Randomized trial of thymectomy in myasthenia gravis

Amelia Evoli; G. I. Wolfe; H. J. Kaminski; I. B. Aban; G. Minisman; H. C. Kuo; A. Marx; P. Ströbel; C. Mazia; J. Oger; J. G. Cea; J. M. Heckmann; W. Nix; E. Ciafaloni; G. Antonini; R. Witoonpanich; J. O. King; S. R. Beydoun; C. H. Chalk; A. C. Barboi; A. A. Amato; A. I. Shaibani; B. Katirji; B. R.F. Lecky; C. Buckley; A. Vincent; E. Dias-Tosta; H. Yoshikawa; M. Waddington-Cruz; M. T. Pulley; M. H. Rivner; A. Kostera-Pruszczyk; R. M. Pascuzzi; C. E. Jackson; G. S. Garcia Ramos; J. J.G.M. Verschuuren; J. M. Massey; J. T. Kissel; L. C. Werneck; M. Benatar; R. J. Barohn; R. Tandan; T. Mozaffar; R. Conwit; J. Odenkirchen; J. R. Sonett; A. Jaretzki; J. Newsom-Davis; G. R. Cutter

doi:10.1056/NEJMoa1602489

Randomized trial of thymectomy in myasthenia gravis

Amelia Evoli, G. I. Wolfe, H. J. Kaminski, I. B. Aban, G. Minisman, H. C. Kuo, A. Marx, P. Ströbel, C. Mazia, J. Oger, J. G. Cea, J. M. Heckmann, W. Nix, E. Ciafaloni, G. Antonini, R. Witoonpanich, J. O. King, S. R. Beydoun, C. H. Chalk, A. C. BarboiA. A. Amato, A. I. Shaibani, B. Katirji, B. R.F. Lecky, C. Buckley, A. Vincent, E. Dias-Tosta, H. Yoshikawa, M. Waddington-Cruz, M. T. Pulley, M. H. Rivner, A. Kostera-Pruszczyk, R. M. Pascuzzi, C. E. Jackson, G. S. Garcia Ramos, J. J.G.M. Verschuuren, J. M. Massey, J. T. Kissel, L. C. Werneck, M. Benatar, R. J. Barohn, R. Tandan, T. Mozaffar, R. Conwit, J. Odenkirchen, J. R. Sonett, A. Jaretzki, J. Newsom-Davis, G. R. Cutter

Risultato della ricerca: Contributo in rivista › Articolo in rivista › peer review

157 Citazioni (Scopus)

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.

Lingua originale	English
pagine (da-a)	511-522
Numero di pagine	12
Rivista	New England Journal of Medicine
Volume	375
DOI	https://doi.org/10.1056/NEJMoa1602489
Stato di pubblicazione	Pubblicato - 2016

Keywords

Glucocorticoids
Hospitalization
Humans
Male
Medicine (all)
Middle Aged
Myasthenia Gravis
Prednisone
Severity of Illness Index
Single-Blind Method
Thymectomy
Treatment Outcome
Young Adult

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10.1056/NEJMoa1602489

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Evoli, A., Wolfe, G. I., Kaminski, H. J., Aban, I. B., Minisman, G., Kuo, H. C., Marx, A., Ströbel, P., Mazia, C., Oger, J., Cea, J. G., Heckmann, J. M., Nix, W., Ciafaloni, E., Antonini, G., Witoonpanich, R., King, J. O., Beydoun, S. R., Chalk, C. H., ... Cutter, G. R. (2016). Randomized trial of thymectomy in myasthenia gravis. New England Journal of Medicine, 375, 511-522. https://doi.org/10.1056/NEJMoa1602489

