Baseline demographics and disease characteristics of patients entering the open-label period
| ETN/ETN (n=102) | PBO/ETN (n=106) | Combined (n=208) | |
|---|---|---|---|
| Age, years | 31.6 (7.8) | 32.1 (7.7) | 31.9 (7.8) |
| Male, n (%) | 65 (63.7) | 61 (57.5) | 126 (60.6) |
| White, n (%) | 77 (75.5) | 77 (72.6) | 154 (74.0) |
| BMI, kg/m2 | 25.6 (5.0) | 24.6 (4.1) | 25.1 (4.6) |
| Duration of disease symptoms, years | 2.4 (2.0) | 2.5 (1.8) | 2.5 (1.9) |
| HLA-B27 positive, n (%) | 68 (66.7) | 80 (75.5) | 148 (71.2) |
| CRP, mg/L | 7.0 (10.7) | 6.4 (10.6) | 6.7 (10.7) |
| Elevated CRP (>3 mg/L), n (%) | 48 (47.1) | 42 (39.6) | 90 (43.3) |
| BASDAI, 0–10 cm VAS | 6.0 (1.8) | 6.0 (1.9) | 6.0 (1.8) |
| BASFI, 0–10 cm VAS | 4.2 (2.4) | 3.8 (2.5) | 4.0 (2.4) |
| BASMI, 0–10 cm VAS | 1.4 (1.3) | 1.2 (1.3) | 1.3 (1.3) |
| Total back pain, 0–10 cm VAS | 5.5 (2.4) | 5.4 (2.4) | 5.5 (2.4) |
| PGA, 0–10 cm VAS | 5.7 (1.8) | 5.2 (1.9) | 5.4 (1.9) |
| PtGA, 0–10 cm VAS | 5.8 (2.2) | 5.8 (2.1) | 5.8 (2.2) |
| ASDAS-CRP | 3.0 (0.9) | 3.0 (1.0) | 3.0 (1.0) |
| EQ-5D utility score, range 0–1 | 0.52 (0.33) | 0.59 (0.28) | 0.56 (0.31) |
| SF-36 MCS, range 0–100 | 42.3 (11.9) | 43.5 (11.1) | 42.9 (11.5) |
| SF-36 PCS, range 0–100 | 37.7 (8.6) | 37.4 (8.3) | 37.5 (8.4) |
| WPAI overall, range 0–100* | 45.0 (26.2) | 43.9 (27.8) | 44.5 (26.9) |
| MRI sacroiliitis positive by ASAS criteria, n (%) | 84 (82.4) | 85 (80.2) | 169 (81.3) |
| SPARCC MRI SIJ score, range 0–72 | 7.9 (10.9) | 7.0 (11.0) | 7.4 (10.9) |
| SPARCC MRI 6-DVU spinal score, range 0–108 | 7.6 (11.4) | 6.9 (9.2) | 7.2 (10.3) |
| ASspiMRI-a score, range 0–138 | 1.6 (2.5) | 1.4 (1.7) | 1.5 (2.1) |
*ETN/ETN, n=58; PBO/ETN, n=58.
Open-label safety population, except BASMI, SF-36 MCS, WPAI overall, SPARCC MRI SIJ, SPARCC MRI spinal, ASspiMRI-a, which are mITT from the double-blind period (ETN/ETN, n=106; PBO/ETN, n=109).
Values are shown as mean (SD) unless stated otherwise.
ASAS, Assessment of SpondyloArthritis international Society; ASDAS-CRP, Ankylosing Spondylitis Disease Activity Score based on C-reactive protein; ASspiMRI-a, Ankylosing Spondylitis spine MRI-activity; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BASFI, Bath Ankylosing Spondylitis Functional Index; BASMI, Bath Ankylosing Spondylitis Metrology Index; BMI, body mass index; CRP, C-reactive protein; DVU, discovertebral units; EQ-5D, EuroQol 5 Dimensions; ETN, etanercept; HLA-B27, human leucocyte antigen B27; MCS, mental component summary; mITT, modified intention-to-treat; PBO, placebo; PCS, physical component summary; PGA, physician global assessment; PtGA, patient global assessment; SF-36, 36-item Short Form Health Survey; SIJ, sacroiliac joint; SPARCC, Spondyloarthritis Research Consortium of Canada; VAS, visual analogue scale; WPAI, Work Productivity and Activity Impairment questionnaire.