Vasculitis & polymyalgia rheumatica
A phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis
- discontinued prematurely
- Discontinued prematurely due to protracted recruitment timelines (impact of COVID-19); 83 of planned 360 randomized
Authors' conclusion
Owing to the small sample size due to the early termination, it is difficult to draw clear conclusions from this study. There were no unexpected safety findings.
Study context
- Population
- Patients with giant cell arteritis (GCA)36 in week 52 analysis
- Participants
- 83 patients
- Comparison
- Sarilumab 200 mg or 150 mg with 26-week GC taper vs placebo with 52-week or 26-week GC taper
- Primary endpoint
- Sustained remission (SR)
- Follow-up
- Week 52
Methodological detailsPhase 3, double-blind, placebo-controlled, descriptive statistics only
- Phase 3
- Double-blind
- Placebo-controlled
- Descriptive statistics only
Primary result
As reported in the abstract
Sustained remission
SAR200 + 26W
46%
6/13 events
SAR150 + 26W
43%
3/7 events
PBO + 52W
30%
3/10 events
PBO + 26W
0
0/6 events
Further findings
| Outcome | PBO + 52W | PBO + 26W |
|---|---|---|
| SR at week 52, sensitivity analysis excluding acute-phase reactants | 60% | 17% |
| Adherence to GC taper · week 12 through week 52 | 60% | 33% |
Sustained remission (SR) at week 52, sensitivity analysis excluding acute-phase reactants
- Similar results for SAR groups
SR at week 24
- Similar findings to week 52
Median actual cumulative GC dose
- Lower in SAR200 + 26W than other groups
Safety
Treatment-emergent adverse events
- Most patients experienced TEAEs, similar incidences across groups
- 80-100%
Original publication
A phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis. Arthritis Res Ther. Published 16 October 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →