Table 1.
Patient demographics and baseline disease characteristics.
| Parameter | Core study (randomized set),
23
N = 1641 |
Participants entering extension
part, N = 1224 |
||
|---|---|---|---|---|
| Siponimod (N = 1105) |
Placebo (N = 546) |
Siponimod (N = 824) |
Placebo (N = 400) |
|
| Age (years) | 48.0 ± 7.8 | 48.1 ± 7.9 | 47.8 ± 7.8 | 48.5 ± 8.1 |
| >41 years, n (%) | 917 (83.0) | 443 (81.1) | 678 (82.3) | 324 (81.1) |
| Time since onset of MS symptoms (years) | 17.1 ± 8.4 | 16.2 ± 8.2 | 16.9 ± 8.3 | 16.2 ± 8.4 |
| Time since conversion to SPMS (years) | 3.9 ± 3.6 | 3.6 ± 3.3 | 3.7 ± 3.5 | 3.5 ± 3.2 |
| Time since onset of the last relapse (years) | 5.15 ± 5.13 | 4.52 ± 4.61 | 4.99 ± 5.04 | 4.82 ± 4.84 |
| Absence of relapses in the last 2 years prior to screening, n (%) a | 712 (64) | 343 (63) | 521 (63) | 260 (65) |
| Absence of relapses in the last year prior to screening, n (%) a | 878 (79) | 416 (76) | 651 (79) | 311 (78) |
| EDSS score | 5.4 ± 1.1 | 5.4 ± 1.0 | 5.4 ± 1.1 | 5.4 ± 1.0 |
| Median (range) | 6.0 (2.0–7.0) | 6.0 (2.5–7.0) | 6.0 (2.5–7.0) | 6.0 (2.5–7.0) |
| SDMT score | 38.9 ± 13.99 | 39.6 ± 13.34 | 38.8 ± 14.09 | 40.6 ± 13.11 |
| Median (range) | 40.0 (0–83) | 42.0 (0–81) | 40.0 (0–80) | 43.0 (1–81) |
| Absence of Gd+ T1 lesions at baseline, n (%) a | 833 (75) | 415 (76) | 613 (74) | 312 (78) |
| Total volume of lesions on T2-weighted images (mm3) |
15,632 ± 16,268 | 14,694 ± 15,620 | 15,165 ± 15,760 | 13,702 ± 15,106 |
| Normalized brain volume (cm3) | 1422 ± 86 | 1425 ± 88 | 1423 ± 87 | 1423 ± 87 |
MS: multiple sclerosis; SPMS: secondary progressive multiple sclerosis; EDSS: Expanded Disability Status Scale; SDMT: Symbol Digit Modalities Test; Gd+: gadolinium-enhancing.
All randomized set. Data represented as mean ± SD, unless otherwise specified.
a
The numbers and percentages of participants with missing screening or baseline observations are not displayed.