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P401. Pregnancy outcomes in women with inflammatory bowel disease exposed to infliximab

Y. Snoeckx1, M. Clark1, A. Geldhof2, J. Morgan2, R. Nissinen2, J. Schlegelmilch3, 1Janssen Research & Development, LLC, United States, 2Janssen Biologics Europe, Netherlands, 3Janssen Services, LLC, United States

Background

IBD can affect women of childbearing potential. Infliximab (IFX) is indicated for Crohn's disease (CD) and ulcerative colitis (UC). The European prescribing information details adequate contraception to prevent pregnancy when using IFX. In the US, IFX is a pregnancy category B drug. To characterize pregnancy outcomes in IBD patients treated with IFX, data from a large cohort is presented.

Methods

This dataset includes individual cases reported through August 2012 to the marketing authorization holder. Cases retrieved included prospectively reported cases (ie, pregnancy outcome not known when first reported) with maternal IFX use for CD or UC during pregnancy or within 2 months of conception. Cases originated from various sources (spontaneous reporting, clinical studies, and registries).

Results

556 prospective pregnancy reports (503 CD; 53 UC) were identified with 417 from spontaneous reporting. Average maternal age was 29.4 years. The majority of pregnancies (81.5%) resulted in live births (Table). Congenital anomalies were reported for 8 (1.8%) live births: hypospadias (2), left hand syndactyly (1), gastroschisis and bladder anomaly (1), hypoplastic left heart syndrome (1), unspecified abnormal cytogenetic analysis (1), congenital bowing of long bones and talipes (1), and teratoma (1). Congenital anomalies with other pregnancy outcomes included Down's syndrome (1 with elective abortion), spinal dysplasia (1 with foetal demise) and an abnormal foetus (1 with spontaneous abortion). Average maternal age for the 11 cases with congenital anomalies was 27.9 years. Of the 331 cases with known trimester of exposure, 84 reported exposure in all 3 trimesters: 83 live births (with 1 congenital anomaly of gastroschisis and bladder anomaly) and 1 foetal demise.

Pregnancy outcomeCount (%)Congenital anomaly
Live birth453 (81.5%)8
Spontaneous abortion55 (9.9%)1
Elective/Induced abortion32 (5.8%)1
Foetal demise/Stillbirth7 (1.3%)1
Abortion planned4 (<1%)0
Abortion unspecified2 (<1%)0
Ectopic pregnancy2 (<1%)0
Molar pregnancy1 (<1%)0
Total55611

Conclusion

This review of pregnancy outcomes after IFX exposure in utero showed no specific pattern of congenital anomalies. While there does not appear to be an increased rate of congenital anomalies or spontaneous abortions when compared to the general population, it should be stressed that most cases come from spontaneous reporting. Limitations include the lack of a direct comparison group and the variable level of data details in the cases.