Sarilumab„ allowed for more-rapid tapering of prednisone in a randomized trial.
When patients with polymyalgia rheumatica (PMR) have recurrent symptoms repeatedly during tapering of steroids, rheumatologists sometimes add agents such as methotrexate to decrease cumulative steroid exposure. Sarilumab (Kevzara; an interleukin-6 receptor antagonist) recently was FDA-approved in the U.S. for this purpose, based on results of this clinical trial.
Researchers identified 118 patients with PMR who had received at least 8 weeks of prednisone (≥10 mg daily) during their treatment course and had at least one symptom flare while taking ≥7.5 mg daily. Patients were randomized to receive either sarilumab, injected twice monthly for 1 year, while tapering prednisone over 14 weeks, or placebo, while tapering prednisone over 1 year. The protocol allowed for steroid “rescue” therapy if symptoms flared.
Sustained remission between weeks 12 and 52 occurred significantly more often in the sarilumab group than in the placebo group (28% vs. 10%). At 52 weeks, patients in the sarilumab group were significantly more likely to be asymptomatic and to have received no rescue therapy (45% vs. 14%). Median cumulative prednisone exposure was much lower in the sarilumab group (777 mg vs. 2044 mg). Neutropenia, diarrhea, and arthralgia occurred more commonly with sarilumab than with placebo. No deaths occurred during the trial.
