Table 4.
Subgroup analysis of ABILHAND outcomes with respect to Expanded Disability Status Scale score and ABILHAND function at baseline
| Endpointa | PR-fampridine (n = 315) | Placebo (n = 318) |
|---|---|---|
| ABILHAND score stratified by baseline EDSS score | ||
| EDSS score ≤ 6.0 | ||
| Participants, n | 244 | 244 |
| Mean (SD) on treatment | 89.98 (12.96) | 88.17 (14.09) |
| Range | 25.5–100.0 | 30.7–100.0 |
| LSM change from baseline over 24 weeksb | 1.32 | 1.22 |
| LSM difference from baseline vs. placebo (95% CI)b | 0.10 (− 1.04 to 1.24) | NA |
| EDSS score 6.5 and 7.0 | ||
| Participants, n | 68 | 71 |
| Mean (SD) on treatment | 83.84 (15.90) | 78.30 (17.53) |
| Range | 43.2–100.0 | 36.2–100.0 |
| LSM change from baseline over 24 weeksb | 2.10 | – 0.95 |
| LSM difference from baseline vs. placebo (95% CI)b | 3.05 (− 0.09 to 6.19) | NA |
| ABILHAND score stratified by normal and abnormal ABILHAND scores at baseline | ||
| Normal (≥ 80) ABILHAND score at baseline | ||
| Participants, n | 234 | 210 |
| Mean (SD) on treatment | 94.56 (6.65) | 93.76 (8.23) |
| Range | 72.5–100.0 | 45.6–100.0 |
| LSM change from baseline over 24 weeksb | − 0.44 | − 1.04 |
| LSM difference from baseline vs. placebo (95% CI)b | 0.61 (− 0.37 to 1.58) | NA |
| Abnormal (< 80) ABILHAND score at baseline | ||
| Participants, n | 78 | 105 |
| Mean (SD) on treatment | 70.89 (14.72) | 70.32 (14.71) |
| Range | 25.5–95.2 | 30.3–96.4 |
| LSM change from baseline over 24 weeksb | 5.62 | 4.81 |
| LSM difference from baseline vs. placebo (95% CI)b | 0.81 (–2.53 to 4.15) | NA |
CI confidence interval, EDSS Expanded Disability Status Scale, LSM least squares mean, NA not applicable, PR prolonged-release, SD standard deviation
aA positive change in ABILHAND score indicates improvement in manual ability; a complete definition of endpoints is provided in Table 1
bBased on a mixed-effect model for repeated measures using a common variance/covariance matrix structure