Efficacy and safety of dupilumab with concomitant topical corticosteroids in children 6 to 11 years old with severe atopic dermatitis: A randomized, double-blinded, placebo-controlled phase 3 trial

Abstract

Background: Children with severe atopic dermatitis (AD) have limited treatment options.Objective: We report the efficacy and safety of dupilumab 1 topical corticosteroids (TCS) in children aged 6-11 years with severe AD inadequately controlled with topical therapies.Methods: In this double-blind, 16-week, phase 3 trial (NCT03345914), 367 patients were randomized 1:1:1 to 300 mg dupilumab every 4 weeks (300 mg q4w), a weight-based regimen of dupilumab every 2 weeks (100 mg q2w, baseline weight \30 kg; 200 mg q2w, baseline weight $30 kg), or placebo; with concomitant medium-potency TCS.Results: Both the q4w and q2w dupilumab 1 TCS regimens resulted in clinically meaningful and statistically significant improvement in signs, symptoms, and quality of life (QOL) versus placebo 1 TCS in all prespecified endpoints. For q4w, q2w, and placebo, 32.8%, 29.5%, and 11.4% of patients, respectively, achieved Investigator's Global Assessment scores of 0 or 1; 69.7%, 67.2%, and 26.8% achieved $75% improvement in Eczema Area and Severity Index scores; and 50.8%, 58.3%, and 12.3% achieved $4-point reduction in worst itch score. Response to therapy was weight-dependent: optimal dupilumab doses for efficacy and safety were 300 mg q4w in children \30 kg and 200 mg q2w in children $30 kg.

Update on Pediatric Atopic Dermatitis

“…The expedited FDA approval was based on the phase 3 results in which the efficacy and safety of dupilumab combined with TCSs were compared to TCSs alone (N=367). 28 In this trial, more than twice as many children achieved clear or almost clear skin and more than 4 times as many achieved itch reduction with dupilumab plus TCSs than with TCSs alone. Three-quarters of patients receiving dupilumab at the subsequently approved dosing achieved at least a 75% improvement in overall disease.…”

“…Three-quarters of patients receiving dupilumab at the subsequently approved dosing achieved at least a 75% improvement in overall disease. 28 An additional study is being conducted that includes pediatric patients aged 6 months to younger than 6 years (ClinicalTrials.gov Identifier NCT03346434).…”

Biological drugs in the treatment of atopic dermatitis – current recommendations of the Polish Dermatological Society, the Polish Society of Allergology, the Polish Pediatric Society and the Polish Society of Family Medicine

“…Data are available from the phase III clinical trial of dupilumab treatment with concomitant topical GCSs treatment in children aged 6–11 years with severe AD, with inadequately controlled topical treatment [ 23 ]. Three hundred sixty seven children were enrolled in the 16-week study.…”

“…Dupilumab was effective and improved the quality of life of patients in this age group. Taking into account the effectiveness and side effects, the optimal dose was 300 mg every 4 weeks for children weighing less than 30 kg and 200 mg every 2 weeks for children weighing 30 kg or more [ 23 ]. Data from registries and descriptions of patients treated with dupilumab, in real life, apart from clinical trials, indicate comparable results to those obtained during clinical trials [ 24 – 29 ].…”

“…In the group of adolescents > 12 years of age treated with dupilumab, a higher percentage of conjunctivitis and reactions at the injection site and lower rates of non-herpetic skin infections were observed [ 21 ]. Children with severe AD, aged 6–11 treated with dupilumab presented more frequent conjunctivitis and injection site reactions than the placebo group [ 23 ]. More research is needed in the pediatric group.…”