Efficacy and Safety of Dupilumab Treatment with Concomitant Topical Corticosteroids in Children Aged 6Months to 5Years with Severe Atopic Dermatitis.

Abstract

Treatment options for children younger than 6years with severe atopic dermatitis (AD) are limited, as systemic immunosuppressants may present safety concerns in this young age group. Dupilumab is the first systemic treatment option approved for infants and young children with severe AD in the European Union. This study reports the efficacy and safety of dupilumab with concomitant low-potency corticosteroids in children aged 6months to 5years with severe AD. This was a pre-specified subgroup analysis of data for patients aged 6months to 5years with severe AD at baseline (Investigator's Global Assessment [IGA] = 4) from a randomised, double-blind, placebo-controlled, phaseIII trial of dupilumab. Patients were randomised to either subcutaneously administered dupilumab (200/300mg) or matched placebo every 4weeks, plus low-potency topical corticosteroids for 16weeks. Co-primary endpoints at week16 were the proportion of patients with IGA ≤ 1 (clear or almost clear skin) and the proportion of patients with ≥ 75% improvement from baseline in Eczema Area and Severity Index (EASI-75). Secondary endpoints at week16 included mean changes in EASI, pruritus, skin pain, sleep loss and quality of life. The analysis included 125 patients (63 receiving dupilumab vs. 62 placebo). At week16, significantly more patients receiving dupilumab vs. placebo had achieved IGA ≤ 1 (14.3% vs. 1.6%; P = 0.0085) and EASI-75 (46.0% vs. 6.6%; P < 0.0001). Significant improvements with dupilumab were observed in all secondary endpoints, including a least squares mean 48.9% reduction in pruritus. The overall incidence of adverse events (AEs) was similar between the dupilumab and placebo groups (66.7% vs. 73.8%). No dupilumab-related AEs were serious or led to treatment discontinuation. Dupilumab significantly improved AD signs, symptoms and quality of life in children aged 6months to 5years with severe AD with acceptable safety. The trial was registered with ClinicalTrials.gov with ID number NCT03346434, part B.