Randomized Trial of Thymectomy in Myasthenia Gravis
- PMID: 27509100
- PMCID: PMC5189669
- DOI: 10.1056/NEJMoa1602489
Randomized Trial of Thymectomy in Myasthenia Gravis
Erratum in
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Randomized Trial of Thymectomy in Myasthenia Gravis.N Engl J Med. 2017 May 25;376(21):2097. doi: 10.1056/NEJMx170003. Epub 2017 May 4. N Engl J Med. 2017. PMID: 28471717 No abstract available.
Abstract
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. Patients 18 to 65 years of age who had generalized nonthymomatous myasthenia gravis with a disease duration of less than 5 years were included if they had Myasthenia Gravis Foundation of America clinical class II to IV disease (on a scale from I to V, with higher classes indicating more severe disease) and elevated circulating concentrations of acetylcholine-receptor antibody. The primary outcomes were the time-weighted average Quantitative Myasthenia Gravis score (on a scale from 0 to 39, with higher scores indicating more severe disease) over a 3-year period, as assessed by means of blinded rating, and the time-weighted average required dose of prednisone over a 3-year period.
Results: A total of 126 patients underwent randomization between 2006 and 2012 at 36 sites. Patients who underwent thymectomy had a lower time-weighted average Quantitative Myasthenia Gravis score over a 3-year period than those who received prednisone alone (6.15 vs. 8.99, P<0.001); patients in the thymectomy group also had a lower average requirement for alternate-day prednisone (44 mg vs. 60 mg, P<0.001). Fewer patients in the thymectomy group than in the prednisone-only group required immunosuppression with azathioprine (17% vs. 48%, P<0.001) or were hospitalized for exacerbations (9% vs. 37%, P<0.001). The number of patients with treatment-associated complications did not differ significantly between groups (P=0.73), but patients in the thymectomy group had fewer treatment-associated symptoms related to immunosuppressive medications (P<0.001) and lower distress levels related to symptoms (P=0.003).
Conclusions: Thymectomy improved clinical outcomes over a 3-year period in patients with nonthymomatous myasthenia gravis. (Funded by the National Institute of Neurological Disorders and Stroke and others; MGTX ClinicalTrials.gov number, NCT00294658.).
Figures
Comment in
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RetroSternal--Looking Back at Thymectomy for Myasthenia Gravis.N Engl J Med. 2016 Aug 11;375(6):576-7. doi: 10.1056/NEJMe1607953. N Engl J Med. 2016. PMID: 27509106 No abstract available.
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[Thymectomy in myasthenia gravis].Chirurg. 2016 Dec;87(12):1080. doi: 10.1007/s00104-016-0323-x. Chirurg. 2016. PMID: 27815619 German. No abstract available.
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JNA Journal Club.J Neurosurg Anesthesiol. 2017 Jan;29(1):74-75. doi: 10.1097/ANA.0000000000000381. J Neurosurg Anesthesiol. 2017. PMID: 27820301 No abstract available.
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A crucial first randomized controlled trial of thymectomy in non-thymomatous myasthenia gravis.J Thorac Dis. 2016 Oct;8(10):E1375-E1378. doi: 10.21037/jtd.2016.10.15. J Thorac Dis. 2016. PMID: 27867633 Free PMC article. No abstract available.
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Commentary on "Randomized trial of thymectomy in myasthenia gravis".J Thorac Dis. 2016 Oct;8(10):E1420-E1422. doi: 10.21037/jtd.2016.10.03. J Thorac Dis. 2016. PMID: 27867646 Free PMC article. No abstract available.
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Randomized Trial of Thymectomy in Myasthenia Gravis.N Engl J Med. 2016 Nov 17;375(20):2006-2007. doi: 10.1056/NEJMc1611704. N Engl J Med. 2016. PMID: 27959593 No abstract available.
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Randomized Trial of Thymectomy in Myasthenia Gravis.N Engl J Med. 2016 Nov 17;375(20):2005. doi: 10.1056/NEJMc1611704. N Engl J Med. 2016. PMID: 27959594 No abstract available.
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Randomized Trial of Thymectomy in Myasthenia Gravis.N Engl J Med. 2016 Nov 17;375(20):2006. doi: 10.1056/NEJMc1611704. N Engl J Med. 2016. PMID: 27959595 No abstract available.
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Thymectomy for myasthenia gravis: what we know and what we don't.J Thorac Dis. 2016 Nov;8(11):3003-3005. doi: 10.21037/jtd.2016.11.88. J Thorac Dis. 2016. PMID: 28066568 Free PMC article. No abstract available.
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Randomized Trial of Thymectomy in Myasthenia Gravis.N Engl J Med. 2016 Nov 17;375(20):2005-2006. doi: 10.1056/NEJMc1611704. N Engl J Med. 2016. PMID: 28112886 No abstract available.
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Improved outcomes with surgery vs. medical therapy in non-thymomatous myesthenia gravis: a perspective on the results of a randomized trial.Ann Transl Med. 2016 Dec;4(24):526. doi: 10.21037/atm.2016.12.54. Ann Transl Med. 2016. PMID: 28149887 Free PMC article.
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Thymectomy for myasthenia gravis: what's next?J Thorac Dis. 2017 Feb;9(2):237-239. doi: 10.21037/jtd.2017.02.32. J Thorac Dis. 2017. PMID: 28275468 Free PMC article. No abstract available.
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