Table 2 Improvements in health-related quality of life at weeks 12, 24 and 52 (ITT population, LOCF)*
Week 12 | Week 24 | Week 52 | |||||||
|---|---|---|---|---|---|---|---|---|---|
CZP 200 mg + MTX (n = 393) | CZP 400 mg + MTX (n = 390) | PBO + MTX (n = 199) | CZP 200 mg + MTX (n = 393) | CZP 400 mg + MTX (n = 390) | PBO + MTX (n = 199) | CZP 200 mg + MTX (n = 393) | CZP 400 mg + MTX (n = 390) | PBO + MTX (n = 199) | |
PCS | |||||||||
Mean score (SD) | 36.1 (8.9) | 36.8 (8.4) | 30.7 (7.1) | 37.8 (9.5) | 38.4 (8.8) | 31.4 (7.3) | 38.1 (9.5) | 38.9 (8.9) | 31.5 (7.4) |
Mean change from BL | 5.8 (0.5)† | 6.4 (0.6)† | 0.7 (0.6) | 7.7 (0.4)† | 8.3 (0.4)† | 1.8 (0.6) | 7.8 (0.4)† | 8.6 (0.4)† | 1.7 (0.6) |
% MCID | 38.2† | 36.5† | 21.4 | 46.6† | 51.7† | 10.9 | 42.2† | 46.1† | 11.5 |
MCS | |||||||||
Mean score (SD) | 45.5 (11.5) | 45.7 (11.6) | 41.4 (10.8) | 45.6 (11.5) | 45.6 (11.6) | 41.3 (10.7) | 45.8 (11.4) | 45.4 (11.5) | 41.1 (10.8) |
Mean change from BL | 5.6 (0.7)† | 5.5 (0.7)† | 2.0 (0.8) | 6.3 (0.6)† | 6.5 (0.6)† | 2.3 (0.8) | 6.4 (0.6)† | 6.4 (0.6)† | 2.1 (0.8) |
% MCID | 36.0‡ | 33.3 | 28.1 | 41.1† | 41.9† | 13.0 | 39.2† | 38.1† | 9.9 |
Physical Functioning | |||||||||
Mean score (SD) | 45.1 (25.8) | 46.1 (24.6) | 31.2 (21.0) | 47.6 (26.5) | 48.8 (24.7) | 33.3 (22.2) | 49.3 (26.9) | 50.3 (24.9) | 33.1 (22.3) |
Mean change from BL | 11.4 (1.4)† | 12.2 (1.4)† | -1.0 (1.7) | 15.6 (1.2)† | 16.5 (1.2)† | 1.9 (1.6) | 16.7 (1.2)† | 17.9 (1.2)† | 1.7 (1.6) |
% MCID | 32.1† | 33.6† | 18.4 | 42.0† | 46.6† | 10.7 | 38.0† | 44.3† | 9.7 |
Role Physical | |||||||||
Mean score (SD) | 34.1 (38.3) | 33.9 (38.5) | 15.0 (28.0) | 37.2 (40.4) | 38.6 (40.2) | 18.0 (30.2) | 37.7 (40.3) | 39.2 (41.8) | 17.3 (30.2) |
Mean change from BL | 24.8 (2.4)† | 24.2 (2.5)† | 6.4 (2.9) | 27.8 (2.0)† | 29.1 (2.0)† | 9.4 (2.8) | 26.9 (2.1)† | 29.1 (2.0)† | 8.1 (2.9) |
% MCID | 24.9† | 24.5‡ | 13.9 | 33.0† | 36.8† | 10.3 | 32.2† | 31.1† | 8.2 |
Bodily Pain | |||||||||
Mean score (SD) | 47.8 (20.1) | 49.6 (20.4) | 33.1 (18.5) | 51.4 (22.3) | 53.4 (20.8) | 33.2 (19.4) | 52.0 (22.8) | 53.9 (22.2) | 34.0 (20.1) |
