Clinical and MRI outcomes at baseline and at 2 years
| Clinical or MRI characteristic | Baseline | 2 years | p Value* |
|---|---|---|---|
| Median EDSS (IQR) | 1.50 (0.50) | 1.50 (1.0) | 0.012 |
| Clinically definite MS | 57/135 (42%) | ||
| Number of subjects with ≥1 relapses | – | 57/135 (42%) | |
| Total number of relapses over 2 years | – | 0.92±1.4 | |
| Annual relapse rate | – | 0.46±0.67 | |
| Median time to first relapse†, months | – | 5.7±7.9 | |
| Contrast-enhancing lesion number | 0.77±2.3 | 0.70±3.9 | 0.21 |
| Contrast-enhancing lesion volume, cm3 | 0.068±0.24 | 0.080±0.53 | 0.27 |
| T2-LV, cm3 | 4.9±5.6 | 4.9±7.6 | 0.022 |
| Normalised WBV, cm3 | 1504±71 | 1486±71 | <0.001 |
| Normalised WMV, cm3 | 712±37 | 706±37 | 0.004 |
| Normalised GMV, cm3 | 792±47 | 779±48 | <0.001 |
| Cumulative contrast-enhancing lesion number | – | 1.1±4.7 | |
| Cumulative number of new T2 lesions | – | 3.8±9.0 | |
| Cumulative number of new/enlarging lesions | – | 5.3±13 | |
| Change in brain volume, % | – | −1.26±1.3 | |
| Change in grey matter volume, % | – | −1.59±2.2 |
The MRI outcomes are shown a mean±SD.
*Non-parametric Wilcoxon test.
†For the subset with≥1 relapses.
GMV, grey matter volume; LV, lesion volume; MS, multiple sclerosis; WBV, whole brain volume; WMV, white matter volume.