It is most clinically relevant to interpret efficacy endpoints defined for clinical trials within the context of patient-reported outcome measures that comprehensively characterize atopic dermatitis (AD) signs, symptoms, and quality of life.

In a randomized, placebo-controlled phase III clinical trial of dupilumab plus concomitant topical corticosteroids in children aged 6–11 years with severe AD, almost all children receiving dupilumab showed significant and clinically relevant improvements in AD skin signs, symptoms, and quality of life after 16 weeks of treatment when compared with placebo plus topical corticosteroids. Dupilumab also provided significant and clinically meaningful improvements within a subgroup of patients who did not achieve the defined primary endpoint of clear or almost clear skin (Investigator’s Global Assessment score of 0 or 1) by week 16.

These findings are consistent with prior findings in adults and adolescents.