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Pilot trial of etanercept in the treatment of inclusion-body myositis

From the Department of Neurology (R.J.B., L.H., D.S.S.), University of Kansas Medical Center, Kansas City, KS; and the Department of Neurology (J.K., W.K., A.L.M., J.R.M.), Ohio State University, Columbus, OH.

address correspondence and reprint requests to Dr. Richard J. Barohn, Department of Neurology, University of Kansas Medical Center, 3599 Rainbow Blvd., MS # 2012, Kansas City, KS 66160; e-mail: rbarohn{at}kumc.edu

Inclusion-body myositis (IBM) is an inflammatory muscle disease that has proven resistant to treatment. Tumor necrosis factor molecules have been detected in muscle biopsies from patients with IBM. Etanercept is a TNF receptor fusion protein that binds and inactivates tumor necrosis factor. Nine patients were treated with etanercept at a dose of 25 mg, two times a week for an average of 17 ± 6.1 months. Each patient was evaluated using quantitative strength testing. Their data were compared to two different control groups. The first control group consisted of patients who participated in trials of beta-interferon-1A and had received placebo. There was no significant difference. The second control group was a natural history cohort of IBM patients. There was no statistically significant difference between the treated group and the natural history group at 6 and 12 months when looking at elbow flexors, or 6 months when looking at hand grip. In the treated patients there was a small but significant improvement (p = 0.002) in handgrip at 12 months.

This article was previously published in electronic format as an Expedited E-Pub at www.neurology.org.

Disclosure: The authors report no conflicts of interest.

Received June 22, 2005. Accepted in final form October 14, 2005.

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