14148 Pharmacokinetics, safety, and efficacy of dupilumab in children aged ≥2 to

Abstract

Limited treatment options are available for children with moderate to severe atopic dermatitis (AD). Dupilumab is a fully human monoclonal antibody that inhibits signaling of interleukin-4 and interleukin-13, cytokines that are key drivers of type 2 inflammation. Dupilumab is approved for subcutaneous administration every 2 weeks for patients aged ≥12 years with moderate to severe AD in the USA. We report pharmacokinetics, safety, and efficacy of dupilumab in children with severe AD inadequately controlled with topical therapies from the LIBERTY AD PRE SCHOOL trial (NCT03346434). Patients aged ≥6 months to <6 years (n = 40), stratified by age and region, were randomized 1:1 to a single subcutaneous dose of dupilumab 3 mg/kg or 6 mg/kg. We report data for the ≥2- to <6-year-old cohort (n = 10 per treatment group). Treatment groups had similar baseline characteristics. Single doses of dupilumab resulted in a slightlyless than dose-proportional increase in mean serum concentrations. Treatment-emergent adverse events were similar across groups. 1 serious adverse event (anaphylactic reaction due to existing peanut allergy) was reported in the 3 mg/kg group. At wk 4, for the 3 mg/kg and 6 mg/kg treatment groups, respectively, patients had improvements from baseline in Eczema Area and Severity Index (EASI): mean percentage change (standard deviation) −26.6 (47.4)/–48.7 (28.9) (P = .1097/P = .0005); and EASI-50/EASI-75 was observed in 30%/40% and 20%/30% patients. Single doses of dupilumab in children aged ≥2 to <6 years showed a slightly less than dose proportional increase in mean serum concentrations and caused improvements in AD signs and symptoms. Dupilumab was well tolerated; safety was generally consistent with previous findings in children.