| PRO measure (scale range) | Change from baseline | Difference between treatment groups (95% CI)† | |||
| ETN | ETN+MTX | ||||
| n* | Mean (SD) | n* | Mean (SD) | ||
| HAQ DI (0–3) | 142 | −0.59 (0.69) | 141 | −0.59 (0.58) | 0.029 (−0.115, 0.172) |
| EQ-5D VAS (0–100) | 154 | 19.76 (27.24) | 151 | 21.00 (26.61) | −2.593 (−7.667, 2.482) |
| EQ-5D (0–1) | 155 | 0.1883 (0.33) | 150 | 0.2399 (0.32) | −0.024 (−0.82, 0.034) |
| EQ-5D: Usual activities | 156 | 0.3077 (0.61) | 150 | 0.2867 (0.55) | 0.017 (−0.102,0.137) |
| EQ-5D: Self care | 156 | 0.1731 (0.55) | 150 | 0.3533 (0.55) | −0.129 (−0.233, −0.025) |
| EQ-5D: Pain/discomfort | 156 | 0.3718 (0.62) | 150 | 0.4400 (0.65) | −0.040 (−0.159, 0.078) |
| EQ-5D:Mobility | 156 | 0.3077 (0.50) | 151 | 0.2318 (0.52) | 0.058 (−0.047, 0.164) |
| EQ-5D: Anxiety/depression | 155 | 0.2323 (0.59) | 150 | 0.24 (0.65) | 0.029 (−0.089, 0.147) |
| PGAD (0–10) | 156 | −2.78 (2.60) | 152 | −2.95 (2.59) | −0.174 (−0.692,0.345) |
| Pain VAS (0–10) | 140 | −29.40 (25.09) | 135 | −29.93 (27.25) | −1.327 (−7.039, 4.386) |
LOCF, last observation carried forward; ETN, etanercept (25 mg biweekly); MTX, methotrexate (⩾12.5 mg/week); HAQ DI, Stanford Health Assessment Questionnaire disability index; EQ-5D, EuroQoL health status; PGAD, patient global assessment of disease; VAS, visual analogue scale.
*Treatment group numbers (n) vary according to evaluable data from different PROs. †Values were not significantly different among groups except in the EQ-5D: Self-care (p = 0.0154).