Vasculitis & polymyalgia rheumatica
1-year results of treatment with rituximab in polymyalgia rheumatica: an extension study of a randomised double-blind placebo-controlled trial
Authors' conclusion
After a single dose of rituximab (1000 mg), the proportion of patients with polymyalgia rheumatica in glucocorticoid-free remission remained stable at 1 year after infusion, and a glucocorticoid sparing effect was evident.
Study context
- Population
- Patients with PMR (2012 EULAR-ACR classification criteria), Sint Maartenskliniek, Nijmegen, Netherlands; 38 recently diagnosed, nine relapsing
- Participants
- 47 patients
- Comparison
- One intravenous dose of 1000 mg rituximab vs placebo, with accelerated GC tapering over 17 weeks, then standard-of-care to 1 year
- Rituximabn = 23
- Placebon = 24reference
- Primary endpoint
- Between-group difference in GC-free remission (PMR-AS <10), all randomly allocated participants, data imputed by predictive mean matching
- Follow-up
- 52 weeks
Methodological detailsdouble-blind, placebo-controlled, proof-of-concept, single-centre
- Double-blind
- Placebo-controlled
- Proof-of-concept
- Single-centre
Primary result
As reported in the abstract
GC-free remission (PMR-AS <10), imputed analysis
Each group vs placeboAbsolute difference in GC-free remission, % (95% CI)P value
Rituximab
31(5–57)
P = 0.04Each group vs placeboRR for GC-free remission (95% CI)P value
Rituximab
2.5(1.0–6.0)
P = 0.04Further findings
| Outcome | Rituximab | Placebo | Absolute difference in GC-free remission (%) (95% CI) | P value | |
|---|---|---|---|---|---|
| GC-free remission, complete case sensitivity analysis · up to 1 year after infusionComplete case analysis | 47% | 23% | 25 (−4 to 53) | P = 0.12 | |
| −50050100Difference, % (linear scale) |
| Outcome | RR for GC-free remission (95% CI) | P value | |
|---|---|---|---|
| GC-free remission, complete case sensitivity analysis · up to 1 year after infusionComplete case analysis | 2.1 (0.8–5.2) | P = 0.12 | |
| 0.20.5125RR for GC-free remission (log scale) |
Safety
Adverse events
Original publication
1-year results of treatment with rituximab in polymyalgia rheumatica: an extension study of a randomised double-blind placebo-controlled trial. Lancet Rheumatol. Published 6 March 2023. doi:10.
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