Base and Covariate Population Pharmacokinetic Analyses of Dupilumab in Adolescents and Children ≥6 to <12 Years of Age Using Phase 3 Data.

ABSTRACT: Population pharmacokinetic (PK) base and covariate analyses were conducted using data from adolescents with moderate-to-severe atopic dermatitis (AD) and children ≥6 to <12 years of age with severe AD. Two phase 3 studies were analyzed (165 adolescents and 241 children on active treatment). A 2-compartment model with linear and Michaelis-Menten elimination and 3 transit compartments describing lag time in absorption was utilized. Weight, albumin, body mass index, and Eczema Area and Severity Index score were statistically significant covariates in at least 1 of the age populations. Only body weight had a consequential effect on central volume. Although an absorption rate and target-mediated clearance somewhat decreased with age, no dose adjustment was needed in addition to the adjustment f

SUBMITTER: Kovalenko P 

PROVIDER: S-EPMC8597115 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature