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OP032 Outcome of pregnancies in female IBD patients treated with vedolizumab

A. Moens1,2*, K. van Hoeve2,3, E. Humblet4, J.-F. Rahier5, P. Bossuyt6, S. Dewit7, D. Franchimont8, E. Macken9, J. Nijs10, A. Posen11, A. Van Hootegem12, W. Van Moerkercke13, S. Vermeire1,2, M. Ferrante1,2

1University Hospitals Leuven, Department of Gastroenterology and Hepatology, Leuven, Belgium, 2KU Leuven, Department of Chronic Diseases, Metabolism and Ageing, Leuven, Belgium, 3University Hospitals Leuven, Department of Paediatric gastroenterology, Leuven, Belgium, 4Ziekenhuis Oost-Limburg-Campus Sint-Jan, Department of Gastroenterology and Hepatology, Genk, Belgium, 5CHU UCL Namur, Université catholique de Louvain, Yvoir, Belgium, 6Imeldaziekenhuis, Department of Gastroenterology and Hepatology, Bonheiden, Belgium, 7Mariaziekenhuis Noord-Limburg, Department of Gastroenterology and Hepatology, Overpelt, Belgium, 8Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium, 9University Hospital Antwerp, Department of Gastroenterology and Hepatology, Antwerp, Belgium, 10Sint-Trudo Ziekenhuis, Department of Gastroenterology and Hepatology, Sint-Truiden, Belgium, 11AZ Vesalius, Department of Gastroenterology and Hepatology, Tongeren, Belgium, 12AZ Klina, Department of Gastroenterology and Hepatology, Brasschaat, Belgium, 13AZ Groeninge, Department of Gastroenterology and Hepatology, Kortrijk, Belgium

Background

Vedolizumab (VDZ) is a gut-targeted IgG1 anti-α4β7 integrin approved for treatment of inflammatory bowel disease (IBD). As IBD typically affects women at childbearing age, studies on pregnancy outcomes in patients under VDZ are important. Animal studies showed that MAdCAM-1, the ligand for α4β7-integrin, is expressed by maternal vessels during placental development and α4β7-expressing cells of the macrophage/monocyte lineage are therefore considered important in maternal/foetal tolerance. Blocking this interaction by VDZ might affect this process.

Methods

This retrospective, national observational study evaluated the outcome of pregnancies in IBD patients under VDZ. Details on disease activity, prenatal complications, delivery and neonatal outcome were collected.

Results

A total of 23 pregnancies were reported. All but five women had disease remission at conception. There were 18 live births (72% female, incl. two twins), two interrupted pregnancies and five pregnancies are still ongoing. Maternal characteristics are displayed in Table 1. Patients, who remained in remission (n = 12), reported the following complications: intra-uterine growth retardation (n = 1), eclampsia (n = 1), premature rupture of the membranes (n = 2) and congenital malformation (n = 2, hip dysplasia and pulmonary valve stenosis). Of the five patients with active disease at conception, three pregnancies were unaffected, one female lost her foetus due to chorioamnionitis at week 22 and one had an active termination due to relational problems. One patient flared during pregnancy and delivered a child with Hirschsprung’s disease. VDZ was continued throughout pregnancy in two females and was stopped in the first, second and third trimester in 4, 11, and 1 patient, respectively. The median (IQR) gestational age, Apgar score at birth and birth weight were respectively 39 (37–39.4) weeks, 9 (9–9) and 3305 (2823–3698) grams. Eight children were breastfed for a median (IQR) of 10 (4–26) weeks. All newborns were vaccinated according to the standard Belgian regimen with 44% receiving Rotavirus vaccination. No serious infections or malignancies were reported during the first year of life.

Conclusion

This is the largest cohort study on pregnancy outcomes in patients treated with VDZ. Despite the still low number of pregnancies, we observed a number of prenatal complications and congenital malformations, which urges more studies on the function of α4β7-MAdCAM1 interaction in the placenta. In the meanwhile, vigilance and strict follow-up of pregnant IBD patients treated with VDZ is necessary.

Table 1: Baseline characteristics.

Baseline characteristicsn = 18Median age (IQR) at IBD diagnosis and conception (year)23 (17–w27) / 31 (26–34)Crohn’s disease/Ulcerative colitis12/18(67%) / 6/18 (33%)Median CRP (IQR) before conception (mg/l)5 (2–13)Median duration (IQR) of VDZ therapy at conception (months)12 (6–14)IBD medication (<12 weeks of conception)Systemic 5-ASA3/18 (17%)Immunomodulators1/18 (6%)Usage during pregnancySmoking3/18 (17%)Folic acid supplementation16/17 (94%)Caesarean section*5/16 (31%)

*All Crohn’s patients with elective Caesarean section due to perianal disease or prior surgery