Patient-reported outcome scores at baseline and week 52 in patients with early RA by treatment group
| PRO measure (score range) | MTX (n = 263) | ETN+MTX (n = 265) | Between-group p value | ||||
| Baseline mean score (SD) | Week 52 mean score (SD)* | Mean difference from baseline | Baseline mean score (SD) | Week 52 mean score (SD)* | Mean difference from baseline | ||
| HAQ (0–3)† | 1.64 (0.65) | 0.92 (0.74) | −0.72 | 1.70 (0.68) | 0.68 (0.71) | −1.02 | <0.001 |
| EQ-5D utility (0.0–1.0) | 0.39 (0.31) | 0.68 (0.25) | 0.29 | 0.39 (0.33) | 0.73 (0.24) | 0.34 | 0.011 |
| EQ-5D VAS (0–100) | 44.6 (21.9) | 66.3 (23.5) | 21.7 | 46.2 (22.4) | 72.8 (22.2) | 26.6 | 0.003 |
| Fatigue VAS (0–100)† | 58.2 (25.6) | 38.5 (27.3) | −19.7 | 61.5 (23.8) | 31.9 (26.3) | −29.6 | <0.001 |
| Pain VAS (0–100)† | 65.1 (20.8) | 33.7 (27.5) | −31.4 | 66.0 (21.4) | 24.1 (24.2) | −41.9 | <0.001 |
| HADS depression (0–21)† | 6.68 (3.93) | 4.66 (4.03) | −2.02 | 6.82 (4.18) | 4.39 (4.09) | −2.43 | NS |
| HADS anxiety (0–21)† | 7.37 (4.14) | 5.45 (4.11) | −1.92 | 7.61 (4.56) | 5.49 (4.57) | −2.12 | NS |
| SF-36 PCS‡ | 29.5 (6.9) | 40.2 (10.6) | 10.7 | 29.3 (8.0) | 43.0 (10.5) | 13.7 | 0.003 |
| SF-36 MCS‡ | 42.2 (11.9) | 48.3 (11.2) | 6.1 | 42.1 (12.0) | 48.9 (11.7) | 6.8 | NS |
EQ-5D, EuroQol health assessment; ETN, etanercept; HADS, Hospital Anxiety and Depression Scale; HAQ, Health Assessment Questionnaire; MCS, mental component summary; MTX, methotrexate; NS, not significant; PCS, physical component summary; PRO, patient-reported outcomes; RA, rheumatoid arthritis; SF-36, Medical Outcomes Short-Form-36; VAS, visual analogue scale.
HAQ: 0 (no difficulty), 3 (unable to do);15 EQ-5D: utility score derived from published tariffs: 0 (death), 1 (perfect health);16 VAS, 0 (worst imaginable health state/no fatigue or pain), 100 (best imaginable health state/maximum fatigue or pain imaginable);16 HADS: scale to determine level and frequency of patient anxiety and depression symptoms, 0 = best;17 SF-36: eight-domain questionnaire covering physical & social functioning, vitality, bodily pain, mental & general health, role limitations-physical & -emotional. 0 (worst), 100 (best) for each of eight domain scores.19
*Each PRO score achieved statistically significant change from baseline to week 52 within each treatment group (p<0.0001).
†A decline in score indicates improvement.
‡Scores are standardised to a general US population with mean 50 and SD 10.18 19