Table 1.
Demographic, Clinical, and MRI Characteristics at Baseline
| Placebo, cohort 2 (n = 12) | Placebo, cohort 1 + 2 (n = 71) | Vidofludimus calcium, 10 mg (n = 47) | Vidofludimus calcium, any dose (n = 178)a | |
| Age (y) | 37.4 (8.8) | 36.7 (8.7) | 38.1 (98) | 37.0 (9.0) |
| Female, n (%) | 8 (67) | 49 (69) | 34 (72) | 117 (66) |
| Race, n (%) | ||||
| White | 12 (100) | 71 (100) | 47 (100) | 178 (100) |
| Clinical characteristics | ||||
| Duration of disease (y)b | 4.96 (1.01, 13.8) | 3.61 (1.26, 10.2) | 4.66 (0.77, 8.38) | 3.61 (1.36, 9.11) |
| EDSS score | 3.50 (1.50, 3.50) | 3.00 (2.00, 3.50) | 3.00 (2.00, 3.50) | 2.50 (2.00, 3.50) |
| Number of relapses in the last 24 mo, n (%) | ||||
| 1c | 4 (33) | 35 (49) | 19 (40) | 82 (46) |
| 2 | 5 (42) | 27 (38) | 19 (40) | 75 (42) |
| ≥3 | 3 (25) | 9 (13) | 9 (19) | 21 (12) |
| MRI characteristics | ||||
| Gadolinium-positive lesions, n (%) | ||||
| 0 | 7 (58) | 36 (51) | 28 (60) | 95 (53) |
| ≥1 | 5 (42) | 35 (49) | 19 (40) | 83 (47) |
| No. of gadolinium-positive lesions | 1.08 (2.07) | 1.24 (2.23) | 0.91 (1.73) | 1.03 (1.73) |
| Volume of T2 lesions per patient (cm3)d | 18.1 (16.8) | 12.7 (12.0) | 10.1 (12.3) | 11.9 (12.9) |
| Treatment-naïve | 7 (58) | 50 (70) | 20 (43) | 99 (56) |
| Previous exposure to disease-modifying drugsc, n (%) | ||||
| Interferon or glatiramer acetate | 4 (33) | 14 (20) | 23 (49) | 51 (29) |
| Oral drugs | 1 (20) | 7 (10) | 4 (9) | 27 (15) |
| Monoclonal antibodies | 0 | 0 | 0 | 2 (<3) |
Abbreviation: EDSS = Expanded Disability Status Scale.
Data are n (%), mean (SD), or median (interquartile range) and consist of the modified full analysis set.
a
Consists of patients receiving 10 mg, 30 mg, or 45 mg vidofludimus calcium. Patient characteristics for the 30 mg and 45 mg groups individually are previously reported.3
b
Duration since time at which the diagnosis of multiple sclerosis was first documented.
c
Last treatment line.
d
Consists of the patients included in the efficacy analysis.