Table 2.
Mean values and paired changes from baseline in MSQOL-54 PCS and MCS and in EDSS scores.
| Dimension | Baseline | 12 months | 24 months | Early termination |
|---|---|---|---|---|
| MSQOL-54 PCS | ||||
| n | 313 | 238 | 182a | 68 |
| Mean (SD) | 60.9 (19.7) | 65.0 (20.0) | 64.9 (20.3) | 60.7 (22.8) |
| Paired change from baseline | ||||
| n | — | 230 | 174a | 66 |
| Mean (SD) | — | 2.0 (14.3) | 2.2 (15.3) | 0.3 (14.4) |
| p valueb | — | 0.014 | 0.027 | NS |
|
| ||||
| MSQOL-54 MCS | ||||
| n | 331 | 249 | 191a | 73 |
| Mean (SD) | 65.6 (20.5) | 71.4 (19.7) | 71.7 (20.0) | 67.3 (22.5) |
| Paired change from baseline | ||||
| n | — | 248 | 190a | 72 |
| Mean (SD) | — | 3.7 (17.5) | 4.3 (19.1) | 1.3 (19.2) |
| p valueb | — | <0.0001 | 0.0003 | NS |
|
| ||||
| EDSS score | ||||
| n | 334 | 251 | 196 | 73 |
| Mean (SD) | 2.0 (1.4) | 1.8 (1.3) | 1.9 (1.4) | 2.2 (1.8) |
| Paired change from baseline | ||||
| n | — | 251 | 196 | 73 |
| Mean (SD) | — | −0.1 (0.9) | 0.1 (1.0) | 0.1 (1.0) |
| p valueb | — | 0.047 | NS | NS |
MCS and PCS are expressed on a scale of 0 (poorest quality of life) to 100 (best possible quality of life). Paired changes from baseline to 24 months and ET in MSQOL-54 PCS and MCS and EDSS scores were also previously reported in Moore et al. [6].
a n numbers lower than 196 (number of patients who completed the 24-month study); data for these endpoints were not available for all patients who completed the study.
b p value calculated using a two-sided Wilcoxon matched pairs signed-rank test.
EDSS, Expanded Disability Status Scale; ET, early termination; MCS, mental health composite score; MSQOL-54, Multiple Sclerosis Quality of Life-54; NS, not statistically significant; PCS, physical health composite score; SD, standard deviation.