Evaluation of discontinuation for adverse events of JAK inhibitors and bDMARDs in an international collaboration of rheumatoid arthritis registers (the 'JAK-pot' study)

Romain Aymon*, Denis Mongin, Sytske Anne Bergstra, Denis Choquette, Catalin Codreanu, Diederik De Cock, Lene Dreyer, Ori Elkayam, Doreen Huschek, Kimme L Hyrich, Florenzo Iannone, Nevsun Inanc, Lianne Kearsley-Fleet, Suleyman Serdar Koca, Tore K Kvien, Burkhard F Leeb, Galina Lukina, Dan C Nordström, Karel Pavelka, Manuel Pombo-SuarezAna Rodrigues, Ziga Rotar, Anja Strangfeld, Patrick Verschueren, Rasmus Westermann, Jakub Zavada, Delphine Sophie Courvoisier, Axel Finckh, Kim Lauper

*Corresponding author for this work

Research output: Contribution to journalJournal articleResearchpeer-review

1 Citation (Scopus)


BACKGROUND: In a clinical trial setting, patients with rheumatoid arthritis (RA) taking the Janus kinase inhibitor (JAKi) tofacitinib demonstrated higher adverse events rates compared with those taking the tumour necrosis factor inhibitors (TNFi) adalimumab or etanercept.

OBJECTIVE: Compare treatment discontinuations for adverse events (AEs) among second-line therapies in an international real-world RA population.

METHODS: Patients initiating JAKi, TNFi or a biological with another mode of action (OMA) from 17 registers participating in the 'JAK-pot' collaboration were included. The primary outcome was the rate of treatment discontinuation due to AEs. We used unadjusted and adjusted cause-specific Cox proportional hazard models to compare treatment discontinuations for AEs among treatment groups by class, but also evaluating separately the specific type of JAKi.

RESULTS: Of the 46 913 treatment courses included, 12 523 were JAKi (43% baricitinib, 40% tofacitinib, 15% upadacitinib, 2% filgotinib), 23 391 TNFi and 10 999 OMA. The adjusted cause-specific hazard rate of treatment discontinuation for AEs was similar for TNFi versus JAKi (1.00, 95% CI 0.92 to 1.10) and higher for OMA versus JAKi (1.11, 95% CI 1.01 to 1.23), lower with TNFi compared with tofacitinib (0.81, 95% CI 0.71 to 0.90), but higher for TNFi versus baricitinib (1.15, 95% CI 1.01 to 1.30) and lower for TNFi versus JAKi in patients 65 or older with at least one cardiovascular risk factor (0.79, 95% CI 0.65 to 0.97).

CONCLUSION: While JAKi overall were not associated with more treatment discontinuations for AEs, subgroup analyses suggest varying patterns with specific JAKi, such as tofacitinib, compared with TNFi. However, these observations should be interpreted cautiously, given the observational study design.

Original languageEnglish
JournalAnnals of the Rheumatic Diseases
Issue number4
Pages (from-to)421-428
Number of pages8
Publication statusPublished - Apr 2024

Bibliographical note

© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.


  • Antirheumatic Agents/therapeutic use
  • Arthritis, Rheumatoid/drug therapy
  • Azetidines
  • Humans
  • Janus Kinase Inhibitors/therapeutic use
  • Purines
  • Pyrazoles
  • Sulfonamides
  • Treatment Outcome
  • Tumor Necrosis Factor Inhibitors/therapeutic use
  • Tumor Necrosis Factor-alpha


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