Patient-reported outcomes at baseline. Modified intent-to-treat population, observed case. Data are mean (SD).
| Characteristics | ETN 50 mg QW, n = 106 | PBO, n = 109 |
|---|---|---|
| General well-being/fatigue/pain | ||
| BAS-G, 0–10 | 6.3 (1.8) | 6.3 (1.7) |
| BAS-G since last week, 0–10 | 6.0 (2.1) | 6.0 (2.1) |
| Nocturnal back pain, 0–10 VAS | 5.5 (2.6) | 5.4 (2.5) |
| Average back pain, 0–10 VAS | 5.5 (2.4) | 5.4 (2.3) |
| MFI, 4–20 | ||
| General fatigue | 14.7 (3.5) | 15.0 (3.5) |
| Mental fatigue | 10.9 (3.8) | 10.5 (3.7) |
| Physical fatigue | 14.0 (3.9) | 13.6 (3.8) |
| Reduced activity | 11.4 (3.8) | 11.8 (3.8) |
| Reduced motivation | 9.6 (3.2) | 8.9 (3.4) |
| Utility/HRQOL | ||
| EQ-5D, 0–100 VAS | 56.5 (21.0) | 56.4 (20.6) |
| EQ-5D utility score, 0–1 | 0.5 (0.3) | 0.6 (0.3) |
| SF-36, 0–100 | ||
| PCS | 37.8 (8.9) | 37.2 (8.1) |
| MCS | 42.3 (11.9) | 43.5 (11.1) |
| ASQOL, 0–18 | 8.6 (4.8) | 8.4 (4.8) |
| Work productivity | ||
| WPAI-AS, 0–100% | ||
| Absenteeism, % work time missed* | 9.1 (25.0) | 11.8 (27.7) |
| Presenteeism, % impairment while working* | 44.9 (26.7) | 42.2 (26.3) |
| Overall work impairment, %* | 45.0 (26.2) | 43.9 (27.8) |
| Activity impairment, % | 53.2 (25.9) | 52.1 (24.3) |
| AS WIS, 0–20 | 12.4 (5.2) | 12.5 (5.2) |
| Sleep/anxiety/depression | ||
| MOS sleep scale I, 0–100 | 43.9 (17.6) | 46.2 (17.4) |
| MOS sleep scale II, 0–100 | 45.5 (17.7) | 48.1 (17.4) |
| HADS anxiety, 0–21 | 6.6 (4.1) | 6.8 (4.0) |
| HADS depression, 0–21 | 5.9 (4.1) | 5.6 (4.1) |
↵* Employed patients at baseline (ETN, n = 66; PBO, n = 63). ETN: etanercept; PBO: placebo; BAS-G: Bath Ankylosing Spondylitis Patient Global Score; VAS: visual analog scale; MFI: Multidimensional Fatigue Inventory; HRQOL: health-related quality of life; MOS: Medical Outcomes Study; SF-36: MOS Short Form-36; PCS: physical component summary; MCS: mental component summary; AS: ankylosing spondylitis; ASQOL: AS quality of life; WPAI-AS: Work Productivity and Activity Index in AS; AS WIS: Work Instability Scale for AS; HADS: Hospital Anxiety and Depression Scale; QW: once weekly.