies, and “their statistics were phenomenal.”

She agreed that “not all autoimmune diseases are created equal when it comes to pregnancy-associated risks.” However, she added that this study’s patient population may not be totally representative of pregnant people with IMIDs or autoimmune diseases.

“We’re making generalizations about autoimmune diseases based on this demographic of White women who are not taking immunosuppression,” she said.

“We know that race and ethnicity play a huge role in pregnancy outcomes, and Black women have higher maternal and fetal morbidity and mortality, which is likely related to systemic racism and biases in the medical system,” she added. “While the study did control for sociodemographic factors, the population studied is not diverse.”

Only 17% of people with IMID in the cohort were on immunosuppressive medication, which could suggest low disease activity in the study population, Dr. Sims said. If the population generally had well-controlled disease, that could have positioned them for better pregnancy outcomes.

The authors noted that their analysis did not have information on IMID disease activity or severity — one of the limitations of the study.

However, the authors argued that the observed low prescription rate during the study may have increased poor pregnancy outcomes.

“Although this reflects real-world care in the population studied, results from this study may show higher risk than might be achieved with recommended care guidelines,” they wrote.

Ultimately, the authors argued that these findings show how co-occurring health conditions can affect pregnancy outcomes in autoimmune diseases, particularly for RA and IBD.

“There is a need to take comorbidities into consideration for guidelines for patients with inflammatory bowel disease and rheumatoid arthritis and when designing future research to investigate maternal health in patients with IMIDs,” they wrote.

The study was funded by the National Institutes of Health. Dr. Sims declared no relevant financial relationships. Dr. Hadlock has received research funding (paid to the institute) from Pfizer, Novartis, Janssen, Bristol-Myers Squibb, and Gilead.

A version of this article first appeared on Medscape.com.

Comorbidities may play a large role in driving poor pregnancy outcomes in pregnant people with certain immune-mediated inflammatory diseases (IMIDs).

In a new study of 12 individual IMIDs, people with rheumatoid arthritis (RA) or inflammatory bowel disease (IBD) did not have signficantly increased risk for preterm birth (PTB) or low birth weight (LBW), compared with people who did not have an IMID, after adjusting for additional chronic conditions and other confounding factors.

The study was published online on February 1 in eClinicalMedicine.

While many studies have explored the relationships between pregnancy outcomes and IMIDs, “the impact of comorbidities on the relation between IMIDs and pregnancy course is insufficiently examined,” the authors wrote. These previous studies also tended to have a small sample size.
 

Pregnancy Outcome Risks Varied Between IMIDs

To remedy this, researchers used electronic health record data from Providence St Joseph Health — a multistate integrated healthcare system — to identify more than 365,000 pregnant people with live births between January 1, 2013, and December 31, 2022. The cohort included more than 5700 people with at least one of 12 IMIDs: Psoriasis, IBD, RA, spondyloarthritis (SpA), multiple sclerosis, systemic lupus erythematosus (SLE), psoriatic arthritis (PsA), antiphospholipid syndrome (APS), Sjögren syndrome (SjS), vasculitis, sarcoidosis, and systemic sclerosis. The study included only live births with a gestational age of 20 weeks or greater.

Researchers compared maternal-fetal health outcomes between the two groups, controlling for comorbidities including diabetes, cardiovascular disease, chronic kidney disease, obesity, and depression. They also accounted for confounding variables including race, age, smoking status, and socioeconomic status.

In total, 83% of people in the IMID group had no immunomodulatory medication prescriptions during their pregnancy. Of the 17% taking medication, 48%-70% continued taking their medication until delivery. Most patients were White, comprising 62.9% of the non-IMID group and 73.1% of the IMID group.

After adjusting for comorbidities, patients with any of the 12 IMIDs had a 10%-20% higher risk for PTB, LBW, small for gestation age (SGA), and cesarean section than did comparators.

But these risks varied between IMIDs. Patients with RA and IBD did not have an increased risk for PTB or LBW. However, when researchers did not control for comorbidities, pregnancy risks were higher and showed statistical significance in these two groups.

“This suggests that for RA and IBD, comorbidities may be a more important factor for adverse outcomes than the underlying autoimmune disease,” senior author Jennifer Hadlock, MD, an associate professor and director of medical data science at the Institute for Systems Biology in Seattle, Washington, said in a video accompanying a press release.

Overall, the analysis found that women with IMIDs were approximately two to three times more likely to have chronic comorbidities than the control group.

Like previous studies, there was a strong association between SLE and APS and poor pregnancy outcomes, even after controlling for confounding factors. Patients with SpA had a 50% increased risk for PTB, while those with SLE and APS had more than a twofold higher risk. Patients with SLE were 90% more likely than comparators to deliver babies with an SGA condition, while RA patients had a 30% higher risk. SLE was the only condition with an increased risk for LBW (relative risk, 3.5). IBD, RA, PsA, SpA, SLE, APS, and SjS were all associated with a higher likelihood of delivery via cesarean section.

“The findings of this study reveal that the associations between IMIDs and adverse pregnancy outcomes are influenced by the specific type of IMIDs and the presence of comorbidities,” the authors wrote.
 

A Large Study, But How Representative Is It?

Asked to comment on the study, Catherine Sims, MD, a rheumatologist at Duke University Medical Center in Durham, North Carolina, noted that the analysis was much larger than many reproductive rheumatology studies, and “their statistics were phenomenal.”

She agreed that “not all autoimmune diseases are created equal when it comes to pregnancy-associated risks.” However, she added that this study’s patient population may not be totally representative of pregnant people with IMIDs or autoimmune diseases.

“We’re making generalizations about autoimmune diseases based on this demographic of White women who are not taking immunosuppression,” she said.

“We know that race and ethnicity play a huge role in pregnancy outcomes, and Black women have higher maternal and fetal morbidity and mortality, which is likely related to systemic racism and biases in the medical system,” she added. “While the study did control for sociodemographic factors, the population studied is not diverse.”

Only 17% of people with IMID in the cohort were on immunosuppressive medication, which could suggest low disease activity in the study population, Dr. Sims said. If the population generally had well-controlled disease, that could have positioned them for better pregnancy outcomes.

The authors noted that their analysis did not have information on IMID disease activity or severity — one of the limitations of the study.

However, the authors argued that the observed low prescription rate during the study may have increased poor pregnancy outcomes.

“Although this reflects real-world care in the population studied, results from this study may show higher risk than might be achieved with recommended care guidelines,” they wrote.

Ultimately, the authors argued that these findings show how co-occurring health conditions can affect pregnancy outcomes in autoimmune diseases, particularly for RA and IBD.

“There is a need to take comorbidities into consideration for guidelines for patients with inflammatory bowel disease and rheumatoid arthritis and when designing future research to investigate maternal health in patients with IMIDs,” they wrote.

The study was funded by the National Institutes of Health. Dr. Sims declared no relevant financial relationships. Dr. Hadlock has received research funding (paid to the institute) from Pfizer, Novartis, Janssen, Bristol-Myers Squibb, and Gilead.

A version of this article first appeared on Medscape.com.

Comorbidities may play a large role in driving poor pregnancy outcomes in pregnant people with certain immune-mediated inflammatory diseases (IMIDs).

In a new study of 12 individual IMIDs, people with rheumatoid arthritis (RA) or inflammatory bowel disease (IBD) did not have signficantly increased risk for preterm birth (PTB) or low birth weight (LBW), compared with people who did not have an IMID, after adjusting for additional chronic conditions and other confounding factors.

The study was published online on February 1 in eClinicalMedicine.

While many studies have explored the relationships between pregnancy outcomes and IMIDs, “the impact of comorbidities on the relation between IMIDs and pregnancy course is insufficiently examined,” the authors wrote. These previous studies also tended to have a small sample size.
 

Pregnancy Outcome Risks Varied Between IMIDs

To remedy this, researchers used electronic health record data from Providence St Joseph Health — a multistate integrated healthcare system — to identify more than 365,000 pregnant people with live births between January 1, 2013, and December 31, 2022. The cohort included more than 5700 people with at least one of 12 IMIDs: Psoriasis, IBD, RA, spondyloarthritis (SpA), multiple sclerosis, systemic lupus erythematosus (SLE), psoriatic arthritis (PsA), antiphospholipid syndrome (APS), Sjögren syndrome (SjS), vasculitis, sarcoidosis, and systemic sclerosis. The study included only live births with a gestational age of 20 weeks or greater.

Researchers compared maternal-fetal health outcomes between the two groups, controlling for comorbidities including diabetes, cardiovascular disease, chronic kidney disease, obesity, and depression. They also accounted for confounding variables including race, age, smoking status, and socioeconomic status.

In total, 83% of people in the IMID group had no immunomodulatory medication prescriptions during their pregnancy. Of the 17% taking medication, 48%-70% continued taking their medication until delivery. Most patients were White, comprising 62.9% of the non-IMID group and 73.1% of the IMID group.

After adjusting for comorbidities, patients with any of the 12 IMIDs had a 10%-20% higher risk for PTB, LBW, small for gestation age (SGA), and cesarean section than did comparators.

But these risks varied between IMIDs. Patients with RA and IBD did not have an increased risk for PTB or LBW. However, when researchers did not control for comorbidities, pregnancy risks were higher and showed statistical significance in these two groups.

“This suggests that for RA and IBD, comorbidities may be a more important factor for adverse outcomes than the underlying autoimmune disease,” senior author Jennifer Hadlock, MD, an associate professor and director of medical data science at the Institute for Systems Biology in Seattle, Washington, said in a video accompanying a press release.

Overall, the analysis found that women with IMIDs were approximately two to three times more likely to have chronic comorbidities than the control group.

Like previous studies, there was a strong association between SLE and APS and poor pregnancy outcomes, even after controlling for confounding factors. Patients with SpA had a 50% increased risk for PTB, while those with SLE and APS had more than a twofold higher risk. Patients with SLE were 90% more likely than comparators to deliver babies with an SGA condition, while RA patients had a 30% higher risk. SLE was the only condition with an increased risk for LBW (relative risk, 3.5). IBD, RA, PsA, SpA, SLE, APS, and SjS were all associated with a higher likelihood of delivery via cesarean section.

“The findings of this study reveal that the associations between IMIDs and adverse pregnancy outcomes are influenced by the specific type of IMIDs and the presence of comorbidities,” the authors wrote.
 

A Large Study, But How Representative Is It?

Asked to comment on the study, Catherine Sims, MD, a rheumatologist at Duke University Medical Center in Durham, North Carolina, noted that the analysis was much larger than many reproductive rheumatology studies, and “their statistics were phenomenal.”

She agreed that “not all autoimmune diseases are created equal when it comes to pregnancy-associated risks.” However, she added that this study’s patient population may not be totally representative of pregnant people with IMIDs or autoimmune diseases.

“We’re making generalizations about autoimmune diseases based on this demographic of White women who are not taking immunosuppression,” she said.

“We know that race and ethnicity play a huge role in pregnancy outcomes, and Black women have higher maternal and fetal morbidity and mortality, which is likely related to systemic racism and biases in the medical system,” she added. “While the study did control for sociodemographic factors, the population studied is not diverse.”

Only 17% of people with IMID in the cohort were on immunosuppressive medication, which could suggest low disease activity in the study population, Dr. Sims said. If the population generally had well-controlled disease, that could have positioned them for better pregnancy outcomes.

The authors noted that their analysis did not have information on IMID disease activity or severity — one of the limitations of the study.

However, the authors argued that the observed low prescription rate during the study may have increased poor pregnancy outcomes.

“Although this reflects real-world care in the population studied, results from this study may show higher risk than might be achieved with recommended care guidelines,” they wrote.

Ultimately, the authors argued that these findings show how co-occurring health conditions can affect pregnancy outcomes in autoimmune diseases, particularly for RA and IBD.

“There is a need to take comorbidities into consideration for guidelines for patients with inflammatory bowel disease and rheumatoid arthritis and when designing future research to investigate maternal health in patients with IMIDs,” they wrote.

The study was funded by the National Institutes of Health. Dr. Sims declared no relevant financial relationships. Dr. Hadlock has received research funding (paid to the institute) from Pfizer, Novartis, Janssen, Bristol-Myers Squibb, and Gilead.

A version of this article first appeared on Medscape.com.

SAN DIEGO — Every year, about 4000 patients in the United States are diagnosed with periocular melanoma, according to Geva Mannor, MD, MPH.

“Though rare, the incidence is thought to be slightly increasing, while the onset tends to occur in patients over age 40 years,” Dr. Mannor, an oculofacial plastic surgeon in the division of ophthalmology at Scripps Clinic, San Diego, said at the annual Cutaneous Malignancy Update. “It may be more common in males and welding is a risk factor. Pain and vision loss are late symptoms, and there are amelanotic variants. Gene expression profiling and other genetic testing can predict metastasis, especially expression of BRCA1-associated protein 1 (BAP1).”

An estimated 83% of periocular melanoma cases are choroid (which involve the intraocular part of the eye and the uvea), about 10% involve the eyelid, while about 1%-3% involve the conjunctiva. Extrapolating from the best available data, Dr. Mannor said that the annual incidence of choroidal melanoma in the United States is less than 2500, the annual incidence of eyelid melanoma is less than 750, and the annual incidence of conjunctival melanoma is less than 250 — much lower than for cutaneous melanomas. Put another way, the ratio between cutaneous and choroid melanoma is 80:1, the ratio between cutaneous and eyelid melanoma is 266:1, and the ratio between cutaneous and conjunctival melanoma is 800:1.

