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JAK in the [Black] Box: A Dermatology Perspective on Systemic JAK Inhibitor Safety


Janus kinase (JAK) inhibitors are immunomodulatory agents with broad potential for use within dermatology. However, the US Food and Drug Administration has recently placed additional warning labels on JAK inhibitors given concern for an increased risk of major adverse cardiovascular events, malignancy, venous thromboembolism, and mortality. Here, we summarize recent efficacy and safety data of multiple JAK inhibitors including tofacitinib, upadacitinib, baricitinib, and abrocitinib. JAK inhibitors have high efficacy in treating psoriatic arthritis and atopic dermatitis, but carry an increased risk of venous thromboembolism and cardiovascular events relative to other approved treatments. Here, we provide current considerations on balancing the benefits of JAK inhibitors with potentially serious, but low-absolute risk, safety concerns.

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Correspondence to Joseph F. Merola.

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Conflict of interest

S.B. Elmariah has served as a consultant, advisory board member, speaker, or investigator for Menlo Therapeutics, Trevi Therapeutics, Sanofi Regeneron, Galderma, RAPT Therapeutics, and Celldex Therapeutics. J.S. Smith has no relevant conflicts of interest. J.F. Merola is a consultant and/or investigator for Amgen, Bristol-Myers Squibb, AbbVie, Dermavant, Eli Lilly, Novartis, Janssen, UCB, Sanofi, Regeneron, Sun Pharma, Biogen, Pfizer Inc., and Leo Pharma.

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JSS, SBE, and JFM wrote the paper.

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Elmariah, S.B., Smith, J.S. & Merola, J.F. JAK in the [Black] Box: A Dermatology Perspective on Systemic JAK Inhibitor Safety. Am J Clin Dermatol 23, 427–431 (2022).

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