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Long-term effect of thymectomy plus prednisone versus prednisone alone in patients with non-thymomatous myasthenia gravis: 2-year extension of the MGTX randomised trial.
Lancet Neurol
March 2019
Department of Biostatistics, University of Alabama at Birmingham, Birmingham, AL, USA.
Background: The Thymectomy Trial in Non-Thymomatous Myasthenia Gravis Patients Receiving Prednisone (MGTX) showed that thymectomy combined with prednisone was superior to prednisone alone in improving clinical status as measured by the Quantitative Myasthenia Gravis (QMG) score in patients with generalised non-thymomatous myasthenia gravis at 3 years. We investigated the long-term effects of thymectomy up to 5 years on clinical status, medication requirements, and adverse events.
Methods: We did a rater-blinded 2-year extension study at 36 centres in 15 countries for all patients who completed the randomised controlled MGTX and were willing to participate.
Randomized Trial of Thymectomy in Myasthenia Gravis.
N Engl J Med
August 2016
From the Department of Neurology, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo (G.I.W.), the Department of Neurology, University of Rochester Medical Center, Rochester (E.C.), and the Section of General Thoracic Surgery, Columbia University Medical Center, New York (J.R.S., A.J.) - all in New York; the Department of Neurology, George Washington University School of Medicine and Health Sciences, Washington, DC (H.J.K.); the Department of Biostatistics, University of Alabama at Birmingham, Birmingham (I.B.A., G.M., H.-C.K., G.R.C.); the Institute of Pathology, University Medical Center Mannheim, University of Heidelberg, Mannheim (A.M.), the Institute of Pathology, University of Göttingen, Göttingen (P.S.), and the Department of Neurology, Johannes Gutenberg University, Mainz (W.N.) - all in Germany; the Department of Neurology, University of Buenos Aires, Buenos Aires (C.M.); the Division of Neurology, University of British Columbia, Vancouver (J. Oger), and the Department of Neurology, McGill University, Montreal (C.H.C.) - both in Canada; the Department of Neurology, University of Chile, Santiago (J.G.C.); the Division of Neurology, Department of Medicine, University of Cape Town, Cape Town, South Africa (J.M.H.); the Department of Neurology, Catholic University (A.E.), and the Department of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome (G.A.) - both in Rome; the Division of Neurology, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand (R.W.); the Department of Neurology, University of Melbourne, Melbourne, VIC, Australia (J.O.K.); the Department of Neurology, University of Southern California, Los Angeles (S.R.B.), and the Department of Neurology, University of California Irvine Medical Center, Orange (T.M.) - both in California; the Department of Neurology, Medical College of Wisconsin, Milwaukee (A.C.B.); the Department of Neurology, Harvard Medical School, Boston (A.A.A.); Nerve and M
Background: Thymectomy has been a mainstay in the treatment of myasthenia gravis, but there is no conclusive evidence of its benefit. We conducted a multicenter, randomized trial comparing thymectomy plus prednisone with prednisone alone.
Methods: We compared extended transsternal thymectomy plus alternate-day prednisone with alternate-day prednisone alone.
The MGTX experience: challenges in planning and executing an international, multicenter clinical trial.
J Neuroimmunol
September 2008
Department of Biostatistics, University of Alabama at Birmingham, 1665 University Boulevard, Birmingham, AL 35294-0022, United States.
We present our experience planning and launching a multinational, NIH/NINDS funded study of thymectomy in myasthenia gravis. We highlight the additional steps required for international sites and analyze and contrast the time investment required to bring U.S.
View Article and Find Full Text PDFStatus of the thymectomy trial for nonthymomatous myasthenia gravis patients receiving prednisone.
Ann N Y Acad Sci
September 2008
University of Oxford, Oxford, UK.
The primary study [MGTX] aims to answer three questions: does extended transsternal thymectomy combined with the prednisone protocol, when compared with the prednisone protocol alone: (1) result in a greater improvement in myasthenic weakness, (2) result in a lower total dose of prednisone, thus decreasing the likelihood of concurrent and long-term toxic effects, (3) enhance the quality of life by reducing adverse events and symptoms associated with the therapies? Inclusion criteria are MGFA Class 2, 3, or 4; acetylcholine receptor antibody positive; age at least 18.0 years and <60.0 years; MG history of <3 years.
View Article and Find Full Text PDFThymectomy for nonthymomatous myasthenia gravis: a critical analysis.
Ann N Y Acad Sci
September 2008
College of Physicians and Surgeons, Columbia University, New York, New York, USA.
There continues to be debate concerning which thymectomy technique is the procedure of choice in the treatment of nonthymomatous myasthenia gravis (MG). The debate persists primarily because of the lack of controlled prospective studies but also because of the varying presentations and clinical courses of MG patients. Analysis has been complicated by the absence, until very recently, of accepted objective definitions of severity of the illness and response to therapy as well as variable patient selection, timing of surgery, type of surgery, and methods of analysis of results.
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