Vasculitis & polymyalgia rheumatica
Sarilumab for Relapse of Polymyalgia Rheumatica during Glucocorticoid Taper
Primary result · Sustained remissionResult — go to the resultDifference 18 percentage points 95% CI 4–32Authors' conclusion
Sarilumab showed significant efficacy in achieving sustained remission and reducing the cumulative glucocorticoid dose in patients with a relapse of polymyalgia rheumatica during glucocorticoid tapering.
Study context
- Population
- Patients with a relapse of PMR during GC tapering
- Participants
- 118 patients
- Comparison
- Sarilumab 200 mg SC twice monthly plus 14-week prednisone taper vs placebo plus 52-week prednisone taper
- Sarilumabn = 60
- Placebon = 58reference
- Primary endpoint
- Sustained remission: resolution of PMR signs and symptoms by week 12 and sustained normalisation of CRP, absence of disease flare, and adherence to the prednisone taper from weeks 12 through 52
- Follow-up
- 52 weeks
Methodological detailsphase 3, placebo-controlled, 1:1 randomisation
- Phase 3
- Placebo-controlled
- 1:1 randomisation
Primary result
Sustained remission · week 52
Difference
18 percentage points
95% CI 4–32
P = 0.02
Events by treatment group
Sarilumabvs Placebo
difference 18 percentage points (95% CI 4–32); P = 0.02
As reported in the abstract
Further findings
Cumulative GC dose · 52 weeks · significantly lower with sarilumab
P < 0.001
Safety
Neutropenia
Arthralgia
Diarrhoea
Treatment-related discontinuations
Original publication
Sarilumab for Relapse of Polymyalgia Rheumatica during Glucocorticoid Taper. N Engl J Med. Published 5 October 2023. doi:10.
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