Publication:
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

Issued Date

2019-03-01

Resource Type

Article

ISSN

14744465
14744422

DOI

10.1016/S1474-4422(18)30392-2

Other identifier(s)

2-s2.0-85060438170

Rights

Mahidol University

Rights Holder(s)

SCOPUS

Bibliographic Citation

The Lancet Neurology. Vol.18, No.3 (2019), 259-268

Suggested Citation

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 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. The Lancet Neurology. Vol.18, No.3 (2019), 259-268. doi:10.1016/S1474-4422(18)30392-2 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/51852

Research Projects

Organizational Units

Authors

Journal Issue

Thesis

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

Author(s)

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

Other Contributor(s)

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

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 ClinicalTrials.gov, 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.

Keyword(s)

Medicine

Availability

URI

https://repository.li.mahidol.ac.th/handle/20.500.14594/51852

Collections

Scopus 2019