Table 1.
DR prednisone/DMARD |
Placebo/DMARD |
Treatment difference (95% CI)‡ | |||||
---|---|---|---|---|---|---|---|
Measure of fatigue | Baseline | Week 12 | Difference‡ | Baseline | Week 12 | Difference‡ | |
Mean FACIT-F score | 28.8 | 32.5 | 3.8 | 28.7 | 30.3 | 1.6 | 2.2 (0.8 to 3.7)* |
(SD) | (10.4) | (10.9) | (10.7) | (10.5) | |||
Range | 0–50 | 0–52 | 3–49 | 0–52 | |||
Mean SF-36 vitality domain | 44.5 | 51.6 | 7.0 | 43.1 | 44.9 | 1.8 | 5.6 (2.3 to 8.9)** |
(SD)§ | (19.4) | (20.6) | (16.5) | (19.3) | (19.8) | (14.1) | |
Range | 0–100 | 0–100 | 0–94 | 0–100 |
*p=0.0032.
**p=0.0010.
‡LSM difference for FACIT-F score.
§Absolute difference from baseline, using baseline observation carried forward imputation.
DMARD, disease-modifying antirheumatic drug; DR, delayed-release; FACIT-F, Functional Assessment of Chronic Illness Therapy-Fatigue; LSM, least squares mean; SF-36, Short Form-36.