Bridging the Pregnancy Knowledge Gap: A Real-World Analysis of Medication Use and Drug-Drug Interaction Risk in Crohn's Disease and Multiple Sclerosis.

Abstract

The exclusion of pregnant individuals from clinical trials has resulted in a significant medical knowledge gap for this population. Leveraging real-world data (RWD) provides a critical window into the prevalence and use of medications during pregnancy. Using the health plan claims database IQVIA PharMetrics(R) Plus, we evaluated the use of disease-modifying therapies (DMTs) and concomitant medications in pregnant individuals. We focused on two case examples-Crohn's Disease (CD) and Multiple Sclerosis (MS)-analyzing patients with a history of DMT use before, during, and after pregnancy between 2021 and 2024. In the CD cohort, we found that 47% (n = 1187) of individuals used a DMT during pregnancy. Among these patients, 67% (n = 694) were prescribed a monoclonal antibody (e.g., adalimumab, ustekinumab). In the MS cohort, 27% (n = 300) of individuals used a DMT during pregnancy, of which the predominant medication used was glatiramer acetate, a well-established immunomodulator. Across both cohorts, a targeted concomitant medication analysis focusing on major metabolic and efflux pathways revealed that several medications taken during pregnancy interact with CYP3A4, P-gp, or BCRP. Other potential DDI pathways were not assessed. These RWD analyses confirm that pregnant individuals are often exposed to complex medication regimens, highlighting the need to understand drug use and disposition in this vulnerable population.