Dr. Mannor

According to an article published in 2021 on the topic, risk factors for periocular melanoma include light eye color (blue/gray; relative risk, 1.75), fair skin (RR, 1.80), and inability to tan (RR, 1.64), but not blonde hair. A review of 210 patients with melanoma of the eyelid from 11 studies showed that 57% were located on the lower lid, 13% were on the upper lid (“I think because the brow protects sun exposure to the upper lid,” Dr. Mannor said), 12% were on the brow, 10% were on the lateral canthus, and 2% were on the medial canthus. In addition, 35% of the eyelid melanomas were superficial spreading cases, 31% were lentigo maligna, and 19% were nodular. The mean Breslow depth was 1.36 mm and the mortality rate was 4.9%.

Dr. Mannor said that cheek and brow melanomas can extend to the inside of the eyelid and conjunctiva. “Therefore, you want to examine the inside of upper and lower eyelids,” he said at the meeting, which was hosted by the Scripps Cancer Center. “Margin-control excision of lid melanoma is the standard treatment.”

On a related note, he said that glaucoma eye drops that contain prostaglandin F2alpha induce cutaneous and iris pigmentation with varying rates depending on the specific type of prostaglandin. “There have been case reports of these eye drops causing periocular pigmentation that masquerades as suspicious, melanoma-like skin cancer, often necessitating a skin biopsy,” he said.

Dr. Mannor reported having no disclosures.

SAN DIEGO — Every year, about 4000 patients in the United States are diagnosed with periocular melanoma, according to Geva Mannor, MD, MPH.

“Though rare, the incidence is thought to be slightly increasing, while the onset tends to occur in patients over age 40 years,” Dr. Mannor, an oculofacial plastic surgeon in the division of ophthalmology at Scripps Clinic, San Diego, said at the annual Cutaneous Malignancy Update. “It may be more common in males and welding is a risk factor. Pain and vision loss are late symptoms, and there are amelanotic variants. Gene expression profiling and other genetic testing can predict metastasis, especially expression of BRCA1-associated protein 1 (BAP1).”

An estimated 83% of periocular melanoma cases are choroid (which involve the intraocular part of the eye and the uvea), about 10% involve the eyelid, while about 1%-3% involve the conjunctiva. Extrapolating from the best available data, Dr. Mannor said that the annual incidence of choroidal melanoma in the United States is less than 2500, the annual incidence of eyelid melanoma is less than 750, and the annual incidence of conjunctival melanoma is less than 250 — much lower than for cutaneous melanomas. Put another way, the ratio between cutaneous and choroid melanoma is 80:1, the ratio between cutaneous and eyelid melanoma is 266:1, and the ratio between cutaneous and conjunctival melanoma is 800:1.

Dr. Mannor

According to an article published in 2021 on the topic, risk factors for periocular melanoma include light eye color (blue/gray; relative risk, 1.75), fair skin (RR, 1.80), and inability to tan (RR, 1.64), but not blonde hair. A review of 210 patients with melanoma of the eyelid from 11 studies showed that 57% were located on the lower lid, 13% were on the upper lid (“I think because the brow protects sun exposure to the upper lid,” Dr. Mannor said), 12% were on the brow, 10% were on the lateral canthus, and 2% were on the medial canthus. In addition, 35% of the eyelid melanomas were superficial spreading cases, 31% were lentigo maligna, and 19% were nodular. The mean Breslow depth was 1.36 mm and the mortality rate was 4.9%.

Dr. Mannor said that cheek and brow melanomas can extend to the inside of the eyelid and conjunctiva. “Therefore, you want to examine the inside of upper and lower eyelids,” he said at the meeting, which was hosted by the Scripps Cancer Center. “Margin-control excision of lid melanoma is the standard treatment.”

On a related note, he said that glaucoma eye drops that contain prostaglandin F2alpha induce cutaneous and iris pigmentation with varying rates depending on the specific type of prostaglandin. “There have been case reports of these eye drops causing periocular pigmentation that masquerades as suspicious, melanoma-like skin cancer, often necessitating a skin biopsy,” he said.

Dr. Mannor reported having no disclosures.

SAN DIEGO — Every year, about 4000 patients in the United States are diagnosed with periocular melanoma, according to Geva Mannor, MD, MPH.

“Though rare, the incidence is thought to be slightly increasing, while the onset tends to occur in patients over age 40 years,” Dr. Mannor, an oculofacial plastic surgeon in the division of ophthalmology at Scripps Clinic, San Diego, said at the annual Cutaneous Malignancy Update. “It may be more common in males and welding is a risk factor. Pain and vision loss are late symptoms, and there are amelanotic variants. Gene expression profiling and other genetic testing can predict metastasis, especially expression of BRCA1-associated protein 1 (BAP1).”

