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 (47) of pregnancies; the rate of congenital anomalies was consistent with the background rate. Out of the 47 pregnancies, 27.7% reported spontaneous abortions. Of the spontaneous abortions, 30.8% of the patients received MTX, an agent that is contraindicated in pregnant women due to its teratogenic and abortifacient properties. Limitations of this analysis included the lack of a direct comparison group, the variable amount of information available in the reports, and the possible bias towards reporting more negative outcomes in retrospective cases. Additionally, MTX use was reported in 12 of the 47 cases, but it is possible that additional patients may have been exposed to MTX during their pregnancy but were not reported, since concomitant MTX use is required for treatment of RA and optional for PsA.
Disclosure of Interest : A. Lau Employee of: Janssen Research & Development, LLC, M. Clark Employee of: Janssen Research & Development, LLC, D. Harrison Employee of: Janssen Research & Development, LLC, A. Geldhof Employee of: Janssen Research & Development, LLC, R. Nissinen Employee of: Janssen Research & Development, LLC, M. Sanders Employee of: Janssen Research & Development, LLC
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