Exposure to Vedolizumab in IBD Pregnant Women Appears of Low Risk for Mother and Neonate: A First Prospective Comparison Study

Am J Gastroenterol. 2019 Jul;114(7):1172-1175. doi: 10.14309/ajg.0000000000000186.

Abstract

Objectives: Despite encouraging data gathered in inflammatory bowel diseases (IBD) patients, Vedolizumabs' (VDZ) safety profile in pregnancy is not established.

Design: Data of 330 consecutive pregnancies with IBD was prospectively collected.

Results: Women with IBD were treated with: VDZ (n = 24), anti-tumor necrosis factors (n = 82) or conventional therapy (n = 224). Gravidity and parity were similar among the 3 groups. The VDZ group was comprised mostly of Crohn's disease patients who were all not naïve to biological treatment. They had significantly higher conception rates during active disease (P < 0.05), with fewer flares during pregnancy.

Discussion: Although further study is needed, VDZ appears of low risk during pregnancy.

Publication types

  • Comparative Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Antibodies, Monoclonal, Humanized / adverse effects
  • Antibodies, Monoclonal, Humanized / therapeutic use*
  • Cohort Studies
  • Crohn Disease / diagnosis
  • Crohn Disease / drug therapy
  • Female
  • Gastrointestinal Agents / administration & dosage
  • Gastrointestinal Agents / adverse effects
  • Humans
  • Infant, Newborn
  • Inflammatory Bowel Diseases / diagnosis
  • Inflammatory Bowel Diseases / drug therapy*
  • Patient Safety*
  • Pregnancy
  • Pregnancy Outcome*
  • Pregnancy, High-Risk
  • Prognosis
  • Prospective Studies
  • Risk Assessment
  • Tumor Necrosis Factor-alpha / therapeutic use*

Substances

  • Antibodies, Monoclonal, Humanized
  • Gastrointestinal Agents
  • Tumor Necrosis Factor-alpha
  • vedolizumab