Table 1.
Demographics and baseline characteristics of the MRI cohort
| Characteristic | Placebo (n = 180) | Delayed-release DMF BID (n = 176) | Delayed-release DMF TID (n = 184) |
|---|---|---|---|
| Age, mean (SD) years | 38.3 (9.16) | 38.3 (9.31) | 38.5 (8.59) |
| <40 years, n (%) | 90 (50) | 92 (52) | 101 (55) |
| ≥40 years, n (%) | 90 (50) | 84 (48) | 83 (45) |
| Female, n (%) | 141 (78) | 136 (77) | 140 (76) |
| McDonald criteria for diagnosis | |||
| Criterion 1, n (%) | 152 (84) | 149 (85) | 147 (80) |
| Criteria 2–4, n (%) | 28 (16) | 27 (15) | 37 (20) |
| Previous approved disease-modifying therapy, n (%)a | 77 (43) | 68 (39) | 74 (40) |
| Time since diagnosis, mean (SD) years | 6.0 (5.76) | 5.6 (5.54) | 5.0 (4.96) |
| Relapses in previous year, mean (SD) | 1.3 (0.73) | 1.3 (0.64) | 1.3 (0.57) |
| ≤1 relapse, n (%) | 122 (68) | 123 (70) | 134 (73) |
| ≥2 relapses, n (%) | 58 (32) | 53 (30) | 50 (27) |
| EDSS score, mean (SD)b | 2.53 (1.25) | 2.29 (1.17) | 2.30 (1.19) |
| EDSS ≤2, n (%) | 88 (49) | 101 (57) | 105 (57) |
| EDSS >2, n (%) | 92 (51) | 75 (43) | 79 (43) |
| Number of T2 lesions, mean (SD) | 49.2 (38.6) | 47.6 (34.7) | 55.8 (44.3) |
| T2 lesion volume, mean (SD) mm3 | 6,524.9 (7,601.50) | 8,463.8 (10,058.73) | 9,014.5 (11,769.21) |
| Number of Gd+ lesions, mean (SD) | 1.6 (3.45) | 1.2 (3.30) | 1.2 (4.10) |
| Patients with Gd+ lesions, n (%) | |||
| 0 lesions | 103 (57) | 117 (66) | 124 (67) |
| 1–4 lesions | 55 (31) | 47 (27) | 49 (27) |
| 5–8 lesions | 13 (7) | 5 (3) | 7 (4) |
| ≥9 lesions | 9 (5) | 6 (3) | 4 (2) |
| Unknown | 0 | 1 (<1) | 0 |
| Number of T1-hypointense lesions, mean (SD) | 27.3 (28.47) | 27.8 (29.66) | 33.6 (34.74) |
| Normalized whole brain volume, mean (SD) cm3 | 1,586.7 (81.7) | 1,573.5 (85.8) | 1,565.5 (93.1) |
BID twice daily, EDSS Expanded Disability Status Scale, Gd+ gadolinium-enhancing, TID three times daily
aData shown for approved disease-modifying treatments only: interferon β-1a (29 % of all patients in the MRI cohort), glatiramer acetate (18 %), interferon β-1b (12 %), and natalizumab (3 %). Patients may have received more than one prior disease-modifying treatment
bScores on the EDSS range from 0 to 10, with higher scores indicating a greater degree of disability. Baseline score was >5.0 for one patient in the placebo group and one patient in the TID group