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A composite score to predict short-term disease activity in patients with relapsing-remitting MS

From Neuroimaging Research Unit (M.P.S., M.R., M.F.) and Department of Neurology (M.R., G.C., M.F.), San Raffaele Scientific Institute, Milan; and DISSAL (M.P.S.), Biostatistics Unit, University of Genoa, Italy.

Address correspondence and reprint requests to Dr. Massimo Filippi, Neuroimaging Research Unit, Department of Neurology, San Raffaele Scientific Institute, via Olgettina 60, 20132 Milan, Italy filippi.massimo{at}hsr.it

Objective: To generate and validate a composite (clinical and MRI-based) score able to identify individual patients with relapsing-remitting multiple sclerosis (RRMS) with a high risk of experiencing relapses in the short term.

Methods: The study was conducted using data from a working and a validation dataset. The former consisted of 539 patients from the placebo arm of a double-blind, placebo-controlled trial of oral glatiramer acetate (GA) in RRMS. The validation sample consisted of 117 patients from the placebo arm of a double-blind, placebo-controlled trial of subcutaneous GA in RRMS. In the working sample, regression analysis was performed to identify clinical or MRI variables independently predicting the occurrence of relapses. A linear predictive score was calculated using the variables included in the multivariable model and the corresponding estimated coefficients. Such a score was then applied to the validation sample.

Results: The variables included in the final model as independent predictors of relapse occurrence were the number of enhancing lesions on a baseline MRI (p < 0.001) and the number of relapses during the previous 2 years (p < 0.001). The resulting score was able to identify patients at high and low risk of relapse occurrence both in the working and in the validation samples.

Conclusions: The composite, clinical/MRI score presented here, which allows us to estimate the short-term risk of relapses in patients with relapsing-remitting multiple sclerosis, may provide us with an additional and useful piece of information for a better planning of phase III trials in multiple sclerosis.

Abbreviations: EDSS = Expanded Disability Status Scale; GA = glatiramer acetate; Gd = gadolinium; HR = hazard ratio; MS = multiple sclerosis; RRMS = relapsing-remitting multiple sclerosis.

*These authors contributed equally.

Disclosure: M.P.S. received a research grant from TEVA Neuroscience, M.R. received honoraria for lectures and travel grants from Biogen-Dompè and TEVA Neuroscience, G.C. received personal compensation from TEVA Neuroscience, Schering, and Serono for speaking activities, M.F. received personal compensation from TEVA Neuroscience, Biogen-Dompè, and Schering for consulting services, and from TEVA Neuroscience, Biogen-Dompè, Schering, and Serono for speaking and educational activities.

Received January 15, 2007. Accepted in final form April 19, 2007.

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