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P621 Long-term safety of in utero exposure to anti-TNFα drugs for the treatment of inflammatory bowel diseases (IBD): Interim results of the TEDDY study

M. Chaparro1, F. Magro2; E. Savarino3, Y. Zabana4, D. Pugliese5, A. Bar-Gil Shitrit6, L. Fernandes Samue7, P. López-Serrano8, M. J. Casanova1, L. Fernández-Salazar9, A. Gutierrez10, R. Vicente11, E. Gravito-Soares12, C. Rodriguez13, L. Sebkova14, D. Lissner15, A. Magarotto16, I. Rodriguez-Lago17, J. M. Huguet18, M. T. Diz-Lois Palomares19, G. Fiorino20, I. Guerra21, G. J. Mantzaris22, M. Silva2, O. Bartolo3, M. G. Donday1, M. Ramas1, J. Martín de Carpi23, J. P. Gisbert1

Gastroenterology Departments from: 1Hospital Universitario de la Princesa, IIS-IP y CIBEREHD, Madrid, Spain; 2Centro Hospitalar Sao Joao, Portugal; 3University of Padua, Italy; 4Hospital Universitari Mutua de Terrassa, Terrassa, Spain; 5Complesso Integrato Columbus Catholic University, Italy; 7Shaare Zedek Medical Center Jerusalem, Israel; 7Hospital de Santa Maria de Lisboa, Portugal; 8Hospital Universitario Fundación de Alcorcón, Spain; 9Hospital Clínico Universitario de Valadolid, Spain; 10Hospital General de Alicante, Spain; 11Hospital Universitario Miguel Servet, Spain; 12Centro Hospitalar e Universitario de Coimbra, Portugal; 13Complejo hospitalario de Navarra, Spain; 14Azienda Ospedaliera “Plugiese-Ciaccio”, Italy; 15Universitatsmedizin Berlin, Campus Benjamin Franklin, Charite, Germany; 16IRCCS Ospedale Ca Granda Policlinico di Milano, Italy; 17Hospital Galdakao, Spain; 18Hospital General Universitario de Valencia, Spain; 19Hospital Universitario A Coruña, Spain; 20Humanitas Research Hospital, Italy; 21Hospital Universitario de Fuenlabrada, Spain; 22Evangelismos, Ophthalmiatreion Athinon and Polyclinic Hospitals, Greece; 23Unidad para el Cuidado Integral de la Enfermedad Inflamatoria Intestinal. Hospital Sant Joan de Déu, Barcelona.

Background

The long-term safety of anti-TNFα therapies during pregnancy has hardly been studied.

Aims: To estimate the relative risk of severe infections in children, from IBD mothers, exposed in utero to anti-TNFα drugs (compared with those who have not been exposed).

Methods

Retrospective multicentre cohort study. Exposed group (EG): Children from IBD mothers under anti-TNFα drugs (with or without thiopurines) at any time during pregnancy or the 3 months before conception. Non-exposed group (NEG): Children from IBD mothers treated neither with anti-TNFα drugs nor with 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 by the log-rank test. Cox-regression analysis was performed to identify potential predictive factors for severe infections.

Results

222 children born to IBD mothers have been included. Among them, 105 (47%) had been exposed to anti-TNFα agents. From them, 39% maintained the treatment along the whole pregnancy. Median follow-up after delivery was 33 months in the EG group and 74 months in the NEG (p=0.3). The proportions of CD patients and previous surgery were higher in the EG than in the NEG (52% vs. 80%, p<0.001) and (34% vs. 19%, p=0.01), respectively. Other relevant characteristics were similar between both groups. The proportions of pregnancy, delivery and newborn complications were similar between EG and NEG. The proportion of breastfed babies was higher in the NEG in comparison with the EG (81% vs. 58%, p<0.001). The majority of children were vaccinated following the local recommendations. A total of 21 children (9.5%) developed severe infections during the follow-up. The incidence rate of severe infection was similar between NEG and EG (3.1 vs. 2.3% person-years). The admission length was longer (9 vs. 4.6 days, p=0.01) and the proportion of children admitted to the intensive care unit was higher (75% vs. 25%, p=0.04) in the EG in comparison with the NEG. No child developed cancer during the follow-up. In the multivariate analysis, adjusted by low birth weight, preterm delivery was the only variable associated with a higher risk of severe infection (HR=3.9; 95%CI=1.2-12.2). Finally, to have been exposed to anti-TNFα drugs during pregnancy was not associated with higher risk of severe infections (HR: 0.5; IC95% 0.2-1.3).

Conclusion

In our preliminary results, the exposition to anti-TNFα agents in utero seems not to be associated with a higher risk of infections in children, in the short- or the long-term. These results need to be confirmed in a larger cohort. Differences found in the severity of the infections in the EG require further evaluation.