Population pharmacokinetic analysis of etrolizumab in patients with moderately-to-severely active ulcerative colitis.

ABSTRACT: Etrolizumab is an IgG1-humanized monoclonal antibody that specifically targets the β7 subunit of α4β7 and α4Eβ7 integrins, and it has been evaluated for the treatment of moderately-to-severely active ulcerative colitis (UC). Population pharmacokinetic (PK) analysis was performed to characterize etrolizumab PK properties in patients with moderately-to-severely active UC and evaluate covariate impacts on exposure. The population PK model was developed based on etrolizumab serum concentrations from patients with moderately-to-severely active UC enrolled in six studies (one phase I, one phase II, and four phase III) and validated using another phase III clinical trial. Stepwise covariate modeling was used to evaluate the impact of 23 prespecified covariates. Etrolizumab PK was best described b

SUBMITTER: Moein A 

PROVIDER: S-EPMC9469700 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature