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

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 du

SUBMITTER: Mahadevan U 

PROVIDER: S-EPMC12854357 | biostudies-literature | 2026 Feb

REPOSITORIES: biostudies-literature