Vasculitis & polymyalgia rheumatica
Abatacept in early polymyalgia rheumatica (ALORS): a proof-of-concept, randomised, placebo-controlled, parallel-group trial
Primary result · Low disease activity (CRP PMR-AS ≤10) without GC or rescueResult — go to the resultRelative risk 2.2 CI 0.9–5.5Authors' conclusion
This study suggests that the effect of abatacept alone is not strong enough to justify larger studies in early polymyalgia rheumatica.
Study context
- Population
- Recent-onset (<6 months) PMR with C-reactive protein (CRP) polymyalgia rheumatica activity score (PMR-AS) >17 without signs or symptoms of GCA (clinical and PET-CT evaluation), five centres in France22 women and 12 men
- Participants
- 34 participants
- Comparison
- Weekly subcutaneous abatacept 125 mg vs matching placebo for 12 weeks
- Abataceptn = 16
- Placebon = 18reference
- Primary endpoint
- Low disease activity (CRP PMR-AS ≤10) without GC and without rescue treatment
- Follow-up
- Week 12
Methodological detailsproof-of-concept, double-blind, placebo-controlled, parallel-group, Powered to demonstrate a 60% difference in response rates between groups
- Proof-of-concept
- Double-blind
- Placebo-controlled
- Parallel-group
- Powered to demonstrate a 60% difference in response rates between groups
Primary result
As reported in the abstract
Low disease activity (CRP PMR-AS ≤10) without GC or rescue
Relative risk
2.2
CI 0.9–5.5
crude p=0.15
Events by treatment group
Abataceptvs Placebo
RR 2.2 (CI 0.9–5.5); crude p=0.15
Further findings
- No deaths or new safety concerns
Safety
Adverse events
Serious adverse events
Original publication
Abatacept in early polymyalgia rheumatica (ALORS): a proof-of-concept, randomised, placebo-controlled, parallel-group trial. Lancet Rheumatol. Published December 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →