Use of Biosimilars to Infliximab During Pregnancy in Women with Inflammatory Bowel Disease: Results from the Pregnancy in Inflammatory Bowel Disease and Neonatal Outcomes (PIANO) Study

Introduction: We aimed to compare pregnancy outcomes of women with inflammatory bowel disease (IBD) utilizing biosimilar vs. originator infliximab (IFX). Methods: In a prospective cohort of pregnant women with IBD, we collected characteristics, medications, pregnancy outcomes, and developmental milestones. We compared outcomes by IFX biosimilar or originator use via bivariate statistics. Results: A total of 100 pregnant women on originator IFX and 20 on biosimilar IFX were included. There were no differences in pregnancy complications between groups (48% vs. 35%, p=0.29). Infant developmental milestones were comparable at 12 months. Conclusions: Biosimilar IFX is not associated with adverse pregnancy or infant outcomes.