Abatacept inhibits inflammation and onset of rheumatoid arthritis in individuals at high risk (ARIAA): a randomised, international, multicentre, double-blind, placebo-controlled trial
Primary result · Improvement in MRI subclinical inflammationResult — go to the resultAbsolute difference 26.5 % 95% CI 5.9–45.6Authors' conclusion
6-month treatment with abatacept decreases MRI inflammation, clinical symptoms, and risk of rheumatoid arthritis development in participants at high risk.
Study context
- Population
- Adults (≥18 years) with ACPA positivity, joint pain (no swelling) and osteitis, synovitis or tenosynovitis on hand MRI; 14 hospitals and community centres in Europe98 in modified ITT
- Participants
- 100 adults
- Comparison
- Weekly subcutaneous abatacept 125 mg vs placebo for 6 months, then 12-month double-blind drug-free observation
- Abataceptn = 50
- Placebon = 50reference
- Primary endpoint
- Proportion of participants with any reduction in inflammatory MRI lesions
- Follow-up
- 6 months
Methodological detailsinternational, multicentre, double-blind, placebo-controlled
- International
- Multicentre
- Double-blind
- Placebo-controlled
Primary result
Improvement in MRI subclinical inflammation
Absolute difference
26.5 %
95% CI 5.9–45.6
P = 0.014
Events by treatment group
Abataceptvs Placebo
absolute difference 26.5 % (95% CI 5.9–45.6); P = 0.014
As reported in the abstract
Further findings
| Outcome | Abatacept | Placebo | HR (CI) | P value | |
|---|---|---|---|---|---|
| Development of RA · 6 months | 8% | 35% | 0.14 (0.04–0.47) | P = 0.0016 | |
| Progression to RA · 18 months (12 months after end of intervention) | 35% | 57% | 0.14 (0.04–0.47) | P = 0.018 | |
| 0.050.21520Hazard ratio (log scale) |
Improvement of MRI inflammation · 18 months (12 months after end of intervention)
P = 0.012
Deaths
- No deaths occurred during the study
Safety
Serious adverse events (12 events in 11 participants)
- Serious adverse events (12 events in 11 participants): abatacept n=48, placebo n=49 in safety analysis
Original publication
Abatacept inhibits inflammation and onset of rheumatoid arthritis in individuals at high risk (ARIAA): a randomised, international, multicentre, double-blind, placebo-controlled trial. Lancet. Published 13 February 2024. doi:10.
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