Malignancy risk with tofacitinib versus TNF inhibitors in rheumatoid arthritis: results from the open-label, randomised controlled ORAL Surveillance trial
Authors' conclusion
Risk of malignancies was increased with tofacitinib versus TNFi, and incidence was highest in patients with HxASCVD or increasing cardiovascular risk.
Study context
- Population
- Patients with rheumatoid arthritis (RA) aged ≥50 years with ≥1 additional cardiovascular risk factor
- Participants
- 4,362 patients
- Comparison
- Tofacitinib 5 or 10 mg twice daily vs TNFi
- Tofacitinib 5 mgn = 1,455
- Tofacitinib 10 mgn = 1,456
- TNFin = 1,451reference
- Primary endpoint
- Adjudicated malignancies excluding NMSC, NMSC and subtypes (IRs and HRs)
Methodological detailsopen-label, post hoc analyses
- Open-label
- Post hoc analyses
Primary result
As reported in the abstract
Malignancies excluding NMSC and NMSC
- Incidence rates (IRs) for malignancies excluding non-melanoma skin cancer (NMSC) and NMSC higher with tofacitinib (combined and individual doses) vs TNFi
- Lung cancer (most common subtype with tofacitinib) risk higher with tofacitinib 10 mg twice daily vs TNFi
Further findings
| Outcome | HR (95% CI) | P value | |
|---|---|---|---|
| Malignancies excluding NMSC, combined tofacitinib doses vs TNFi, by period · baseline to month 18; month 18 onwardsTofacitinib (combined doses)vs TNFiBaseline to month 18 | 0.93 (0.53–1.62) | interaction p=0.0469 | |
| Malignancies excluding NMSC, combined tofacitinib doses vs TNFi, by period · baseline to month 18; month 18 onwardsTofacitinib (combined doses)vs TNFiMonth 18 onwards | 1.93 (1.22–3.06) | interaction p=0.0469 | |
| 0.20.5125Hazard ratio (log scale) |
Interaction between treatment and baseline risk factors (post hoc Cox analyses)
- Interaction analyses generally did not show statistical evidence of interaction between treatment groups and risk factors
- Post hoc
Malignancy IRs by HxASCVD and cardiovascular risk scores
- HxASCVD or increasing cardiovascular risk scores associated with higher malignancy IRs across treatments
- Post hoc
Original publication
Malignancy risk with tofacitinib versus TNF inhibitors in rheumatoid arthritis: results from the open-label, randomised controlled ORAL Surveillance trial. Ann Rheum Dis. Published 5 December 2022. doi:10.
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