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Title: 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
Authors: Gil I. Wolfe
Henry J. Kaminski
Inmaculada B. Aban
Greg Minisman
Hui Chien Kuo
Alexander Marx
Philipp Ströbel
Claudio Mazia
Joel Oger
J. 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
Márcia Waddington-Cruz
Michael T. Pulley
Michael H. Rivner
Anna Kostera-Pruszczyk
Robert M. Pascuzzi
Carlayne E. Jackson
Jan J.G.M. Verschuuren
Janice M. Massey
John T. Kissel
Lineu C. Werneck
Michael Benatar
Richard J. Barohn
Rup Tandan
Tahseen Mozaffar
Nicholas J. Silvestri
Robin Conwit
Joshua R. Sonett
Alfred Jaretzki
John Newsom-Davis
Gary R. Cutter
Gary Cutter
Inmaculada Aban
Michelle Feese
Gil Wolfe
Henry Kaminski
Joshua Sonett
Valeria Saluto
Moises Rosenberg
Valeria Alvarez
Lisa Rey
John King
Helmut Butzkueven
John Goldblatt
John Carey
John Pollard
Stephen Reddel
Nicholas Handel
Brian McCaughan
Linda Pallot
Ricardo Novis
Carlos Boasquevisque
Rubens Morato-Fernandez
Manoel Ximenes
Lineu Werneck
Rosana Scola
Paulo Soltoski
Colin Chalk
Fraser Moore
David Mulder
Lisa Wadup
Michele Mezei
Kenneth Evans
Theresa Jiwa
Anne Schaffar
Chris White
Cory Toth
Gary Gelfand
Susan Wood
Elizabeth Pringle
Jocelyn Zwicker
Donna Maziak
Farid Shamji
Sudhir Sundaresan
Andrew Seely
Gabriel Cea
Renato Verduga
Alberto Aguayo
Sebastian Jander
Philipp Zickler
Michael Klein
Cleo Aron Weis
Arthur Melms
Duke University Medical Center
Augusta University
Medical University of Warsaw
Hospital de Base do Distrito Federal
Università degli Studi di Roma La Sapienza
University at Buffalo, State University of New York
Università Cattolica del Sacro Cuore, Rome
University of Vermont College of Medicine
Universität Göttingen
Johannes Gutenberg Universität Mainz
University of Southern California
Columbia University Irving Medical Center
The University of Alabama at Birmingham
University of Oxford
University of Melbourne
School of Medicine and Health Sciences
Kanazawa University
University of Rochester Medical Center
Indiana University School of Medicine Indianapolis
University of Miami Leonard M. Miller School of Medicine
Walton Centre for Neurology and Neurosurgery NHS Trust
University of Texas Health Science Center at San Antonio
Leiden University Medical Center - LUMC
Universidade Federal do Parana
University of Florida
National Institute of Neurological Disorders and Stroke
Mahidol University
Medical College of Wisconsin
Universidad de Chile
The University of British Columbia
University of Kansas Medical Center
University of California, Irvine
Ohio State University
Harvard Medical School
McGill University
Universitätsklinikum Mannheim
Universidad de Buenos Aires
University of Cape Town
Case Western Reserve University
Universidade Federal do Rio de Janeiro
Nerve and Muscle Center of Texas
Keywords: Medicine
Issue Date: 1-Mar-2019
Citation: The Lancet Neurology. Vol.18, No.3 (2019), 259-268
Abstract: © 2019 Elsevier Ltd 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. MGTX patients were aged 18 to 65 years at enrolment, had generalised non-thymomatous myasthenia gravis of less than 5 years' duration, had acetylcholine receptor antibody titres of 1·00 nmol/L or higher (or concentrations of 0·50–0·99 nmol/L if diagnosis was confirmed by positive edrophonium or abnormal repetitive nerve stimulation, or abnormal single fibre electromyography), had Myasthenia Gravis Foundation of America Clinical Classification Class II–IV disease, and were on optimal anticholinesterase therapy with or without oral corticosteroids. In MGTX, patients were randomly assigned (1:1) to either thymectomy plus prednisone or prednisone alone. All patients in both groups received oral prednisone at doses titrated up to 100 mg on alternate days until they achieved minimal manifestation status. The primary endpoints of the extension phase were the time-weighted means of the QMG score and alternate-day prednisone dose from month 0 to month 60. Analyses were by intention to treat. The trial is registered with, number NCT00294658. It is closed to new participants, with follow-up completed. Findings: Of the 111 patients who completed the 3-year MGTX, 68 (61%) entered the extension study between Sept 1, 2009, and Aug 26, 2015 (33 in the prednisone alone group and 35 in the prednisone plus thymectomy group). 50 (74%) patients completed the 60-month assessment, 24 in the prednisone alone group and 26 in the prednisone plus thymectomy group. At 5 years, patients in the thymectomy plus prednisone group had significantly lower time-weighted mean QMG scores (5·47 [SD 3·87] vs 9·34 [5·08]; p=0·0007) and mean alternate-day prednisone doses (24 mg [SD 21] vs 48 mg [29]; p=0·0002) than did those in the prednisone alone group. 14 (42%) of 33 patients in the prednisone group, and 12 (34%) of 35 in the thymectomy plus prednisone group, had at least one adverse event by month 60. No treatment-related deaths were reported during the extension phase. Interpretation: At 5 years, thymectomy plus prednisone continues to confer benefits in patients with generalised non-thymomatous myasthenia gravis compared with prednisone alone. Although caution is appropriate when generalising our findings because of the small sample size of our study, they nevertheless provide further support for the benefits of thymectomy in patients with generalised non-thymomatous myasthenia gravis. Funding: National Institutes of Health, National Institute of Neurological Disorders and Stroke.
ISSN: 14744465
Appears in Collections:Scopus 2019

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