Regeneron, Sanofi present results from Dupixent clinical trial

Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) presented positive results from the clinical trial assessing Dupixent in adults and adolescents with uncontrolled moderate-to-severe atopic hand and foot dermatitis. The trial, the first evaluating a biologic for this difficult-to-treat population, met its primary and key secondary endpoints. The results were featured in a late-breaking session, one of more than 20 Dupixent scientific presentations, at the American Academy of Dermatology 2023 Annual Meeting. In the trial, patients received Dupixent every two weeks or placebo. At 16 weeks, patients treated with Dupixent experienced the following: 40% achieved clear or almost clear skin on hands and feet compared to 17% with placebo, the primary endpoint. 52% saw a clinically meaningful reduction in itch on hands and feet compared to 14% with placebo, the key secondary endpoint. 69% average reduction in signs of hand and foot lesions from baseline compared to 31% with placebo. 75% average improvement in hand eczema disease severity from baseline compared to 40% with placebo. There were significant improvements in measures of hand and foot skin pain, sleep, and hand eczema-related quality of life. The trial demonstrated similar safety results to the known safety profile of Dupixent in atopic dermatitis. Overall rates of adverse events were 66% for Dupixent and 74% for placebo. AEs more commonly observed with Dupixent compared to placebo included nasopharyngitis, upper respiratory tract infection, conjunctivitis, herpes viral infections and increased blood creatine phosphokinase. Additionally, 3% of patients taking Dupixent used at least one rescue medication compared to 21% of patients on placebo. The potential use of Dupixent in chronic spontaneous urticaria is currently under clinical development, and the safety and efficacy have not been fully evaluated by any regulatory authority.