Study Examines Skin Infection Risk Among Patients With AD
Findings from a recent study, which was published in the Journal of the American Academy of Dermatology, demonstrated that treatment with dupilumab (Dupixent) reduced the risk for skin infections among patients with atopic dermatitis (AD).
“A common concern for patients when starting any medication that works on the immune system is whether it increases the risk for infection,” said co-author Aaron M. Drucker, MD, ScM, associate professor of dermatology at the University of Toronto and scientist at Women’s College Research Institute.
Given these concerns, all biologics and other modulators of the immune system should be evaluated on the risk of infections, he said. “Dermatologists should be aware of the data around infection for dupilumab and other medications for atopic dermatitis.”
To determine the impact of dupilumab on the rate of infection, Dr Drucker and Patrick Fleming, MD, MSc, conducted a meta-analysis and systematic review of 8 randomized controlled trials that included 2607 participants with moderate to severe AD. They calculated the risk ratios for skin infections, herpes virus infections, and overall infections and infestations, as well as the odds ratio for eczema herpeticum.
The risk ratios for skin infection was 0.54 for dupilumab compared with placebo, and the odds ratio of eczema herpeticum was 0.34. However, there were no significant associations between treatment with dupilumab and overall herpes virus infection and overall infection.
“Dermatologists can be reassured by our results” said Dr Drucker. “We found no increased risk for infection overall with dupilumab and a decreased risk of skin infections.”
While the mechanisms underlying this association are uncertain, the researchers suggest that the reduced risk for skin infections among patients with AD treated with dupilumab is related to improved disease severity.
Fleming, P. Drucker AM. Risk of infection in patients with atopic dermatitis treated with dupilumab: A meta-analysis of randomized controlled trials. J Am Acad Dermatol. 2018;78(1):62-69.e1.
Novel Atopic Dermatitis Therapy to Enter Phase 2b Trial
An investigational treatment for moderate to severe atopic dermatitis (AD), GBR 830 (Glenmark Pharmaceutical) will begin enrollment of a phase 2b trial in June 2018.
The randomized, double-blind, placebo-controlled trial will include 392 participants divided among 4 dosing arms of GBR 830 and placebo. The study’s primary endpointwill be the effectiveness of GBR 830 at reducing the severity of AD, assessed using the Investigator’s Global Assessment, compared with placebo. Secondary endpoints will include participants who achieve a 75% or greater improvement on disease severity on the Eczema Area and Severity Index, as well as improvements on other validated measures of disease activity. In addition, safety biomarkers relevant to AD and mechanisms of GBR 830 will be measured.