Findings from a phase 3 clinical trial support the use of weight-based Dupixent dosing in adolescents with moderate to severe atopic dermatitis.
“To our knowledge, this trial is the largest to date of a systemic treatment for pediatric atopic dermatitis 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,” Eric L. Simpson, MD, of the department of dermatology at Oregon Health & Science University, and colleagues wrote.
A total of 251 patients were randomly assigned into three treatment arms to 16 weeks of treatment with Dupixent (dupilumab, Sanofi/Regeneron) 200 mg (n = 43) or 300 mg (n = 39) every 2 weeks or dupilumab 300 mg every 4 weeks (n = 84) or placebo (n = 85).
The every 2-week (41.5%) and every 4-week (38.1%) dupilumab groups had a significantly higher proportion of patients reach a 75% reduction in Eczema Area Severity Index (EASI) at week 16 vs. placebo (8.2%).
Patients treated with dupilumab every 2 weeks (n = 20; 24.4%) and every 4 weeks (n = 15; 17.9%) reached Investigator Global Assessment of 0 or 1 at week 16 compared with placebo (n = 2; 2.4%).
The first key secondary endpoint of least-squares mean percentage change from baseline to week 16 in EASI was also met by both dupilumab regimens (every 2 weeks, –65.9; every 4 weeks –64.8; placebo, –23.6).
Higher proportions of patients in both dupilumab regimens reached EASI-50 (every 2 weeks, 61%; every 4 weeks, 54.8%; placebo, 12.9%) and EASI-90 at week 16 (every 2 weeks, 23.2%; every 4 weeks, 19%; placebo, 2.4%).
Additionally, both dupilumab groups significantly improved Scoring of Atopic Dermatitis (SCORAD) results at week 16.
As for safety, treatment-emergent adverse events were similar across all treatment groups, according to researchers.
“The findings provide evidence of the importance of targeted type 2 cytokine blockade, in particular interleukin-4/IL-13 in reducing the clinical severity and extensive effect of atopic dermatitis in adolescents with the potential to simultaneously address the high burden of type 2 comorbidities,” Simpson and colleagues wrote. – by Abigail Sutton
Disclosures: The research was sponsored by Sanofi and Regeneron. Simpson reports he received personal fees from AbbVie, Boehringer Ingelheim, Dermavant, Dermira, Galderma, GlaxoSmithKline, Incyte, LEO Pharma, Lilly, Menlo Therapeutics, Pfizer, Pierre Fabre Dermo Cosmetique, Regeneron Pharmaceuticals, Sanofi Genzyme and Valeant. He has received grants from AbbVie, Celgene, Dermira, Galderma, LEO Pharma, Lilly, Pfizer, Regeneron, Roivant, Sanofi Genzyme and nonfinancial support from Regeneron Pharmaceuticals and Sanofi Genzyme. Please see the study for all other authors’ financial disclosures.