Table 1.
Patient baseline characteristics.
| Characteristic | TotalN = 1105 | Newly diagnosedn = 184 | EDSS ≤3.5n = 978 | Relapse ≤1n = 993 |
|---|---|---|---|---|
| Mean (SD) age, y | 38.8 ±10.0 | 35 (10) | 38 (10) | 39 (10) |
| Age category, y, n (%) | ||||
| 18–19 | 17 (2) | 6 (3) | 16 (2) | 14 (1) |
| 20–29 | 202 (18) | 63 (34) | 199 (20) | 164 (17) |
| 30–39 | 367 (33) | 60 (33) | 338 (35) | 329 (33) |
| 40–49 | 363 (33) | 39 (21) | 311 (32) | 338 (34) |
| 50–59 | 124 (11) | 13 (7) | 93 (10) | 118 (12) |
| ≥60 | 32 (3) | 3 (2) | 21 (2) | 30 (3) |
| Female, n (%) | 805 (72) | 116 (63) | 704 (72) | 718 (72) |
| Relapses in year before study enrolment, mean (SD) | 0.6 (0. 7) | 1.1 (0.7) | 0.6 (0.7) | 0.5 (0.5) |
| Time since most recent pre-study relapse, mean (SD), ya | 4.7 (3.3) | 4.1 (3.0) | 4.8 (3.3) | 5.1 (3.4) |
| Time since diagnosis of MS, mean (SD), y | 6.6 (6.1) | 0.4 (0.5) | 6.0 (5.5) | 6.9 (6.1) |
| EDSS score, median (range) | 2.0 (0, 7.0) | 1.6 (0, 6.5) | 1.6 (0, 3.5) | 2.0 (0.7) |
| Patients with any prior MS disease-modifying therapy n (%)b,c | 828 (75) | 2 (1) | 722 (74) | 763 (77) |
| Interferon beta-1a | 499 (45) | 0 (0) | 442 (46) | 460 (45) |
| Glatiramer acetate | 318 (28) | 0 (0) | 276 (29) | 293 (29) |
| Interferon beta-1b | 175 (16) | 0 (0) | 139 (15) | 157 (15) |
| Median (min, max) time since last MS disease-modifying therapy discontinuation, mo | 0.57 (0.03, 363.2) | |||
| Reason for prior MS treatment discontinuation, n (%)d | ||||
| Tolerability | 556 (50) | 0 (0) | 495 (52) | 519 (51) |
| Efficacy reasons | 335 (30) | 0 (0) | 266 (28) | 291 (29) |
| Safety | 58 (5) | 1 (50) | 50 (5) | 53 (5) |
| Other | 167 (15) | 1 (50) | 145 (15) | 156 (15) |
Total are patients in the primary analysis population.
EDSS: Expanded Disability Status Scale; values represent mean (SD) unless stated otherwise.
Race was not reported in 1001 patients due to confidentiality reasons implemented during the study.
aBased on data from 583 patients.
bOnly MS therapies taken before the first dose date of DMF initiation were included; patients may have received >1 therapy for MS.
cMedications previously taken by >10% of patients are shown. Other medications taken by >1% of patients include azathioprine, interferon beta, interferon, and teriflunomide.
dIf patients have >1 discontinuation reason for same MS therapy, only the last reason was used.