Identification of two tofacitinib subpopulations with different relative risk versus TNF inhibitors: an analysis of the open label, randomised controlled study ORAL Surveillance
An erratum to this article was published (Ann Rheum Dis, 15 Feb 2024 ↗)
Primary result · Malignancies (excl. non-melanoma skin cancer), MACE, MI, VTE and all-cause death: 'high-risk' subpopulation (age ≥65 years or ever smoker)Result — go to the resultHazard ratio 1.41-5.19Authors' conclusion
This posthoc analysis of ORAL Surveillance identified two tofacitinib subpopulations with different relative risk versus TNFi. High risk was confined to patients defined by distinct risk factors age ≥65 years or smoking, and these differentiating risk factors accounted for the excess risk observed with tofacitinib versus TNFi.
Study context
- Population
- Patients with RA aged ≥50 years with ≥1 additional cardiovascular risk factor
- Comparison
- Tofacitinib 5 or 10 mg twice daily (combined doses) vs TNFi, by age and smoking subpopulations
Methodological detailsopen label, post hoc, event-driven, subgroup analysis
- Open label
- Post hoc
- Event-driven
- Subgroup analysis
Primary result
As reported in the abstract
Malignancies (excl. non-melanoma skin cancer), MACE, MI, VTE and all-cause death: 'high-risk' subpopulation (age ≥65 years or ever smoker)
Hazard ratio
1.41-5.19
Original publication
Identification of two tofacitinib subpopulations with different relative risk versus TNF inhibitors: an analysis of the open label, randomised controlled study ORAL Surveillance. Ann Rheum Dis. Published 17 March 2023. doi:10.
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