Ustekinumab and Vedolizumab are intravenous drugs that belong to a class known as monoclonal antibodies. They are targeted antibodies and anti-inflammatory therapeutic agents used to manage inflammatory conditions and bowel disorders such as plaque psoriasis, psoriatic arthritis, Crohns Disease, and ulcerative colitis. Their general mode of operation involves blocking or stopping the action of certain cells or specific natural substances (integrin) in the body that cause the symptoms of gastrointestinal disorders. These are gut-selective immunosuppressive biologic that has shown efficacy in inflammatory bowel disease and have expanded the spectrum of the biological treatment of IBD in recent years.

Inflammatory bowel disease (IBD) is diagnosed, generally, in young women of fertile age, and a significant number of patients become pregnant while they have the disease. Achieving clinical remission from conception to delivery using current medications is a major concern in IBD. Pregnant women with inflammatory bowel disease (IBD) are often concerned about using medicaments to manage their IBD during pregnancy. So far, anti-tumor necrosis factor (TNF) medications have been evidenced to be safe for pregnant patients with IBD. Vedolizumab (VDZ) and ustekinumab (UST) are newer monoclonal antibodies with different mechanisms of effect compared to anti-TNF treatment. This multi-center observational study aims to assess the safety of vedolizumab and ustekinumab for pregnancy, fetal development, and neonatal outcome.

A retrospective-prospective observational analysis was conducted on pregnant women with IBD, who were administered ustekinumab (UST) or vedolizumab (VDZ) during pregnancy or within two months before conception; and a comparative study was done with the women exposed to anti-TNF treatment during pregnancy. The study included 68 women with 73 pregnancies taking VDZ or UST, 44 and 29 pregnancies respectively; and 76 women with 88 pregnancies in the anti-TNF group. Other related data on demographics of patients, clinical characteristics, pregnancy, and newborn outcomes were also collected and analyzed.

This cohort study inferred that prematurity rates, spontaneous abortions, congenital malformations, and maternal complications were comparable in women taking VDZ, UST, and anti-TNF medications, showing no adverse events on maternal or neonatal outcomes of VDZ or UST administration, thus confirming the safety profile of new biologics in pregnancy. However, further prospective studies are still required on the pregnancy outcomes with new biologic drugs.

Keywords: Inflammatory Bowel Disease; Placental Transfer; Pregnancy; Ustekinumab; Vedolizumab.

Source –Katarina Mitrova, Barbora Pipek, Martin Bortlik, et al.; Safety of Ustekinumab and Vedolizumab During Pregnancy—Pregnancy, Neonatal, and Infant Outcome: A Prospective Multicentre Study; Journal of Crohns and Colitis, 2022;jjac086.