Table 3.
Mean (SD) HRQoL scores by cohort at baseline and EOS
| Measure | Baselinea | End of study | ||||
|---|---|---|---|---|---|---|
| De novo (N=395) | Rollover (N=87) | All participants (N=482) | De Novo (N=198) | Rollover (N=36) | All participants (N=234) | |
| EQ-5D-5L | ||||||
| Index | 0.86 (0.15) | 0.84 (0.18) | 0.85 (0.16) | 0.85 (0.15) | 0.83 (0.18) | 0.85 (0.15) |
| VAS | 81.0 (17.9) | 83.1 (18.9) | 81.4 (18.1) | 82.9 (15.1) | 82.3 (16.8) | 82.8 (15.4) |
| SF-36v2 | ||||||
| Bodily pain | 73.2 (26.3) | 73.2 (27.0) | 73.2 (26.4) | 75.4 (27.1) | 69.3 (25.9) | 74.5 (26.9) |
| General health | 67.8 (21.7) | 67.0 (19.4) | 67.7 (21.3) | 67.5 (21.2) | 63.0 (22.9) | 66.8 (21.5) |
| Mental health | 67.3 (22.5) | 67.0 (19.3) | 67.3 (21.9) | 70.3 (20.6) | 63.1 (22.4) | 69.2 (21.0) |
| Physical functioning | 71.5 (28.1) | 73.8 (28.7) | 71.9 (28.2) | 70.7 (27.0)b | 65.7 (33.6) | 69.9 (28.1)b |
| Role-emotional | 67.8 (29.3) | 65.3 (26.9) | 67.3 (28.9) | 68.9 (28.5)b | 65.5 (29.7) | 68.4 (28.7)b |
| Role-physical | 68.1 (28.9) | 69.6 (27.3) | 68.4 (28.6) | 65.5 (28.9)b | 64.6 (29.1) | 65.4 (28.9)b |
| Social functioning | 69.8 (25.9) | 65.8 (23.5) | 69.0 (25.5) | 71.1 (25.4)b | 72.2 (23.5) | 71.3 (25.1)b |
| Vitality | 62.5 (21.2) | 62.1 (18.2) | 62.5 (20.6) | 63.1 (22.5)b | 60.2 (25.5) | 62.6 (23.0)b |
| PCS | 50.0 (9.1) | 50.7 (9.2) | 50.1 (9.1) | 49.4 (8.8) | 48.1 (10.0) | 49.2 (9.0) |
| MCS | 45.8 (11.5) | 44.5 (9.6) | 45.6 (11.2) | 47.0 (10.7) | 45.2 (10.1) | 46.7 (10.6) |
Notes: aOpen-label baseline. bFor these domains, the number of participants responding were 1 less than the overall N reported.
Abbreviations: EQ-5D-5L, EuroQol 5-Dimensions 5-Level; EOS, end of study; HRQoL, health-related quality of life; MCS, mental component summary; PCS, physical component summary; SF-36v2, Short-Form 36-item Questionnaire Version 2.