Table 3 Mean changes in HRQoL scores from baseline to study phase completion (week 16) by categories of change in SDAI, all dose groups combined
| Â | SDAI Categories of change | |||||
|---|---|---|---|---|---|---|
|  | > +10 (n = 4) | +10 to -10 (n = 67) | -10 to -21 (n = 57) | -22 to -57 (n = 53) | F | p-value |
PRO Instruments | Â | Â | Â | Â | Â | Â |
SF-36 | Â | Â | Â | Â | Â | Â |
Physical functioning | -7.5 (40.9) | 2.5 (14.3) | 6.5 (16.5) | 14.8 (20.2) | 5.8 | 0.0008 |
Role physical | 0.0 (15.3) | 1.7 (18.9) | 9.5 (20.3) | 20.5 (24.2) | 8.2 | 0.0000 |
Bodily pain | -13.0 (11.2) | 0.4 (14.5) | 11.4 (17.0) | 23.3 (19.9) | 20.6 | 0.0000 |
General health | -10.0 (17.3) | -1.1 (13.5) | 3.1 (13.7) | 10.2 (13.8) | 8.0 | 0.0001 |
Vitality | -1.6 (25.2) | 0.2 (16.8) | 5.0 (18.3) | 17.5 (20.9) | 8.9 | 0.0000 |
Social functioning | -28.1 (21.3) | -0.4 (21.4) | 3.7 (26.0) | 16.3 (26.7) | 7.3 | 0.0001 |
Role emotional | -14.6 (14.2) | -0.4 (22.6) | 5.1 (26.6) | 11.6 (28.2) | 3.0 | 0.0332 |
Mental health | -1.3 (7.5) | -1.0 (15.2) | 5.4 (18.5) | 9.4 (20.3) | 3.6 | 0.0156 |
Physical summary | -3.0 (10.5) | 0.8 (4.6) | 3.2 (5.4) | 7.6 (7.1) | 15.5 | 0.0000 |
Mental summary | -4.7 (9.6) | -0.7 (8.5) | 1.9 (10.6) | 5.3 (12.1) | 3.8 | 0.0108 |
HAQ-DI | 0.16 (0.07) | -0.04 (0.31) | -0.25 (0.39) | -0.53 (0.52) | 15.6 | 0.0000 |
FACIT-Fatigue | -6.8 (5.2) | 0.6 (7.2) | 3.5 (7.3) | 8.3 (7.3) | 14.1 | 0.0000 |