Informing pregnancy dose via target-mediated drug disposition modeling and simulations for a recombinant human monoclonal antibody

The article titled “Informing pregnancy dose via target-mediated drug disposition modeling and simulations for a recombinant human monoclonal antibody,” authored by Courtney Moc Willeford, Krithika Shetty, Douglas Sheridan, and Frank Engler, focuses on the development of a target-mediated drug disposition (TMDD) model for RLYB212, a human monoclonal antibody aimed at preventing fetal and neonatal alloimmune thrombocytopenia (FNAIT). The TMDD model characterizes the pharmacokinetics of RLYB212 and the dynamics of HPA-1a-positive platelets in HPA-1b/b volunteers, allowing for simulations that inform dosing regimens for pregnant women. The optimal dosing identified was 0.06 mg with a loading dose of 0.12 mg, ensuring that drug exposure remains below the target upper limit of ~10 ng/mL throughout pregnancy. This study enhances the understanding of monoclonal antibody pharmacokinetics in pregnancy and supports the safe use of RLYB212 in at-risk pregnancies.