Pregnancy outcomes in inflammatory bowel disease patients treated with vedolizumab, anti-TNF or conventional therapy: results of the European CONCEIVE study

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]


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Leuven, Belgium.

Rotterdam, The Netherlands.

Aarhus, Denmark.

Genk, Belgium.

Dublin, Ireland.

Edmonton, AB, Canada.

Toulouse, France.

Lyon, France.

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.


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.

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