Evaluating Sarilumab for Polymyalgia Rheumatica Treatment in Older Adults
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Reviewed & translated by Dat Tien Nguyen, B.A, ScM.
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Posted on October 25th, 2023
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Polymyalgia rheumatica, an autoimmune disease primarily affecting individuals over 50 years old, has its root in inflammation triggered by interleukin-6 (IL-6). Current treatment relies on glucocorticoids like prednisone and immunosuppressants such as methotrexate, but these approaches come with side effects and do not offer lasting remission. To address this, a study was undertaken to evaluate the efficacy of Sarilumab, an antibody capable of binding to IL-6 receptors, in the treatment of polymyalgia rheumatica.
The phase 3 clinical trial included 118 adults whose average age was 70 years old and had been receiving glucocorticoid treatment for polymyalgia rheumatica, but disease flared up after treatment was tapered. Biochemistry assessments indicated a baseline erythrocyte sedimentation rate of 30 mm per hour and a C-reactive protein concentration exceeding 10 mg per liter. Randomly, participants were assigned to receive either a placebo or 200 mg of sarilumab via subcutaneous injection every 2 weeks. After a 52-week treatment period, the study's findings showed that sarilumab reduced the risk of relapse by 18% and decreased patients' reliance on glucocorticoids, with a significantly lower cumulative dose of 777 mg, compared to 2044 mg in the placebo group. However, sarilumab was associated with a higher rate of adverse events, including an increased frequency of neutropenia, arthralgia, and diarrhea. These side effects were severe enough to prompt 12% of patients to discontinue treatment, which was 5% more than the control group.
The phase 3 clinical trial included 118 adults whose average age was 70 years old and had been receiving glucocorticoid treatment for polymyalgia rheumatica, but disease flared up after treatment was tapered. Biochemistry assessments indicated a baseline erythrocyte sedimentation rate of 30 mm per hour and a C-reactive protein concentration exceeding 10 mg per liter. Randomly, participants were assigned to receive either a placebo or 200 mg of sarilumab via subcutaneous injection every 2 weeks. After a 52-week treatment period, the study's findings showed that sarilumab reduced the risk of relapse by 18% and decreased patients' reliance on glucocorticoids, with a significantly lower cumulative dose of 777 mg, compared to 2044 mg in the placebo group. However, sarilumab was associated with a higher rate of adverse events, including an increased frequency of neutropenia, arthralgia, and diarrhea. These side effects were severe enough to prompt 12% of patients to discontinue treatment, which was 5% more than the control group.