Safety of Janus kinase inhibitors in immune-mediated inflammatory diseases - a systematic literature review informing the 2024 update of an international expert consensus statement
- PMID: 39934016
- DOI: 10.1016/j.ard.2025.01.024
Safety of Janus kinase inhibitors in immune-mediated inflammatory diseases - a systematic literature review informing the 2024 update of an international expert consensus statement
Abstract
Objectives: This systematic literature review (SLR) on safety outcomes was performed to inform the 2024 update of the expert consensus statement on the treatment of immune-mediated inflammatory diseases (IMIDs) with Janus kinase inhibitors (JAKi).
Methods: An update of the 2019 SLR was performed in MEDLINE, Embase, and the Cochrane Library. For safety, randomised, placebo-controlled or active-controlled trials on all JAKi investigated in IMIDs, long-term extension (LTE) studies, pooled trial data analyses, and cohort and claims studies were included.
Results: We screened 13,905 records, of which 209 were finally included. Three safety trials and 13 post hoc analyses, 83 efficacy randomised controlled trials (RCTs) with adequate safety reporting, 56 integrated safety analyses and LTE of RCTs, 20 additional conference abstracts on RCT data, as well as 37 real-world cohort studies were presented to the task force. Safety profiles of JAKi were overall consistent across compounds and indications, but impacts of patient profiles, treatment dosing, and other cofactors like background medications on drug safety could be observed. Furthermore, differential effects of variously selective JAKi on distinct adverse events of special interest (AESI) and laboratory outcomes were discerned.
Conclusion: A substantial amount of literature was published on JAKi safety since 2019. A comprehensive overview of these data supports the optimal use of JAKi in patients with IMIDs, by consideration and balance of their benefits as well as risks in every patient.
Copyright © 2025 The Author(s). Published by Elsevier B.V. All rights reserved.
Conflict of interest statement
Competing interests VK received speaker fees from Eli Lilly and AstraZeneca. JSS received grants from AbbVie, AstraZeneca, Eli Lilly, and Galapagos and speaker or consultancy fees from AbbVie, Amgen, Anada, Astro Pharma, BMS, Celltrion, Chugai, Eli Lilly, Gilead, Immunovant, MSD, Novartis, Pfizer, Roche, R-Pharma, Samsung, Sanofi, and UCB. PN received grants from AbbVie, BMS, Pfizer, Novartis, Eli Lilly, UCB, and Janssen and speaker or consultancy fees from Eli Lilly, Novartis, AbbVie, Pfizer, BMS, Novartis, Janssen, and UCB. DA received grants from Eli Lilly and Galapagos and speaker or consultancy fees from AbbVie, Gilead, J&J, Eli Lilly, MSD, Novartis, and Sandoz. KW received grants from BMS and Pfizer and speaker or consultancy fees from BMS, Pfizer, AbbVie, Union Chimique Belge (UCB), Eli Lilly & Company, Galapagos, GlaxoSmithKline (GSK), Roche, Gilead, Regeneron, Sanofi, AstraZeneca, Novartis, and Moderna. TD received grants from BMS, Eli Lilly, and J&J and speaker or consultancy fees from BMS, Eli Lilly, J&J, Pfizer, Novartis, Roche/GNE, and Remegen. RF received grants from AbbVie, BMS, Galvani, GSK, Gilead, Janssen, Eli Lilly, Novartis, Pfizer, and UCB and consultancy fees from AbbVie, Almirall, Artiva, Biotherapeutics, Atomwise, Biohaven, Pharmaceuticals, BMS, Cyoxone, Deep Cure, Dren Bio, Galvani, Gates Bio, Gilead, GSK, Halia, Immunovant, ImmuneMed, InventisBio, Istesso, Janssen, Janux, Eli Lilly, Monte Rosa, Novartis, Overland, Pfizer, Spyre, Synact, Teijin Pharma, TPG, UCB, Vyne, and Xencor. YT received grants from Mitsubishi Tanabe, Eisai, Chugai, and Taisho and speaker or consultancy fees from Eli Lilly, AstraZeneca, AbbVie, Gilead Sciences, Chugai, Boehringer Ingelheim, GlaxoSmithKline, Eisai, Taisho, BMS, and Pfizer. XB received speaker or consultancy fees from AbbVie, Alphasigma, Amgen, BMC, Cesas, Celltrion, Galapagos, Janssen, Eli Lilly, Moonlake, Novartis, Pfizer, Roche, Sandoz, Springer, Stada, Takeda, UCB, and Zuellig. IBM received grants from AbbVie, Amgen, BMS, Causeway Therapeutics, Cabaletta, Dextera, Eli Lilly, Gilead, Janssen, Novartis, Montai, Pfizer, Sanofi Regeneron, UCB, Compugen, AstraZeneca, and Moonlake and speaker or consultancy fees from AbbVie, Amgen, BMS, Causeway Therapeutics, Cabaletta, Dextera, Eli Lilly, Gilead, Janssen, Novartis, Montai, Pfizer, Sanofi Regeneron, UCB Pharma, Compugen, AstraZeneca, and Moonlake. MT received grants from Albireo, Alnylam, Cymabay, Falk Pharma, Genentech, Gilead, Intercept, MSC, Takeda, and UltraGenyx and speaker or consultancy fees from AbbVie, Agomab, Albireo, BiomX, Boehringer Ingelheim, Chemomab, Cymabay, Falk, Gilead, Genit, Hightide, Intercept, Ipsen, Janssen, LoopLab, Mirum, MSD, Novartis, Phenex, Pliant, Rectify, Regulus, Shire, and Siemens. NS received grants from AstraZeneca, Boehringer Ingelheim, Novartis, and Roche Diagnostics and speaker or consultancy fees from Abbott Laboratories, AbbVie, Amgen, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Hanmi Pharmaceuticals, Janssen, Menarini-Ricerche, Novartis, Novo Nordish, Pfizer, Roche Diagnostics, and Sanofi. MdW received speaker fees from Evidera, UCB, Zürich Hospital, and the REMEDI Consortium. AK received speaker or consultancy fees from AbbVie, Eli Lilly, Gilead, Janssen, UCB, Galapagos, MSD, Novartis, and Pfizer. JP and JWS have nothing to declare.
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