Optimizing Maternal and Fetal Antibody Exposure and Dosing Regimens During Pregnancy Using a Physiologically Based Pharmacokinetic Model.

ABSTRACT: Therapeutic antibodies are often prescribed off-label to pregnant patients to treat inflammatory, autoimmune, or malignant conditions. Despite their broad use, the extent of fetal exposure to such therapeutic antibodies and the risk to fetal development remain largely unknown. Given the ethical challenges to conduct randomized trials in pregnant patients, modeling and simulation approaches offer an opportunity to yield mechanistic insights using data from observational studies. In this study, a physiologically based pharmacokinetic (PBPK) modeling framework was developed to predict maternal and fetal therapeutic antibody exposures throughout pregnancy. The model incorporates expression data on the placental neonatal Fc receptor (FcRn), a receptor critical to transplacental IgG transfer. Fc

SUBMITTER: Kardouh MS 

PROVIDER: S-EPMC12670718 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature