Clinical and magnetic resonance imaging changes correlate in a clinical trial monitoring cyclosporine therapy for multiple sclerosis. The MS Study Group.
Magnetic resonance imaging (MRI) was used to monitor cyclosporine therapy for chronic progressive multiple sclerosis in a multicenter clinical trial and an analysis was performed to determine whether there was a correlation between clinical changes and MRI changes. MRI was performed on 163 patients at the onset and completion of the 2-year study. Burden of disease (BOD, lesion load) was quantitated by a single observer using a computer program. Active lesions were also identified. The Expanded Disability Status Scale (EDSS) score was determined every 3 months MRI data did not show any effect of cyclosporine treatment on BOD progression (mean 24.5% increase/yr) or lesion activity. However, there was a statistically significant positive correlation between the baseline total BOD value and the baseline EDSS score (r = 0.221, p = 0.005) and a positive correlation between the percent changes in BOD from baseline to exit and EDSS score (r = 0.186, p = 0.018). The study supports the concepts that MRI is a useful technique in monitoring therapeutic trials and that MRI is a direct measure of pathology.
Zhao
G J
GJ
Division of Neurology, University of British Columbia, Vancouver Hospital and Health Sciences Centre, Canada.
Li
D K
DK
Wolinsky
J S
JS
Koopmans
R A
RA
Mietlowski
W
W
Redekop
W K
WK
Riddehough
A
A
Cover
K
K
Paty
D W
DW
D001921:Brain / Q000473:pathology; D015331:Cohort Studies; D016572:Cyclosporine / Q000009:adverse effects / Q000627:therapeutic use*; D004185:Disability Evaluation; D004311:Double-Blind Method; D016903:Drug Monitoring; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D008279:Magnetic Resonance Imaging; D009103:Multiple Sclerosis / Q000175:diagnosis / Q000188:drug therapy*; D009460:Neurologic Examination / Q000187:drug effects*; D016896:Treatment Outcome
D007166:Immunosuppressive Agents; D016572:Cyclosporine