Characteristics | Double-blind, Week 12* | p† | Open-label, Week 24** | ||||||
---|---|---|---|---|---|---|---|---|---|
ETN 50 mg QW | PBO | ETN 50 mg QW | PBO to ETN 50 mg QW | ||||||
Week 12, Mean (SE) | Change from Baseline (SE) | Week 12, Mean (SE) | Change from Baseline (SE) | Week 24, Mean (SD) | Change from Baseline (SE) | Week 24, Mean (SD) | Change from Baseline (SE) | ||
General well-being/fatigue/pain | |||||||||
BAS-G total, 0–10 | 4.4 (0.3) | −1.9 (0.3) | 5.0 (0.3) | −1.3 (0.3) | 0.027 | 3.5 (2.3) | −2.8‡ (0.2) | 3.3 (2.1) | −2.9‡ (0.2) |
BAS-G since last week, 0–10 | 4.0 (0.3) | −2.0 (0.3) | 4.8 (0.3) | −1.2 (0.3) | 0.013 | 3.2 (2.5) | −2.8‡ (0.3) | 2.7 (2.3) | −3.2‡ (0.2) |
Nocturnal back pain, 0–10 VAS | 3.5 (0.4) | −2.0 (0.4) | 4.6 (0.4) | −0.9 (0.4) | 0.003 | 2.7 (2.5) | −2.8‡ (0.3) | 2.1 (2.3) | −3.2‡ (0.3) |
Average back pain, 0–10 VAS | 3.5 (0.4) | −2.0 (0.4) | 4.5 (0.3) | −1.0 (0.3) | 0.002 | 2.7 (2.4) | −2.8‡ (0.3) | 2.3 (2.4) | −3.0‡ (0.2) |
MFI, 4–20 | |||||||||
General fatigue | 13.6 (0.5) | −1.2 (0.5) | 14.0 (0.4) | −0.9 (0.4) | 0.433 | 13.1 (4.1) | −1.6‡ (0.4) | 12.3 (4.0) | −2.6‡ (0.4) |
Mental fatigue | 10.4 (0.5) | −0.3 (0.5) | 10.2 (0.5) | −0.4 (0.5) | 0.774 | 10.0 (4.4) | −0.9‡ (0.4) | 9.0 (3.6) | −1.2‡ (0.4) |
Physical fatigue | 12.6 (0.5) | −1.2 (0.5) | 12.8 (0.5) | −1.1 (0.5) | 0.732 | 11.5 (3.7) | −2.6‡ (0.4) | 10.8 (3.9) | −2.8‡ (0.4) |
Reduced activity | 10.9 (0.5) | −0.7 (0.5) | 10.8 (0.4) | −0.8 (0.4) | 0.907 | 10.3 (3.8) | −1.2‡ (0.4) | 9.7 (3.8) | −1.9‡ (0.4) |
Reduced motivation | 8.3 (0.4) | −1.0 (0.4) | 9.0 (0.4) | −0.3 (0.4) | 0.106 | 8.6 (3.4) | −1.1‡ (0.4) | 8.2 (3.3) | −0.7 (0.4) |
Utility/HRQOL | |||||||||
EQ-5D, 0–100 VAS | 66.0 (3.0) | 9.3‡ (3.0) | 60.0 (2.8) | 3.3 (2.8) | 0.039 | 70.5 (19.9) | 13.5‡ (2.2) | 72.5 (19.0) | 17.0‡ (2.3) |
EQ-5D utility score, 0–1 | 0.7 (0.0) | 0.1 (0.0) | 0.6 (0.0) | 0.1 (0.0) | 0.135 | 0.7 (0.2) | 0.2‡ (0.0) | 0.8 (0.2) | 0.2‡ (0.0) |
SF-36, 0–100 | |||||||||
PCS | 43.6 (1.0) | 6.2 (1.0) | 41.3 (0.9) | 3.8 (0.9) | 0.013 | 44.4 (9.1) | 6.7‡ (0.9) | 44.6 (8.9) | 7.2‡ (0.8) |
MCS | 45.4 (1.3) | 2.4 (1.3) | 44.5 (1.2) | 1.6 (1.2) | 0.498 | 45.9 (12.0) | 3.4‡ (1.3) | 48.4 (9.1) | 4.4‡ (1.0) |
ASQOL, 0–18 | 6.6 (0.5) | −1.9 (0.5) | 7.1 (0.5) | −1.4 (0.5) | 0.329 | 5.5 (4.7) | −3.1‡ (0.5) | 5.0 (4.5) | −3.2‡ (0.4) |
Work productivity | |||||||||
WPAI-AS, 0–100% | |||||||||
Absenteeism, % work time missed# | 10.1 (4.4) | −0.2 (4.4) | 5.4 (4.3) | −4.9 (4.3) | 0.240 | 6.2 (21.4) | −0.7 (3.4) | 6.3 (19.0) | −7.2 (4.5) |
Presenteeism, % impairment while working# | 20.5 (4.7) | −21.2‡ (4.7) | 29.7 (4.7) | −12.1‡ (4.7) | 0.046 | 24.8 (27.2) | −16.5‡ (4.7) | 24.3 (21.5) | −18.0‡ (3.4) |
Overall work impairment# | 22.3 (4.9) | −20.8‡ (4.9) | 31.0 (4.9) | −12.1 (4.9) | 0.069 | 26.3 (28.0) | −14.9‡ (4.5) | 26.2 (25.0) | −17.7‡ (3.7) |
Activity impairment | 33.6 (3.4) | −18.9‡ (3.4) | 40.5 (3.1) | −12.1‡ (3.1) | 0.040 | 32.6 (25.3) | −20.7‡ (3.1) | 29.2 (24.7) | −22.2‡ (2.5) |
AS WIS, 0–20 | 10.0 (0.6) | −2.4‡ (0.6) | 10.8 (0.6) | −1.6‡ (0.6) | 0.183 | 9.1 (5.9) | −3.1‡ (0.6) | 9.3 (5.8) | −2.6‡ (0.6) |
Sleep/anxiety/depression | |||||||||
MOS sleep scale I, 0–100 | 38.8 (2.0) | −6.0‡ (2.0) | 40.7 (1.9) | −4.1‡ (1.9) | 0.335 | 36.8 (17.4) | −7.0‡ (1.8) | 37.1 (17.6) | −8.2‡ (1.8) |
MOS sleep scale II, 0–100 | 40.6 (2.0) | −6.0‡ (2.0) | 41.9 (1.9) | −4.7‡ (1.9) | 0.515 | 37.7 (17.7) | −7.7‡ (1.8) | 37.5 (17.3) | −10.0‡ (1.7) |
HADS anxiety, 0–21 | 5.3 (0.5) | −1.3 (0.5) | 5.9 (0.4) | −0.8 (0.4) | 0.244 | 5.6 (4.5) | −1.0‡ (0.4) | 4.9 (3.3) | −1.7‡ (0.3) |
HADS depression, 0–21 | 5.3 (0.5) | −0.5 (0.5) | 5.6 (0.4) | −0.1 (0.4) | 0.384 | 4.7 (3.9) | −1.2‡ (0.4) | 4.4 (3.7) | −1.1‡ (0.3) |
↵* Week 12 mean values adjusted for treatment, region, and SI status for between-treatment group comparison (ANCOVA model).
↵** Week 24 mean values are unadjusted; no between-group comparisons were conducted because all patients received the same treatment.
↵† p value between treatment groups.
↵‡ p ≤ 0.05 within treatment group versus baseline (paired Student t test).
↵# Employed patients only. ETN: etanercept; QW: once weekly; 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; SI: sacroiliac.