Thymectomy in Non-thymomatous Myasthenia Gravis: Results from MGTX, a Randomized, Controlled Trial (S28.003)
Abstract
OBJECTIVE: Does extended transsternal thymectomy (ETTX) combined with a defined prednisone protocol, compared with the prednisone protocol alone: result in a greater improvement in myasthenic weakness; result in a lower total dose of prednisone; and enhance the quality of life by reduction of adverse events?
BACKGROUND
Since first utilized in 1941, a benefit from thymectomy in non-thymomatous myasthenia gravis (MG) has been claimed by numerous studies. In 2000, an evidence-based review summarized outcomes from 21 controlled, non-randomized MG cohorts, pointed out methodological flaws preventing definite conclusions regarding the procedure’s benefit and concluded that thymectomy should be a treatment option. In concert with calls dating back a half century, the reviewers recommended a controlled, randomized study that employed a standardized medical therapy.
METHODS
MGTX was organized as a five-continent, international, single-blinded, randomized trial with the aim to answer three questions posed above. Inclusion criteria were MG Foundation of America Clinical Classification 2 to 4, elevated acetylcholine receptor antibody levels, age >18.0 and <65.0 years, and disease history <5 years. Patients were followed in single-blind fashion for a minimum of 3 years.
RESULTS
A total of 126 patients were enrolled between 2006 and 2012 across 36 sites. The mean age was 35.1 years. MGFA Class at the time of randomization: 39.7[percnt] were class IIa, 25[percnt] Class IIb , 22[percnt]…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 126 participants or records.
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