P279 Vedolizumab is safe for use in pregnant patients with IBD; report of our preliminary data

Abstract

Background: Knowledge regarding safety of new biologics during pregnancy is sparse. The recent 2015 ECCO guidelines have no recommendations for or against use of vedolizumab (VDZ) during pregnancy. Aim: To evaluate the safety profile of VDZ during pregnancy. Methods: Prospective data of pregnant women with IBD between January 2015 and November 2017 were collected. The study group comprised patients treated with VDZ during pregnancy. The two control groups included patients treated with an anti‐TNF (control 1) and patients not treated by any biologic (control 2). Results: The VDZ group included 21 pregnancies. The control groups included 83 and 196 pregnancies in control groups 1 and 2, respectively. Disease flare at conception was seen in 5/21 (24%) patients in the VDZ group compared with 12/83 (14%) and 33/196 (16%) in control groups 1 and 2, p = 0.27, p = 0.35, respectively. Disease flare during pregnancy, when in remission at conception, occurred in 1/16 (6.3%) patients receiving VDZ compared with 21/71 (29%), and 57/163 (35%), in control groups 1 and 2, p = 0.06, p = 0.02, respectively. Early pregnancy loss, between 6‐12 weeks, occurred in 6 (28.5%) of VDZ treated patients, three had active disease at conception, two pregnancies were by in‐vitro fertilisations in a woman 45 years old with active disease, and one occurred by a patient in remission. One patient had induced early termination of pregnancy. One preterm delivery was reported in the VDZ group, due to severe pre‐eclampsia. Mean gestational age at birth was similar among all groups. Neonatal mean birth weight was found to be appropriate for gestational age and similar between the groups. All neonates had a 5' Apgar score of 8 and above. One newborn from the VDZ group who was born at 32 weeks of pregnancy developed an atypical Kawasaki disease with eosinophilia at 3 months old. He responded well to corticosteroids and his development was normal. One newborn from control group 2 (exposed to thiopurines) had tetralogy of Fallot. He underwent a successful surgical repair. No other major congenital malformations were reported. Conclusions: VDZ continued throughout pregnancy was found to be safe. More patients had active disease at conception. The high rates of early pregnancy loss may reflect disease severity at conception.