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Abstract
Objective: We aimed to determine the effectiveness of IV immunoglobulin (IVIG) in the treatment of patients with myasthenia gravis (MG) and worsening weakness in a randomized, placebo-controlled, masked study.
Methods: Fifty-one patients with worsening weakness due to MG were randomized to infusion with 2 g/kg of IVIG or an equivalent volume of IV dextrose 5% in water. The Quantitative Myasthenia Gravis (QMG) Score for Disease Severity, a validated clinical composite scale, was calculated by a masked observer at baseline and days 14 and 28.
Results: In IVIG-treated patients, a clinically meaningful improvement in QMG Score for Disease Severity was observed at day 14 and persisted at day 28. The greatest improvement occurred in patients with more severe disease as defined by a QMG Score for Disease Severity greater than 10.5.
Conclusion: This study provides level 1 evidence for the effectiveness of IV immunoglobulin in patients with worsening weakness due to myasthenia gravis.
Footnotes
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Editorial, see page 803
Disclosure: Talecris (formerly Bayer) provided an unrestricted education grant for this study. Bayer/Talecris was not involved in the study design, conduct of the study, collection and management of data, or interpretation of results. A Bayer statistician provided technical support and review of our own analyses of the data. Bayer/Telecric did not play a role in the preparation or approval of the manuscript..
Received July 14, 2006. Accepted in final form October 19, 2006.
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