A recent study published in The Lancet Rheumatology demonstrated that sarilumab led to clinically meaningful improvements in health-related quality of life, supporting its use in patients with polymyalgia rheumatica inadequately managed with glucocorticoid monotherapy.
This phase 3, double-blind, randomised controlled trial was conducted across 60 centres in 17 countries and enrolled 118 patients aged 50 years or older who had experienced at least one disease flare during glucocorticoid tapering within the previous 12 weeks. Participants were randomly assigned to receive either subcutaneous sarilumab 200 mg every two weeks with a 14-week glucocorticoid taper or placebo with a 52-week taper. Patient-reported outcomes were assessed up to week 52 using validated instruments, including the SF-36, EQ-5D, HAQ-DI, Pain VAS, and FACIT-F.
At week 52, patients in the sarilumab group demonstrated significantly greater improvements than those in the placebo group in the SF-36 Physical Component Summary (7.65 vs 2.87, p=0.020) and Mental Component Summary scores (3.04 vs –1.71, p=0.030), as well as in five of the eight SF-36 domains. Improvements also favoured sarilumab in the EQ-5D utility index (0.11 vs –0.02, p=0.034), HAQ-DI (–0.39 vs –0.15, p=0.054), FACIT-F (7.91 vs 4.17, p=0.060), and Pain VAS (–20.57 vs –12.04, p=0.20). Notably, more than half of the sarilumab-treated patients reached normative values in several SF-36 domains, an outcome not observed in the placebo group.
Glucocorticoids have long been the cornerstone of treatment for polymyalgia rheumatica. Although moderate doses (15–20 mg of prednisone) are effective in controlling symptoms, more than half of patients are unable to taper off therapy successfully, leading to prolonged use and the risk of glucocorticoid-related adverse effects. Interleukin-6 (IL-6) has been implicated in the pathogenesis of polymyalgia rheumatica, with elevated circulating levels and increased tissue expression observed in affected individuals.
Sarilumab, a fully human monoclonal antibody, targets the IL-6 receptor α (IL-6Rα) and effectively inhibits IL-6 signalling. It binds with high affinity to both monomeric and dimeric forms of IL-6Rα—approximately 20 times more strongly than tocilizumab, a humanised IL-6R antibody. Sarilumab has demonstrated a favourable immunogenicity profile, with a low incidence and low titres of anti-drug antibodies. Importantly, the presence of these antibodies does not appear to impact the safety or efficacy of sarilumab, regardless of concurrent disease-modifying antirheumatic drug (DMARD) use. While it shares its mechanism of action with tocilizumab, sarilumab differs in molecular structure and binding characteristics.
Overall, the findings indicate that patients with relapsing polymyalgia rheumatica experience significantly impaired health-related quality of life, with the greatest improvements seen in those with more severe disease. These results provide strong evidence supporting the use of sarilumab in patients whose disease activity and quality of life remain inadequately managed with glucocorticoid monotherapy.
References
- Strand V, Msihid J, Sloane J, Nivens MC, Chao J, Giannelou A, Fiore S, Araujo L, Dasgupta B. Sarilumab in relapsing polymyalgia rheumatica: patient-reported outcomes from a phase 3, double-blind, randomised controlled trial. Lancet Rheumatol. 2025 Aug;7(8):e544-e553.
- Spiera RF, Unizony S, Warrington KJ, Sloane J, Giannelou A, Nivens MC, Akinlade B, Wong W, Bhore R, Lin Y, Buttgereit F, Devauchelle-Pensec V, Rubbert-Roth A, Yancopoulos GD, Marrache F, Patel N, Dasgupta B; SAPHYR Investigators. Sarilumab for Relapse of Polymyalgia Rheumatica during Glucocorticoid Taper. N Engl J Med. 2023 Oct 5;389(14):1263-1272.
- Kameda H, Maezawa R, Minegishi Y, Imaizumi C, Katagiri T, Ogura T. Sarilumab in the treatment of rheumatoid arthritis: future perspectives. Expert Opin Biol Ther. 2025 Jul;25(7):683-685.