Table 2.
Patient demographics and baseline clinical characteristics according to treatment group for the ITT population with valid scan at Baseline and Year 2.
| Placebo, n = 234 | 7 mg, n = 240 | 14 mg, n = 235 | |
|---|---|---|---|
| Age, mean (SD), years | 37.6 (8.7) | 37.5 (8.9) | 37.9 (8.5) |
| Female sex, no. (%) | 184 (78.6) | 171 (71.3) | 168 (71.5) |
| Time since diagnosis of MS, mean (SD), years | 4.6 (5.1) | 5.1 (5.4)a | 5.7 (5.9) |
| Time since first symptoms of MS, mean (SD), years | 8.3 (6.8) | 8.5 (7.0) | 9.0 (7.1) |
| Time since most recent relapse onset, mean (SD), months | 6.7 (3.8) | 6.5 (3.3) | 6.9 (3.8) |
| Relapses, mean (SD), no. | |||
| In previous year | 1.4 (0.7)b | 1.4 (0.6)c | 1.3 (0.7)c |
| In previous 2 years | 2.1 (0.8) | 2.2 (1.0) | 2.2 (0.9) |
| MS subtype, n (%) | |||
| Relapsing remitting | 216 (92.3) | 220 (91.7) | 226 (96.2) |
| Use of previous MS treatment in the last 2 years, n (%) | 50 (21.4) | 57 (23.8) | 58 (24.7) |
| Baseline EDSS score, mean (SD) | 2.5 (1.3) | 2.5 (1.3) | 2.5 (1.2) |
| Number of contrast-enhancing lesions, mean (SD) | 1.3 (3.1) | 1.5 (3.7) | 1.7 (5.4)d |
| Baseline normalized brain volume, cm3, mean (SD) | 1506.3 (80.3) | 1508.9 (82.6) | 1499.6 (74.8) |
| Baseline T2-weighted lesion volume, mL, mean (SD) | 15.2 (15.7) | 16.6 (16.4) | 14.2 (13.5) |
EDSS: Expanded Disability Status Scale; ITT: intent-to-treat; SD: standard deviation.
a
n =239.
b
n = 180.
c
n = 186.
d
n = 234.