Treatment Reduces Disease Activity in Patients With Steroid-Refractory Polymyalgia Rheumatica

A combination of sarilumab and tapered glucocorticoids curbed disease activity and improved quality of life in patients with relapsing polymyalgia rheumatica (PMR), according to findings published in Arthritis & Rheumatology.

Patients with active PMR have heightened levels of IL-6, an inflammatory marker associated with disease relapse and severity. “Clinical trials with IL-6 receptor (IL-6R) inhibitors in PMR showed higher remission rates and reduced glucocorticoid use” as compared to treatment with glucocorticoids alone, study authors said.

The phase 3, randomized SAPHYR study recruited 280 patients whose PMR was refractory to steroids. Of these, only 117 received treatment due to interruptions caused by the COVID-19 pandemic. Those in the placebo group received a 52-week course of tapered glucocorticoids, while those assigned to the sarilumab group were treated with a dose of 200 mg every 2 weeks for 1 year, plus glucocorticoids tapered over 14 weeks.

Patients treated with sarilumab demonstrated a significantly higher sustained remission rate compared to those in the placebo arm (28.3% vs 10.3%; P = .0193). Once patients achieved remission, sarilumab was also associated with a 44% lower likelihood of PMR flares compared to placebo (16.7% vs 29.3%; HR 0.56; 95% CI 0.35 to 0.90; P = .0153).

“All sustained remission components favored [sarilumab],” investigators said.

Additionally, PMR activity scores improved among those receiving sarilumab vs placebo (least squares mean -15.57 vs -10.27, nominal P = .0002), as did patient-reported outcomes related to quality of life.

Participants in the placebo arm required more glucocorticoids than those in the sarilumab arm, largely due to disease flares. Study authors noted cumulative glucocorticoid toxicity scores favored the sarilumab arm, but the difference was not statistically significant.

By the end of the study, a total of 78 patients completed treatment, comprised of 42 in the sarilumab cohort and 36 in the placebo cohort. Adverse events (sarilumab n=7; placebo n=4) and lack of efficacy (sarilumab n=4; placebo n=9) were the most common factors driving treatment discontinuation, according to the findings.

Overall, treatment-emergent adverse events occurred more often in the sarilumab arm (94.9% vs 84.5%), but investigators noted serious adverse events were more common in the placebo group (20.7% vs 13.6%). The most common adverse events were neutropenia (15.3%) and arthralgia (15.3%) in the sarilumab group, while insomnia (15.5%) was most common in the placebo group.

No patients died during the study.

Reference:
Spiera R, Unizony S, Warrington K, et al. Sarilumab in patients with relapsing polymyalgia rheumatica: a phase 3, multicenter, randomized, double blind, placebo controlled trial (SAPHYR). Arthritis Rheumatol. 2022;74(suppl 9). American College of Rheumatology Convergence 2022 abstract 1676.