Exposure-response relationships of etrolizumab in patients with moderately-to-severely active ulcerative colitis.

ABSTRACT: Etrolizumab is an IgG1-humanized monoclonal anti-β7 integrin antibody. Phase III trials with induction and/or maintenance phases were conducted in patients with moderately-to-severely active ulcerative colitis (UC) who were either previously treated with tumor necrosis factor (TNF) inhibitors (HICKORY) or were TNF inhibitor naïve (HIBISCUS I/II, LAUREL, and GARDENIA). A total of eight exposure-response analyses were conducted for two clinical outcomes (remission and endoscopic improvement) at the end of induction for studies HIBISCUS I/II (combined) and HICKORY and at the end of maintenance for studies HICKORY and LAUREL. Trough concentration at week 4 (C_trough,wk4 ) of induction was selected as the exposure metric. Exposure-response (ER) modeling was conducted using logistic re

SUBMITTER: Kassir N 

PROVIDER: S-EPMC9469693 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature