Table 4.
Patient characteristics in SPMS trials.
| Parameter | IFN-beta 1b
s.c. (European Study group)57–59 |
IFN-beta 1b s.c. (North American Study Group)58,60 |
Siponimod (EXPAND)64 |
|||
|---|---|---|---|---|---|---|
| IFN-beta 1b
s.c. N = 360 |
Placebo N = 358 |
IFN-beta 1b s.ca
N = 317 |
Placebo N = 308 |
Siponimod N = 1105b |
Placebo N = 546 |
|
| Age in years, mean (SE/SD) | 41.1 (SD 7.2) | 40.9 (SD 7.2) | 46.1 (SE 0.45) | 47.6 (SE 0.46) | 48.0 (SD 7.8) | 48.1 (SD 7.9) |
| Female, n (%) | 209 (58.1) | 230 (64.2) | 210 (66.2) | 185 (60.1) | 669 (60.5) | 323 (59.2) |
| Duration of MS since diagnosis in years, mean (SE/SD) | 8.1 (SD 5.6) | 8.2 (SD 6.1) | 14.6 (SE 0.44) | 14.9 (SE 0.48) | 12.9 (SD 7.9) | 12.1 (SD 7.5) |
| Duration of SPMS in years, mean (SE/SD) | 3.8 (SD 2.7) | 3.8 (SD 3.4) | 4.0 (SE 0.19) | 4.1 (SE 0.20) | 3.9 (SD 3.6) | 3.6 (SD 3.3) |
| EDSS, mean (SE/SD) | 5.1 (SD 1.1) | 5.2 (SD 1.1) | 5.2 (SE 0.06) | 5.1 (SE 0.07) | 5.4 (SD 1.1) | 5.4 (SD 1.0) |
| EDSS ⩾ 6, n (%) | 153 (42.5) | 169 (47.2) | n.a. | n.a. | 622 (56.3) | 296 (54.2) |
| Relapse-free in prior 2 years, n (%) | 115 (31.9) | 101 (28.2) | 170 (53.6) | 174 (56.5) | 712 (64.4)c | 343 (62.8)c |
| Proportion of patients with Gd+ T1 lesions, % | 30 | 55 | 21 | |||
Gd, gadolinium; IFN, interferon; MRI, magnetic resonance imaging; N, number of randomized patients; n.a., not available; s.c., subcutaneous; SD, standard deviation; SE, standard error; SPMS, secondary progressive multiple sclerosis; w, week.
a
Only results for the approved standard dose (250 µg) are presented.
b
A total of 1105 patients were randomized to the siponimod arm, but 6 were excluded from efficacy analysis.
c
For three patients in the siponimod and one patient in the placebo group, information on the number of relapses in the past 2 years was not available.