Sunday, May 3

A longitudinal study of cerebral gray matter volume in patients receiving Tysabri (natalizumab) for multiple sclerosis: STUDY


To assess the change in cerebral gray matter volume (GMV) during one year of Tysabri therapy in patients with multiple sclerosis (MS). BACKGROUND: Brain atrophy in patients with MS selectively affects the gray matter (GM). Several studies have shown the high clinical relevance of GM atrophy in predicting physical disability and cognitive impairment. The effect of disease-modifying therapies on such atrophy has not been extensively studied.

We retrospectively identified 20 consecutive patients who had 1.5T brain MRI ~1 year apart during treatment with Tysabri The patients had relapsing-remitting (n=18) or progressive (n=2) forms of MS. At the time of the first scan, the patients had been on Tysabri for (mean±SD) 16.6±10.9 months. Baseline characteristics were age 38.5±7.4 and disease duration 9.7±4.3 years; six (30[percnt]) were men. GMV was determined by a semi-automated technique using output from a template driven segmentation.

At baseline, GMV was 664.0±56.4 ml, Expanded Disability Status Scale (EDSS) score was 2.3±2.0 and timed 25 foot walk (T25FW) was 6.1±3.4 seconds. At follow-up, GMV was 664.03±60.08 mL; EDSS was 2.6±2.1 and T25FW was 5.9±2.9 seconds. One sample t-tests showed no significant annualized change in GMV [estimated mean difference -0.17, 95[percnt] confidence interval (CI) -10.49, 10.15, p=0.97)], EDSS (estimated mean difference 0.38, 95[percnt] CI -0.15, 0.91, p=0.15), or T25FW (estimated mean difference -0.22, 95[percnt] CI -1.14, 0.70, p=0.63). No patients had clinical relapses during the observation period.

This pilot study shows the lack of cerebral GM atrophy during one year of Tysabri therapy in patients with MS. The lack of GM atrophy paralleled the lack of clinical worsening in terms of relapses or change in physical disability measures. Further controlled prospective comparison group studies with larger sample sizes and longer study durations are necessary to confirm and extend these results. Study Supported by: Biogen, Inc.

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