Table 1 Patient-reported outcomes at baseline (ITT populations)
Methotrexate add-on study | Monotherapy study | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
Placebo (N = 86) | 50 mg q.d. (N = 82) | 100 mg q.d. (N = 85) | 200 mg q.d. (N = 86) | 25 mg b.i.d. (N = 86) | 50 mg b.i.d. (N = 85) | 100 mg b.i.d. (N = 84) | Placebo (N = 72) | 50 mg q.d. (N = 72) | 100 mg q.d. (N = 70) | 200 mg q.d. (N = 69) | Score interpretation | |
HAQ-DI, mean (SE) | 1.69 (0.06) | 1.71 (0.07) | 1.70 (0.07) | 1.76 (0.06) | 1.70 (0.05) | 1.78 (0.06) | 1.78 (0.07) | 1.80 (0.06) | 1.84 (0.07) | 1.80 (0.07) | 1.79 (0.06) | 0–3; higher score indicates higher disability |
Patient Global, mean (SE) | 64.2 (1.96) | 68.2 (2.23) | 67.6 (2.09) | 68.7 (2.09) | 64.3 (1.95) | 65.7 (1.92) | 66.6 (2.20) | 71.1 (2.02) | 68.6 (2.41) | 71.5 (2.23) | 68.9 (2.07) | VAS score 0–100; higher score indicates lower health state |
Patient Pain, mean (SE) | 65.7 (2.16) | 66.9 (2.20) | 65.4 (2.41) | 67.0 (2.16) | 65.7 (2.23) | 67.8 (2.12) | 67.2 (2.19) | 71.6 (2.37) | 71.0 (2.38) | 72.6 (1.85) | 68.1 (2.35) | VAS score 0–100; higher score indicates more severe pain |
FACIT-Fatigue, mean (SE) | 26.2 (1.09) | 26.2 (1.10) | 26.6 (1.06) | 25.2 (1.25) | 28.1 (1.18) | 26.2 (1.04) | 25.6 (1.25) | 25.1 (1.12) | 25.1 (1.28) | 24.8 (1.13) | 24.8 (1.16) | 0–52; higher score indicates better QoL |
SF-36 PCS, mean (SE) | 33.0 (0.71) | 32.7 (0.75) | 31.6 (0.79) | 31.6 (0.64) | 31.6 (0.69) | 31.3 (0.73) | 32.2 (0.78) | 31.1 (0.70) | 31.1 (0.82) | 30.9 (0.76) | 31.8 (0.90) | 0–100; higher score indicates better QoL |
SF-36 MCS, mean (SE) | 42.8 (1.09) | 42.2 (1.26) | 44.0 (1.11) | 41.4 (1.14) | 45.5 (1.29) | 44.7 (1.23) | 42.1 (1.29) | 40.5 (1.31) | 42.8 (1.32) | 41.2 (1.23) | 42.6 (1.17) | 0–100; higher score indicates better QoL |