Safety of ustekinumab or vedolizumab in pregnant inflammatory bowel disease patients: a multicentre cohort study

Aliment Pharmacol Ther. 2020 Dec 7. doi: 10.1111/apt.16192. Online ahead of print.

Pauline Wils 1, Philippe Seksik 2, Carmen Stefanescu 3, Stephane Nancey 4, Matthieu Allez 2, Guillaume Pineton de Chambrun 5, Romain Altwegg 5, Cyrielle Gilletta 6, Lucine Vuitton 7, Stéphanie Viennot 8, Mélanie Serrero 9, Mathurin Fumery 10, Guillaume Savoye 11, Michael Collins 2, Felix Goutorbe 12, Hedia Brixi 13, Guillaume Bouguen 14, Noémie Tavernier 15, Medina Boualit 16, Aurélien Amiot 17, Vered Abitbol 2, David Laharie 18, Benjamin Pariente 1, PREGNANCY-GETAID study group



  • PREGNANCY-GETAID study group: 

Benjamin Pariente, Maria Nachury, Pauline Wils, Pierre Desreumaux, Julien Branche, Romain Gérard, Philippe Seksik, Anne Bourrier, Laurent Beaugerie, Harry Sokol, Julien Kirchgesner, Carmen Stefanescu, Yoram Bouhnik, Xavier Treton, Stephane Nancey, Gilles Boschetti, Bernard Flourié, Claire Gay, Pauline Danion, Chloe Venturin, Matthieu Allez, Jean-Marc Gornet, Clotilde Baudry, Guillaume Pineton de Chambrun, Romain Altwegg, Cyrielle Gilletta, Lucine Vuitton, Stephanie Viennot, Melanie Serrero, Jean Charles Grimaud, Mathurin Fumery, Franck Brazier, Clara Yzet, Michael Collins, Félix Goutorbe, Hedia Brixi, Guillaume Cadiot, Guillaume Bouguen, Noémie Tavernier, Médina Boualit, Aurélien Amiot, Charlotte Gagnière, Jenny Tannoury, Vered Abitbol, David Laharie, Pauline Rivière, Florian Poullenot


Author information

  • 1Lille, France.
  • 2Paris, France.
  • 3Clichy, France.
  • 4Lyon, France.
  • 5Montpellier, France.
  • 6Toulouse, France.
  • 7Besancon, France.
  • 8Caen, France.
  • 9Marseille, France.
  • 10Amiens, France.
  • 11Rouen, France.
  • 12Bayonne, France.
  • 13Reims, France.
  • 14Rennes, France.
  • 15Tourcoing, France.
  • 16Valenciennes, France.
  • 17Créteil, France.
  • 18Bordeaux, France.
  • PMID: 33345331

DOI: 10.1111/apt.16192


Background: The prevalence of inflammatory bowel diseases (IBD) is high in women of childbearing age. Achieving clinical remission from conception to delivery using current medications is a major issue in IBD.

Aims: To assess maternal and neonatal complications and management of vedolizumab or ustekinumab) in pregnant women with IBD receiving these agents.

Methods: We performed a retrospective cohort study among GETAID centres including women with IBD who received ustekinumab or vedolizumab during pregnancy or within the 2 months before conception and compared outcomes to women exposed to anti-TNF treatment during pregnancy.

Results: Seventy-three pregnancies in 68 women with IBD were analysed: 29 on ustekinumab resulting in 26 (90%) live births, two (7%) spontaneous abortions and one (3%) elective termination; 44 on vedolizumab resulting in 38 (86%) live births, five (11%) spontaneous abortions and one (3%) medical interruption. The control group included 88 pregnancies exposed to anti-TNF in 76 women with IBD. The median age at conception, the proportion of women who smoked or in clinical activity at conception was comparable between groups. Only the proportion of patients exposed to >2 anti-TNF agents was significantly increased among the ustekinumab and vedolizumab groups compared to control group (22% and 10% vs 3%, P < 0.005). Rates of prematurity, spontaneous abortion, congenital malformations and maternal complications were comparable between groups.

Conclusion: We report 73 pregnancies in patients receiving vedolizumab or ustekinumab without a negative signal on maternal or neonatal outcomes. Further prospective studies are needed on the outcomes of pregnancies with new biologic drugs.

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