Abatacept in individuals at high risk of rheumatoid arthritis (APIPPRA): a randomised, double-blind, multicentre, parallel, placebo-controlled, phase 2b clinical trial
Authors' conclusion
T-cell co-stimulation modulation with abatacept for 12 months reduces progression to rheumatoid arthritis, with evidence of sustained efficacy beyond the treatment period, and with no new safety signals.
Study context
- Population
- Adults (≥18 years) at risk of RA, positive for antibodies to citrullinated protein antigens (ACPA) and RF, with inflammatory joint pain; no previous clinical synovitis, GC or DMARD use; 28 early arthritis clinics in the UK and three in the Netherlands
- Participants
- 213 adults
- Comparison
- Abatacept 125 mg SC weekly for 12 months vs placebo, then 12 months follow-up
- Abataceptn = 110
- Placebon = 103reference
- Primary endpoint
- Time to clinical synovitis in ≥3 joints or RA (ACR/EULAR 2010 criteria), whichever first; synovitis confirmed by US
Methodological detailsdouble-blind, multicentre, parallel, placebo-controlled, phase 2b
- Double-blind
- Multicentre
- Parallel
- Placebo-controlled
- Phase 2b
Primary result
Met primary endpoint during treatment period
Difference in restricted mean survival time
53 days
95% CI 28–78
P < 0.0001
Events by treatment group
Abataceptvs Placebo
difference in restricted mean survival time 53 days (95% CI 28–78); P < 0.0001
As reported in the abstract
Further findings
| Outcome | Abatacept | Placebo | Difference in restricted mean survival time (days) (95% CI) | P value | |
|---|---|---|---|---|---|
| Progression to RA at 24 monthsIn favour of abatacept | 25% | 37% | 99 (38–161) | P = 0.0016 | |
| −1000100200Difference, days (linear scale) |
| Outcome | Abatacept | Placebo | P value |
|---|---|---|---|
| Arthritis-free at 12 months (estimated proportion) | 92.8% (SE 2.6) | 69.2% (SE 4.7) | |
| Progression to RA at 24 monthsFavoured abatacept | log-rank test p=0.044 | ||
| Deaths (deemed unrelated to treatment) | 1 events | 1 events |
Pain, functional wellbeing, quality of life, subclinical synovitis by US · treatment period
- Improved with abatacept vs placebo during treatment; not sustained at 24 months
Safety
Events
| Outcome | Abatacept | Placebo |
|---|---|---|
| Serious adverse events | 7 | 11 |
Original publication
Abatacept in individuals at high risk of rheumatoid arthritis (APIPPRA): a randomised, double-blind, multicentre, parallel, placebo-controlled, phase 2b clinical trial. Lancet. Published 13 February 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →