Mean component/domain score (SD) | DR prednisone/DMARD | Placebo/DMARD | Treatment difference (95% CI) | ||||
---|---|---|---|---|---|---|---|
Baseline | Week 12 | Difference‡ | Baseline | Week 12 | Difference‡ | ||
Physical component | 31.6 (7.0)§ | 35.1 (8.1) | 3.4 (5.8) | 31.5 (6.9) | 32.7 (7.3) | 1.2 (5.1) | 2.3 (1.1 to 3.5)* |
Range | 14–56 | 14–56 | 18–48 | 15–58 | |||
Mental component | 45.3 (10.7)§ | 46.9 (10.7) 21–70 | 1.6 (7.3) | 45.4 (9.6) | 45.9 (9.6) | 0.5 (6.3) | 1.1 (−0.4 to 2.5) |
Range | 17–68 | 23–64 | 14–64 | ||||
Physical functioning | 40.2 (21.2) | 47.3 (24.1) | 7.1 (16.5) | 40.7 (20.5) | 44.2 (22.3) | 3.5 (13.8) | 3.6 (0.2 to 7.0)** |
Range | 0–95 | 0–100 | 0–90 | 0–100 | |||
Role physical | 44.5 (22.3) | 50.8 (23.8) | 6.0 (20.1) | 43.3 (21.9) | 45.4 (21.1) | 2.1 (14.6) | 4.5 (0.7 to 8.3)** |
Range | 0–100 | 0–100 | 0–100 | 0–100 | |||
Bodily pain | 34.4 (16.2) | 45.7 (20.5) | 11.3 (17.8) | 34.0 (15.5) | 38.4 (18.8) | 4.5 (16.1) | 7.0 (3.3 to 10.7)* |
Range | 0–84 | 0–100 | 0–74 | 0–100 | |||
General health | 39.8 (18.4) | 44.6 (20.1) | 4.7 (12.9) | 40.6 (16.5) | 41.9 (17.1) | 1.3 (13.7) | 3.3 (0.5 to 6.2)** |
Range | 0–97 | 0–97 | 0–92 | 5–100 | |||
Social functioning | 57.9 (25.6) | 63.9 (25.1) | 5.9 (18.9) | 56.5 (23.3) | 58.5 (23.7) | 2.0 (19.8) | 4.4 (0.5 to 8.4)** |
Range | 0–100 | 0–100 | 0–100 | 0–100 | |||
Role emotional | 57.2 (28.8) | 59.6 (26.6) | 2.5 (22.5) | 56.0 (25.6) | 58.5 (27.1) | 2.5 (21.2) | 0.7 (−3.6 to 5.1) |
Range | 0–100 | 0–100 | 0–100 | 0–100 | |||
Mental health | 59.1 (20.7) | 63.7 (21.1) | 4.6 (15.7) | 61.0 (20.0) | 62.5 (19.5) | 1.5 (12.3) | 2.7 (−0.4 to 5.7) |
Range | 0–100 | 10–100 | 10–95 | 0–100 |
*p≤0.0003
**p≤0.0374.
‡Absolute difference from baseline, using baseline observation carried forward imputation.
§Data missing for two patients.
DMARD, disease-modifying antirheumatic drug; DR, delayed-release; SF-36, Short Form-36.