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.
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Chaparro M, Verreth A, Lobaton T, Gravito-Soares E, Julsgaard M, Savarino E, Magro F, Biron Avni I, Lopez-Serrano P, Casanova M J, Gompertz M, Vitor S, Arroyo M, Pugliese D, Zabana Y, Vicente R, Aguas M, Shitrit Bar-Gil A, Gutierrez A, Doherty G A, Fernandez-Salazar L, Cadilla Martínez J, Huguet J M, OʼToole A, Stasi E, Marcos Manceñido N, Villoria A, Karmiris K, Rahier J F, Rodriguez C, Palomares Diz-Lois M, Fiorino G, Benitez J M, Principi M, Naftali T, Taxonera C, Mantzaris G, Sebkova L, Iade B, Lissner D, Bradley Ferrer I, Roman Lopez-San A, Marin-Jimenez I, Merino O, Sierra M, Van Domselaar M, Caprioli F, Guerra I, Peixe P, Piqueras M, Rodriguez-Lago I, Ber Y, van Hoeve K, Torres P, Gravito-Soares M, Rudbeck-Resdal D, Bartolo O, Peixoto A, Martin G, Armuzzi A, Garre A, Donday M G, de Carpi Martín F J, Gisbert J P
Аннотация
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.