Towards the Lowest Efficacious Dose: Results From a Multicenter Noninferiority Randomized Open‐Label Controlled Trial Assessing Tocilizumab or Abatacept Injection Spacing in Rheumatoid Arthritis in Remission
Authors' conclusion
The Towards the Lowest Efficacious Dose trial failed to demonstrate NI for the proposed ABA or TCZ tapering strategy.
Study context
- Population
- Patients with established RA in sustained remission receiving ABA or tocilizumab (TCZ) at a stable dose202 per protocol
- Participants
- 233 patients
- Comparison
- Progressive TCZ or ABA injection spacing vs maintenance at full dose
- S-armn = 90
- M-armn = 112reference
- Primary endpoint
- Evolution of disease activity by Disease Activity Score in 44 joints, linear mixed-effects model, NI test on slope difference (NI margin 0.25)
- Follow-up
- 2-year follow-up
Methodological detailsmulticentre, open-label, non-inferiority
- Multicentre
- Open-label
- Non-inferiority
Primary result
As reported in the abstract
Disease activity (Disease Activity Score in 44 joints) evolution, slope difference · 2 years
Slope difference
0.10
95% CI 0.10–0.31
Further findings
Flare incidence
- Difference (95% CI 30.0-55.1); Noninferiority (NI) not demonstrated
- 42.6%
- Per protocol
Rate of structural damage progression · two years
- Difference (95% CI −6.7 to 34.4); NI not demonstrated
- 13.9%
- Per protocol
Original publication
Towards the Lowest Efficacious Dose: Results From a Multicenter Noninferiority Randomized Open‐Label Controlled Trial Assessing Tocilizumab or Abatacept Injection Spacing in Rheumatoid Arthritis in Remission. Arthritis Rheumatol. Published 25 January 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →