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Methotrexate, cyclosporine not helpful to patients with myositis, poor response to glucocorticoids
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Neither methotrexate nor cyclosporine improved symptoms in patients with dermatomyositis or polymyositis who did not respond fully to treatment with glucocorticoids, according to recently published research.
Fifty-eight patients were randomly assigned to treatment groups, of whom, 37 completed 12 months of treatment. Fifteen were treated with methotrexate and cyclosporine (11 completed the trial), 12 were treated with methotrexate alone (six completed the trial), 16 were treated with cyclosporine alone (11 completed the trial) and 15 received placebo (nine completed the trial). Patients’ outcomes were evaluated at baseline and at 12, 28, 40 and 56 months.
Outcomes were based on manual muscle strength testing (MMT), functional rating scale (FRS), 30-minute walking time (WT), creatinine kinase concentration, erythrocyte sedimentation rate (ESR), withdrawal from treatment and adverse reactions.
Overall MMT increased from 64 to 73 (14% improvement) in patients who completed 12 months of treatment, WT decreased from 36 to 28 (22% improvement) and FRS increased from 33 to 36 (9% improvement). Additionally, all of the improvements were correlated, according to the researchers. However, in comparison with placebo, no evidence of additional benefits were seen with cyclosporine or methotrexate monotherapy, or with combination therapy. Mean daily use of prednisolone was not reduced; patients in the placebo group received 18 mg mean daily prednisolone compared with 22 mg to 26 mg in the treatment groups.
Fifty patients reported adverse events, leading to withdrawal of 14 patients. The most common adverse events were of the musculoskeletal, gastrointestinal or respiratory type. – by Shirley Pulawski
Disclosure: The researchers report no relevant financial disclosures.
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