Dupilumab Eases Poorly Controlled Atopic Dermatitis in Adolescents

By Reuters Staff

November 12, 2019

NEW YORK (Reuters Health) - In adolescents with poorly controlled moderate to severe atopic dermatitis (AD), treatment with dupilumab significantly improved signs and symptoms of AD, including pruritus and sleep loss, as well as quality of life with an "acceptable" safety profile in a phase 3 study.

Dupilumab is a targeted biologic agent that inhibits interleukin-4 and interleukin-13, believed to play a key role in type 2 inflammation involved in AD and other allergic diseases.

Earlier this year, the U.S. Food and Drug Administration approved dupilumab for adolescents 12 to 17 years old with moderate-to-severe AD not adequately responsive to topical prescription therapies. The phase 3 study that led to approval was published in JAMA Dermatology, November 6.

At total of 251 adolescents (148 male; mean age, 14.5 years) were randomly allocated to 16 weeks of treatment with dupilumab subcutaneous injection given every two or four weeks or placebo every two weeks.

At 16 weeks, a significantly higher proportion of patients achieved at least 75% improvement from baseline in Eczema Area and Severity Index (EASI-75) with both the biweekly (41.5%) and four-week (38.1%) dupilumab groups versus placebo (8.2%).

"Efficacy of the every-2-week regimen was generally superior to the every-4-week regimen," report Dr. Ashish Bansal of Regeneron Pharmaceuticals and colleagues.

Conjunctivitis was seen more often with dupilumab than placebo (in about one in 10 patients on active treatment vs. one in 20). Injection-site reactions also occurred more often with dipilumab than placebo. None of these events was serious or severe or led to patients stopping treatment.

The authors say that, to their knowledge, this trial is the largest to date of a systemic treatment for pediatric AD and "the first confirmatory trial showing a favorable benefit-to-risk profile of a monoclonal antibody in this patient population with high unmet medical need."

"The findings provide evidence of the importance of targeted type 2 cytokine blockade, in particular IL-4/IL-13, in reducing the clinical severity and extensive effect of AD in adolescents, with the potential to simultaneously address the high burden of type 2 comorbidities," they add.

The study was sponsored by Sanofi and Regeneron Pharmaceuticals Inc. Medical writing and editorial assistance were provided by an employee of Excerpta Medica, funded by Sanofi Genzyme and Regeneron Pharmaceuticals.

SOURCE: http://bit.ly/2JYWCDq

JAMA Dermatol 2019.