An estimated 83% of periocular melanoma cases are choroid (which involve the intraocular part of the eye and the uvea), about 10% involve the eyelid, while about 1%-3% involve the conjunctiva. Extrapolating from the best available data, Dr. Mannor said that the annual incidence of choroidal melanoma in the United States is less than 2500, the annual incidence of eyelid melanoma is less than 750, and the annual incidence of conjunctival melanoma is less than 250 — much lower than for cutaneous melanomas. Put another way, the ratio between cutaneous and choroid melanoma is 80:1, the ratio between cutaneous and eyelid melanoma is 266:1, and the ratio between cutaneous and conjunctival melanoma is 800:1.

Dr. Mannor

According to an article published in 2021 on the topic, risk factors for periocular melanoma include light eye color (blue/gray; relative risk, 1.75), fair skin (RR, 1.80), and inability to tan (RR, 1.64), but not blonde hair. A review of 210 patients with melanoma of the eyelid from 11 studies showed that 57% were located on the lower lid, 13% were on the upper lid (“I think because the brow protects sun exposure to the upper lid,” Dr. Mannor said), 12% were on the brow, 10% were on the lateral canthus, and 2% were on the medial canthus. In addition, 35% of the eyelid melanomas were superficial spreading cases, 31% were lentigo maligna, and 19% were nodular. The mean Breslow depth was 1.36 mm and the mortality rate was 4.9%.

Dr. Mannor said that cheek and brow melanomas can extend to the inside of the eyelid and conjunctiva. “Therefore, you want to examine the inside of upper and lower eyelids,” he said at the meeting, which was hosted by the Scripps Cancer Center. “Margin-control excision of lid melanoma is the standard treatment.”

On a related note, he said that glaucoma eye drops that contain prostaglandin F2alpha induce cutaneous and iris pigmentation with varying rates depending on the specific type of prostaglandin. “There have been case reports of these eye drops causing periocular pigmentation that masquerades as suspicious, melanoma-like skin cancer, often necessitating a skin biopsy,” he said.

Dr. Mannor reported having no disclosures.

ORLANDO, FLORIDA — New potential treatment strategies for people with rosacea include botulinum toxin, the antidepressant paroxetine, and a low-molecular-weight analog of heparan sulfate, according to evidence published in the last year. At the same time, there is new recognition that systemic inflammation can occur with rosacea, and targeting treatment to the phenotype continues to gain steam as a way to help people with this difficult-to-manage condition.

National Rosacea Society

“Anyone here think they’ve got rosacea under control? No, I wish — not yet,” Diane Dr. Thiboutot, MD, said at the annual ODAC Dermatology, Aesthetic & Surgical Conference.
 

Botulinum Toxin Benefits

With that in mind, Dr. Thiboutot highlighted emerging therapies for treating rosacea. “Last year, there were a couple of reports … looking at the use of botulinum toxin injections for patients with rosacea,” said Dr. Thiboutot, professor of dermatology and vice chair for research in the Department of Dermatology at Penn State College of Medicine, Hershey, Pennsylvania.

One report describes the case of a woman with rosacea who had severe recurrent episodes of erythema and flushing. She also experienced occasional papules and pustules and had been recalcitrant to multiple treatments for rosacea, according to the report published in the Journal of Drugs in Dermatology in June 2023. The patient was treated with a total of 150-180 units of botulinum toxin administered as 3-6 units spaced 1 cm apart every 2-4 months. She was “eventually maintained every 6 months with excellent improvement,” Dr. Thiboutot said.

In another case, a man with refractory vascular and papulopustular rosacea was treated with half of a unit of botulinum toxin spaced every 0.5 cm. Images taken at baseline, 1 month, and 3 months after treatment demonstrated improvements, as reported in June 2023.

Regarding botulinum toxin for rosacea, Dr. Thiboutot said, “it’s a very interesting thing to think about.”

Susan Weinkle, MD, ODAC conference cochair, session moderator, and collaborative associate professor of dermatology at the University of South Florida, Tampa, Florida, agreed. “I do think it holds some interesting potential,” she said. “How good are your hands? Because administering 0.5-unit injections evenly is a little bit challenging.”

However, one approach that might help is “if we could be a little more innovative like they are in Europe.” Physicians in Europe can use a metered syringe, one where they dial in the exact amount per injection, which allows them to be consistent, she added.

With rosacea erythema, Dr. Thiboutot noted, a spotted effect can result if injections are not administered uniformly.
 

Potential Role for Paroxetine

The antidepressant paroxetine, a potent selective serotonin reuptake inhibitor, could be an effective treatment for refractory erythema of rosacea, Dr. Thiboutot said. It is approved for treating depression, obsessive-compulsive disorder, and social phobia. The agent has also shown effectiveness in alleviating hot flashes associated with vascular dysregulation in menopause.

