Efficacy of prednisone for the treatment of ocular myasthenia (EPITOME): A randomized, controlled trial.
In this study we evaluated the safety, tolerability, and efficacy of prednisone in patients with ocular myasthenia gravis (OMG) concurrently treated with pyridostigmine.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.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.A strategy of low-dose prednisone with gradual escalation appears to be safe, well-tolerated, and effective in treating OMG.
Benatar, M; Mcdermott, MP; Sanders, DB; Wolfe, GI; Barohn, RJ; Nowak, RJ; Hehir, M; Juel, V; Katzberg, H; Tawil, R; Muscle Study Group (MSG),
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