Table 1.
Baseline demographic and disease characteristics (ITT population).
| Characteristic | Treatment-naïve patients (n = 185) | Previously treated patients (n = 135) | Total (n = 320) | p-valuea |
|---|---|---|---|---|
| Age, years | 33.1 (32.0, 34.3) | 34.0 (32.7, 35.3) | 33.5 (32.6, 34.4) | 0.3023 |
| Women, n (%) | 137 (74.1) | 88 (65.2) | 225 (70.3) | 0.0864b |
| Education, n (%) | 0.0323b | |||
| Primary | 21 (11.4) | 19 (14.1) | 40 (12.5) | |
| Secondary | 46 (24.9) | 53 (39.3) | 99 (30.9) | |
| Higher | 91 (49.2) | 53 (39.3) | 144 (45.0) | |
| Time since first symptoms of MS, years | 2.4 (2.2, 2.5) (n = 178) | 3.2 (3.0, 3.4) (n = 128) | 2.7 (2.6, 2.9) (n = 306) | <0.0001 |
| Time since diagnosis of MS, years | 0.6 (0.5, 0.7) (n = 182) | 2.5 (2.3, 2.7) (n = 135) | 1.4 (1.3, 1.6) (n = 317) | <0.0001 |
| Time since first relapse, years | 2.0 (1.8, 2.2) (n = 184) | 2.9 (2.7, 3.2) (n = 135) | 2.4 (2.3, 2.6) (n = 319) | <0.0001 |
| Relapses in the 2 years before screening, n | 2.6 (2.5, 2.7) (n = 183) | 3.0 (2.7, 3.2) (n = 133) | 2.8 (2.6, 2.9) (n = 316) | 0.0749 |
| ARR in the 2 years before screening | 2.3 (1.9, 2.8) (n = 184) | 1.4 (1.3, 1.5) (n = 134) | 1.9 (1.6, 2.2) (n = 318) | <0.0001 |
| ARR in the year before screening | 2.1 (1.8, 2.4) (n = 184) | 1.6 (1.4, 1.7) (n = 134) | 1.9 (1.7, 2.1) (n = 318) | 0.0074 |
| Patients experiencing relapses requiring hospitalization, n (%) | 0.0183c | |||
| 0 relapses | 123 (66.5) | 108 (80.0) | 231 (72.2) | |
| 1 relapse | 56 (30.3) | 23 (17.0) | 79 (24.7) | |
| 2 relapses | 4 (2.2) | 2 (1.5) | 6 (1.9) | |
| Maximum severity of relapses before enrolment, n (%) | 0.0318c | |||
| Mild | 67 (36.2) | 34 (25.2) | 101 (31.6) | |
| Moderate | 102 (55.1) | 93 (68.9) | 195 (60.9) | |
| Severe | 13 (7.0) | 5 (3.7) | 18 (5.6) | |
| EDSS score | 1.6 (1.4, 1.7) (n = 179) | 2.0 (1.9, 2.2) (n = 130) | 1.8 (1.7, 1.9) (n = 309) | NR |
| Normalized brain volume, mL | 1548 (1532, 1565) (n = 92) | 1532 (1508, 1557) (n = 43) | 1543 (1530, 1557) (n = 135) | 0.1998 |
| T2 lesion volume, mL | 7.0 (5.6, 8.4) (n = 163) | 6.9 (5.1, 8.6) (n = 106) | 6.9 (5.9, 8.0) (n = 269) | 0.3764 |
| T2 lesions at screening, n | 41.6 (36.1, 47.2) (n = 163) | 40.2 (33.9, 46.6) (n = 106) | 41.1 (36.9, 45.2) (n = 269) | 0.6872 |
Note: Data are mean (95% confidence interval) unless specified otherwise.
ARR: annualized relapse rate; EDSS: Expanded Disability Status Scale; ITT: intention-to-treat; NR: not reported.
aTreatment-naïve patients vs previously treated patients determined using the Mann–Whitney–Wilcoxon test unless noted otherwise.
bχ2test.
cFisher’s exact test.