A composite score to predict short-term disease activity in patients with relapsing-remitting MS.
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.
Sormani
Maria Pia
MP
Neuroimaging Research Unit, San Raffaele Scientific Institute, Milan, Italy.
Rovaris
Marco
M
Comi
Giancarlo
G
Filippi
Massimo
M
D000293:Adolescent; D000328:Adult; D002490:Central Nervous System / Q000473:pathology* / Q000503:physiopathology; D002986:Clinical Trials as Topic / Q000379:methods*; D018450:Disease Progression; D004311:Double-Blind Method; D006801:Humans; D008279:Magnetic Resonance Imaging; D008875:Middle Aged; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000175:diagnosis* / Q000503:physiopathology; D010919:Placebos; D011237:Predictive Value of Tests; D011379:Prognosis; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data; D012044:Regression Analysis; D055502:Secondary Prevention; D012720:Severity of Illness Index
D010919:Placebos