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P295. Prospective assessment of the adalimumab discontinuation during pregnancy in inflammatory bowel disease patients

Z. Zelinkova1, C. Van der Ent1, C.J. Van der Woude1

1Erasmus MC, Rotterdam, Netherlands

Background: Adalimumab (ADA) is considered to be safe for the use during pregnancy but placental transfer of ADA, presumably starting in the second trimester, has been reported. In order to limit the intra-uterine exposure to ADA, it is advised to stop the treatment during the third trimester but the data evaluating the safety of this approach for the mothers are scarce. Therefore, the aim of this study was to assess the effect of the discontinuation of ADA treatment during pregnancy on disease activity and potential complications of the resumption of the treatment.

Methods: Pregnant inflammatory bowel disease (IBD) patients using ADA were prospectively followed during pregnancy and post partum until the resumption of the treatment. In patients with quiescent disease, the treatment was discontinued in the second trimester. Disease activity and complications of the treatment resumption were assessed by the treating physician. In addition, pregnancy outcomes were noted.

Results: In total, thirteen pregnancies in 12 IBD patients (mean age 30 years, range 21 to 38) were prospectively followed. One patient had spontaneous miscarriage at gestational week 8; 12 pregnancies resulted in live births. The mean gestational age was 39 weeks (range 36 to 41) and the mean birth weight was 3260 grams (range 2000 to 4320), there were no congenital malformations.

All patients discontinued the treatment during the second trimester, mean gestational week of discontinuation was 23 (range 21 to 27). The resumption of the treatment post partum went uneventful. Two patients (16%) experienced a relapse of the disease after discontinuation, at respective gestational weeks 30 and 36. One patient was successfully treated with systemic steroids, the second patient underwent an elective C‑section at gestational week 37 and ADA was resumed immediately after delivery without complications. Both relapsing patients were the only patients with weekly use of 40 mg of ADA, the remaining patients were using 40 mg every other week.

Conclusions: In the majority of IBD patients in remission with adalimumab, the treatment can be discontinued in the second trimester of the pregnancy without the risk of flare. However, this approach might not be suitable for patients on established treatment with escalated dose.