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A phase 2, open‐label study of single dose dupilumab in children aged 6 months to < 6 years with severe uncontrolled atopic dermatitis: Pharmacokinetics, safety and efficacy

Journal of the European Academy of Dermatology and Venereology Sep 11, 2020

Paller AS, Siegfried EC, Simpson EL, et al. - In this open‐label, multicenter, phase 2, sequential, two‐age cohort, two dose level study (LIBERTY AD PRE‐SCHOOL), researchers tested the pharmacokinetics, safety, and effectiveness of single‐dose dupilumab in children with severe atopic dermatitis (AD) aged ≥ 6 months to < 6 years. They involved an initial cohort of older children aged ≥ 2 to < 6 years, followed by a younger cohort aged ≥ 6 months to < 2 years. After a single subcutaneous injection of dupilumab, pharmacokinetic sampling, safety monitoring, and efficacy assessments were performed in two sequential dosing groups (3 mg/kg, then 6 mg/kg) over the 4-week period. Between December 20, 2017, and July 22, 2019, 40 patients were enlisted (20/age cohort, 10/dose level within a cohort). According to findings, single-dose dupilumab was generally well tolerated and clinical signs/symptoms of AD were significantly reduced. In older children, somewhat better responses were seen than in younger ones. The dupilumab pharmacokinetics were non-linear, consistent with preceding adult and adolescent studies.

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