THU0153 Pregnancy Outcomes in Women Exposed to the Tumor Necrosis Factor Inhibitor, Golimumab

Background Rheumatologic conditions and inflammatory bowel disease can affect women of childbearing potential. Golimumab (GLM) is approved for the treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), and ulcerative colitis (UC). GLM should be used during pregnancy only if clearly needed. For RA patients and some PsA patients, GLM is administered with methotrexate (MTX), an agent with teratogenic and abortifacient properties. Objectives To characterize pregnancy outcomes in patients treated with GLM, data obtained from maternal exposure to GLM are presented. Methods This dataset includes individual patient cases reported to the manufacturer through 06 October 2013. Cases retrieved included prospectively reported (ie, pregnancy outcome not known when first reported) and retrospectively reported (ie, pregnancy outcome known when first reported) maternal exposures to GLM for all approved indications during pregnancy or within 2 months prior to conception, and with a reported known pregnancy outcome. Cases originated from various sources, including spontaneous reporting, clinical studies, and registries. Results Forty-seven pregnancy reports with reported outcomes (30 RA; 1 PsA; 5 AS; 11 UC) were identified (35 prospective, 12 retrospective). Of these 47 pregnancies, 33 were reported from clinical trials. Average maternal age was 33.4 years. Of the 47 pregnancy reports, 26 (55.3%) resulted in live births, 13 (27.7%) resulted in spontaneous abortion, 7 (14.9%) resulted in induced abortion, and 1 (2.1%) resulted in ectopic pregnancy (Table). The average maternal age in reports of spontaneous abortions was higher (35.5 years) than the average maternal age in reports of live births (32.4 years). One prospectively reported patient case (2.1%) from a spontaneous source reported a congenital anomaly with an unspecified birth defect resulting in intrauterine death and an induced abortion. Of the 47 reports, MTX use was reported in 12 pregnancies; all of the MTX use occurred in RA patients. Four of the 13 (30.8%) reports with a pregnancy outcome of spontaneous abortion involved patients who received MTX concomitantly with GLM, as compared to 5 of the 26 (19.2%) reported in the GLM exposed pregnancies resulting in live births. In the 1 pregnancy with a congenital anomaly, the patient had been exposed to MTX. Conclusions This review of pregnancy outcomes after GLM exposure in utero reported 1 congenital anomaly in a small number