Tocilizumab vs prednisone in established rheumatoid arthritis patients (TOPIRA): an investigator-initiated randomized clinical trial
Primary result · CDAI averaged over months 6-12 (square root scale)Result — go to the resultMean difference on square root scale −0.64 95% CI −1.18 to −0.09Authors' conclusion
TCZ led to greater improvement in disease activity than prednisone. There was no significant difference in joint damage progression over 12 months and there were no major differences in adverse events.
Study context
- Population
- Patients with established rheumatoid arthritis (RA) with an insufficient response to csDMARDsITT population
- Participants
- 65 patients
- Comparison
- Weekly SC tocilizumab 162 mg vs prednisone 10 mg daily, both added to stable csDMARD therapy, for 12 months
- Primary endpoint
- Clinical Disease Activity Index (CDAI) averaged over months 6-12
- Follow-up
- Months 6-12
Methodological detailsinvestigator-initiated, open-label, treat-to-target strategy, switch to alternative arm if inadequate response at 3 months
- Investigator-initiated
- Open-label
- Treat-to-target strategy
- Switch to alternative arm if inadequate response at 3 months
Primary result
As reported in the abstract
CDAI averaged over months 6-12 (square root scale)
Mean difference on square root scale
−0.64
95% CI −1.18 to −0.09
TCZvs Prednisone
mean difference on square root scale −0.64 (95% CI −1.18 to −0.09)
Secondary outcomes
Treatment switched
- Radiographic progression · no significant difference
- P = 0.376
Safety
| Outcome | P value |
|---|---|
| Toxicity: GTINo significant difference | P = 0.922 |
| TCZ-related adverse eventsNo significant difference | P = 1.00 |
Original publication
Tocilizumab vs prednisone in established rheumatoid arthritis patients (TOPIRA): an investigator-initiated randomized clinical trial. Rheumatology (Oxford). Published 9 November 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →