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Address correspondence and reprint requests to Dr. Donald B. Sanders, Box 3403, Duke University Medical Center, Durham, NC 27710 Donald.Sanders{at}Duke.edu
Objective: To test the hypothesis that mycophenolate mofetil (MMF) with prednisone provides better control of myasthenic weakness than prednisone alone in the initial management of generalized myasthenia gravis (MG).
Methods: Eighty immunosuppression naïve subjects with mild to moderate generalized, acetylcholine receptor positive MG at 13 centers were randomized to 2.5 g/day MMF plus 20 mg/day prednisone (n = 41) or placebo plus 20 mg/day prednisone (n = 39) and followed in a double-blind fashion for 12 weeks. Subjects over 18 years of age were included if judged to be candidates for immunosuppression; excluded were those with thymoma or severe oropharyngeal or respiratory muscle weakness. The primary measure of efficacy was change in the quantitative MG (QMG) score from baseline to week 12. Study completers could take open-label MMF for an additional 24 weeks, while prednisone was reduced to the minimally effective dosage.
Results: The mean change in QMG score was similar in the treated (–4.4 ± 5.1) and placebo (–3.6 ± 5.0) groups (p = 0.71). The dosage of prednisone was reduced by a similar amount in both groups during the open-label phase. Subjects tolerated the study drug well, without unexpected adverse events.
Conclusions: This study demonstrated no benefit of mycophenolate mofetil (MMF) with 20 mg/day prednisone compared to 20 mg/day of prednisone alone after 12 weeks. This may be due to greater than predicted benefit from the prednisone dosage used, the short duration of the study, or the absence of any benefit of MMF in this population of patients with myasthenia gravis.
Abbreviations: AChR-Ab = acetylcholine receptor antibody; FVC = forced vital capacity; IMPDH = inosine monophosphate dehydrogenase; MG = myasthenia gravis; MG-ADL = MG-related activities of daily living; MGFA = Myasthenia Gravis Foundation of America; MMF = mycophenolate mofetil; MMT = manual muscle testing; MSG = Muscle Study Group; QMG = quantitative MG.
Supplemental data at www.neurology.org
Editorial, page 390
See also page 400
e-Pub ahead of print on April 23, 2008, at www.neurology.org.
*See the appendix for a list of participating Muscle Study Group members.
Supported by grant FD-R-002154-01 from the Orphan Products Development Program of the US FDA, F. Hoffmann-La Roche Ltd. (Roche) Grant CEL248, and Aspreva Pharmaceuticals, and General Clinical Research Center (GCRC) grants MO1 RR00034, M01-RR00044, M01-RR-01346, and M01 RR023940 from the National Center for Research Resources, NIH.
Disclosure: Dr. Sanders has received consultation fees from Sanofi-Aventis and Accordant Health Services and his institution has received research funds from Aspreva Pharmaceuticals for his consultation services. He is on the speakers program for Athena Diagnostics and has received research support through his institution from Roche Laboratories and Aspreva Pharmaceuticals.
Received July 27, 2007. Accepted in final form December 28, 2007.
This article has been cited by other articles:
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  Mycophenolate Mofetil to Treat Myasthenia Gravis? Journal Watch Neurology, September 23, 2008; 2008(923): 1 - 1. [Full Text]
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 R. Gold, R. Hohlfeld, and K. V. Toyka Review: Progress in the treatment of myasthenia gravis Therapeutic Advances in Neurological Disorders, September 1, 2008; 1(2): 99 - 114. [Abstract] [PDF]
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