Demographics and baseline patient characteristics (all-treated analysis set)
| Characteristic | Placebo (n=121) | Ponesimod 10 mg (n=108) | Ponesimod 20 mg (n=114) | Ponesimod 40 mg (n=119) | Total (n=462) |
|---|---|---|---|---|---|
| Age, years | |||||
| Mean (SD) | 36.6 (8.6) | 36.9 (9.2) | 35.5 (8.5) | 36.5 (8.5) | 36.4 (8.7) |
| Median (range) | 35 (18–55) | 38 (18–55) | 35 (19–55) | 38 (18–55) | 36 (18–55) |
| Female, n (%) | 85 (70.2) | 71 (65.7) | 77 (67.5) | 79 (66.4) | 312 (67.5) |
| White race, n (%) | 114 (94.2) | 105 (97.2) | 112 (98.2) | 114 (95.8) | 445 (96.3) |
| EDSS score | |||||
| Mean (SD) | 2.2 (1.23) | 2.4 (1.25) | 2.2 (1.31) | 2.2 (1.17) | 2.3 (1.24) |
| Median (range) | 2.0 (0–5.5) | 2.0 (0–5.5) | 2.0 (0–5.5) | 2.0 (0–5.5) | 2.0 (0–5.5) |
| Time since first symptoms, years | |||||
| Mean (SD) | 6.9 (5.70) | 6.7 (6.57) | 7.3 (6.25) | 8.0 (7.05) | 7.2 (6.41) |
| Median (range) | 5.0 (0.2–28.0) | 4.3 (0.2–30.3) | 5.5 (0.4–31.2) | 6.0 (0.4–35.8) | 5.2 (0.2–35.8) |
| Time since most recent documented relapse, months | (n=121) | (n=105) | (n=113) | (n=118) | (n=457) |
| Mean (SD) | 5.6 (4.53) | 4.7 (3.42) | 5.1 (5.51) | 5.7 (4.12) | 5.3 (4.48) |
| Median (range) | 4.1 (0.5–36.5) | 3.8 (0.4–20.9) | 3.9 (0–50.0) | 4.5 (0.2–19.4) | 4.1 (0–50.0) |
| Documented relapses within past 24 months, n (%) | |||||
| 0* | 1 (0.8) | 4 (3.7) | 2 (1.8) | 1 (0.8) | 8 (1.7) |
| 1 | 49 (40.5) | 49 (45.4) | 49 (43.0) | 47 (39.5) | 194 (42.0) |
| ≥2 | 71 (58.7) | 55 (50.9) | 63 (55.3) | 71 (59.7) | 260 (56.3) |
| Total number of T1 Gd+ lesions | (n=116) | (n=107) | (n=110) | (n=114) | (n=447) |
| Mean (SD) | 1.7 (3.31) | 2.5 (6.03) | 2.5 (6.61) | 1.8 (3.63) | 2.1 (5.06) |
| Median (range) | 0 (0–20) | 1.0 (0–53) | 0 (0–59) | 0 (0–24) | 0 (0–59) |
| Patients free of T1 Gd+ lesions, n (%) | (n=116) 61 (52.6) | (n=107) 52 (48.6) | (n=110) 66 (60.0) | (n=114) 61 (53.5) | (n=447) 240 (53.7) |
| T2 lesion volume (mm3) | (n=115) | (n=107) | (n=111) | (n=113) | (n=446) |
| Mean (SD) | 6125 (8988) | 6310 (6862) | 7747 (10 005) | 5350 (6566) | 6377 (8262) |
| Median (range) | 2973 (0–44 344) | 3671 (0–31 583) | 3365 (0–51 943) | 2896 (63–42 524) | 3208 (0–51 943) |
*These patients were included in the study based on the presence of Gd+ lesions on screening MRI.
EDSS, Expanded Disability Status Score; T1 Gd+, T1-weighted gadolinium-enhanced.