TABLE 1.
Baseline demographic, clinical and MRI lesion characteristics of the study population
| Pseudo‐atrophy (BSL‐M06) analysis | Treatment period (M06‐M24) analysis | |||
|---|---|---|---|---|
| Placebo | Cladribine tablets 3.5 mg/kg | Placebo | Cladribine tablets 3.5 mg/kg | |
| N | 265 | 267 | 186 | 184 |
| Age, years | ||||
| Mean (SD) | 39.35 (9.77) | 38.71 (10.16) | 39.9 (9.3) | 39.44 (10.3) |
| Median (min; max) | 39 (18; 64) | 39 (19; 63) | 40 (18; 64) | 39 (19; 63) |
| Female, n (%) | 172 (64.9) | 191 (71.5%) | 118 (63.4) | 138 (75) a |
| Prior use of DMT, n (%) | 71 (26.8) | 69 (25.8) | 39 (21.2) | 46 (24.7) |
| Disease duration | ||||
| Mean (SD) | 5.27 (5.46) | 4.81 (5.32) | 5.16 (5.4) | 4.48 (5.3) |
| Median (min; max) | 3.6 (0; 28) | 2.93 (0; 27) | 3.48 (0; 25) | 2.26 (0; 27) |
| EDSS score | ||||
| Mean (SD) | 2.92 (1.34) | 2.81 (1.22) | 2.85 (1.3) | 2.79 (1.2) |
| Median (min; max) | 3 (0; 6) | 2.5 (0; 6) | 3 (0; 6) | 2.5 (0; 6) |
| T2 lesions, n | ||||
| Mean (SD) | 26.75 (17.6) | 24.46 (15.6) | 25.49 (15.5) | 23.82 (15.2) |
| Median (min; max) | 22 (3; 134) | 20 (3; 89) | 22 (3; 100) | 20 (3; 79) |
| T2 lesion volume, cm3 | ||||
| Mean (SD) | 13.82 (13.1) | 13.43 (14.16) | 13.79 (12.74) | 13.01 (14.69) |
| Median (min; max) | 9.75 (0; 77) | 8.95 (0; 96) | 10.05 (0; 72) | 8.18 (0; 96) |
| T1 Gd + lesions, n | ||||
| Mean (SD) | 0.81 (2.67) | 1 (3.032) | 0.83 (2.46) | 0.92 (3.06) |
| Median (min; max) | 0 (0; 27) | 0 (0; 32) | 0 (0; 27) | 0 (0; 32) |
| GM volume, cm3 | ||||
| Mean (SD) | 766.52 (75.86) | 769.37 (77.85) | 767.18 (80.12) | 768.86 (80.28) |
| Median (min; max) | 763.29 (483.3; 975.9) | 775.36 (500.3; 950.2) | 762.21(485.3; 975.9) | 776.81 (500.3; 950.2) |
| WM volume, cm3 | ||||
| Mean (SD) | 772.52 (81.60) | 774.46 (83.13) | 774.42 (83.08) | 777.18 (86.75) |
| Median (min; max) | 766.52 (627.4; 1330.3) | 765.55 (622.6; 1326.0) | 769.81(627.4; 1319.8) | 768.22 (622.5; 1326.0) |
Abbreviations: BSL, baseline; DMT, disease‐modifying therapy; EDSS, Expanded Disability Status Scale; Gd+, gadolinium enhancing; M, month; SD, standard deviation.
a
The number of female participants in the two patient groups and in the treatment period was the only significant difference.