Pregnancy outcome after tocilizumab therapy in early pregnancy – a case series from the German Embryotox Pharmacovigilance Center

Reproductive Toxicology doi:10.1016/j.reprotox.2016.01.002

MTX users have an increased incidence of spontaneous abortions (SABs) compared to baseline risk (42.5%1 vs. 13-17%2). Tocilizumab (TCZ) has been shown to have similar efficacy with or without MTX. There is currently limited data on the effect of TCZ on pregnancy, but with more safety data, TCZ could be an alternative for RA patients of reproductive age. The patients were enrolled at Embryotox Berlin, a pharmacovigilance center providing risk assessment during pregnancy, between 2011 and 2014 during early pregnancy. Telephone interviews and paper questionnaires were answered by the mother and/or her physician(s). Data collected focused on pregnancy outcomes including complications and birth defects. 18 cases of TCZ exposure during or shortly before pregnancy were completed, 16 maternal and 2 paternal. Of the 16 maternal exposure pregnancies, 4 SABs, 1 elective termination, and 11 live-born infants were reported. One of the SABs occurred at 15 weeks +3 days and was complicated by hydrops fetalis. The parents denied autopsy or chromosomal analysis, and the cause of the hydrops fetalis remains unknown. This mother was on hydroxychloroquine and sulfasalazine in addition to TCZ. No mothers developed preeclampsia, but there was a higher than average number of cesarean sections. In the 2 pregnancies fathered by TCZ users, one ended in SAB and one in a healthy term born infant. No major malformations were reported in the live-born infants. Although a small sample size, the case series presented by Weber-Schoendorfer and Schaefer provide reassurance that TCZ use during early pregnancy will not have a teratogenic effect.