Recent phase 3 trial data confirms that dupilumab is the first biologic medicine is the first to reduce severity and symptoms of atopic dermatitis in pediatric patients.
Today, Sanofi and Regeneron Pharmaceuticals announced that dupilumab (Dupixent) met all the primary and secondary endpoints established in the recent phase 3 trial results.
Dupilumab is a fully human monoclonal antibody, representing the first biologic medicine to reduce disease severity and symptoms of moderate-to-severe atopic dermatitis in children aged 6 months to 5 years.
In a joint statement by Sanofi and Regeneron, the phase 3 data is said to reinforce the efficacy and safety profile of the biologic in several other age groups.
During the recent trial, patients received dupilumab every 4 weeks (200 mg or 300 mg, depending on body weight) plus TCS or placebo.
Dupilumab patients were 50% less likely to experience a skin infection, and the total number of infections was roughly 70% lower than the placebo group.
Additionally, 28% of patients who took dupilumab achieved clear or almost-clear skin compared to 4% with placebo, and 53% achieved 75% or greater overall disease improvement from baseline.
The overall rates of adverse events for the biologic were 10%fewer than placebo.
In a statement published by Regeneron Pharmaceuticals, John Reed, MD, PhD, Global Head of Research and Development at Sanofi, noted parents and caregivers of children with moderate-to-severe atopic dermatitis are often challenged with finding safe and effective treatment options.
“Knowing that safety is of the utmost importance for physicians and parents when considering treatment options for children and infants, we are encouraged by the results of this trial showing Dupixent addressed the signs and symptoms of atopic dermatitis without broadly suppressing the immune system, demonstrating the potential it could have for these very young patients," Reed said.