Table 1.
Standard-resolution MRI subset
(N = 1007) |
High-resolution MRI subset
(N = 546) |
MTR subset
(N = 606) |
Overall EXPAND population
b
(combined MRI) (N = 1560) |
|||||
---|---|---|---|---|---|---|---|---|
Siponimod (n = 656) | Placebo (n = 351) | Siponimod (n = 376) | Placebo (n = 170) | Siponimod (n = 388) | Placebo (n = 218) | Siponimod (n = 1037) | Placebo (n = 523) | |
Age, years, mean (SD) | 48.0 (7.5) | 48.4 (8.0) | 47.6 (8.4) | 48.0 (7.5) | 48.0 (7.5) | 48.0 (8.3) | 47.9 (7.9) | 48.2 (7.9) |
Women, n (%) | 396 (60.4) | 209 (59.5) | 231 (61.4) | 101 (59.4) | 238 (61.3) | 129 (59.2) | 631 (60.8) | 310 (59.3) |
Duration of MS since first symptom, years, mean (SD) | 17.1 (8.4) | 16.1 (8.5) | 16.8 (8.2) | 16.6 (7.8) | 16.7 (8.1) | 16.2 (8.7) | 17.0 (8.3) | 16.2 (8.3) |
Time since conversion to SPMS, years, mean (SD) | 3.6 (3.3) | 3.2 (3.2) | 4.1 (3.9) | 4.0 (3.2) | 3.5 (3.3) | 3.1 (3.2) | 3.8 (3.5) | 3.5 (3.2) |
Baseline EDSS score, median (range) | 6.0 (2.5–6.5) | 6.0 (2.5–7.0) | 6.0 (2.5–7.0) | 6.0 (3.0–6.5) | 6.0 (2.5–6.5) | 6.0 (2.5–7.0) | 6.0 (2.5–7.0) | 6.0 (2.5–7.0) |
SDMT score, mean (SD) | 39.5 (13.7) | 39.9 (13.6) | 37.5 (14.3) | 38.0 (13.1) | 39.6 (13.3) | 40.3 (13.3) | 38.8 (14.0) | 39.3 (13.4) |
Normalized brain volume, cm3, mean (SD) | 1434.0 (81.2) | 1431.9 (86.0) | 1403.4 (92.0) | 1405.2 (87.1) | 1430.3 (80.5) | 1434.1 (89.7) | 1422.7 (86.5) | 1423.5 (87.3) |
Cortical gray matter volume, cm3, mean (SD) | 514.4 (49.4) | 511.5 (56.8) | 542.3 (56.0) | 542.8 (52.3) | 516.2 (47.7) | 512.9 (55.6) | 524.3 (53.5) | 521.6 (57.3) |
Thalamic volume, cm3, mean (SD) | 13.9 (1.9) | 13.9 (1.9) | 14.0 (2.1) | 14.1 (1.9) | 14.0 (1.8) | 14.0 (1.9) | 13.9 (2.0) | 13.9 (1.9) |
Patients with ⩾1 Gd+ T1 lesion at baseline, n (%) | 133 (20.9) | 69 (20.2) | 94 (25.8) | 37 (22.6) | 77 (20.4) | 39 (18.6) | 227 (22.6) | 107 (21.1) |
T2 lesion volume, cm3, mean (SD) | 15.1 (16.1) | 14.3 (15.9) | 16.7 (16.9) | 15.7 (15.2) | 14.3 (15.1) | 14.2 (15.9) | 15.7 (16.4) | 14.7 (15.7) |
EDSS: Expanded Disability Status Scale; FAS: full analysis set; Gd+: gadolinium-enhancing; GM: gray matter; MRI: magnetic resonance imaging; MS: multiple sclerosis; MTR: magnetization transfer ratio; PPS: per-protocol set; SD: standard deviation; SDMT: Symbol Digit Modalities Test; SPMS: secondary progressive multiple sclerosis.
PPS included all patients from the FAS who did not have any major protocol deviations that could confound interpretation.
Seven patients from the overall EXPAND population did not have any GM measurement and accordingly are not included in the high-resolution nor in the standard-resolution set.