Population PK modeling of certolizumab pegol in pregnant women with chronic inflammatory diseases.

ABSTRACT: Certolizumab pegol (CZP; CIMZIA™) is the only Fc-free tumor necrosis factor inhibitor with data from a clinical study demonstrating no to minimal placental transfer. The pharmacokinetics (PK) of certolizumab pegol during pregnancy and postpartum in women with chronic inflammatory diseases were assessed using a population PK model based on data from the CHERISH study (NCT04163016), a longitudinal, prospective, open-label PK phase IB study. Model development was performed in NONMEM using a frequentist prior approach, with prior information based on a population PK model for certolizumab pegol in non-pregnant adult patients (NCT04740814). A one-compartment model with first-order absorption (K_a = 0.236 1/day) and linear elimination (CL/F = 0.416 L/day) from the central compartment (

SUBMITTER: Menshykau D 

PROVIDER: S-EPMC11578139 | biostudies-literature | 2024 Nov

REPOSITORIES: biostudies-literature