Pregnancy Outcomes After Maternal or Paternal Exposure to Tofacitinib Across Clinical Programs.

Mahadevan, Uma; Chaparro, María; Segovia, Michelle; Guo, Xiang; Kulisek, Nicole; Wu, Joseph; Vranic, Ivana; Diehl, Annette et al. · Am J Gastroenterol · 2026

case_series · Level IV

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Abstract

This analysis reports updated pregnancy outcomes after tofacitinib exposure in patients with immune-mediated diseases. Pregnancy/partner pregnancy cases from interventional studies were identified in Pfizer safety database through March 2023. 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. 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.

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