Dupixent Demonstrates Positive Phase 3 Results in Children Aged 6–11 with Severe Atopic Dermatitis

Today, Regeneron Pharmaceuticals, Inc. and Sanofi announced that Dupixent (dupilumab), a blockbuster drug jointly developed by the two companies, achieved positive top-line results in a pivotal Phase 3 clinical trial for the treatment of children aged 6 to 11 years with severe atopic dermatitis. The press release stated that Dupixent is the first and only biologic therapy to demonstrate positive outcomes in pediatric patients with atopic dermatitis. In the United States, Dupixent is currently approved for the treatment of adolescents aged 12 to 17 years with moderate-to-severe atopic dermatitis, as well as adults with moderate-to-severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP).

Atopic dermatitis, also known as eczema, is a common chronic inflammatory skin disease. Its clinical manifestations include dry skin, erythema, and pruritus. In patients with moderate-to-severe atopic dermatitis, the rash may cover a large portion of the body, leading to severe and persistent itching. This intense pruritus can impose a significant burden on patients. Atopic dermatitis typically onset in early childhood. Although symptoms may alleviate in some children as they age, for the majority, the condition persists into adolescence and adulthood.

Dupixent is a humanized monoclonal antibody that inhibits the overactive signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13). Clinical trial data have shown that IL-4 and IL-13 are key drivers of type 2 inflammation. Dupixent has achieved positive results in three trials for type 2 allergic inflammatory conditions, including atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyps.

The pivotal randomized, double-blind, placebo-controlled Phase 3 clinical trial of Dupixent enrolled 367 pediatric patients aged 6 to 11 years with severe atopic dermatitis inadequately controlled by topical medications. Overall, 92% of the pediatric patients had at least one comorbidity, such as allergic rhinitis, asthma, or food allergy. Patients were randomized into three groups: the first group received subcutaneous injections of Dupixent 300 mg every 4 weeks (with an initial dose of 600 mg); the second group received weight-based subcutaneous injections of Dupixent 100 mg every 2 weeks (<30 kg) or 200 mg every 2 weeks (>30 kg) (with initial doses of 200 mg or 400 mg, respectively); and the third group received placebo every 2 or 4 weeks.

The study results showed that 70% of patients in the group receiving Dupixent every 4 weeks and 67% of patients in the group receiving Dupixent every 2 weeks achieved a skin improvement of 75% or higher (EASI-75), compared to only 27% in the placebo group. In addition, 33% of patients in the every-4-week Dupixent group and 30% of patients in the every-2-week Dupixent group achieved complete or nearly complete clearance of skin symptoms (IGA score of 0 or 1), versus 11% in the placebo group. Detailed data from this trial will be presented at future medical conferences, and regulatory submissions to the U.S. FDA are expected to begin in the fourth quarter of 2019.

“This trial is the first to evaluate the efficacy of biologic therapy in treating atopic dermatitis in children under 12 years of age, and its results are highly significant given the substantial unmet need in this patient population. The pediatric participants in the trial had suffered from severe atopic dermatitis for most of their lives,” said Dr. George D. Yancopoulos, President and Chief Scientific Officer of Regeneron. “The trial demonstrated that Dupixent provides robust therapeutic benefits, significantly improving the quality of life for young patients.”

References:

[1] Dupixent^® (dupilumab) Showed Positive Topline Results in Phase 3 Trial of Children Aged 6 to 11 Years with Severe Atopic Dermatitis. Retrieved August 6, 2019, from https://www.prnewswire.com/news-releases/dupixent-dupilumab-showed-positive-topline-results-in-phase-3-trial-of-children-aged-6-to-11-years-with-severe-atopic-dermatitis-300896733.html

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