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Antirheumatic agents

Tofacitinib Use Linked to Increased Risk of Venous Thromboembolism in Patients with Rheumatoid Arthritis

Strategic Insights

— 2 min read

Researchers at Fujian Medical University have conducted a study to assess the association between tofacitinib use and the risk of venous thromboembolism (VTE) events in patients with rheumatoid arthritis (RA). The study, published in Naunyn-Schmiedeberg's Archives of Pharmacology, found that tofacitinib was associated with a significantly elevated risk of VTE compared to tumor necrosis factor inhibitors (TNFi) and the overall FAERS database.

The study analyzed data from the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) from the first quarter of 2012 to the fourth quarter of 2024, identifying 1,786,456 adverse event reports related to RA. Among these, 635 VTE events were associated with tofacitinib use and 1,354 VTE events were associated with TNFi agents. The results showed that tofacitinib was associated with a higher reporting risk of VTE events compared to TNFi in RA patients, with a notable increase in the risk of pulmonary embolism (PE) (ROR 1.90, 95% CI 1.69-2.12) and deep vein thrombosis (DVT) (ROR 1.36, 95% CI 1.16-1.59).

Key Takeaways:

  • Tofacitinib, a Janus kinase (JAK) inhibitor, was associated with a significantly elevated risk of venous thromboembolism (VTE) compared to tumor necrosis factor inhibitors (TNFi) and the overall FAERS database.
  • The study analyzed data from the FDA Adverse Event Reporting System (FAERS) from the first quarter of 2012 to the fourth quarter of 2024, identifying 1,786,456 adverse event reports related to RA.
  • The results showed that tofacitinib was associated with a higher reporting risk of VTE events compared to TNFi in RA patients, with a notable increase in the risk of pulmonary embolism (PE) and deep vein thrombosis (DVT).
  • Subgroup analysis revealed that the increased risk was particularly notable for PE (ROR 1.90, 95% CI 1.69-2.12) and DVT (ROR 1.36, 95% CI 1.16-1.59).
  • The study underscores the need for careful patient selection and risk assessment when prescribing tofacitinib.
  • Further prospective studies are warranted to confirm these associations and explore the underlying mechanisms.

Statistics:

  • 1,786,456 adverse event reports related to RA were identified in the study.
  • 635 VTE events were associated with tofacitinib use.
  • 1,354 VTE events were associated with TNFi agents.
  • The reporting odds ratio (ROR) for VTE associated with tofacitinib was 1.56 (95% CI 1.43-1.70) compared to the overall FAERS database.
  • The ROR for VTE associated with tofacitinib compared to TNFi was 2.20 (95% CI 2.00-2.40).
  • The increased risk of VTE was particularly notable for PE (ROR 1.90, 95% CI 1.69-2.12) and DVT (ROR 1.36, 95% CI 1.16-1.59).

Sources:

  • Fujian Medical University
  • Naunyn-Schmiedeberg's Archives of Pharmacology
  • Springer
  • U.S. Food and Drug Administration (FDA)
  • Adverse Event Reporting System (FAERS)

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