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Relapsing-Remitting Multiple Sclerosis: Longitudinal Analysis of MR Images-Lack of Correlation between Changes in T2 Lesion Volume and Clinical Findings¹

¹ From the Departments of Radiology (Y.M., R.I.G., J.K.U., L.W., L.J.M.) and Neurology (D.L.K.), Hospital of the University of Pennsylvania, Ground Fl, Founders, 3400 Spruce St, Philadelphia, PA 19104-4283; the Division of Biometrics, Hahnemann University, Philadelphia, Pa (M.P.); and the Department of Nuclear Medicine and Diagnostic Imaging, Kyoto University Hospital, Kyoto, Japan (Y.M.). Received June 1, 1998; revision requested July 22; final revision received January 8, 1999; accepted April 22. Supported in part by grants R01 NS29029 and M01-RR00040 from the National Institutes of Health, and grant RG2109B from the National Multiple Sclerosis Society. Address reprint requests to R.I.G. (e-mail: grossman@oasis .rad.upenn.edu).

PURPOSE: To determine the relationship between T2 lesion volume and either disability measurements or change in T2 lesion volume over time in multiple sclerosis (MS).

MATERIALS AND METHODS: Eighteen patients (age range, 26–53 years) with clinically proved relapsing-remitting MS were examined every 6 months for over 2 years. Three-millimeter-thick contiguous images of the whole brain were obtained. T2 lesion volume was calculated with a highly reproducible volumetric computer method.

RESULTS: A substantial annual increase in T2 lesion volume, with a median annual increase of approximately 8%, was demonstrated. However, there was no significant correlation between absolute T2 lesion volume and either the absolute expanded disability status scale (EDSS) grade (P = .32) or the absolute ambulation index (AI) (P = .20). In addition, no significant correlation between change in T2 lesion volume and change in EDSS grade (P = .42) or AI (P = .37) was found. There was no significant correlation between T2 lesion volume and duration of disease (P = .08).

CONCLUSION: There is no significant correlation between T2 lesion volume and standardized disability measurements despite a substantial increase in T2 lesion volume over time. Patients have an increase in total T2 lesion volume in the brain regardless of their clinical status or disability measurements. T2 lesion volumes as outcomes in therapeutic clinical trials on MS should be viewed as secondary outcomes rather than as surrogate markers of clinical responses.

Index terms: Brain, diseases, 10.871 • Brain, MR, 18.121416 • Magnetic resonance (MR), volume measurement, 10.121416 • Sclerosis, multiple, 10.871

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