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P275. Evaluation of the discontinuation of infliximab during pregnancy in inflammatory bowel disease patients

Z. Zelinkova1, C. Van der Ent1, K. Bruin2, O. Van Baalen3, H. Vermeulen4, H. Smalbraak5, R. Ouwendijk4, A. Hoek6, S. Van der Werf7, E.J. Kuipers1, C.J. Van der Woude1

1Erasmus MC, Netherlands; 2Twee Steden Ziekenhuis, Tilburg, Netherlands; 3Beatrix Ziekenhuis, Gorinchem, Netherlands; 4Ikazia Ziekenhuis, Rotterdam, Netherlands; 5Lievensberg Ziekenhuis, Bergen op Zoom, Netherlands; 6Van Weel-Bethesda ziekenhuis, Dirksland, Netherlands; 7Medisch Centrum Haaglanden, Den Haag, Netherlands

Background: For the use of infliximab (IFX) during pregnancy, it is advised to discontinue the treatment prior to the third trimester in order to limit the early postnatal exposure to IFX. It is unclear whether this approach is safe for the mother and whether it reduces the neonatal exposure to IFX. Therefore, the aim of this study was first, to assess the disease course during the pregnancy after discontinuation of IFX and second, to evaluate whether early discontinuation leads to the reduction of IFX levels in newborns.

Methods: Pregnant IBD patients using IFX were prospectively followed. In case of remission, IFX was discontinued prior to gestational week 30. Disease activity and complications of the resumption of the treatment were evaluated. IFX levels in the newborns` cord blood were assessed by ELISA. The differences in these levels between the patients with time from the last infusion to delivery 10 weeks and less were compared with the group of patients with more than 10 weeks from the last infusion to delivery (early discontinuation) by t‑test. For the correlation of gestational week of IFX discontinuation with IFX levels in the newborns a nonparametric correlation test was used.

Results: In total, 17 pregnancies in 16 patients (mean age 29 years, range 18 to 37; 10 with Crohn's disease and 6 with ulcerative colitis) were followed. There was one spontaneous miscarriage at week 6 and 16 live births with an average birth weight of 3278 grams (range 2200 to 4210).

Twelve patients (75%) had quiescent disease and discontinued the treatment between gestational weeks 18 and 27 (average week 23). All 12 patients remained in remission and the treatment was resumed after delivery without complications. Four patients (25%) were not in remission and received last infusion between gestational weeks 30 and 32.

The cord blood was collected from 12 newborns. Overall mean IFX level was 5.0±SEM 1.4 µg/mL. The mean cord blood IFX level in the early discontinuation group was significantly lower than in the group with 10 or less weeks from the last infusion to delivery (2.4±SEM 1.0 µg/mL and 8.5±SEM 2.2 µg/mL, respectively; p = 0.02). The levels of IFX in the cord blood correlated significantly with the gestational week of IFX discontinuation (Spearman's rho=0.69, p = 0.013).

Conclusions: In quiescent disease, early discontinuation of infliximab during pregnancy in inflammatory bowel disease patients is safe for the mothers-to-be and reduces the neonatal exposure to infliximab.