Uptake in serotonin and changes in receptors are closely related to vascular dilation and constriction, Dr. Thiboutot added, so paroxetine “may be beneficial in treating vascular dysfunction” including in people with rosacea. Evidence to support this potential approach comes from the primary results of a randomized controlled trial published in June 2023. Based on the results, the researchers concluded that paroxetine “appears to be an efficacious and well-tolerated treatment for refractory erythema in rosacea.”

In the trial, almost 43% of people treated with paroxetine met the primary endpoint for improving recalcitrant erythema at week 12 compared with almost 21% who took a placebo, a statistically significant difference.
 

Heparan Sulfate Analog in a Cream

Evidence suggests that a low-molecular-weight heparan sulfate analog is another agent that holds potential for treating rosacea. For example, a 2023 randomized controlled trial evaluated the immune response in rosacea, focusing on a specific cathelicidin peptide called LL-37 that activates an inflammasome in rosacea. Low-molecular-weight heparan sulfate holds the potential to inhibit LL-37 activity, as LL-37 is inhibited by binding to heparan sulfate, a cell surface glycosaminoglycan.

The study of 16 people assessed the ability of the analog to modulate this response; they were also treated with the pulsed dye laser. Participants who applied a dermal repair cream that contained this ingredient experienced a one-grade reduction in erythema at weeks 4 and 8 compared with a control group applying a moisturizer.

A Growing Case for Systemic Inflammation

In the meantime, treating rosacea with more traditional therapies remains challenging.

But there’s hope. Success has been reported in the few years since an expert panel recommended treating based on phenotype — a treat-what-you-see approach, Dr. Thiboutot said.

“We don’t have a single treatment that is one-size-fits-all. We have to individualize our treatment [based] more on what we are seeing and what the patient is experiencing.”

Eventually, therapies to treat systemic inflammation could provide benefits as well. As with hidradenitis suppurativa and psoriasis, “there’s evidence of systemic inflammation in some of our rosacea patients,” Dr. Thiboutot said.

For example, researchers compared blood taken from people with and without rosacea and found increased levels of some inflammatory markers among participants with the condition.

The retrospective study published in June 2023 in Scientific Reports included 100 patients with rosacea and 58 controls. The investigators found significantly higher elevations in the SII index, erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP) levels in the patients with rosacea.

“There was no significant link between the severity of rosacea and the ESR, CRP, or SII index values, Dr. Thiboutot added. “This study suggests inflammation beyond the skin in rosacea patients.”

For more guidance on treating rosacea through standard management options, including how to tailor therapy to each individual, she recommended the 2019 Update by the National Rosacea Society Expert Committee. “It’s a nice quick way to see, based on expert opinion, the most effective treatments and what the evidence base is,” said Dr. Thiboutot, lead author of the paper, published in the Journal of the American Academy of Dermatology in February 2020.

Dr. Thiboutot reported no relevant financial relationships.

ORLANDO, FLORIDA — New potential treatment strategies for people with rosacea include botulinum toxin, the antidepressant paroxetine, and a low-molecular-weight analog of heparan sulfate, according to evidence published in the last year. At the same time, there is new recognition that systemic inflammation can occur with rosacea, and targeting treatment to the phenotype continues to gain steam as a way to help people with this difficult-to-manage condition.

National Rosacea Society

“Anyone here think they’ve got rosacea under control? No, I wish — not yet,” Diane Dr. Thiboutot, MD, said at the annual ODAC Dermatology, Aesthetic & Surgical Conference.
 

Botulinum Toxin Benefits

With that in mind, Dr. Thiboutot highlighted emerging therapies for treating rosacea. “Last year, there were a couple of reports … looking at the use of botulinum toxin injections for patients with rosacea,” said Dr. Thiboutot, professor of dermatology and vice chair for research in the Department of Dermatology at Penn State College of Medicine, Hershey, Pennsylvania.

One report describes the case of a woman with rosacea who had severe recurrent episodes of erythema and flushing. She also experienced occasional papules and pustules and had been recalcitrant to multiple treatments for rosacea, according to the report published in the Journal of Drugs in Dermatology in June 2023. The patient was treated with a total of 150-180 units of botulinum toxin administered as 3-6 units spaced 1 cm apart every 2-4 months. She was “eventually maintained every 6 months with excellent improvement,” Dr. Thiboutot said.

In another case, a man with refractory vascular and papulopustular rosacea was treated with half of a unit of botulinum toxin spaced every 0.5 cm. Images taken at baseline, 1 month, and 3 months after treatment demonstrated improvements, as reported in June 2023.

Regarding botulinum toxin for rosacea, Dr. Thiboutot said, “it’s a very interesting thing to think about.”

