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Sanofi’s Dupixent improves skin clearance in paediatric atopic dermatitis

pharmafile | August 7, 2019 | News story | Research and Development Dupixent, Sanofi, atopic dermatitis, pharma 

As the therapy secured approval in Europe for treatment of adolescent patients with moderate-to-severe atopic dermatitis, Sanofi has revealed new Phase 3 data for Dupixent (dupilumab) in the treatment of severe atopic dermatitis in paediatric patients aged between six and 11 years old.

When used in combination with standard-of-care topical corticosteroids (TCS), 33% of patients receiving Dupixent every four weeks and 30% receiving it every two weeks achieved clear or almost clear skin with an Investigator’s Global Assessment (IGA) score of 0 or 1, compared to 11% with placebo. Furthermore, 70% and 67% respectively of these same two populations achieved a 75% or greater skin improvement compared to 27% with placebo, as well as an average 82% and 78% improvement form baseline, compared to 49% with placebo.

“In this trial, children with severe atopic dermatitis had uncontrolled disease covering, on average, nearly 60% of their skin. The unrelenting symptoms of this disease, which impact not just the child but the whole family, include widespread rashes, intense and persistent itching, and skin lesions,” commented Dr John Reed, Global Head of Research and Development at Sanofi. “Symptoms of severe atopic dermatitis can take a toll on children both physically and emotionally. We are encouraged by these results, which demonstrate that Dupixent improved skin lesions, reduced itching, cleared the skin and importantly, improved health-related quality of life measures for these young patients.” 

Regeneron President and Chief Scientific Officer George Yancopoulos added: “The results from this trial, the first to assess a biologic medicine in children under 12 with atopic dermatitis, are very important because of the significant unmet needs in this patient population. Children in the trial had suffered from severe atopic dermatitis for most of their lives. The trial showed that Dupixent significantly improved outcomes and quality of life, with no new safety signals.”

Matt Fellows

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