Sarilumab Plus Short Steroid Taper course Improves Outcomes in Polymyalgia Rheumatica: Lancet

A recent international clinical trial published in the journal of The Lancet Rheumatology found that sarilumab 200 mg every 2 weeks combined with a 14-week glucocorticoid taper led to better quality of life and patient-reported outcomes among patients with polymyalgia rheumatica (PMR), when compared to placebo with a 52-week taper.

This study enrolled a total of 118 adults across 60 centers in 17 countries from October 2018 to July 2020. The participants, all aged 50 years or older, had experienced at least one disease flare during glucocorticoid tapering and carried markers of systemic inflammation. They were randomly assigned to receive either subcutaneous sarilumab 200 mg every 2 weeks with a rapid 14-week steroid taper or a placebo along with a prolonged 52-week taper.

Th patient-reported outcomes were evaluated through validated instruments including the Health Assessment Questionnaire Disability Index (HAQ-DI), the Short Form-36 survey (SF-36 v2), EuroQoL 5-Dimensions (EQ-5D), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), and visual analog scales (VAS) for pain and global health. The results were analyzed in the intention-to-treat population up to 52 weeks.

The cohort had a mean age of 68.9 years, with women comprising nearly 70%. At baseline, more than 70 percent reported moderate-to-severe fatigue. At week 52, sarilumab-treated patients demonstrated marked improvements over placebo across multiple domains of health-related quality of life.

Also, physical and mental functioning measured by SF-36 improved more in the sarilumab arm, with least-squares mean (LSM) changes of 7.65 versus 2.87 for the Physical Component Summary (p=0.020) and 3.04 versus –1.71 for the Mental Component Summary (p=0.030). Gains were also observed across 5 of the 8 SF-36 subdomains.

Other patient-reported outcomes mirrored this trend. EQ-5D utility scores rose in the sarilumab group (+0.11) while dipping in the placebo group (–0.02, p=0.034). Fatigue, measured by FACIT-F, improved by 7.91 points with sarilumab when compared with 4.17 points for placebo.

Disability, pain, and global health ratings also trended favorably, though some differences did not reach conventional statistical significance. More than half of patients on sarilumab achieved health status scores at or above population normative values in several domains, particularly mental health, whereas none in the placebo group reached this benchmark.

The odds of achieving at least a minimal clinically important difference in physical health scores were more than 3-times higher with sarilumab when compared to placebo (OR 3.46; p=0.020). Overall, the trial illuminates that patients with relapsing PMR often live with impaired quality of life, beyond what corticosteroids alone can address.

Source:

Strand, V., Msihid, J., Sloane, J., Nivens, M. C., Chao, J., Giannelou, A., Fiore, S., Araujo, L., & Dasgupta, B. (2025). Sarilumab in relapsing polymyalgia rheumatica: patient-reported outcomes from a phase 3, double-blind, randomised controlled trial. The Lancet. Rheumatology, 7(8), e544–e553. https://doi.org/10.1016/S2665-9913(25)00041-4