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

Clin Transl Gastroenterol. 2024 Dec 1;15(12):e00795. doi: 10.14309/ctg.0000000000000795.

Abstract

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.

Publication types

  • Comparative Study

MeSH terms

  • Adult
  • Biosimilar Pharmaceuticals* / administration & dosage
  • Biosimilar Pharmaceuticals* / adverse effects
  • Biosimilar Pharmaceuticals* / therapeutic use
  • Female
  • Gastrointestinal Agents* / therapeutic use
  • Humans
  • Infant, Newborn
  • Inflammatory Bowel Diseases* / drug therapy
  • Infliximab* / administration & dosage
  • Infliximab* / therapeutic use
  • Pregnancy
  • Pregnancy Complications* / drug therapy
  • Pregnancy Outcome*
  • Prospective Studies
  • Young Adult

Substances

  • Infliximab
  • Biosimilar Pharmaceuticals
  • Gastrointestinal Agents