Tocilizumab Use in Pregnancy: Analysis of a Global Safety Database Including Data from Clinical Trials and Post-marketing Data
This dataset is the largest series of tocilizumab (TCZ)-exposed pregnancies to date; considering the limitations of global safety databases, the data presented provide information to assist physicians and patients in making informed decisions.
At present, published experience on TCZ use during pregnancy is very limited. In the current analysis, all pregnancy-related reports in the Roche Global Safety Database until December 31, 2014 were analysed. Outcomes assessed included: spontaneous abortion, elective termination of pregnancy (ETOP), and stillbirth.
Of the 288 pregnancies with reported pregnancy outcomes, 180 were prospectively reported (outcome not known at the time of reporting): 109 live births (including two sets of twins [n=111]), 21.7% spontaneous abortions, 17.2% ETOP, and 1 stillbirth. Preterm birth (before Week 37 completed) was observed in 31.1%, which is higher than in the general population. The rate of malformations was 4.5%.
An analysis of retrospectively reported pregnancies (outcome known at time of reporting) is also presented however to avoid reporting bias, prospectively reported pregnancies are the focus of this report.
The data presented do not yet prove safety; further prospective studies are needed. It cannot be ruled out that the increased rate of preterm birth and low birth weight children may be associated with TCZ.