Susan Weinkle, MD, ODAC conference cochair, session moderator, and collaborative associate professor of dermatology at the University of South Florida, Tampa, Florida, agreed. “I do think it holds some interesting potential,” she said. “How good are your hands? Because administering 0.5-unit injections evenly is a little bit challenging.”

However, one approach that might help is “if we could be a little more innovative like they are in Europe.” Physicians in Europe can use a metered syringe, one where they dial in the exact amount per injection, which allows them to be consistent, she added.

With rosacea erythema, Dr. Thiboutot noted, a spotted effect can result if injections are not administered uniformly.
 

Potential Role for Paroxetine

The antidepressant paroxetine, a potent selective serotonin reuptake inhibitor, could be an effective treatment for refractory erythema of rosacea, Dr. Thiboutot said. It is approved for treating depression, obsessive-compulsive disorder, and social phobia. The agent has also shown effectiveness in alleviating hot flashes associated with vascular dysregulation in menopause.

Uptake in serotonin and changes in receptors are closely related to vascular dilation and constriction, Dr. Thiboutot added, so paroxetine “may be beneficial in treating vascular dysfunction” including in people with rosacea. Evidence to support this potential approach comes from the primary results of a randomized controlled trial published in June 2023. Based on the results, the researchers concluded that paroxetine “appears to be an efficacious and well-tolerated treatment for refractory erythema in rosacea.”

In the trial, almost 43% of people treated with paroxetine met the primary endpoint for improving recalcitrant erythema at week 12 compared with almost 21% who took a placebo, a statistically significant difference.
 

Heparan Sulfate Analog in a Cream

Evidence suggests that a low-molecular-weight heparan sulfate analog is another agent that holds potential for treating rosacea. For example, a 2023 randomized controlled trial evaluated the immune response in rosacea, focusing on a specific cathelicidin peptide called LL-37 that activates an inflammasome in rosacea. Low-molecular-weight heparan sulfate holds the potential to inhibit LL-37 activity, as LL-37 is inhibited by binding to heparan sulfate, a cell surface glycosaminoglycan.

The study of 16 people assessed the ability of the analog to modulate this response; they were also treated with the pulsed dye laser. Participants who applied a dermal repair cream that contained this ingredient experienced a one-grade reduction in erythema at weeks 4 and 8 compared with a control group applying a moisturizer.

A Growing Case for Systemic Inflammation

In the meantime, treating rosacea with more traditional therapies remains challenging.

But there’s hope. Success has been reported in the few years since an expert panel recommended treating based on phenotype — a treat-what-you-see approach, Dr. Thiboutot said.

“We don’t have a single treatment that is one-size-fits-all. We have to individualize our treatment [based] more on what we are seeing and what the patient is experiencing.”

Eventually, therapies to treat systemic inflammation could provide benefits as well. As with hidradenitis suppurativa and psoriasis, “there’s evidence of systemic inflammation in some of our rosacea patients,” Dr. Thiboutot said.

For example, researchers compared blood taken from people with and without rosacea and found increased levels of some inflammatory markers among participants with the condition.

The retrospective study published in June 2023 in Scientific Reports included 100 patients with rosacea and 58 controls. The investigators found significantly higher elevations in the SII index, erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP) levels in the patients with rosacea.

“There was no significant link between the severity of rosacea and the ESR, CRP, or SII index values, Dr. Thiboutot added. “This study suggests inflammation beyond the skin in rosacea patients.”

For more guidance on treating rosacea through standard management options, including how to tailor therapy to each individual, she recommended the 2019 Update by the National Rosacea Society Expert Committee. “It’s a nice quick way to see, based on expert opinion, the most effective treatments and what the evidence base is,” said Dr. Thiboutot, lead author of the paper, published in the Journal of the American Academy of Dermatology in February 2020.

Dr. Thiboutot reported no relevant financial relationships.

ORLANDO, FLORIDA — New potential treatment strategies for people with rosacea include botulinum toxin, the antidepressant paroxetine, and a low-molecular-weight analog of heparan sulfate, according to evidence published in the last year. At the same time, there is new recognition that systemic inflammation can occur with rosacea, and targeting treatment to the phenotype continues to gain steam as a way to help people with this difficult-to-manage condition.

National Rosacea Society

“Anyone here think they’ve got rosacea under control? No, I wish — not yet,” Diane Dr. Thiboutot, MD, said at the annual ODAC Dermatology, Aesthetic & Surgical Conference.
 

Botulinum Toxin Benefits

With that in mind, Dr. Thiboutot highlighted emerging therapies for treating rosacea. “Last year, there were a couple of reports … looking at the use of botulinum toxin injections for patients with rosacea,” said Dr. Thiboutot, professor of dermatology and vice chair for research in the Department of Dermatology at Penn State College of Medicine, Hershey, Pennsylvania.

