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Risk minimization of JAK inhibitors in ulcerative colitis following regulatory guidance

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.

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


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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).

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