Long-Term Safety of In Utero Exposure to Anti-TNFα Drugs for the Treatment of Inflammatory Bowel Disease: Results from the Multicenter ... View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2018-03

AUTHORS

M Chaparro, A Verreth, T Lobaton, E Gravito-Soares, M Julsgaard, E Savarino, F Magro, I Avni Biron, P Lopez-Serrano, M J Casanova, M Gompertz, S Vitor, M Arroyo, D Pugliese, Y Zabana, R Vicente, M Aguas, A Bar-Gil Shitrit, A Gutierrez, G A Doherty, L Fernandez-Salazar, J Martínez Cadilla, J M Huguet, A O'Toole, E Stasi, N Manceñido Marcos, A Villoria, K Karmiris, J F Rahier, C Rodriguez, M Diz-Lois Palomares, G Fiorino, J M Benitez, M Principi, T Naftali, C Taxonera, G Mantzaris, L Sebkova, B Iade, D Lissner, I Ferrer Bradley, A Lopez-San Roman, I Marin-Jimenez, O Merino, M Sierra, M Van Domselaar, F Caprioli, I Guerra, P Peixe, M Piqueras, I Rodriguez-Lago, Y Ber, K van Hoeve, P Torres, M Gravito-Soares, D Rudbeck-Resdal, O Bartolo, A Peixoto, G Martin, A Armuzzi, A Garre, M G Donday, F J Martín de Carpi, J P Gisbert

ABSTRACT

OBJECTIVES: The long-term safety of exposure to anti-tumor necrosis factor (anti-TNFα) drugs during pregnancy has received little attention. We aimed to compare the relative risk of severe infections in children of mothers with inflammatory bowel disease (IBD) who were exposed to anti-TNFα drugs in utero with that of children who were not exposed to the drugs. METHODS: Retrospective multicenter cohort study. Exposed cohort: children from mothers with IBD receiving anti-TNFα medication (with or without thiopurines) at any time during pregnancy or during the 3 months before conception. Non-exposed cohort: children from mothers with IBD not treated with anti-TNFα agents or thiopurines at any time during pregnancy or the 3 months before conception. The cumulative incidence of severe infections after birth was estimated using Kaplan-Meier curves, which were compared using the log-rank test. Cox-regression analysis was performed to identify potential predictive factors for severe infections in the offspring. RESULTS: The study population comprised 841 children, of whom 388 (46%) had been exposed to anti-TNFα agents. Median follow-up after delivery was 47 months in the exposed group and 68 months in the non-exposed group. Both univariate and multivariate analysis showed the incidence rate of severe infections to be similar in non-exposed and exposed children (1.6% vs. 2.8% per person-year, hazard ratio 1.2 (95% confidence interval 0.8-1.8)). In the multivariate analysis, preterm delivery was the only variable associated with a higher risk of severe infection (2.5% (1.5-4.3)). CONCLUSIONS: In utero exposure to anti-TNFα drugs does not seem to be associated with increased short-term or long-term risk of severe infections in children. More... »

PAGES

396

References to SciGraph publications

Journal

TITLE

The American Journal of Gastroenterology

ISSUE

3

VOLUME

113

Identifiers

URI

http://scigraph.springernature.com/pub.10.1038/ajg.2017.501

DOI

http://dx.doi.org/10.1038/ajg.2017.501

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1101123363

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/29460920


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    "datePublishedReg": "2018-03-01", 
    "description": "OBJECTIVES: The long-term safety of exposure to anti-tumor necrosis factor (anti-TNF\u03b1) drugs during pregnancy has received little attention. We aimed to compare the relative risk of severe infections in children of mothers with inflammatory bowel disease (IBD) who were exposed to anti-TNF\u03b1 drugs in utero with that of children who were not exposed to the drugs.\nMETHODS: Retrospective multicenter cohort study. Exposed cohort: children from mothers with IBD receiving anti-TNF\u03b1 medication (with or without thiopurines) at any time during pregnancy or during the 3 months before conception. Non-exposed cohort: children from mothers with IBD not treated with anti-TNF\u03b1 agents or thiopurines at any time during pregnancy or the 3 months before conception. The cumulative incidence of severe infections after birth was estimated using Kaplan-Meier curves, which were compared using the log-rank test. Cox-regression analysis was performed to identify potential predictive factors for severe infections in the offspring.\nRESULTS: The study population comprised 841 children, of whom 388 (46%) had been exposed to anti-TNF\u03b1 agents. Median follow-up after delivery was 47 months in the exposed group and 68 months in the non-exposed group. Both univariate and multivariate analysis showed the incidence rate of severe infections to be similar in non-exposed and exposed children (1.6% vs. 2.8% per person-year, hazard ratio 1.2 (95% confidence interval 0.8-1.8)). In the multivariate analysis, preterm delivery was the only variable associated with a higher risk of severe infection (2.5% (1.5-4.3)).\nCONCLUSIONS: In utero exposure to anti-TNF\u03b1 drugs does not seem to be associated with increased short-term or long-term risk of severe infections in children.", 
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