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. 2014 Jul 3;261(9):1794–1802. doi: 10.1007/s00415-014-7412-x

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