Evoli, Amelia ; Wolfe, G. I. ; Kaminski, H. J. ; Aban, I. B. ; Minisman, G. ; Kuo, H. C. ; Marx, A. ; Ströbel, P. ; Mazia, C. ; Oger, J. ; Cea, J. G. ; Heckmann, J. M. ; Nix, W. ; Ciafaloni, E. ; Antonini, G. ; Witoonpanich, R. ; King, J. O. ; Beydoun, S. R. ; Chalk, C. H. ; Barboi, A. C. ; Amato, A. A. ; Shaibani, A. I. ; Katirji, B. ; Lecky, B. R.F. ; Buckley, C. ; Vincent, A. ; Dias-Tosta, E. ; Yoshikawa, H. ; Waddington-Cruz, M. ; Pulley, M. T. ; Rivner, M. H. ; Kostera-Pruszczyk, A. ; Pascuzzi, R. M. ; Jackson, C. E. ; Garcia Ramos, G. S. ; Verschuuren, J. J.G.M. ; Massey, J. M. ; Kissel, J. T. ; Werneck, L. C. ; Benatar, M. ; Barohn, R. J. ; Tandan, R. ; Mozaffar, T. ; Conwit, R. ; Odenkirchen, J. ; Sonett, J. R. ; Jaretzki, A. ; Newsom-Davis, J. ; Cutter, G. R. / Randomized trial of thymectomy in myasthenia gravis. In: New England Journal of Medicine. 2016 ; Vol. 375. pagg. 511-522.

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title = "Randomized trial of thymectomy in myasthenia gravis",

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.",

keywords = "Glucocorticoids, Hospitalization, Humans, Male, Medicine (all), Middle Aged, Myasthenia Gravis, Prednisone, Severity of Illness Index, Single-Blind Method, Thymectomy, Treatment Outcome, Young Adult, Glucocorticoids, Hospitalization, Humans, Male, Medicine (all), Middle Aged, Myasthenia Gravis, Prednisone, Severity of Illness Index, Single-Blind Method, Thymectomy, Treatment Outcome, Young Adult",

author = "Amelia Evoli and Wolfe, {G. I.} and Kaminski, {H. J.} and Aban, {I. B.} and G. Minisman and Kuo, {H. C.} and A. Marx and P. Str{\"o}bel and C. Mazia and J. Oger and Cea, {J. G.} and Heckmann, {J. M.} and W. Nix and E. Ciafaloni and G. Antonini and R. Witoonpanich and King, {J. O.} and Beydoun, {S. R.} and Chalk, {C. H.} and Barboi, {A. C.} and Amato, {A. A.} and Shaibani, {A. I.} and B. Katirji and Lecky, {B. R.F.} and C. Buckley and A. Vincent and E. Dias-Tosta and H. Yoshikawa and M. Waddington-Cruz and Pulley, {M. T.} and Rivner, {M. H.} and A. Kostera-Pruszczyk and Pascuzzi, {R. M.} and Jackson, {C. E.} and {Garcia Ramos}, {G. S.} and Verschuuren, {J. J.G.M.} and Massey, {J. M.} and Kissel, {J. T.} and Werneck, {L. C.} and M. Benatar and Barohn, {R. J.} and R. Tandan and T. Mozaffar and R. Conwit and J. Odenkirchen and Sonett, {J. R.} and A. Jaretzki and J. Newsom-Davis and Cutter, {G. R.}",

year = "2016",

doi = "10.1056/NEJMoa1602489",

language = "English",

volume = "375",

pages = "511--522",

journal = "New England Journal of Medicine",

issn = "0028-4793",

publisher = "Massachusetts Medical Society:860 Winter Street:Waltham, MA 02451:(800)843-6356, (781)893-3800, EMAIL: nejmcust@mms.org, INTERNET: http://www.massmed.org/, Fax: (781)647-5785, (781)893-7368",

}

Evoli, A, Wolfe, GI, Kaminski, HJ, Aban, IB, Minisman, G, Kuo, HC, Marx, A, Ströbel, P, Mazia, C, Oger, J, Cea, JG, Heckmann, JM, Nix, W, Ciafaloni, E, Antonini, G, Witoonpanich, R, King, JO, Beydoun, SR, Chalk, CH, Barboi, AC, Amato, AA, Shaibani, AI, Katirji, B, Lecky, BRF, Buckley, C, Vincent, A, Dias-Tosta, E, Yoshikawa, H, Waddington-Cruz, M, Pulley, MT, Rivner, MH, Kostera-Pruszczyk, A, Pascuzzi, RM, Jackson, CE, Garcia Ramos, GS, Verschuuren, JJGM, Massey, JM, Kissel, JT, Werneck, LC, Benatar, M, Barohn, RJ, Tandan, R, Mozaffar, T, Conwit, R, Odenkirchen, J, Sonett, JR, Jaretzki, A, Newsom-Davis, J & Cutter, GR 2016, 'Randomized trial of thymectomy in myasthenia gravis', New England Journal of Medicine, vol. 375, pagg. 511-522. https://doi.org/10.1056/NEJMoa1602489

Randomized trial of thymectomy in myasthenia gravis. / Evoli, Amelia; Wolfe, G. I.; Kaminski, H. J.; Aban, I. B.; Minisman, G.; Kuo, H. C.; Marx, A.; Ströbel, P.; Mazia, C.; Oger, J.; Cea, J. G.; Heckmann, J. M.; Nix, W.; Ciafaloni, E.; Antonini, G.; Witoonpanich, R.; King, J. O.; Beydoun, S. R.; Chalk, C. H.; Barboi, A. C.; Amato, A. A.; Shaibani, A. I.; Katirji, B.; Lecky, B. R.F.; Buckley, C.; Vincent, A.; Dias-Tosta, E.; Yoshikawa, H.; Waddington-Cruz, M.; Pulley, M. T.; Rivner, M. H.; Kostera-Pruszczyk, A.; Pascuzzi, R. M.; Jackson, C. E.; Garcia Ramos, G. S.; Verschuuren, J. J.G.M.; Massey, J. M.; Kissel, J. T.; Werneck, L. C.; Benatar, M.; Barohn, R. J.; Tandan, R.; Mozaffar, T.; Conwit, R.; Odenkirchen, J.; Sonett, J. R.; Jaretzki, A.; Newsom-Davis, J.; Cutter, G. R.

In: New England Journal of Medicine, Vol. 375, 2016, pag. 511-522.

Risultato della ricerca: Contributo in rivista › Articolo in rivista › peer review

TY - JOUR

T1 - Randomized trial of thymectomy in myasthenia gravis

AU - Evoli, Amelia

AU - Wolfe, G. I.

AU - Kaminski, H. J.

AU - Aban, I. B.

AU - Minisman, G.

AU - Kuo, H. C.

AU - Marx, A.

AU - Ströbel, P.

AU - Mazia, C.

AU - Oger, J.

AU - Cea, J. G.

AU - Heckmann, J. M.

AU - Nix, W.

AU - Ciafaloni, E.

AU - Antonini, G.

AU - Witoonpanich, R.

AU - King, J. O.

AU - Beydoun, S. R.

AU - Chalk, C. H.

AU - Barboi, A. C.

AU - Amato, A. A.

AU - Shaibani, A. I.

AU - Katirji, B.

AU - Lecky, B. R.F.

AU - Buckley, C.

AU - Vincent, A.

AU - Dias-Tosta, E.

AU - Yoshikawa, H.

AU - Waddington-Cruz, M.

AU - Pulley, M. T.

AU - Rivner, M. H.

AU - Kostera-Pruszczyk, A.

AU - Pascuzzi, R. M.

AU - Jackson, C. E.

AU - Garcia Ramos, G. S.

AU - Verschuuren, J. J.G.M.

AU - Massey, J. M.

AU - Kissel, J. T.

AU - Werneck, L. C.

AU - Benatar, M.

AU - Barohn, R. J.

AU - Tandan, R.

AU - Mozaffar, T.

AU - Conwit, R.

AU - Odenkirchen, J.

AU - Sonett, J. R.

AU - Jaretzki, A.

AU - Newsom-Davis, J.

AU - Cutter, G. R.

PY - 2016

Y1 - 2016

N2 - 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.

AB - 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.

KW - Glucocorticoids

KW - Hospitalization

KW - Humans

KW - Male

KW - Medicine (all)

KW - Middle Aged

KW - Myasthenia Gravis

KW - Prednisone

KW - Severity of Illness Index

KW - Single-Blind Method

KW - Thymectomy

KW - Treatment Outcome

KW - Young Adult

KW - Glucocorticoids

KW - Hospitalization

KW - Humans

KW - Male

KW - Medicine (all)

KW - Middle Aged

KW - Myasthenia Gravis

KW - Prednisone

KW - Severity of Illness Index

KW - Single-Blind Method

KW - Thymectomy

KW - Treatment Outcome

KW - Young Adult

UR - http://hdl.handle.net/10807/94686

UR - http://wwwnejmorg/doi/pdf/101056/nejmoa1602489

U2 - 10.1056/NEJMoa1602489

DO - 10.1056/NEJMoa1602489

M3 - Article

VL - 375

SP - 511

EP - 522

JO - New England Journal of Medicine

JF - New England Journal of Medicine

SN - 0028-4793

ER -