SAPHYR
Trial question
What is the effect of sarilumab in patients with relapsing polymyalgia rheumatica during corticosteroid tapering?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
69.0% female
31.0% male
N = 118
118 patients (82 female, 36 male).
Inclusion criteria: adult patients, aged ≥ 50 years, with relapsing polymyalgia rheumatica during corticosteroid tapering.
Key exclusion criteria: giant cell arteritis; active fibromyalgia; concurrent rheumatoid arthritis or other inflammatory arthritis or other connective tissue diseases; concurrent diagnosis of rhabdomyolysis or neuropathic muscular diseases; inadequately treated hypothyroidism; organ transplant recipient; therapeutic failure; prior or concurrent use of immunosuppressive therapies.
Interventions
N=60 sarilumab (subcutaneous dose of 200 mg once every 2 weeks with a 14-week corticosteroid taper).
N=58 placebo (subcutaneous matching placebo with a 52-week corticosteroid taper).
Primary outcome
Sustained remission at week 52
28%
10%
28.0 %
21.0 %
14.0 %
7.0 %
0.0 %
Sarilumab
Placebo
Significant
increase ▲
NNT = 5
Significant increase in sustained remission at week 52 (28% vs. 10%; AD 18%, 95% CI 4 to 32).
Secondary outcomes
Significant decrease in median cumulative glucocorticoid dose by week 52 (777 mg vs. 2044 mg; MD -1267, 95% CI -2018.78 to -515.22).
Safety outcomes
No significant difference in adverse events leading to permanent treatment discontinuation.
Significant difference in neutropenia (15% vs. 0%).
Conclusion
In adult patients, aged ≥ 50 years, with relapsing polymyalgia rheumatica during corticosteroid tapering, sarilumab was superior to placebo with respect to sustained remission at week 52.
Reference
Robert F Spiera, Sebastian Unizony, Kenneth J Warrington et al. Sarilumab for Relapse of Polymyalgia Rheumatica during Glucocorticoid Taper. N Engl J Med. 2023 Oct 5;389(14):1263-1272.
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