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4th Feb, 2025 12:00 AM
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JAK Inhibitors During Pregnancy: Safety Data Reviewed

TOPLINE:

A systematic review of 256 pregnancies exposed to Janus kinase inhibitors (JAKis) found spontaneous abortion and congenital malformation rates were similar to those in the general population, but current evidence supports a recommendation to avoid JAKis during pregnancy

METHODOLOGY:

  • Researchers conducted a systematic review using searches across PubMed, Cochrane, Google Scholar, and ClinicalTrials databases to examine the current evidence regarding the use of JAKis during pregnancy and lactation and subsequent fetal outcomes.
  • A total of 15 articles met eligibility criteria, 12 case reports or series, and three reviews of over 30 randomized controlled trials.
  • A total of 256 patients (mean age, 32 years) received four JAKis (baricitinib, tofacitinib, upadacitinib, or ruxolitinib) for rheumatoid arthritis, atopic dermatitis, inflammatory bowel disease, psoriasis, psoriatic arthritis, ulcerative colitis, hemophagocytic lymphohistiocytosis, myelofibrosis, or alopecia areata.

TAKEAWAY:

  • JAKis were used before conception in 253 cases, during pregnancy in 254 cases, and after delivery in four cases. In addition, 169 patients used the JAKis in the first trimester only, three patients through the second trimester, and 82 patients through the third trimester.
  • All case reports described favorable pregnancy outcomes. Clinical trial data showed similar rates of spontaneous abortion and congenital malformations compared with the general population (8%). Congenital malformations occurred in cases in which patients were taking other systemic agents (1%).
  • In four studies, the effects of JAKis in lactation were evaluated and “some evidence” of transmission via breast milk was found.

IN PRACTICE:

“Although healthy pregnancy outcomes are reported, JAKi have demonstrated ex vivo transfer via human placenta and breast milk. Thus, it is currently advised to discontinue JAKi 4 weeks prior to conception and avoid JAKi use during pregnancy and lactation,” the authors wrote. More research on outcomes of pregnancies exposed to JAK inhibitors, they added, “may provide more nuanced guidelines based on higher levels of evidence and risk-benefit analysis of pregnant patients’ health and fetal outcomes.”

SOURCE:

This study was led by Emily R. Gordon, Columbia University, New York City, and Mitchell Hanson, Department of Medicine, Medical College of Georgia at Augusta, Georgia. It was published online on December 3, 2024, in the Journal of the American Academy of Dermatology.

LIMITATIONS:

Reporting bias was listed as a possible limitation of the case report data.

DISCLOSURES:

No funding sources were reported for this study. One author reported being a consultant, advisory board member, principal investigator, and member of the speakers bureau for various pharmaceutical companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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