Long-Term Safety of In Utero Exposure to Anti-TNFα Drugs for the Treatment of Infl ammatory Bowel Disease: Results from the Multicenter European TEDDY Study
| Title: | Long-Term Safety of In Utero Exposure to Anti-TNFα Drugs for the Treatment of Infl ammatory Bowel Disease: Results from the Multicenter European TEDDY Study |
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| Authors: | M. Chaparro; A. Verreth; T. Lobaton; E. Gravito-Soares; M. Julsgaard; E. Savarino; F. Magro; 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. 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 |
| Contributors: | Chaparro, M.; Verreth, A.; Lobaton, T.; Gravito-Soares, E.; Julsgaard, M.; Savarino, E.; Magro, F.; Biron, Avni; Lopez-Serrano, P.; Casanova, M. J.; Gompertz, M.; Vitor, S.; Arroyo, M.; Pugliese, D.; Zabana, Y.; Vicente, R.; Aguas, M.; Bar-Gil Shitrit, A.; Gutierrez, A.; Doherty, G. A.; Fernandez-Salazar, L.; Martínez Cadilla, J.; Huguet, J.; O’Toole, A.; Stasi, E.; Manceñido Marcos, N.; Villoria, A.; Karmiris, K.; Rahier, J. F.; Rodriguez, C.; Diz-Lois Palomares, M.; Fiorino, G.; Benitez, J. M.; Principi, M.; Naftali, T.; Taxonera, C.; Mantzaris, G.; Sebkova, L.; Iade, B.; Lissner, D.; Ferrer Bradley, I.; Lopez-San Roman, 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.; Martín de Carpi, F. J.; Gisbert, J. P. |
| Publisher Information: | NATURE PUBLISHING GROUP, 75 VARICK ST, 9TH FLR, NEW YORK, NY 10013-1917 USA |
| Publication Year: | 2018 |
| Collection: | Padua Research Archive (IRIS - Università degli Studi di Padova) |
| Subject Terms: | inflammatory bowel disease (IBD); anti-tumor necrosis factor (anti-TNF); pregnanacy |
| Description: | OBJECTIVES: The long-term safety of exposure to anti-tumor necrosis factor (anti-TNF) drugs during pregnancy has received little attention. We aimed to compare the relative risk of severe infections in children of mothers with infl ammatory bowel disease (IBD) who were exposed to anti-TNF 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-TNF 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 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-TNF 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% confi dence 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-TNF drugs does not seem to be associated with increased short-term or long-term risk of severe infections in children. |
| Document Type: | article in journal/newspaper |
| File Description: | STAMPA |
| Language: | English |
| Relation: | info:eu-repo/semantics/altIdentifier/pmid/29460920; info:eu-repo/semantics/altIdentifier/wos/WOS:000427261900015; volume:113; issue:3; firstpage:396; lastpage:403; numberofpages:8; journal:THE AMERICAN JOURNAL OF GASTROENTEROLOGY; https://hdl.handle.net/11577/3255831 |
| DOI: | 10.1038/ajg.2017.501 |
| Availability: | https://hdl.handle.net/11577/3255831; https://doi.org/10.1038/ajg.2017.501 |
| Accession Number: | edsbas.E3DC551B |
| Database: | BASE |