Background/Purpose: Rheumatologic conditions and inflammatory bowel disease can affect women of childbearing potential. Golimumab (GLM) is approved for 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 and some PsA patients, GLM is administered with methotrexate (MTX), an agent with teratogenic and abortifacient properties. 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 April 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 a reported pregnancy outcome. Cases originated from various sources, including spontaneous reporting, clinical studies, and registries.

Results : Forty pregnancy reports with reported outcomes (24 RA; 1 PsA; 5 AS; 10 UC) were identified (32 prospective, 8 retrospective). Of these 40 pregnancies, 30 were reported from clinical trials. Average maternal age was 33.2 years. Of the 40 pregnancy reports, 19 (47.5%) resulted in live births, 13 (32.5%) resulted in spontaneous abortion, 7 (17.5%) resulted in induced abortion, and 1 (2.5%) resulted in ectopic pregnancy (Table). One spontaneous prospectively reported patient case (2.5%) reported a congenital anomaly with an unspecified birth defect resulting in intrauterine death and an induced abortion. Of the 13 reports with a pregnancy outcome of spontaneous abortion, 4 (30.8%) patients received MTX concomitantly with GLM, as compared to 3 out of 19 (15.8%) reports in the GLM exposed pregnancies resulting in live births. In the 1 pregnancy with a congenital anomaly, the patient had used MTX, but the timing of MTX use was not available.

Conclusion: This review of pregnancy outcomes after GLM exposure in utero reported 1 congenital anomaly in a small number (40) of pregnancies; the rate of congenital anomalies was consistent with the background rate. Out of the 40 pregnancies, 32.5% reported spontaneous abortions. Of those pregnancies, 30.8% of the patients received MTX, an agent which is contraindicated in pregnant women due to its teratogenic and aborifacient properties. Limitations of this analysis included the lack of a direct comparison group, the variable amount of data available in the reports, and the possible bias towards reporting more negative outcomes in retrospective cases.

Table:    Summary of pregnancy outcomes in patients treated with GLM for RA, PsA, AS, and UC