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This Article Figures Only Full Text Full Text (PDF) CME: Take the course for this article: Volume 57, Number 9, November 13, 2001 A correction has been published Correspondence: Submit a response Alert me when this article is cited Alert me when Correspondence are posted Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Search for Related Content PubMed PubMed Citation Related Collections Muscle disease All Clinical trials Clinical trials Randomized controlled (CONSORT agreement)

Randomized pilot trial of ßINF1a (Avonex) in patients with inclusion body myositis

Address correspondence and reprint requests to Dr. R. Tawil, Neuromuscular Disease Center, 601 Elmwood Ave., Box 673, Rochester, NY 14642; e-mail: Rabi_Tawil{at}URMC.Rochester.edu

Background:— Inclusion body myositis (IBM) is the most common acquired disease of muscle in adults over the age of 50 years. Although there is compelling evidence for the importance of immunologic abnormalities in its pathogenesis, the cause of the disease is not known, and it is considered to be resistant to treatment with corticosteroids and other conventional immunosuppressive agents. ß-Interferon (ßIFN), an immunomodulatory cytokine, is a candidate therapeutic agent for IBM.

Method:— A 24-week, multicenter, randomized, placebo-controlled, parallel-group clinical trial of 30 µg of ß-interferon-1a (ßINF1a) administered IM once a week in 30 patients with IBM was conducted. The primary goal was to establish the safety and tolerability of ßINF1a in IBM. A secondary goal was to obtain preliminary data on the efficacy of ßINF1a by measuring changes from baseline in muscle strength and muscle mass.

Results:— Twenty-nine of the 30 subjects enrolled completed the study. Two subjects (one in the placebo group, one in the ßINF1a group) experienced severe adverse events. One subject, randomized to receive ßINF1a, died from an ischemic bowel after resection of a colonic mass. No subjects required dosage reductions, and the adverse event profile was similar for the placebo and ßINF1a groups. There were no significant differences in the changes in muscle strength and muscle mass between the placebo and ßINF1a groups at 6 months.

Conclusions:— ßINF1a at a dose of 30 µg/week IM is well tolerated in IBM. Further studies are needed to establish its therapeutic usefulness in this inflammatory myopathy.

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