One report describes the case of a woman with rosacea who had severe recurrent episodes of erythema and flushing. She also experienced occasional papules and pustules and had been recalcitrant to multiple treatments for rosacea, according to the report published in the Journal of Drugs in Dermatology in June 2023. The patient was treated with a total of 150-180 units of botulinum toxin administered as 3-6 units spaced 1 cm apart every 2-4 months. She was “eventually maintained every 6 months with excellent improvement,” Dr. Thiboutot said.

In another case, a man with refractory vascular and papulopustular rosacea was treated with half of a unit of botulinum toxin spaced every 0.5 cm. Images taken at baseline, 1 month, and 3 months after treatment demonstrated improvements, as reported in June 2023.

Regarding botulinum toxin for rosacea, Dr. Thiboutot said, “it’s a very interesting thing to think about.”

Susan Weinkle, MD, ODAC conference cochair, session moderator, and collaborative associate professor of dermatology at the University of South Florida, Tampa, Florida, agreed. “I do think it holds some interesting potential,” she said. “How good are your hands? Because administering 0.5-unit injections evenly is a little bit challenging.”

However, one approach that might help is “if we could be a little more innovative like they are in Europe.” Physicians in Europe can use a metered syringe, one where they dial in the exact amount per injection, which allows them to be consistent, she added.

With rosacea erythema, Dr. Thiboutot noted, a spotted effect can result if injections are not administered uniformly.
 

Potential Role for Paroxetine

The antidepressant paroxetine, a potent selective serotonin reuptake inhibitor, could be an effective treatment for refractory erythema of rosacea, Dr. Thiboutot said. It is approved for treating depression, obsessive-compulsive disorder, and social phobia. The agent has also shown effectiveness in alleviating hot flashes associated with vascular dysregulation in menopause.

Uptake in serotonin and changes in receptors are closely related to vascular dilation and constriction, Dr. Thiboutot added, so paroxetine “may be beneficial in treating vascular dysfunction” including in people with rosacea. Evidence to support this potential approach comes from the primary results of a randomized controlled trial published in June 2023. Based on the results, the researchers concluded that paroxetine “appears to be an efficacious and well-tolerated treatment for refractory erythema in rosacea.”

In the trial, almost 43% of people treated with paroxetine met the primary endpoint for improving recalcitrant erythema at week 12 compared with almost 21% who took a placebo, a statistically significant difference.
 

Heparan Sulfate Analog in a Cream

Evidence suggests that a low-molecular-weight heparan sulfate analog is another agent that holds potential for treating rosacea. For example, a 2023 randomized controlled trial evaluated the immune response in rosacea, focusing on a specific cathelicidin peptide called LL-37 that activates an inflammasome in rosacea. Low-molecular-weight heparan sulfate holds the potential to inhibit LL-37 activity, as LL-37 is inhibited by binding to heparan sulfate, a cell surface glycosaminoglycan.

The study of 16 people assessed the ability of the analog to modulate this response; they were also treated with the pulsed dye laser. Participants who applied a dermal repair cream that contained this ingredient experienced a one-grade reduction in erythema at weeks 4 and 8 compared with a control group applying a moisturizer.

A Growing Case for Systemic Inflammation

In the meantime, treating rosacea with more traditional therapies remains challenging.

But there’s hope. Success has been reported in the few years since an expert panel recommended treating based on phenotype — a treat-what-you-see approach, Dr. Thiboutot said.

“We don’t have a single treatment that is one-size-fits-all. We have to individualize our treatment [based] more on what we are seeing and what the patient is experiencing.”

Eventually, therapies to treat systemic inflammation could provide benefits as well. As with hidradenitis suppurativa and psoriasis, “there’s evidence of systemic inflammation in some of our rosacea patients,” Dr. Thiboutot said.

For example, researchers compared blood taken from people with and without rosacea and found increased levels of some inflammatory markers among participants with the condition.

The retrospective study published in June 2023 in Scientific Reports included 100 patients with rosacea and 58 controls. The investigators found significantly higher elevations in the SII index, erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP) levels in the patients with rosacea.

“There was no significant link between the severity of rosacea and the ESR, CRP, or SII index values, Dr. Thiboutot added. “This study suggests inflammation beyond the skin in rosacea patients.”

For more guidance on treating rosacea through standard management options, including how to tailor therapy to each individual, she recommended the 2019 Update by the National Rosacea Society Expert Committee. “It’s a nice quick way to see, based on expert opinion, the most effective treatments and what the evidence base is,” said Dr. Thiboutot, lead author of the paper, published in the Journal of the American Academy of Dermatology in February 2020.

Dr. Thiboutot reported no relevant financial relationships.