Topline results from a phase 3 study investigating dupilumab in the treatment of pediatric patients with severe atopic dermatitis showed that the interleukin-4 receptor alpha antagonist was both safe and effective in this patient population.
The double blind, placebo controlled trial included 367 patients aged 6 to 11 years with severe atopic dermatitis whose disease could not be adequately controlled with topical medications. Patients were randomized to receive 1 of 3 treatments for 16 weeks: dupilumab subcutaneous injection 300mg every 4 weeks (with an initial dose of 600mg); dupilumab 100mg (<30kg) or 200mg (≥30kg) every 2 weeks (with an initial dose of 200mg or 400mg, respectively); and placebo every 2 or 4 weeks. Each group also received background treatment with topical corticosteroids and moisturizers.
At 16 weeks, a significantly greater proportion of patients treated with dupilumab achieved clear or almost clear skin as measured by Investigator’s Global Assessment (IGA; primary end point) (33% for dupilumab every 4 weeks [P<.0001] and 30% for dupilumab every 2 weeks [P=.0004] vs 11% for placebo). In addition, results showed that 70% of patients who received dupilumab every 4 weeks and 67% of patients who received dupilumab every 2 weeks had a ≥75% improvement from baseline in the Eczema Area and Severity Index (EASI-75), compared with 27% of the placebo group (both P<.0001). With regard to safety, the most common adverse events reported were conjunctivitis, nasopharyngitis, and injection site reactions.
“In this trial, children with severe atopic dermatitis had uncontrolled disease covering, on average, nearly 60% of their skin,” said John Reed, MD, PhD, Global Head of Research and Development at Sanofi. “We are encouraged by these results, which demonstrate that [dupilumab] improved skin lesions, reduced itching, cleared the skin and importantly, improved health-related quality of life measures for these young patients.”
Results from the trial will be submitted to the Food and Drug Administration in the fourth quarter of 2019.
Dupilumab (Dupixent; Sanofi US and Regeneron) is currently approved for moderate to severe atopic dermatitis in patients ≥12 years old who are not adequately controlled with topical prescription therapies or when they are not advisable. It is also indicated for use as add-on maintenance treatment in patients with moderate to severe asthma with an eosinophilic phenotype or with oral corticosteroid dependent asthma and as add-on maintenance treatment in patients with inadequately controlled chronic rhinosinusitis with nasal polyposis.
For more information visit dupixent.com.