Efficacy of prednisone for the treatment of ocular myasthenia (EPITOME): A randomized, controlled trial

Muscle and Nerve - Tập 53 Số 3 - Trang 363-369 - 2016
Michael Benatar1, Michael McDermott1, Donald B. Sanders1, Gil I. Wolfe1, Richard J. Barohn1, Richard J. Nowak1, Michael K. Hehir1, Vern C. Juel1, Hans Katzberg1, Rabi Tawil1
1Department of Neurology; Miller School of Medicine, University of Miami; 1120 NW 14th Street, CRB 1318 Miami Florida 33136 USA

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ABSTRACT

Introduction: In this study we evaluated the safety, tolerability, and efficacy of prednisone in patients with ocular myasthenia gravis (OMG) concurrently treated with pyridostigmine. Methods: This investigation was a randomized, double‐blind, placebo‐controlled trial. Participants whose symptoms failed to remit on pyridostigmine were randomized to receive placebo or prednisone, initiated at 10 mg every other day, and titrated to a maximum of 40 mg/day over 16 weeks. The primary outcome measure was treatment failure. Results: Fewer subjects were randomized than the 88 planned. Of the 11 randomized, 9 completed 16 weeks of double‐blind therapy. Treatment failure incidence was 100% (95% CI 48%–100%) in the placebo group (n = 5) vs. 17% (95% CI 0%–64%) in the prednisone group, P = 0.02 (n = 6). Median time to sustained minimal manifestation status (MMS) was 14 weeks, requiring an average prednisone dose of 15 mg/day. Adverse events were infrequent and generally mild in both groups. Conclusions: A strategy of low‐dose prednisone with gradual escalation appears to be safe, well‐tolerated, and effective in treating OMG. Muscle Nerve 53: 363–369, 2016

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Muscle and Nerve

Tập 53 Số 3

363-369

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