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September 18, 2007; 69 (12) Articles

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

Maria Pia Sormani, Marco Rovaris, Giancarlo Comi, Massimo Filippi
First published September 17, 2007, DOI: https://doi.org/10.1212/01.wnl.0000276940.90309.15
Maria Pia Sormani
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Giancarlo Comi
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Massimo Filippi
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A composite score to predict short-term disease activity in patients with relapsing-remitting MS
Maria Pia Sormani, Marco Rovaris, Giancarlo Comi, Massimo Filippi
Neurology Sep 2007, 69 (12) 1230-1235; DOI: 10.1212/01.wnl.0000276940.90309.15

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This article has a correction. Please see:

  • CORRECTION - March 18, 2008
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Abstract

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.

Glossary

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