Dupilumab improves severe Atopic Dermatitis in children between 6 to 11 years: Phase 3 Data

TARRYTOWN, N.Y. and PARIS/ --Patients who added Dupixent to topical corticosteroids improved skin clearance; average overall disease improved by approximately 80% based on mean EASI score

Data further reinforce consistent safety and tolerability profile observed across adult and adolescent atopic dermatitis trials, including a numerically lower rate of skin infections compared to placebo

Expanded Dupixent indication in children aged 6 to 11 years currently under Priority Review with the FDA; decision expected by May 26, 2020

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced detailed positive results from a pivotal Phase 3 trial evaluating Dupixent® (dupilumab) for children aged 6 to 11 years with uncontrolled severe atopic dermatitis. In the trial, Dupixent combined with standard-of-care topical corticosteroids (TCS) significantly improved disease signs, symptoms and health-related quality of life in these children. Detailed results will be presented during a session at the 2020 Revolutionizing Atopic Dermatitis (RAD) Virtual Conference on April 5. The companies previously announced topline positive results of this trial in August 2019.

"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 from the 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 and TCS, 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.

Dupixent is a fully-human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins. Data from Dupixent clinical trials have shown that IL-4 and IL-13 are key drivers of the type 2 inflammation that plays a major role in atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP). Across all approved indications in the U.S., more than 100,000 patients have started treatment with Dupixent.

The results from the Phase 3 pediatric trial are currently being reviewed by regulatory authorities, including in the U.S., EU and Canada. In the U.S., the supplemental Biologics License Application for children aged 6 to 11 years is currently under Priority Review, with a target action date of May 26, 2020. There are currently no biologic medicines approved for children with severe atopic dermatitis. In 2016, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to review Dupixent for the treatment of severe atopic dermatitis in children 6 months to 11 years of age not well controlled on topical prescription medications. Dupixent is also being studied in a Phase 3 trial for children with uncontrolled persistent asthma, with results expected later this year. The safety and efficacy of Dupixent in these pediatric populations have not been fully evaluated by any regulatory authority.

The virtual late-breaking presentation at RAD included the following data:

The Phase 3, randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of Dupixent combined with TCS in 367 children with severe atopic dermatitis that covered on average 60% of their skin. More than 90% of children in the trial had a history of at least one atopic comorbidity, including asthma (nearly 50%).

Results at 16 weeks showed:

33% of patients who received Dupixent every four weeks (300 mg, regardless of weight) and 30% of patients who received Dupixent every two weeks (100 mg or 200 mg, based on weight) achieved clear or almost clear skin (Investigator's Global Assessment or IGA), compared to 11% for TCS alone (p<0.0001 and p=0.0004, respectively), the primary endpoint in the U.S.

70% of patients who received Dupixent every four weeks and 67% of patients who received Dupixent every two weeks achieved EASI-75 (Eczema Area and Severity Index-75), compared to 27% for TCS alone (p<0.0001 for both), a co-primary endpoint outside of the U.S.

The average EASI score improvement from baseline was 82% in patients who received Dupixent every four weeks and 78% in patients who received Dupixent every two weeks, compared to 49% for TCS alone (p<0.0001 for both).

60% of patients who received Dupixent every four weeks and 68% of patients who received Dupixent every two weeks experienced at least a 3-point reduction in itch intensity on an 11-point scale (weekly average of daily Peak Pruritus Numerical Rating Scale), compared to 21% for TCS alone (p<0.0001 for both).

Safety data over the 16-week treatment period showed:

Overall rates of adverse events were 65% for Dupixent every four weeks, 67% for Dupixent every two weeks and 73% for TCS alone.

Adverse events that were more commonly observed with Dupixent included conjunctivitis (7% for Dupixent every four weeks, 15% for Dupixent every two weeks and 4% for placebo), nasopharyngitis (13% for Dupixent every four weeks, 7% for Dupixent every two weeks and 7% placebo) and injection site reactions (10% for Dupixent every four weeks, 11% for Dupixent every two weeks and 6% for placebo).

Additional prespecified adverse events included skin infections (6% for Dupixent every four weeks, 8% for Dupixent every two weeks and 13% for placebo) and herpes viral infections (2% for Dupixent every four weeks, 3% for Dupixent every two weeks and 5% for placebo)

SOURCE Regeneron Pharmaceuticals, Inc.