Table 3. Comparison of disease activity over 2 years in placebo SPMS versus placebo PPMS by various definitions of intermittent activity, progression, and improvement.
| SPMS (%) | PPMS (%) | p-value | |
| Average of Intermittent Activity (median) a | 21.6 | 19.9 | |
| MRI | 64.6 | 68.0 | 0.79b |
| EDSS Total Score | 28.2 | 32.1 | 0.74 |
| EDSS Cerebral | 24.3 | 14.2 | 0.21 |
| EDSS Visual | 20.9 | 11.9 | 0.22 |
| EDSS Brain Stem | 19.9 | 19.4 | 1 |
| EDSS Pyramidal | 3.4 | 7.5 | 0.38 |
| EDSS Sensory | 14.1 | 22.4 | 0.24 |
| EDSS Cerebellar | 22.3 | 19.4 | 0.79 |
| EDSS Bowel & Bladder | 17.5 | 11.2 | 0.38 |
| T25FW | 50.0 | 48.4 | 0.94 |
| 9HP | 32.4 | 20.3 | 0.17 |
| PASAT | 20.4 | 30.6 | 0.22 |
| MRI Progression c | |||
| 1 (≥1 SD) | 1.9 | 1.6 | 1 |
| 2 (≥0.5 SD) | 6.5 | 5.5 | 0.92 |
| 3 (≥0.25 SD) | 36.8 | 26.6 | 0.28 |
| Average of Clinical Progression 1 (median) | 11.8 | 13.4 | |
| EDSS Total Score | 19.2 | 22.5 | 0.75 |
| EDSS Cerebral | 7.8 | 11.4 | 0.67 |
| EDSS Visual | 14.9 | 9.1 | 0.38 |
| EDSS Brain Stem | 11.9 | 6.1 | 0.31 |
| EDSS Pyramidal | 11.3 | 13.4 | 0.80 |
| EDSS Sensory | 6.0 | 19.5 | 0.008* |
| EDSS Cerebellar | 15.6 | 17.2 | 0.94 |
| EDSS Bowel & Bladder | 16.1 | 14.4 | 0.94 |
| T25FW | 19.8 | 29.8 | 0.22 |
| 9HP | 10.7 | 6.2 | 0.42 |
| PASAT | 1.5 | 1.5 | 1 |
| Average of Clinical Progression 2 (median) | 12.3 | 14.4 | |
| EDSS Total Score | 19.1 | 23.2 | 0.70 |
| EDSS Cerebral | 6.7 | 9.6 | 0.70 |
| EDSS Visual | 12.3 | 12.0 | 1 |
| EDSS Brain Stem | 11.8 | 7.2 | 0.55 |
| EDSS Pyramidal | 8.2 | 11.2 | 0.74 |
| EDSS Sensory | 7.7 | 19.2 | 0.04* |
| EDSS Cerebellar | 10.8 | 19.4 | 0.22 |
| EDSS Bowel & Bladder | 13.3 | 12.8 | 1 |
| T25FW | 58.5 | 56.5 | 0.94 |
| 9HP | 58.7 | 40.5 | 0.04* |
| PASAT | 22.6 | 14.4 | 0.29 |
| Average of Clinical Improvement (median) | 13.6 | 12.4 | |
| EDSS Total Score | 5.3 | 4.1 | 0.94 |
| EDSS Cerebral | 13.6 | 16.5 | 0.75 |
| EDSS Visual | 14.7 | 20.7 | 0.50 |
| EDSS Brain Stem | 16.2 | 13.2 | 0.75 |
| EDSS Pyramidal | 9.5 | 12.4 | 0.74 |
| EDSS Sensory | 22.0 | 9.9 | 0.07 |
| EDSS Cerebellar | 17.5 | 18.2 | 0.99 |
| EDSS Bowel & Bladder | 22.5 | 15.7 | 0.40 |
| T25FW | 2.3 | 4.7 | 0.65 |
| 9HP | 0.0 | 0.9 | 0.70 |
| PASAT | 5.3 | 10.1 | 0.42 |
a
For each clinical disease activity pattern (intermittent, clinical progression 1, clinical progression 2, and improvement) we present the median percentage as an average of all the measurements within each category.
b
All P values have been adjusted for multiple comparisons.
c
Brain parenchymal fraction (BFP) was measured in IMPACT study while whole brain volume was measured in OLYMPUS study. For the purpose of multiple comparison correction, MRI progression was considered as a single variable (with MRI progression 1, 2, and 3 being presented as a sensitivity analysis).