Population pharmacokinetic and exposure-response analysis of apremilast in Japanese subjects with moderate to severe psoriasis.

ABSTRACT: Apremilast is an orally available phosphodiesterase 4 inhibitor used for the treatment of moderate to severe psoriasis. The aims of this analysis were to develop a population pharmacokinetic (PPK) model of apremilast based on observed data from phase 1 studies combined with clinical trial data from subjects with moderate to severe psoriasis, and to develop exposure-response (E-R) models to determine whether Japanese subjects with moderate to severe psoriasis achieve response to apremilast treatment similar to that observed in non-Japanese, predominantly Caucasian subjects with moderate to severe psoriasis. The PPK model demonstrated that apremilast plasma concentrations and overall apparent clearance rate were comparable between the Japanese and Caucasian subgroups. The E-R analyses of ≥75

SUBMITTER: Okubo Y 

PROVIDER: S-EPMC9290614 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature