Table 1.
Group 1 Least BVL (⩽0.52% reduction) n = 221 |
Group 2 Intermediate BVL (>0.52%–2.18% reduction) n = 357 |
Group 3 Most BVL (>2.18% reduction) n = 131 |
|
---|---|---|---|
Age, mean (SD), years | 38.4 (8.0) | 37.8 (8.8) | 36.1 (9.3) |
Female sex, no. (%) | 152 (68.8) | 272 (76.2) | 99 (75.6) |
Time since diagnosis of MS, mean (SD), years | 5.2 (5.8) | 5.3 (5.5)b | 4.3 (4.8) |
Time since first symptoms of MS, mean (SD), years | 8.6 (7.2) | 8.9 (7.0) | 7.7 (6.5) |
Time since most recent relapse onset, mean (SD), months | 6.6 (3.4) | 6.8 (3.7) | 6.8 (4.0) |
Relapses, mean (SD), no. | |||
In previous year | 1.3 (0.7)c | 1.3 (0.7)d | 1.4 (0.7)e |
In previous 2 years | 2.1 (0.9) | 2.2 (0.9) | 2.3 (1.0) |
MS subtype, n (%) | |||
Relapsing remitting | 204 (92.3) | 336 (94.1) | 122 (93.1) |
Use of previous MS treatment in the last 2 years, n (%) | 47 (21.3) | 83 (23.2) | 35 (26.7) |
Baseline EDSS score, mean (SD) | 2.4 (1.2) | 2.5 (1.3) | 2.8 (1.3) |
Number of contrast-enhancing lesions, mean (SD) | 0.5 (1.2)f | 1.2 (2.8) | 4.0 (7.9) |
Baseline normalized brain volume, cm3, mean (SD) | 1514.6 (74.8) | 1509.5 (77.7) | 1476.3 (85.1) |
Baseline T2-weighted lesion volume, mL, mean (SD) | 10.1 (11.1) | 14.8 (14.8) | 25.5 (17.7) |
BVL: brain volume loss; EDSS: Expanded Disability Status Scale; ITT: intent-to-treat; SD: standard deviation.
The ITT population represents pooled data from placebo and active treatment groups.
n = 356.
n = 172.
n = 277.
n = 103.
n = 220.