INTRODUCTION: Long-term data are needed for offspring exposed in utero to medications for inflammatory bowel disease (IBD). METHODS: We used a prospective cohort of pregnant women with IBD and their offspring (Pregnancy in IBD and Neonatal Outcomes) to compare rates of serious infection, congenital malformations, and developmental delay by medication exposures. RESULTS: We included 438 offspring with at least 4 years of follow-up. No differences in adverse outcomes were observed by medication. Preterm birth, but not specific drug exposure, was associated with infection risk. Breastfeeding was not associated with serious infection differences. DISCUSSION: These findings support the use of effective IBD therapies throughout pregnancy.
Use of Biosimilars to Infliximab During Pregnancy in Women With Inflammatory Bowel Disease: Results From the Pregnancy in Inflammatory Bowel Disease and Neonatal Outcomes Study
INTRODUCTION: We aimed to compare pregnancy outcomes of women with inflammatory bowel disease using biosimilar vs originator infliximab (IFX). METHODS: In a prospective cohort of pregnant women with inflammatory bowel disease, 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. DISCUSSION: Biosimilar IFX is not associated with adverse pregnancy or infant outcomes.