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Is there evidence to suggest a true remittive effect of JAK inhibitors for atopic dermatitis?
Clinical Applications
Dr. Schwarzenberger is the former physician editor of DermWorld. She interviews the author of a recent study each month.
By Kathryn Schwarzenberger, MD, April 1, 2021
In this month’s Clinical Applications column, Physician Editor Kathryn Schwarzenberger, MD, talks with Jonathan Silverberg, MD, PhD, MPH, about his recent JAMA Dermatology article "Efficacy and safety of baricitinib combined with topical corticosteroids for treatment of moderate to severe atopic dermatitis."
DermWorld: You and your colleagues recently published the results of your study looking at the efficacy and safety of baricitinib combined with topical corticosteroids for the treatment of moderate to severe atopic dermatitis. Can you briefly describe the study and your results?
Dr. Silverberg: Baricitinib is an oral preferential Janus kinase (JAK)1/JAK2 inhibitor that is currently FDA approved for the treatment of rheumatoid arthritis.
BREEZE-AD7 is an international, double-blind, placebo-controlled, phase 3 randomized clinical trial, examining baricitinib 2 mg or 4 mg or placebo once daily in combination with low-to-moderate potency topical corticosteroids in adults with moderate-to-severe atopic dermatitis. Patients were treated for 16 weeks in the double-blind period of the study. The primary efficacy end point was the proportion of patients achieving a validated Investigator Global Assessment for Atopic Dermatitis score of clear or almost clear at week 16. The primary endpoint was achieved by 31% of patients treated with 4 mg of baricitinib and 24% of patients treated with 2 mg of baricitinib compared with only 15% in the placebo arm.
DermWorld: Did you feel you followed patients long enough to see if the drug might have an enduring remittive effect?
Dr. Silverberg: This study assessed patients at week 16, which has become a fairly standard time-point for primary efficacy assessment in trials of moderate-to-severe AD. While baricitinib showed good efficacy at week 16, we do not have clear evidence to suggest a true remittive effect of baricitinib or other JAK inhibitors.
DermWorld: What side effects did you observe in your AD patients and are they specific for the drug or common to the class of JAK inhibitors?
Dr. Silverberg: Overall, both doses of baricitinib were well tolerated, with the most common adverse events reported being nasopharyngitis, upper respiratory tract infections, and folliculitis. Across the baricitinib program, and as seen with other JAK inhibitors, increased herpes simplex and herpes zoster were observed and rarely venous thromboembolis.
“Both doses of baricitinib were well tolerated, with the most common adverse events reported being nasopharyngitis, upper respiratory tract infections, and folliculitis.”
─ Jonathan Silverberg, MD, PhD, MPH
DermWorld: Many of our patients have expressed concern about using potentially immunosuppressive or immunomodulatory drugs during the COVID-19 crisis. Baricitinib has, in fact, been used to treat COVID infection when used in combination with remdesivir. Can you comment on this?
Dr. Silverberg: It is indeed reassuring that baricitinib can improve outcomes in COVID-19. Though, I think it is important to recognize that there are different stages of disease with respect to COVID-19. We do not have much data about the safety of baricitinib in the early phase of COVID-19 or whether baricitinib increases the risk of COVID-19 transmission. The efficacy of baricitinib stems from use in later stage COVID-19.
DermWorld: How does this drug compare to dupilumab in the management of atopic dermatitis? Can you envision when one drug would be prescribed over the other?
Dr. Silverberg: There are no head-to-head studies of dupilumab compared to baricitinib. If we compare across studies, it appears that dupilumab may be more effective than baricitinib. Though, patients who achieve a good clinical response with baricitinib tend to do so quite rapidly. Baricitinib looks to be most effective in patients with moderate disease and can be an important treatment option for patients who prefer an oral therapy instead of an injection.
Jonathan Silverberg, MD, PhD, MPH, serves as associate professor, director of clinical research, and director of patch testing at George Washington University School of Medicine and Health Sciences. His paper was published in JAMA Dermatology.
Dr. Silverberg has received honoraria as a consultant and/or advisory board member for Abbvie, Afyx, Arena, Asana, BioMX, Bluefin, Bodewell, Boehringer-Ingelheim, Celgene, Dermavant, Dermira, Eli Lilly, Galderma, GlaxoSmithKline, Incyte, Kiniksa, Leo, Luna, Menlo, Novartis, Pfizer, RAPT, Regeneron, and Sanofi. He has been a speaker for Pfizer, Regeneron, and Sanofi. His institution received grants from Galderma.
Disclaimer: The views and opinions expressed in this article do not necessarily reflect those of DermWorld.
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