Moens A¹, van der Woude CJ², Julsgaard M³, Humblet E⁴, Sheridan J⁵, Baumgart DC⁶, Gilletta De Saint-Joseph C⁷, Nancey S⁸, Rahier JF⁹, Bossuyt P¹⁰, Cremer A¹¹, Dewit S¹², Eriksson C¹³, Hoentjen F¹⁴, Krause T¹⁵, Louis E¹⁶, Macken E¹⁷, Milenkovic Z¹⁸, Nijs J¹⁹, Posen A²⁰, Van Hootegem A²¹, Van Moerkercke W²², Vermeire S¹, Bar-Gil Shitrit A²³, Ferrante M¹. Aliment Pharmacol Ther. 2019 Nov 6. doi: 10.1111/apt.15539. [Epub ahead of print]

Author information

1 Leuven, Belgium.

2 Rotterdam, The Netherlands.

3 Aarhus, Denmark.

4 Genk, Belgium.

5 Dublin, Ireland.

6 Edmonton, AB, Canada.

7 Toulouse, France.

8 Lyon, France.

9 Yvoir, Belgium.

10 Bonheiden, Belgium.

11 Brussels, Belgium.

12 Overpelt, Belgium.

13 Örebro, Sweden.

14 Nijmegen, The Netherlands.

15 Kassel, Germany.

16 Liège, Belgium.

17 Antwerpen, Belgium.

18 Belgrade, Serbia.

19 Sint-Truiden, Belgium.

20 Tongeren, Belgium.

21 Brasschaat, Belgium.

22 Kortrijk, Belgium.

23 Jerusalem, Israel.

Abstract

BACKGROUND: Women with inflammatory bowel diseases (IBD) often receive biologicals during pregnancy to maintain diseaseremission. Data on outcome of vedolizumab-exposed pregnancies (VDZE) are sparse.

AIMS: The aim was to assess pregnancy and child outcomes of VDZE pregnancies and to compare these results to anti-TNF exposed (TNFE) or both immunomodulatory and biologic unexposed (CON IBD) pregnancies.

METHODS: A retrospective multicentre case-control observational study was performed.

RESULTS: VDZE group included 79 pregnancies in 73 IBD women. The TNFE and CON IBD group included 186 pregnancies (162 live births) in 164 IBD women and 184 pregnancies (163 live births) in 155 IBD women, respectively. At conception, cases more often had active disease ([VDZE: 36% vs TNFE: 17%, P = .002] and [VDZE: 36% vs CON IBD: 24%, P = .063]). No significant difference in miscarriage rates were found between groups (VDZE and TNFE: 16% vs 13%, P = .567; VDZE and CON IBD: 16% vs 10%, P = .216). In live-born infants, median gestational age and birthweight were similar between groups. Median Apgar score at birth was numerically equal. Prematurity was similar in the VDZE group compared to the control groups, even when correcting for disease activity during pregnancy. The frequency of congenital anomalies was comparable between groups as were the percentages of breastfed babies. During the first year of life, no malignancies were reported and infants' infection risk did not significantly differ between groups.

CONCLUSION: No new safety signal was detected in VDZE pregnancies although larger, prospective studies are required for confirmation.