ArticleDrug safety2025
Major Adverse Cardiovascular Events Related to JAK Inhibitors: A Disproportionality Analysis Using the WHO Global Individual Case Safety Database.
Article in Drug safety, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 6 papers, 1 of them a synthesis that pooled it.
What it found
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
6 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Ocular disorders during treatment with GLP-1 receptor agonists: a systematic review and meta-analysis of observational studies.Frontiers in pharmacology · 2026Pooled it
- Disruption of metabolic licensing by JAK inhibitors constrains CD8 T cell activation and effector function.Cell death & disease · 2026Article
- Infectious retinitis associated with JAK inhibitors: the ongoing duality of JAK inhibitors.International journal of retina and vitreous · 2026Article
- JAK Inhibitors and Memory Impairment: Disproportionality Analyses in the WHO Global Pharmacovigilance Database, VigiBase.Fundamental & clinical pharmacology · 2026Article
- Disruption of metabolic licensing by JAK inhibitors constrains CD8 T cell activation and effector function.Research square · 2025Article
- Post-marketing surveillance of upadacitinib: multilevel analysis of venous thromboembolism reporting in global data and rheumatoid arthritis.Frontiers in medicine · 2025Article
Corrections and comments
- Erratum issued
- Erratum issued
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundRheumatoid arthritis (RA) is commonly treated with Janus kinase inhibitors (JAKis) and anti-tumor necrosis factor-α (anti-TNFα), but the cardiovascular safety profiles of these drugs remain unclear.
objectiveThe aim of this study was to describe the individual case safety reports of major adverse cardiac events (MACE) or stroke and to determine whether there was a difference in the frequency of reporting of cardiovascular events between JAKis and anti-TNFα used in RA.
methodsA case/non-case study was conducted using the WHO VigiBase
resultsA total of 18,099 cases of MACE were identified, of which 2543 (14%) were associated with JAKis, predominantly in women (65.4%) and in patients aged ≥65 years (49.9%). The median time to onset was 210 days (IQR 60-510) for JAKis and 690 days (210-1460) for anti-TNFα. JAKis were associated with higher odds of reporting MACE (ROR 1.38 [95% CI 1.32-1.44]), mainly due to non-fatal stroke (1.65 [1.55-1.75]). Stroke as a whole showed similar results (1.62 [1.53-1.72]). The ROR of MACE was also slightly increased in patients aged <65 years treated with JAKis (1.29 [1.21-1.39]).
conclusionsCompared with anti-TNFα, JAKis were more associated with MACE, especially stroke, and with a shorter time to onset. These data support the hypothesis of a different cardiovascular reporting frequency between JAKis and anti-TNFα. In patients with identified cardiovascular risk, anti-TNFα should be preferred to JAKis until more definitive results are available.
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