Abstract
INTRODUCTION: This analysis reports updated pregnancy outcomes after tofacitinib exposure in patients with immune-mediated diseases. METHODS: Pregnancy/partner pregnancy cases from interventional studies were identified in Pfizer safety database through March 2023. RESULTS: Of 184 pregnancies reported, 85 were maternal exposure events: 46 healthy newborns, 12 medical terminations, 1 fetal death, 1 congenital malformation, 14 spontaneous abortions, and 11 pending/lost to follow-up. There were 99 paternal exposure events: 67 healthy newborns, 1 fetal death, 9 spontaneous abortions, and 22 pending/lost to follow-up. DISCUSSION: Outcomes of maternal/paternal tofacitinib exposure were similar to those expected in the general population; tofacitinib should not be used during pregnancy unless clearly necessary.