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This is a Quantitative Study study.

September 28, 2025Open Access

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

Key Points

Of 184 reported pregnancies, maternal exposure events resulted in 46 healthy newborns and 14 spontaneous abortions.
Paternal exposure reported 67 healthy newborns, with one fetal death and nine spontaneous abortions identified.
Exposure outcomes were comparable to those in the general population, suggesting no significant increased risk.
Tofacitinib should be avoided during pregnancy unless absolutely necessary, based on current findings.

Abstract

Introduction: This analysis reports updated pregnancy outcomes following tofacitinib exposure in patients with immune-mediated diseases. Methods: Pregnancy/partner pregnancy cases from interventional studies were identified in Pfizer’s safety database through March 2023. Results: Of 184 pregnancies reported, 85 were maternal exposure events: 46 healthy newborns, 12 medical terminations, one fetal death, one congenital malformation, 14 spontaneous abortions, 11 pending/lost to follow-up. There were 99 paternal exposure events: 67 healthy newborns, one fetal death, nine spontaneous abortions, 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. ClinicalTrials.gov: NCT01465763, NCT01458951, NCT01458574, NCT03281304, NCT01470612, NCT00147498, NCT00847613, NCT00856544, NCT01039688, NCT02187055, NCT00413699, NCT00661661, NCT03502616, NCT02592434, NCT01500551, NCT01877668, NCT01882439, NCT03486457, NCT01976364, NCT01276639, NCT01309737, NCT01241591, NCT01186744, NCT01519089, NCT01815424, NCT01163253

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