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Randomized pilot trial of high-dose ßINF-1a in patients with inclusion body myositis

Address correspondence and reprint requests to Dr. Rabi Tawil, Neuromuscular Disease Center, 601 Elmwood Avenue, Box 673, Rochester, NY 14642-8673; e-mail: Rabi_Tawil{at}URMC.Rochester.edu

ß-Interferon-1a (ßINF-1a) is well tolerated at low dose (30 µg IM/week) in inclusion body myositis (IBM). The authors investigated the safety and tolerability of high-dose (60 µg IM/week) ßINF-1a in a randomized, placebo-controlled trial in IBM. Twenty-seven of the 30 subjects enrolled completed the study. The adverse event profile was similar for the placebo and ßINF-1a groups. ßINF-1a, at a dose of 60 µg IM/week, is well tolerated in IBM, but no differences in muscle strength or mass were observed between the placebo and ßINF-1a groups at 6 months in this pilot study.

Received November 4, 2003. Accepted in final form April 8, 2004.

Additional material related to this article can be found on the Neurology Web site. Go to www.neurology.org and scroll down the Table of Contents for the August 24 issue to find the title link for this article.

*Members of the Muscle Study Group are listed in the Appendix on page 720.

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