Abstract
Assess the sensitivity of the Magnetic Resonance Disease Severity Scale (MRDSS), based on cerebral lesions and atrophy, for treatment monitoring of glatiramer acetate (GA) in relapsing-remitting multiple sclerosis (MS). This retrospective non-randomized pilot study included patients who started daily GA [n = 23, age (median, range) 41 (26.2, 53.1) years, Expanded Disability Status Scale (EDSS) score 1.0 (0, 3.5)], or received no disease-modifying therapy (noDMT) [n = 21, age 44.8 (28.2, 55.4), EDSS 0 (0, 2.5)] for 2 years. MRDSS was the sum of z-scores (normalized to a reference sample) of T2 hyperintense lesion volume (T2LV), the ratio of T1 hypointense LV to T2LV (T1/T2), and brain parenchymal fraction (BPF) multiplied by negative 1. The two groups were compared by Wilcoxon rank sum tests; within group change was assessed by Wilcoxon signed rank tests. Glatiramer acetate subjects had less progression than noDMT on T1/T2 [(median z-score change (range), 0 (−1.07, 1.20) vs. 0.41 (−0.30, 2.51), p = 0.003)] and MRDSS [0.01 (−1.33, 1.28) vs. 0.46 (−1.57, 2.46), p = 0.01]; however, not on BPF [0.12 (−0.18, 0.58) vs. 0.10 (−1.47,0.50), p = 0.59] and T2LV [−0.03 (−0.90, 0.57) vs. 0.01 (−1.69, 0.34), p = 0.40]. While GA subjects worsened only on BPF [0.12 (−0.18, 0.58), p = 0.001], noDMT worsened on BPF [0.10 (−1.47, 0.50), p = 0.002], T1/T2 [0.41 (−0.30, 2.51), p = 0.0002], and MRDSS [0.46 (−1.57, 2.46), p = 0.0006]. These preliminary findings show the potential of two new cerebral MRI metrics to track MS therapeutic response. The T1/T2, an index of the destructive potential of lesions, may provide particular sensitivity to treatment effects.
Highlights
MRI has provided a range of tools to define pathological changes in the brain and spinal cord in patients with multiple sclerosis (MS) [1]
The first such measure, the Z4 score, combined measures of disease activity and disease severity, and has been applied to assess treatment response [2, 4, 8]. These MS-MRI composite scales have shown higher effect sizes in their relationship to clinical status or longitudinal change as compared to established individual MS-MRI measures [5,6,7, 11, 12]. Building on this previous work, we tested a cerebral MRI composite scale focusing on MS disease severity as shown by lesions and atrophy which includes an assessment of the destructive potential of individual lesions, the intrasubject ratio of T1 hypointense to T2 hyperintense lesion volume (T1/T2)
When assessing the on-study changes within the no disease-modifying therapy (noDMT) group, statistically significant worsening was seen in brain parenchymal fraction (BPF) [0.01 (-1.47, 0.50), p = 0.002], T1/T2 [0.41 (-0.30, 2.51), p = 0.0002], and Magnetic Resonance Disease Severity Scale (MRDSS) [0.46 (-1.57, 2.46), p = 0.0006]
Summary
MRI has provided a range of tools to define pathological changes in the brain and spinal cord in patients with multiple sclerosis (MS) [1]. Prior studies have combined cerebral MRI lesion and atrophy measures to create composite scales to increase sensitivity, provide a comprehensive assessment of disease status, and, in turn, provide more clinical relevance than individual MRI measures on their own [2,3,4,5,6,7,8,9,10,11] The first such measure, the Z4 score, combined measures of disease activity and disease severity, and has been applied to assess treatment response [2, 4, 8]. Known as the Magnetic Resonance Disease Severity Scale (MRDSS) [5],
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