Sanofi and Regeneron’s phase 3 clinical trial results announced Friday show Dupixent (dupilumab) combined with standard-of-care topical corticosteroids (TCS) in children aged 6-11 years with uncontrolled severe atopic dermatitis significantly improved disease signs, symptoms and health-related quality of life.
Sanofi and Regeneron previously announced topline positive results of this trial in August 2019.
Detailed results will be presented during a session at the 2020 Revolutionizing Atopic Dermatitis (RAD) Virtual Conference on April 5.
“In my practice, I see children with severe atopic dermatitis struggling with intense, persistent itching and skin lesions covering much of their body, and caregivers who are desperate for additional treatment options that can help control this disease,” said Amy S. Paller, M.D.,Walter J. Hamlin Professor and Chair of Dermatology and Professor of Pediatrics at Northwestern University Feinberg School of Medicine and principal investigator of the trial.
“Data fromthe Phase 3 trial in children aged 6 to 11 adds to the established efficacy and safety data in adults and adolescents and provides hope to physicians and families for a potential new treatment option for children with this chronic disease.”
Data to be presented at RAD show that at 16 weeks, nearly three times as many children achieved clear or almost clear skin when treated with Dupixent and TCS, and more than two-thirds experienced at least a 75% overall improvement of their disease compared to TCS alone. Additionally, more than three times as many children experienced a significant reduction in itch with Dupixent compared to TCS alone. Itch is often described as the most burdensome symptom of atopic dermatitis. Improvements in itch and disease severity were observed with Dupixent as early as two weeks after the first dose and continued throughout active treatment.