Clin Gastroenterol Hepatol. 2025 Jan;23(1):144-153.e22.doi: 10.1016/j.cgh.2023.12.029. Epub 2024 Jan 8.

Antoine Meyer ¹, Sara Miranda ², Jérôme Drouin ², Alain Weill ², Franck Carbonnel ³, Rosemary Dray-Spira ²

Author information

¹EPI-PHARE, Épidémiologie des produits de santé, Saint-Denis, France; Assistance Publique-Hôpitaux de Paris, Hôpital Bicêtre & Université Paris-Saclay, Le Kremlin Bicêtre, France. Electronic address: antoinemeyer@gmail.com.

²EPI-PHARE, Épidémiologie des produits de santé, Saint-Denis, France.

³Assistance Publique-Hôpitaux de Paris, Hôpital Bicêtre & Université Paris-Saclay, Le Kremlin Bicêtre, France.

Abstract

Background & aims: Limited data are available on the consequences of prenatal exposure to vedolizumab and ustekinumab. We aimed to compare the safety of vedolizumab and ustekinumab with that of anti-tumor necrosis factor (TNF) in pregnant women with inflammatory bowel diseases (IBD).

Methods: Using nationwide, comprehensive data of the EPI-MERES registry, we identified pregnancies in women with IBD in France, exposed to anti-TNF, vedolizumab, and ustekinumab between 2014 and 2021. We compared pregnancy outcomes and complications in the offspring according to treatment exposure during pregnancy. We applied a propensity score matching for maternal, IBD, and pregnancy characteristics.

Results: Three hundred ninety-eight pregnancies exposed to vedolizumab were compared with 1592 pregnancies exposed to anti-TNF; 464 pregnancies exposed to ustekinumab were compared with 1856 pregnancies exposed to anti-TNF. Overall, compared with anti-TNF, neither vedolizumab nor ustekinumab was associated with increased risks of abortion, caesarean section, stillbirth, preterm birth, serious infections, malignancies, or congenital abnormality in children. Women exposed to ustekinumab had an increased risk of small for gestational age births.

Conclusions: Overall, the safety of vedolizumab and ustekinumab compared with anti-TNF use during pregnancy is reassuring. Further studies are needed to confirm these findings.