In 162 children aged 6 months to younger than 6 years, dupilumab significantly improved atopic dermatitis signs and symptoms with a safety profile similar to those in older children and adults, researchers report. The trial, conducted in Europe and North America, included 162 infants and children with moderate-to-severe atopic dermatitis that was refractory to treatment with topical corticosteroids.
Based on a primary endpoint of the proportion of patients with clear or almost clear skin (Investigator’s Global Assessment [IGA] score of 0–1), the results showed: “At week 16, significantly more patients in the dupilumab group than in the placebo group had IGA 0–1 (23 [28%] vs three [4%], difference 24% [95% CI 13–34]; P <0.0001) and EASI-75 (44 [53%] vs eight [11%], difference 42% [95% CI 29–55]; P <0.0001). Overall prevalence of adverse events was similar in the dupilumab group (53 [64%] of 83 patients) and placebo group (58 [74%] of 78 patients). Conjunctivitis incidence was higher in the dupilumab group (four [5%]) than the placebo group (none). No dupilumab-related adverse events were serious or led to treatment discontinuation.”