Fetal exposure to tofacitinib during the first trimester: A healthy newborn case report

Birth Defects Res. 2021 Oct 15;113(17):1275-1279. doi: 10.1002/bdr2.1942. Epub 2021 Jul 26.


Introduction: Preclinical studies with tofacitinib demonstrated teratogenic effects. Data about effects on human fetuses are limited and current recommendations are to immediately discontinue the treatment. Our purpose is to report a case of exposure to tofacitinib during the first trimester of pregnancy.

Case summary: A 40-year-old woman with psoriatic arthritis became pregnant during the first month of treatment with tofacitinib. Tofacitinib was interrupted immediately, and parents were informed about the possible risks of teratogenicity. At the end of pregnancy, our patient gave birth to a healthy newborn.

Conclusion: All the available evidence of tofacitinib exposure during pregnancy in humans belongs to outcomes of unexpected pregnancies in the context of clinical trials and post-marketing cases. This case may contribute to enriching available data about teratogenic risks of tofacitinib exposure during pregnancy.

Keywords: JAK inhibitors; pregnancy; psoriatic arthritis; teratogenic effects; teratogenicity; tofacitinib.

Publication types

  • Case Reports

MeSH terms

  • Adult
  • Female
  • Humans
  • Infant, Newborn
  • Piperidines / adverse effects
  • Pregnancy
  • Pregnancy Trimester, First
  • Protein Kinase Inhibitors*
  • Pyrimidines* / adverse effects


  • Piperidines
  • Protein Kinase Inhibitors
  • Pyrimidines
  • tofacitinib