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 onpyridostigmine 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.
RCT Entities:
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.
Authors: D Lavrnić; M Jarebinski; V Rakocević-Stojanović; Z Stević; S Lavrnić; S Pavlović; R Trikić; I Tripković; V Nesković; S Apostolski Journal: Acta Neurol Scand Date: 1999-09 Impact factor: 3.209
Authors: Ikjae Lee; Hui-Chien Kuo; Inmaculada B Aban; Gary R Cutter; Tarrant McPherson; Henry J Kaminski; Jon Sussman; Philipp Ströbel; Joel Oger; Gabriel Cea; Jeannine M Heckmann; Amelia Evoli; Wilfred Nix; Emma Ciafaloni; Giovanni Antonini; Rawiphan Witoonpanich; John O King; Said R Beydoun; Colin H Chalk; Alexandru C Barboi; Anthony A Amato; Aziz I Shaibani; Bashar Katirji; Bryan R F Lecky; Camilla Buckley; Angela Vincent; Elza Dias-Tosta; Hiroaki Yoshikawa; Marcia Waddington-Cruz; Michael T Pulley; Michael H Rivner; Anna Kostera-Pruszczyk; Robert M Pascuzzi; Carlayne E Jackson; Jan J G Verschuuren; Janice M Massey; John T Kissel; Lineu C Werneck; Michael Benatar; Richard J Barohn; Rup Tandan; Tahseen Mozaffar; Robin Conwit; Greg Minisman; Joshua R Sonett; Gil I Wolfe Journal: Neurology Date: 2020-07-01 Impact factor: 9.910
Authors: Julie R Brahmer; Hamzah Abu-Sbeih; Paolo Antonio Ascierto; Jill Brufsky; Laura C Cappelli; Frank B Cortazar; David E Gerber; Lamya Hamad; Eric Hansen; Douglas B Johnson; Mario E Lacouture; Gregory A Masters; Jarushka Naidoo; Michele Nanni; Miguel-Angel Perales; Igor Puzanov; Bianca D Santomasso; Satish P Shanbhag; Rajeev Sharma; Dimitra Skondra; Jeffrey A Sosman; Michelle Turner; Marc S Ernstoff Journal: J Immunother Cancer Date: 2021-06 Impact factor: 13.751