Efficacy and safety of dupilumab with concomitant topical corticosteroids for severe atopic dermatitis in children

According to a recent study, dupilumab demonstrated notable improvements in the quality of life of young children who suffer from severe atopic dermatitis (AD), while maintaining an acceptable level of safety. The study’s findings were published in the journal, Advances in therapy.

In this pre-specified subgroup analysis, data of 125 patients aged 6 months to 5 years with severe AD at baseline (Investigator's Global Assessment [IGA] = 4) from a randomized, double-blind, placebo-controlled, phase III trial of dupilumab was examined. Patients were assigned randomly to receive either subcutaneous dupilumab (200/300 mg) [n=63] or a placebo [n=62] every 4 weeks, in addition to low-potency topical corticosteroids for a duration of 16 weeks. The study’s co-primary endpoints at week 16 included the proportion of patients displaying a ≥ 75% improvement from the baseline in Eczema Area and Severity Index (EASI-75) and the proportion of patients achieving IGA ≤ 1 (representing clear or almost clear skin). Secondary endpoints at week 16 included pruritis, mean changes in EASI, sleep loss, skin pain, and quality of life.

At week 16, a significantly higher percentage of patients who were given dupilumab compared to those who were given a placebo had achieved IGA ≤ 1 (14.3% vs. 1.6%) and EASI-75 (46.0% vs. 6.6%). Notable enhancements with dupilumab were seen in all secondary endpoints measured, with a least squares mean reduction of 48.9% in pruritus. The overall occurrence of adverse events (AEs) was comparable in both the dupilumab group (66.7%) and the placebo group (73.8%). No AEs related to dupilumab were severe or led to treatment discontinuation.

Based on the above results, it can be concluded that dupilumab may lead to significant improvement in the signs, symptoms, and overall quality of life for children between the ages of 6 months and 5 years with severe AD. Furthermore, the dupilumab treatment exhibited an acceptable level of safety.