Vasculitis & polymyalgia rheumatica
Four months of treatment with anakinra combined with glucocorticoids for giant cell arteritis: a multicenter, randomized, double-blind, placebo-controlled trial
- stopped prematurely (SARS-CoV-2 pandemic)
- Stopped prematurely given the emergence of the SARS-CoV-2 pandemic
Authors' conclusion
Although prematurely discontinued, this study does not support the use of 4 months of treatment with anakinra combined with GCs to reduce the risk of relapse or GC exposure.
Study context
- Population
- Patients with new giant cell arteritis (GCA) diagnoses, 5 centres
- Participants
- 30 patients5 centres
- Comparison
- Anakinra 100 mg SC daily to week 16 vs placebo, combined with glucocorticoid (GC)
- Anakinra (ANK)n = 17
- Placebo (PBO)n = 13reference
- Primary endpoint
- Relapse rates at W16, W26 and W52 and completion of GC tapering
- Follow-up
- W16
Methodological detailsphase 3, prospective, multicentre, double-blind, placebo-controlled
- Phase 3
- Prospective
- Multicentre
- Double-blind
- Placebo-controlled
Primary result
As reported in the abstract
Relapse rate · first 16 weeks
P = 0.63
Further findings
Relapse · week 26
P = 0.47
Relapse rate · W52
P = 1
Events
| Outcome | ANK | PBO | P value |
|---|---|---|---|
| GC discontinuation | 2 | 2 | P = 0.87 |
- Relapse: overall 12 (40%) relapsed
- Relapse rate: overall 50%
Safety
- Serious AEs — ANK
- 4 events
- Serious AEs — Seven serious AEs in five patients overall
- 7
Original publication
Four months of treatment with anakinra combined with glucocorticoids for giant cell arteritis: a multicenter, randomized, double-blind, placebo-controlled trial. Arthritis Res Ther. Published 7 June 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →