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P334. The safety of immunomodulators and anti-TNF drugs for the treatment of inflammatory bowel disease (IBD) during pregnancy

M. Casanova1, M. Chaparro1, E. Iglesias2, L. Rodrigo3, E. Domènech4, X. Calvet5, E. Garcia Planella6, F. Bermejo7, C. Taxonera8, M. Barreiro-de Acosta9, S. García10, D. Ginard11, M. López12, E. Garrido13, M. Gómez14, J. Pérez-Calle15, C. Saro16, M. Piqueras17, B. Beltrán18, M. Esteve19, B. Botella20, C. Dueñas21, V. García2, J. Maté1, J.P. Gisbert1

1La Princesa, Madrid, Spain; 2Reina Sofía, Córdoba, Spain; 3Central de Asturias, Asturias, Spain; 4Germans Trias i Pujol, Badalona, Spain; 5Parc Tauli, Barcelona, Spain; 6Santa Creu i Sant Pau, Barcelona, Spain; 7Fuenlabrada, Madrid, Spain; 8San Carlos, Madrid, Spain; 9Santiago, Santiago, Spain; 10Miguel Servet, Zaragoza, Spain; 11Son Dureta, Mallorca, Spain; 12Galdakao, Galdakao, Spain; 13Ramón y Cajal, Madrid, Spain; 14Virgen de las Nieves, Granada, Spain; 15Alcorcón, Madrid, Spain; 16Cabueñes, Gijón, Spain; 17Consorcio Sanitario Terrassa, Terrassa, Spain; 18La Fe, Valencia, Spain; 19Mutua de Terrassa, Terrassa, Spain; 20Infanta Cristina, Madrid, Spain; 21San Pedro Alcántara, Cáceres, Spain

Aim: To assess the safety of immunomodulators and anti-TNF drugs for the treatment of IBD during pregnancy.

Methods: Retrospective, multicenter, case–control study. Cases were considered those pregnancies developed with the IBD patient on immunomodulators or anti-TNF drugs during pregnancy or during the 6 months before conception, and controls those in which the mother with IBD did not receive these drugs either during pregnancy or the 6 months before conception. Data were obtained from the review of medical records and by an interview with the patient when additional information was necessary. A favourable Pregnancy Outcome (PO) was considered if pregnancy had been developed without obstetric complications in the mother and in the newborn.

Results: 312 pregnancies have been included: 202 pregnancies in the case group and 110 pregnancies in the control group. 58% of mothers had Crohn's disease (CD) and 29% had active disease during pregnancy. 15% of pregnancies were exposed to anti-TNF drugs (infliximab 11%, adalimumab 3%, certolizumab 1%) and 58% to immunomodulators (azathioprine 54%, mercaptopurine 3% and methotrexate 1%). The characteristics of the mothers were similar in both groups except for the type of IBD, with higher prevalence of CD among cases (71% vs. 33%, p < 0.001) and also a higher prevalence of surgery due to IBD among cases (36% vs. 9%, p < 0.001). The prevalence of unfavourable PO was higher in control than in case group (37% vs. 24%, p = 0.02). The distribution of pregnancy and newborn complications in cases and controls were as follow: spontaneous abortion (10% vs. 17%, p = 0.06), preterm delivery (4% vs. 12%, p = 0.01), cesarean section (26% vs. 21%, p = 0.4), instrumental delivery (4% vs. 3%, p = 0.08), low birth weight (6% vs. 10%, p = 0.2), ICU admission (3% vs. 3%, p = 0.8), and malformations (1% vs. 0%, p = 0.6). In the multivariate analysis, the treatment with immunomodulators (OR = 0.3; 95%CI = 0.2–0.6) and having CD (vs. ulcerative colitis) (OR = 0.5; 95%CI = 0.3–0.9) were the only predictors of favourable PO. The treatment with anti-TNF drugs was not associated with an unfavourable PO (OR = 1.1; 95%CI = 0.6–2.3).

Conclusions: The treatment with immunomodulators and anti-TNF drugs do not seem to increase the risk of complications during pregnancy and are safe for the newborn.