P447 No severe neonatal and maternal complications in inflammatory bowel diseases patients treated with ustekinumab or vedolizumab during pregnancy

Abstract

Introduction: Inflammatory bowel disease (IBD) has a high incidence in population of childbearing age. Ustekinumab, a fully human monoclonal antibody targeting the p40 subunit of interleukins 12 and 23, and vedoli- zumab, an anti ?4?7 integrin, are biologics currently used in IBD with immunosuppressant or anti TNF failure. Data concerning use and safety of these new biologics during pregnancy are scarce. Aims & Methods: We conducted a retrospective multicenter study in the GETAID group and collected cases of women with IBD who received at least one injection of ustekinumab or vedolizumab during pregnancy or in the last 2 months before conception. The aims of the study were (1) to evalu- ate pregnancy and neonatal outcomes in IBD female patients exposed to ustekinumab or vedolizumab during pregnancy, and (2) to observe the im- pact of ustekinumab or vedolizumab withdrawal on disease activity during pregnancy and postpartum. Results: Sixty-seven pregnancies in 62 IBD females (43 for Crohn’s disease and 19 for ulcerative colitis) were reported among 19 centers of the GETAID group. Median age at conception was 29 years. Median time between in- troduction of ustekinumab or vedolizumab treatment and pregnancy was 12 months. Twenty-five pregnancies occurred on ustekinumab: 7 received ustekinumab in the last 2 months before conception, 11 received 1 injec- tion after conception, and 7 stopped ustekinumab in the 2nd trimester. Among the 25 pregnancies occurred on ustekinumab, there were 22 (88%) live births, 1 elective termination and 2 spontaneous abortions. Maternal complications were reported in 2 women (one gestational diabetes and one threat of premature labor). Fetal complications were reported in 3 pregnancies (intra uterine growth restriction). Four newborns presented a non severe neonatal complication (3 preterm deliveries, one low birth weight) and one a Tetralogy of Fallot . Forty-two pregnancies occurred on vedolizumab: 15 received vedolizumab in the last 2 months before concep- tion, 16 received 1 injection after conception, and 11 stopped vedolizumab (6 during the 2nd trimester and 5 during the 3rd trimester). Among the 42 pregnancies occurred on vedolizumab, there were 36 (86%) live births, 1 elective termination (for Down Syndrom) and 5 (12%) spontaneous abor- tions. Maternal complications were reported in 5 women (one cholestasis and 4 pre-eclampsia). Fetal complications were reported in one pregnancy (intra uterine growth restriction) and 13 newborns developed a neonatal complication (6 preterm deliveries, 6 low birth weight and one congenital corpus callosum hypoplasia). Concerning IBD activity, 65% of women were in remission at conception. Among them, only 2 patients flared during pregnancy. Conclusion: We reported in 67 pregnancies under vedolizumab or ustekin- umab exposition, no severe neonatal (except a cardiac malformation) and maternal complications. However, additional prospective evaluations re- garding safety concerns pregnancy outcomes in patients directly exposed to ustekinumab or vedolizumab are needed.