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Oral surveillance and JAK inhibitor safety: the theory of relativity

Nature Reviews Rheumatology volume 18, pages 301–304 (2022)Cite this article

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Abstract

The published results of the post-marketing ORAL Surveillance study, which compared the Janus kinase (JAK) inhibitor tofacitinib with anti-TNF therapy in older patients with rheumatoid arthritis who have cardiovascular risk factors, have led to changes in the recommendations for the use of JAK inhibitors. Although new safety signals have emerged for tofacitinib, namely malignancy and cardiovascular disease, it should be noted that these signals are relative to those seen with TNF blockers. The new data further raise our intrigue that venous thromboembolism might be a true risk related to JAK inhibition. Reassuringly, the totality of the findings from this newly published study and the other data collected to date suggest that JAK inhibitors can be used safely at approved doses by many patients with rheumatoid arthritis.

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Fig. 1: Timeline of approved indications for Janus kinase inhibitors for rheumatic diseases.

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Authors and Affiliations

  1. Division of Infectious Diseases, Schools of Medicine and Public Health, Oregon Health and Sciences University, Portland, OR, USA

    Kevin L. Winthrop

  2. Division of Rheumatology, Presbyterian Hospital, Dallas, TX, USA

    Stanley B. Cohen

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  1. Kevin L. Winthrop
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  2. Stanley B. Cohen
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The authors contributed equally to all aspects of the article.

Corresponding author

Correspondence to Kevin L. Winthrop.

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Competing interests

K.L.W. declares that he has acted as a consultant for AbbVie, Union AstraZeneca, Bristol Myers Squibb (BMS), Chimique Belge (UCB), Eli Lilly & Company, Galapagos, Gilead, GlaxoSmithKline, Novartis, Pfizer, Regeneron, Roche and Sanofi, and has received research funding from Bristol Myers Squibb and Pfizer. S.B.C. declares that he has acted as a consultant for and received research funding from AbbVie, Amgen, Gilead, Lilly and Pfizer.

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Nature Reviews Rheumatology thanks the anonymous reviewers for their contribution to the peer review of this work.

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Winthrop, K.L., Cohen, S.B. Oral surveillance and JAK inhibitor safety: the theory of relativity. Nat Rev Rheumatol 18, 301–304 (2022). https://doi.org/10.1038/s41584-022-00767-7

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