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Observational Study
. 2020 Jan;51(1):129-138.
doi: 10.1111/apt.15539. Epub 2019 Nov 6.

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

Annick Moens  1 , C Janneke van der Woude  2 , Mette Julsgaard  3 , Evelien Humblet  4 , Juliette Sheridan  5 , Daniel C Baumgart  6 , Cyrielle Gilletta De Saint-Joseph  7 , Stéphane Nancey  8 , Jean-François Rahier  9 , Peter Bossuyt  10 , Anneline Cremer  11 , Sophie Dewit  12 , Carl Eriksson  13 , Frank Hoentjen  14 , Thomas Krause  15 , Edouard Louis  16 , Elisabeth Macken  17 , Zoran Milenkovic  18 , Jochen Nijs  19 , Annelies Posen  20 , Anneleen Van Hootegem  21 , Wouter Van Moerkercke  22 , Séverine Vermeire  1 , Ariella Bar-Gil Shitrit  23 , Marc Ferrante  1
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Free article
Observational Study

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

Annick Moens et al. Aliment Pharmacol Ther. 2020 Jan.
Free article

Abstract

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

Aims: 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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REFERENCES

    1. Mahadevan U, Robinson C, Bernasko N, et al. Inflammatory bowel disease in pregnancy clinical care pathway: a report from the American Gastroenterological Association IBD Parenthood Project Working Group. Gastroenterology. 2019;156:1508-1524
    1. van der Woude CJ, Ardizzone S, Bengtson MB, et al. The second European evidenced-based consensus on reproduction and pregnancy in inflammatory bowel disease. J Crohns Colitis. 2015;9:107-124.
    1. Vermeire S, Loftus EV, Colombel JF, et al. Long-term efficacy of Vedolizumab for Crohn's disease. J Crohns Colitis. 2017;11:412-424.
    1. Amiot A, Serrero M, Peyrin-Biroulet L, et al. Three-year effectiveness and safety of vedolizumab therapy for inflammatory bowel disease: a prospective multi-centre cohort study. Aliment Pharmacol Ther. 2019;50:40-53.
    1. Chaparro M, Garre A, Ricart E, et al. Short and long-term effectiveness and safety of vedolizumab in inflammatory bowel disease: results from the ENEIDA registry. Aliment Pharmacol Ther. 2018;48:839-851.

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