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Risk minimization of JAK inhibitors in ulcerative colitis following regulatory guidance

Nature Reviews Gastroenterology & Hepatology volume 20, pages 129–130 (2023)Cite this article

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The European Medicines Agency safety committee has revisited the label and recommended the use of Janus kinase inhibitors in patients with certain risk factors only if no suitable treatment alternatives are available. Although regulatory decisions are key to place therapeutic options based on safety, broad restrictions might lead to unintended consequences without an individualized benefit–risk evaluation.

Since the approval of the first Janus kinase (JAK) inhibitor (tofacitinib) for use in rheumatoid arthritis in 2012, there has been some evidence to suggest that this class should be used with caution in patients at increased risk of major adverse cardiovascular events, venous thromboembolism, cancer and serious infections1 (Supplementary Fig. 1).

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Fig. 1: Risk minimization of JAK inhibitors in ulcerative colitis following regulatory guidance.

References

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Authors and Affiliations

  1. Gastroenterology and Gastrointestinal Endoscopy Unit, IRCCS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy

    Silvio Danese

  2. Department of Medicine, Division of Gastroenterology, Western University, London, Ontario, Canada

    Virginia Solitano & Vipul Jairath

  3. Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy

    Virginia Solitano

  4. Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada

    Vipul Jairath

  5. University Hospital of Nancy, University of Lorraine, Vandoeuvre-lès-Nancy, France

    Laurent Peyrin-Biroulet

  6. Groupe Hospitalier privé Ambroise Paré - Hartmann, Paris IBD center, Neuilly-sur-Seine, France

    Laurent Peyrin-Biroulet

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  1. Silvio Danese
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Correspondence to Silvio Danese.

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Competing interests

S.D. has served as a speaker, consultant and advisory board member for Schering-Plough, AbbVie, Actelion, Alphawasserman, AstraZeneca, Cellerix, Cosmo Pharmaceuticals, Ferring, Genentech, Grunenthal, Johnson and Johnson, Millenium Takeda, MSD, Nikkiso Europe GmbH, Novo Nordisk, Nycomed, Pfizer, Pharmacosmos, UCB Pharma and Vifor. V.J. has received consulting/advisory board fees from AbbVie, Alimentiv Inc, Arena pharmaceuticals, Asahi Kasei Pharma, Asieris, AstraZeneca, Bristol Myers Squibb, Celltrion, Eli Lilly, Ferring, Flagship Pioneering, Fresenius Kabi, Galapagos, GlaxoSmithKline, Genentech, Gilead, Janssen, Merck, Metacrine, Mylan, Pandion, Pendopharm, Pfizer, Protagonist, Prometheus, Reistone Biopharma, Roche, Sandoz, Second Genome, Sorriso pharmaceuticals, Takeda, Teva, Topivert, Ventyx and Vividion, and speaker’s fees from Abbvie, Ferring, Bristol Myers Squibb, Galapagos, Janssen Pfizer Shire, Takeda and Fresenius Kabi. L.P.-B. reports personal fees from Galapagos, AbbVie, Janssen, Genentech, Alimentiv, Ferring, Tillots, Celltrion, Takeda, Pfizer, Index Pharmaceuticals, Sandoz, Celgene, Biogen, Samsung Bioepis, Inotrem, Allergan, MSD, Roche, Arena, Gilead, Amgen, BMS, Vifor, Norgine, Mylan, Lilly, Fresenius Kabi, OSE Immunotherapeutics, Enthera, Theravance, Pandion Therapeutics, Gossamer Bio, Viatris, Thermo Fisher, ONO Pharma, Mopac, Cytoki Pharma, Morphic, Prometheus and Applied Molecular Transport. V.S. declares no competing interests.

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Danese, S., Solitano, V., Jairath, V. et al. Risk minimization of JAK inhibitors in ulcerative colitis following regulatory guidance. Nat Rev Gastroenterol Hepatol 20, 129–130 (2023). https://doi.org/10.1038/s41575-022-00722-7

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