Vasculitis & polymyalgia rheumatica
Sarilumab in relapsing polymyalgia rheumatica: patient-reported outcomes from a phase 3, double-blind, randomised controlled trial
Authors' conclusion
The use of sarilumab 200 mg once every 2 weeks with a 14-week glucocorticoid taper led to clinically important improvements in health-related quality of life and patient-reported outcomes versus placebo with a 52-week glucocorticoid taper.
Study context
- Population
- Adults ≥50 years with relapsing PMR (flare during GC taper within 12 weeks before screening, ≥8 weeks of GC treatment, ESR >30 mm/h or CRP ≥10 mg/L), 60 centres in 17 countries117 received treatment
- Participants
- 118 adults
- Comparison
- Sarilumab 200 mg SC every 2 weeks with 14-week GC taper vs placebo with 52-week GC taper
- Sarilumabn = 60
- Placebon = 58reference
- Primary endpoint
- Patient-reported outcomes (Health Assessment Questionnaire Disability Index (HAQ-DI), Patient Global Assessment Visual Analog Scale (VAS), Pain VAS, SF-36 v2, EQ-5D, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)) as changes from baseline
- Follow-up
- Week 52
Methodological detailspatient-reported outcomes, double-blind, multicentre (60 centres, 17 countries), post-hoc analyses (MCID, normative values), nominal p values
- Patient-reported outcomes
- Double-blind
- Multicentre (60 centres, 17 countries)
- Post-hoc analyses (MCID, normative values)
- Nominal p values
Primary result
As reported in the abstract
SF-36 Physical Component Summary (PCS), LSM change from baseline
Sarilumab
7.65
LSM change
Placebo
2.87
LSM change
P = 0.020
Further findings
| Outcome | OR (95% CI) | P value | |
|---|---|---|---|
| Improvement ≥MCID in SF-36 PCS (post hoc)Post-hoc analysis | 3.46 (1.16–10.62) | P = 0.020 | |
| 0.050.21520Odds ratio (log scale) |
LSM change
| Outcome | Sarilumab | Placebo | P value |
|---|---|---|---|
| SF-36 MCS, LSM change · week 52 | 3.04 | −1.71 | P = 0.030 |
| EQ-5D utility index, LSM change · week 52 | 0.11 | −0.02 | P = 0.034 |
| EQ-5D VAS, LSM change · week 52 | 8.37 | −0.46 | P = 0.084 |
| FACIT-F, LSM change · week 52 | 7.91 | 4.17 | P = 0.060 |
| HAQ-DI, LSM change · week 52 | −0.39 | −0.15 | P = 0.054 |
| Pain VAS, LSM change · week 52 | −20.57 | −12.04 | P = 0.20 |
| Patient Global Assessment VAS, LSM change · week 52 | −15.01 | −6.08 | P = 0.13 |
Scores ≥ normative values (post hoc)
- >50% of sarilumab patients reached normative values for SF-36 Mental Component Summary (MCS) and four domains; not the case for any domain with placebo
- Post-hoc analysis
Original publication
Sarilumab in relapsing polymyalgia rheumatica: patient-reported outcomes from a phase 3, double-blind, randomised controlled trial. Lancet Rheumatol. Published 19 June 2025. doi:10.
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