Adverse cardiovascular events in rheumatoid arthritis patients treated with Janus Kinase (JAK) inhibitors: An analysis of postmarketing spontaneous safety reports
Authors' conclusion
In this global postmarketing study, JAK inhibitors are associated with increased reporting of VTE, stroke, IHD, and tachyarrhythmias.
Study context
- Population
- Rheumatoid arthritis (RA) patients in FDA adverse event reporting system (FAERS) safety reports, January 2015–June 2023FAERS safety reports
- Participants
- 75,407 vs 303,278
- Exposure
- JAK inhibitors vs biologic disease-modifying antirheumatic drugs (bDMARDs)
- JAK inhibitorsn = 75,407
- bDMARDsn = 303,278reference
- Outcome
- Disproportionate reporting of adverse cardiovascular events (adj.ROR)
Methodological detailsFAERS spontaneous reports, multivariable logistic regression, adjusted reporting odds ratio
- FAERS spontaneous reports
- Multivariable logistic regression
- Adjusted reporting odds ratio
Main finding
As reported in the abstract
Adverse cardiovascular event reporting, JAKi vs bDMARDs
- JAKi
- adj.ROR (venous thromboembolism (VTE), n = 1,393) 2.11 (CI 1.97–2.25)
- JAKi
- adj.ROR (stroke, n = 973) 1.25 (CI 1.16–1.34)
- JAKi
- adj.ROR (ischemic heart disease, n = 999) 1.23 (CI 1.13–1.33)
- JAKi
- adj.ROR (peripheral edema, n = 2699) 1.22 (CI 1.17–1.28)
- JAKi
- adj.ROR (tachyarrhythmias, n = 370) 1.15 (CI 1.00–1.33)
Observational data: associations, not effects.
Further findings
Comparison between JAK inhibitors
- VTE, stroke, and IHD more frequently reported with upadacitinib and baricitinib than tofacitinib
Age-stratified analysis
- All safety signals statistically significant in patients aged ≤65 years
Original publication
Adverse cardiovascular events in rheumatoid arthritis patients treated with JAK inhibitors: An analysis of postmarketing spontaneous safety reports. Semin Arthritis Rheum. Published 17 May 2024. doi:10.
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