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Safety of ustekinumab or vedolizumab in pregnant inflammatory bowel disease patients: a multicentre cohort study
Author(s) -
Wils Pauline,
Seksik Philippe,
Stefanescu Carmen,
Nancey Stephane,
Allez Matthieu,
Pineton de Chambrun Guillaume,
Altwegg Romain,
Gilletta Cyrielle,
Vuitton Lucine,
Viennot Stéphanie,
Serrero Mélanie,
Fumery Mathurin,
Savoye Guillaume,
Collins Michael,
Goutorbe Felix,
Brixi Hedia,
Bouguen Guillaume,
Tavernier Noémie,
Boualit Medina,
Amiot Aurélien,
Abitbol Vered,
Laharie David,
Pariente Benjamin
Publication year - 2021
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/apt.16192
Subject(s) - vedolizumab , medicine , ustekinumab , pregnancy , obstetrics , inflammatory bowel disease , crohn's disease , retrospective cohort study , cohort study , live birth , cohort , pediatrics , gynecology , disease , infliximab , biology , genetics
Summary 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.