Pregnancy outcomes in inflammatory bowel disease patients treated with vedolizumab, anti-TNF or conventional therapy: results of the European CONCEIVE study.
Adult
Antibodies, Monoclonal, Humanized
/ therapeutic use
Biological Products
/ therapeutic use
Breast Feeding
/ statistics & numerical data
Case-Control Studies
Europe
/ epidemiology
Female
Humans
Immunologic Factors
/ therapeutic use
Infant
Infant, Newborn
Inflammatory Bowel Diseases
/ drug therapy
Live Birth
/ epidemiology
Male
Pregnancy
Pregnancy Complications
/ drug therapy
Pregnancy Outcome
/ epidemiology
Prenatal Care
/ methods
Retrospective Studies
Standard of Care
Tumor Necrosis Factor-alpha
/ antagonists & inhibitors
Young Adult
Journal
Alimentary pharmacology & therapeutics
ISSN: 1365-2036
Titre abrégé: Aliment Pharmacol Ther
Pays: England
ID NLM: 8707234
Informations de publication
Date de publication:
01 2020
01 2020
Historique:
received:
16
05
2019
revised:
08
07
2019
accepted:
23
09
2019
pubmed:
7
11
2019
medline:
20
8
2020
entrez:
7
11
2019
Statut:
ppublish
Résumé
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. 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. A retrospective multicentre case-control observational study was performed. 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. No new safety signal was detected in VDZE pregnancies although larger, prospective studies are required for confirmation.
Sections du résumé
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.
Substances chimiques
Antibodies, Monoclonal, Humanized
0
Biological Products
0
Immunologic Factors
0
Tumor Necrosis Factor-alpha
0
vedolizumab
9RV78Q2002
Types de publication
Journal Article
Multicenter Study
Observational Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
129-138Subventions
Organisme : Research Foundation Flanders (FWO)
Pays : International
Commentaires et corrections
Type : CommentIn
Informations de copyright
© 2019 John Wiley & Sons Ltd.
Références
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
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.
Vermeire S, Loftus EV, Colombel JF, et al. Long-term efficacy of Vedolizumab for Crohn's disease. J Crohns Colitis. 2017;11:412-424.
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.
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.
Bye WA, Jairath V, Travis S. Systematic review: the safety of vedolizumab for the treatment of inflammatory bowel disease. Aliment Pharmacol Ther. 2017;46:3-15.
Mahadevan U, Vermeire S, Lasch K, et al. Vedolizumab exposure in pregnancy: outcomes from clinical studies in inflammatory bowel disease. Aliment Pharmacol Ther. 2017;45:941-950.
Moens A, van Hoeve K, Humblet E, et al. Outcome of pregnancies in female patients with inflammatory bowel diseases treated with vedolizumab. J Crohns Colitis 2019;13:12-18.
Flanagan E, Gibson PR, Begun J, et al. Letter: vedolizumab drug concentrations in neonates following intrauterine exposure. Aliment Pharmacol Ther. 2018;48:1328-1330.
Julsgaard M, Kjeldsen J, Brock B, Baumgart DC. Letter: vedolizumab drug levels in cord and maternal blood in women with inflammatory bowel disease. Aliment Pharmacol Ther. 2018;48:386-388.
Mahadevan U, Vermeire S, Lasch K, et al. Letter: vedolizumab drug levels in cord and maternal blood in women with inflammatory bowel disease-authors' reply. Aliment Pharmacol Ther. 2018;48:388-389.
Julsgaard M, Kjeldsen J, Baumgart DC. Vedolizumab safety in pregnancy and newborn outcomes. Gut. 2017;66:1866-1867.
Bar-Gil Shitrit A, Ben Yaʼacov A, Livovsky DM, et al. Exposure to vedolizumab in IBD pregnant women appears of low risk for mother and neonate: a first prospective comparison study. Am J Gastroenterol. 2019;114:1172-1175.
Seirafi M, de Vroey B, Amiot A, et al. Factors associated with pregnancy outcome in anti-TNF treated women with inflammatory bowel disease. Aliment Pharmacol Ther. 2014;40:363-373.
Kammerlander H, Nielsen J, Knudsen T, Kjeldsen J, Friedman S, Nørgård BM. Anti-TNF-α use during the third trimester of pregnancy in women with moderate-severe inflammatory bowel disease and the risk of preterm birth and low birth weight. Inflamm Bowel Dis. 2017;23:1916-1923.
Mahadevan U, Sandborn WJ, Li DK, Hakimian S, Kane S, Corley DA. Pregnancy outcomes in women with inflammatory bowel disease: a large community-based study from Northern California. Gastroenterology. 2007;133:1106-1112.
Boyd HA, Basit S, Harpsøe MC, Wohlfahrt J, Jess T. Inflammatory bowel disease and risk of adverse pregnancy outcomes. PLoS ONE. 2015;10:e0129567.
Feagan BG, Sandborn WJ, D'Haens G, et al. Induction therapy with the selective interleukin-23 inhibitor risankizumab in patients with moderate-to-severe Crohn's disease: a randomised, double-blind, placebo-controlled phase 2 study. Lancet. 2017;389(10080):1699-1709.
Zelinkova Z, Berakova K,Podmanicky D, Kadleckova B.Placental MADCAM1 expression and potential consequences for the treatment with vedolizumab during pregnancy. Digestive Disease Week, AGA abstract.
Kanis SL, de Lima A, van der Ent C, Rizopoulos D, van der Woude CJ. Anti-TNF levels in cord blood at birth are associated with anti-TNF type. J Crohns Colitis. 2018;12:939-947.
Beaulieu DB, Ananthakrishnan AN, Martin C, Cohen RD, Kane SV, Mahadevan U. Use of biologic therapy by pregnant women with inflammatory bowel disease does not affect infant response to vaccines. Clin Gastroenterol Hepatol. 2018;16:99-105.
Duricova D, Dvorakova E, Hradsky O, et al. Safety of anti-TNF-alpha therapy during pregnancy on long-term outcome of exposed children: a controlled multicenter observation. Inflamm Bowel Dis. 2019;25:789-796.
Bortlik M, Duricova D, Machkova N, et al. Impact of anti-tumor necrosis factor alpha antibodies administered to pregnant women with inflammatory bowel disease on long-term outcome of exposed children. Inflamm Bowel Dis. 2014;20:495-501.
Chaparro M, Verreth A, Lobaton T, et al. Long-term safety of in utero exposure to anti-TNFα drugs for the treatment of inflammatory bowel disease: results from the multicenter European TEDDY study. Am J Gastroenterol. 2018;113:396-403.
Julsgaard M, Christensen LA, Gibson PR, et al. Concentrations of adalimumab and infliximab in mothers and newborns, and effects on infection. Gastroenterology. 2016;151:110-119.
de Lima A, Zelinkova Z, Mulders AG, van der Woude CJ. Preconception care reduces relapse of inflammatory bowel disease during pregnancy. Clin Gastroenterol Hepatol. 2016;14:1285-1292.e1.
Pinder M, Lummis K, Selinger CP. Managing inflammatory bowel disease in pregnancy: current perspectives. Clin Exp Gastroenterol. 2016;9:325-335.