Upadacitinib Population Pharmacokinetics and Exposure-Response Relationships in Ulcerative Colitis Patients.

ABSTRACT:

Background and objective

Upadacitinib, an oral selective and reversible Janus kinase (JAK) inhibitor, showed favorable efficacy and safety in patients with moderate-to-severe ulcerative colitis (UC). The objective was to characterize upadacitinib pharmacokinetics in UC patients across Phase 2b and 3 trials and evaluate the relationships between upadacitinib plasma exposures and key efficacy or safety endpoints.

Methods

Population pharmacokinetics and exposure-response analyses were performed to characterize upadacitinib pharmacokinetics in UC patients and evaluate the relationships between plasma exposures and key efficacy or safety endpoints at the end of 8-week induction and 52-week maintenance periods. Data from 1234 UC patients from Phase 2 and 3 induction trials and 449

SUBMITTER: Ponce-Bobadilla AV 

PROVIDER: S-EPMC9898395 | biostudies-literature | 2023 Jan

REPOSITORIES: biostudies-literature