Dupilumab in children ages 6 months to 5 years with uncontrolled atopic dermatitis: a randomised, double-blind, placebo-controlled, phase 3 trial

Amy S Paller, Eric L Simpson, Elaine C Siegfried, Michael J Cork, Andreas Wollenberg, Peter D. Arkwright, Weily Soong, Mercedes E. Gonzalez, Lynda C. Schneider, Robert Sidbury, Benjamin Lockshin, Steven Meltzer, Zhixiao Wang, Leda P. Mannent, Nikhil Amin, Yiping Sun, Elizabeth Laws, Bolanle Akinlade, Myles Dillon, Matthew P. KosloskiMohamed A Kamal, Ariane Dubost-Brama, Naimish Patel , David M Weinreich, George D. Yancopoulos, John T O'Malley, Ashish Bansal

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Background Current systemic treatments for children <6 years with moderate-to-severe atopic dermatitis (AD) uncontrolled with topical therapies may have suboptimal efficacy and safety. Dupilumab is approved for older children and adults with AD and for other type 2 inflammatory conditions.
Methods This randomised, double-blind, placebo-controlled, phase 3 trial assessed dupilumab in patients ≥6 months to <6 years with moderate-to-severe AD inadequately controlled with topical therapies. Patients were enrolled from 31 hospitals, clinics, and academic institutions in Europe and North America. Patients were randomised 1:1 to subcutaneous placebo or dupilumab (≥5 kg to <15 kg: 200 mg; ≥15 kg to <30 kg: 300 mg) every 4 weeks plus low-potency topical corticosteroids (TCS) for 16 weeks. Randomisation was stratified by age, baseline weight, and region. Primary/key secondary endpoints at week 16 included proportions of patients with Investigator’s Global Assessment (IGA) score 0/1 (clear/almost clear skin), and ≥75% improvement from baseline in Eczema Area and Severity Index (EASI-75).
Findings Participants were recruited from June 30, 2020, to February 12, 2021. A total of 162 patients were randomised to receive dupilumab (n=83) or placebo (n=79) plus TCS. Significantly more dupilumab- versus placebo-treated patients achieved IGA 0/1 (28% vs 4% [difference, 24%; 95% CI 13%, 34%]; p<0·0001) and EASI-75 (53% vs 11% [difference, 42%; 95% CI 29%, 55%]; p<0·0001) at week 16. Overall prevalence of adverse events was similar in the dupilumab (58/78 patients [74%]) and placebo arms (53/83 [64%]). Conjunctivitis incidence was higher with dupilumab than placebo (5% vs 0%). No dupilumab-related adverse events were serious or led to treatment discontinuation.
Interpretation Dupilumab significantly improved AD signs and symptoms versus placebo in children <6 years. Dupilumab was well tolerated, demonstrating an acceptable safety profile, similar to results in older children and adults.
Original languageEnglish
JournalThe Lancet
Publication statusAccepted/In press - 10 Aug 2022


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