THURSDAY, Oct. 5, 2023 (HealthDay News) — For patients with polymyalgia rheumatica with relapse during tapering of glucocorticoid therapy, treatment with sarilumab, the human monoclonal antibody that binds to the interleukin-6 receptor α, is efficacious for achieving sustained remission and reducing cumulative glucocorticoid dose, according to a study published in the Oct. 5 issue of the New England Journal of Medicine.
Robert F. Spiera, M.D., from Weill Cornell Medical College in New York City, and colleagues conducted a phase 3 trial in which patients were randomly assigned to receive 52 weeks of a twice-monthly subcutaneous injection of either sarilumab or placebo plus a 14-week prednisone taper (60 and 58 patients, respectively). The primary outcome was sustained remission at 52 weeks.
The researchers found that at week 52, sustained remission occurred in 28 and 10 percent of patients in the sarilumab and placebo groups, respectively. At 52 weeks, the median glucocorticoid dose was significantly lower in the sarilumab group versus placebo group (777 versus 2,044 mg, respectively). Neutropenia, arthralgia, and diarrhea were the most common adverse events with sarilumab versus placebo (15 versus 0 percent; 15 versus 5 percent; and 12 versus 2 percent, respectively). Compared with the placebo group, the sarilumab group reported more treatment-related discontinuations (12 versus 7 percent).
“These findings indicate a glucocorticoid-sparing and remission-maintenance effect of sarilumab,” the authors write.
The study was funded by Sanofi and Regeneron Pharmaceuticals, which manufacture sarilumab.
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