Table 3.
Twelve-week confirmed disability progression by patient subgroup and in total population.
| Subgroup | Probability of disability progression at week 108a (95% CI) |
||
|---|---|---|---|
| Placebo (n=363) | 7 mg (n=365) | 14 mg (n=358) | |
| Gender | |||
| Male | 0.35 (0.24, 0.46) | 0.23 (0.14, 0.32) | 0.23 (0.14, 0.31) |
| Female | 0.25 (0.20, 0.31) | 0.21 (0.16, 0.27) | 0.19 (0.14, 0.24) |
| p-value for interactionb | 0.26 | 0.51 | |
| Age | |||
| <38 years | 0.28 (0.20, 0.35) | 0.22 (0.15, 0.29) | 0.18 (0.12, 0.25) |
| ≥38 years | 0.27 (0.20, 0.34) | 0.21 (0.15, 0.28) | 0.22 (0.15, 0.28) |
| p-value for interactionb | 0.82 | 0.33 | |
| Region | |||
| Eastern Europe | 0.27 (0.18, 0.35) | 0.14 (0.07, 0.21) | 0.15 (0.07, 0.22) |
| Western Europe | 0.33 (0.25, 0.41) | 0.26 (0.19, 0.33) | 0.23 (0.17, 0.30) |
| Americas | 0.17 (0.09, 0.26) | 0.24 (0.14, 0.33) | 0.21 (0.11, 0.30) |
| p-value for interactionb | 0.09 | 0.31 | |
| EDSS score | |||
| ≤3.5 | 0.26 (0.20, 0.31) | 0.23 (0.18, 0.29) | 0.22 (0.17, 0.27) |
| >3.5 | 0.34 (0.22, 0.46) | 0.16 (0.07, 0.25) | 0.14 (0.05, 0.22) |
| p-value for interactionb | 0.09 | 0.07 | |
| Relapses | |||
| ≤1 | 0.23 (0.13, 0.34) | 0.16 (0.07, 0.25) | 0.18 (0.08, 0.28) |
| 2 | 0.28 (0.21, 0.35) | 0.23 (0.17, 0.30) | 0.22 (0.16, 0.28) |
| 3 | 0.26 (0.15, 0.37) | 0.21 (0.10, 0.32) | 0.15 (0.05, 0.24) |
| ≥4 | 0.36 (0.16, 0.55) | 0.27 (0.12, 0.43) | 0.26 (0.08, 0.44) |
| p-value for interactionb | 0.95 | 0.80 | |
| MS subtype | |||
| SP/PR MS | 0.32 (0.13, 0.51) | 0.13 (0.00, 0.26) | 0.19 (0.00, 0.39) |
| RRMS | 0.27 (0.22, 0.32) | 0.23 (0.18, 0.27) | 0.20 (0.16, 0.25) |
| p-value for interactionb | 0.29 | 0.60 | |
| Previous DMT use | |||
| Yes | 0.36 (0.25, 0.47) | 0.33 (0.23, 0.43) | 0.20 (0.12, 0.29) |
| No | 0.25 (0.19, 0.30) | 0.18 (0.13, 0.23) | 0.20 (0.15, 0.26) |
| p-value for interactionb | 0.55 | 0.15 | |
| Gd-enhancing lesions | |||
| 0 | 0.26 (0.20, 0.33) | 0.23 (0.17, 0.29) | 0.20 (0.15, 0.26) |
| ≥1 | 0.29 (0.20, 0.37) | 0.20 (0.12, 0.27) | 0.20 (0.12, 0.27) |
| p-value for interactionb | 0.34 | 0.50 | |
| Total lesion volume | |||
| <13 mL | 0.26 (0.19, 0.33) | 0.19 (0.13, 0.26) | 0.19 (0.13, 0.25) |
| ≥13 mL | 0.29 (0.21, 0.36) | 0.24 (0.17, 0.31) | 0.21 (0.14, 0.27) |
| p-value for interactionb | 0.82 | 0.94 | |
| Total population | 0.27 (0.22, 0.32) | 0.22 (0.17, 0.26) | 0.20 (0.16, 0.25) |
CI: confidence interval; DMT: disease-modifying therapy; EDSS: Expanded Disability Status Scale; Gd: gadolinium; MS, multiple sclerosis; PR: progressive relapsing; RRMS: relapsing–remitting multiple sclerosis; SP: secondary progressive.
a
Derived from Kaplan–Meier estimates.
b
Derived from Cox proportional hazard model with treatment, EDSS strata at baseline and region, subgroup and treatment-by-subgroup interaction as covariate.