Physiologically Motivated Sequential Population Modeling of Albumin Trends and Vedolizumab Pharmacokinetics for Pregnancy Dosing Regimen Optimization.

ABSTRACT: The pharmacokinetics (PK) of monoclonal antibodies (mAbs) during pregnancy remains poorly characterized, despite active inflammatory bowel diseases (IBD) being the greatest risk factor for adverse pregnancy outcomes. To quantify pregnancy-induced changes, vedolizumab concentrations from 39 pregnant patients on various dosing regimens were analyzed using a sequential albumin-trend/PK modeling approach, extending a published vedolizumab non-pregnancy model. Albumin trends were first characterized using a polynomial mixed-effect model. Then, individual changes in albumin from their pre-pregnancy concentrations, implemented as time-varying patient-influential factor (covariate) in the PK model, served as potential biomarker of pregnancy-induced plasma volume expansion. The modeling framework a

SUBMITTER: Duvnjak Z 

PROVIDER: S-EPMC12816427 | biostudies-literature | 2026 Feb

REPOSITORIES: biostudies-literature