Mean change from BL | 18.0 (1.3)† | 20.2 (1.4)† | 4.5 (1.6) | 23.3 (1.1)† | 25.8 (1.1)† | 6.3 (1.5) | 23.5 (1.1)† | 26.2 (1.1)† | 6.8 (1.6) |
% MCID | 45.9‡ | 43.3‡ | 33.3 | 52.5† | 58.2† | 15.9 | 48.8† | 50.7† | 14.9 |
General Health | |||||||||
Mean score (SD) | 44.0 (18.9) | 48.4 (19.6) | 36.9 (18.0) | 47.4 (19.6) | 48.5 (19.7) | 37.2 (17.1) | 47.5 (20.3) | 47.6 (19.2) | 36.9 (16.6) |
Mean change from BL | 8.9 (1.1)† | 11.1 (1.1)† | 2.4 (1.3) | 13.2 (0.9)† | 14.0 (0.9)† | 3.7 (1.2) | 13.0 (0.9)† | 13.0 (0.9)† | 3.1 (1.3) |
% MCID | 31.1 | 32.7‡ | 24.2 | 44.3† | 45.7† | 11.3 | 40.3† | 40.6† | 10.3 |
Vitality | |||||||||
Mean score (SD) | 48.2 (21.4) | 50.0 (21.3) | 37.0 (19.1) | 50.9 (21.6) | 51.4 (21.3) | 38.3 (19.9) | 50.7 (21.7) | 51.1 (20.9) | 38.4 (20.0) |
Mean change from BL | 12.9 (1.3)† | 14.4 (1.4)† | 2.8 (1.6) | 15.5 (1.1)† | 16.2 (1.1)† | 4.7 (1.5) | 15.1 (1.0)† | 15.6 (1.0)† | 4.5 (1.5) |
% MCID | 35.5‡ | 35.3‡ | 27.0 | 45.1† | 45.7† | 12.2 | 40.8† | 42.8† | 11.2 |
Social Functioning | |||||||||
Mean score (SD) | 64.8 (25.2) | 64.0 (24.4) | 50.6 (25.1) | 66.6 (25.7) | 65.7 (24.4) | 50.8 (25.7) | 67.2 (25.9) | 66.2 (25.3) | 50.6 (25.4) |
Mean change from BL | 15.6 (1.6)† | 14.7 (1.6)† | 2.6 (1.9) | 18.3 (1.3)† | 18.1 (1.3)† | 3.4 (1.8) | 18.5 (1.3)† | 18.6 (1.3)† | 3.2 (1.8) |
% MCID | 39.5‡ | 36.8 | 30.1 | 45.3† | 48.3† | 11.7 | 43.5† | 44.4† | 11.2 |
Role Emotional | |||||||||
Mean score (SD) | 50.4 (43.0) | 50.8 (43.9) | 37.4 (41.2) | 50.2 (42.9) | 54.1 (43.4) | 36.3 (40.9) | 52.8 (43.0) | 53.9 (43.5) | 35.7 (40.6) |
Mean change from BL | 19.2 (2.8)‡ | 19.3 (2.9)‡ | 6.6 (3.3) | 22.2 (2.2)† | 26.4 (2.2)† | 7.8 (3.1) | 23.9 (2.3)† | 26.1 (2.2)† | 7.1 (3.1) |
% MCID | 25.5‡ | 22.4 | 17.4 | 31.7† | 33.2† | 10.8 | 29.0† | 29.7† | 9.2 |
Mental Health | |||||||||
Mean score (SD) | 64.1 (19.4) | 64.5 (20.2) | 56.1 (19.7) | 64.3 (20.1) | 63.8 (20.2) | 56.3 (21.1) | 64.3 (20.4) | 63.3 (19.9) | 55.8 (21.1) |
Mean change from BL | 9.3 (1.2)† | 8.9 (1.2)† | 2.1 (1.4) | 11.0 (1.0)† | 10.5 (1.0)† | 3.7 (1.3) | 10.7 (1.0)† | 9.9 (1.0)† | 3.0 (1.4) |
% MCID | 33.3‡ | 27.4 | 27.0 | 40.8† | 37.1† | 14.3 | 37.3† | 33.9† | 11.2 |