Risk of major adverse cardiovascular events with tofacitinib versus tumour necrosis factor inhibitors in patients with rheumatoid arthritis with or without a history of atherosclerotic cardiovascular disease: a post hoc analysis from ORAL Surveillance
Primary result · MACE in patients with history of ASCVDResult — go to the resultHazard ratio 1.98 95% CI 0.95–4.14Authors' conclusion
This post hoc analysis observed higher MACE risk with tofacitinib versus TNFi in patients with RA and history of ASCVD. Among patients without history of ASCVD, all with prevalent CV risk factors, MACE risk did not appear different with tofacitinib 5 mg two times per day versus TNFi.
Study context
- Population
- Patients with rheumatoid arthritis (RA) aged ≥50 years with ≥1 additional CV risk factor, with or without a history of atherosclerotic CVD (atherosclerotic cardiovascular disease (ASCVD))640 with history of ASCVD
- Participants
- 4,362 patients
- Comparison
- Tofacitinib 5 mg or 10 mg twice daily vs TNFi, by history of ASCVD
- Primary endpoint
- MACE, by history of ASCVD
Methodological detailsexploratory analysis
- Exploratory analysis
Primary result
MACE in patients with history of ASCVD
Hazard ratio
1.98
95% CI 0.95–4.14
interaction p values: 0.196 (for HR)/0.059 (for incidence rate difference)
Events by treatment group
Combined tofacitinib dosesvs TNFi
HR 1.98 (95% CI 0.95–4.14); interaction p values: 0.196 (for HR)/0.059 (for incidence rate difference)
As reported in the abstract
Further findings
| Outcome | Tofacitinib 5 mg | Tofacitinib 10 mg | TNFi | HR (CI) | |
|---|---|---|---|---|---|
| MACE in patients without history of ASCVDTofacitinib 5 mgvs TNFi | 2.4% · 30 of 1251 | 2.8% · 34 of 1234 | 2.3% · 28 of 1237 | 1.03 (0.62–1.73) | |
| MACE in patients without history of ASCVDTofacitinib 10 mgvs TNFi | 1.25 (0.76–2.07) | ||||
| 0.512Hazard ratio (log scale) |
Major adverse cardiovascular events (MACE), MI and sudden cardiac death, overall ORAL Surveillance population
- Risk increased with tofacitinib vs TNFi
Original publication
Risk of major adverse cardiovascular events with tofacitinib versus tumour necrosis factor inhibitors in patients with rheumatoid arthritis with or without a history of atherosclerotic cardiovascular disease: a post hoc analysis from ORAL Surveillance. Ann Rheum Dis. Published 22 September 2022. doi:10.
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