Sarilumab, tapered glucocorticoids improve steroid-resistant polymyalgia rheumatica
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PHILADELPHIA — Patients with steroid-resistant polymyalgia rheumatica who received sarilumab and tapered glucocorticoids achieved higher remission rates vs. glucocorticoid taper alone, according to data presented at ACR Convergence 2022.
“Polymyalgia rheumatica, as we know, is a really important rheumatic disease, and is among the most common inflammatory diseases of the elderly,” Robert Spiera, MD, of the Hospital for Special Surgery, in New York, told attendees. “It is relatively easy to treat with glucocorticoids, but unfortunately, relapses are common, resulting in long courses of glucocorticoid therapy with its attendant morbidities.
“We recognize that a steroid-sparing drug in polymyalgia rheumatica seems to be an unmet need,” he added.
To investigate the safety and efficacy of sarilumab (Kevzara, Sanofi) and a 14-week glucocorticoid taper in patients with steroid-resistant polymyalgia rheumatica, who had a disease flare while receiving 7.5 mg or more of daily prednisone, Spiera and colleagues conducted the SAPHYR trial. According to the researchers, SAPHYR is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial in which patients were randomized 1:1 to receive either sarilumab 200 mg every 2 weeks while tapering glucocorticoids for 14 weeks, or placebo doses every 2 weeks with a 52-week glucocorticoid taper.
were required to follow tapering guidelines from weeks 12 through 52 for the primary endpoints to be met.
A total of 118 patients were recruited, while 117 patients were treated and analyzed. In all, 78 patients completed the treatment, with 42 patients receiving sarilumab arm and 36 in the control arm. Seven patients receiving sarilumab discontinued therapy due to adverse events and nine control patients discontinued the trial due to a lack of efficacy.
According to the researchers, patients in the sarilumab arm achieved “significantly higher” rates of remission compared with patients in the control arm — 28.3% vs 10.3% (P = .0193).
“In summary, the primary endpoint of sustained remission at week 52 was achieved by a greater proportion of patients treated with sarilumab and a 14-week glucocorticoid taper vs. a 52-week glucocorticoid taper,” Spiera said. “The secondary endpoint of glucocorticoid dose was statistically significantly lower in patients treated with sarilumab.”
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Spiera R. Abstract 1672. Presented at: ACR Convergence 2022; Nov. 11-14, 2022; Philadelphia (hybrid meeting).
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