Table 1.
Characteristics at baseline of the ASSERT, the GO–RAISE and the combined datasets
| Variables at baseline | ASSERT | GO–RAISE | Combined |
|---|---|---|---|
| N | 279 | 356 | 635 |
| Male (%) | 80.6 | 71.6 | 75.6 |
| Age (years) | 39.8±10.2 | 39.3±12.1 | 39.5±11.3 |
| BASDAI score | 6.4±1.6 | 6.7±1.5 | 6.6±1.5 |
| BASFI score | 5.8±2.0 | 5.1±2.4 | 5.4±2.2 |
| BASMI score | 4.0±2.1 | 3.5±2.2 | 3.7±2.1 |
| Cervical rotation (°) | 45.8±21.9 | 48.8±20.3 | 47.5±21.0 |
| Intermalleolar distance (cm) | 95.3±30.6 | 100.8±24.8 | 98.3±27.7 |
| Lateral flexion (cm) | 11.2±11.0 | 11.0±5.8 | 11.1±8.5 |
| Tragus to wall distance (cm) | 17.0±6.3 | 14.2±5.7 | 15.4±6.1 |
| CRP (mg/dl) | 2.4±2.7 | 1.8±2.0 | 2.1±2.4 |
| Enthesitis, presence of (%) | 63.3 | 63.7 | 63.5 |
| HLA-B27 positive (%) | 87.1 | 83.4 | 85.0 |
| PGA (cm) | 6.8±1.8 | 7.0±1.8 | 6.9±1.8 |
| Concomitant medications for placebo patients | |||
| NSAID (%) | 90.7 | 92.3 | – |
| Methotrexate (%) (mean dose (mg/week)) | – | 19.2 (14.2) | – |
| Sulphasalazine (%) (mean dose (g/day)) | – | 30.8 (1.8) | – |
| Oral corticosteroids (%) (mean dose (mg/day)) | – | 16.7 (7.2) | – |
| Anti-inflammatory/antirheumatic drugs (%) | 38.5 | – | – |
Values are mean±SD for continuous variables or percentages for categorical variables unless otherwise specified.
BASDAI, Bath ankylosing spondylitis disease activity index; BASFI, Bath ankylosing spondylitis functional index; BASMI, Bath ankylosing spondylitis metrology index; CRP, C-reactive protein; NSAID, non-steroidal anti-inflammatory drug; PGA, patient global assessment.