Risk of extended major adverse cardiovascular event endpoints with tofacitinib versus TNF inhibitors in patients with rheumatoid arthritis: a post hoc analysis of a phase 3b/4 randomised safety study
Authors' conclusion
In ORAL Surveillance, risk of composite CV endpoints combining all ischaemic CV events and HF did not appear different with tofacitinib versus TNFi. The totality of CV risk was higher with tofacitinib 10 mg two times per day versus TNFi, driven by an increase in VTE.
Study context
- Population
- Patients with rheumatoid arthritis (RA) aged ≥50 years with ≥1 additional cardiovascular (CV) risk factor
- Comparison
- Tofacitinib 5 mg or 10 mg two times per day vs TNFi
- Primary endpoint
- Extended MACE composite:
- Outcomes (MACE-4 to MACE-8 and MACE-8 plus venous thromboembolism (VTE))
- Component events
Primary result
As reported in the abstract
Extended MACE composites
Each group vs TNFiHazard ratio (CI)
Tofacitinib 5 mg
1.12(0.82–1.52)
Tofacitinib 10 mg
1.38(1.02–1.85)
Further findings
Individual CV events
- Risk of myocardial infarction (MI) higher with tofacitinib vs TNFi; difference in risk of other individual CV events not suggested
Extended MACE in atherosclerotic CVD or age ≥65 years (subgroups)
- Risk appeared higher with tofacitinib vs TNFi across extended MACE definitions
Original publication
Risk of extended major adverse cardiovascular event endpoints with tofacitinib versus TNF inhibitors in patients with rheumatoid arthritis: a post hoc analysis of a phase 3b/4 randomised safety study. RMD Open. Published 12 April 2024. doi:10.
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