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

Autores de IIS La Fe

• Manuel Fernández Sánchez

  Autor

• Hugo Ribes Artero

  Autor

• Eva Romá Sánchez

  Autor

• Rosa Maria Gomez Portero

  Autor

• Eduardo Guerrero Hurtado

  Autor

• Javier García Pellicer

  Autor

• José Luis Poveda Andrés

  Autor

Grupos

• Endocrinología Reproductiva e Infertilidad

  Leader

  José Remohí Giménez

• Farmacogenética

  Investigador Principal

  María José Herrero Cervera

• Infección Grave

  

  Investigador Principal

  María Ángeles Tormo Mas

Abstract

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