Baseline characteristics of the study patients. Values presented are median (range) unless otherwise stated
| Infliximab + MTX group (n = 28) | Placebo + MTX group (n = 14) | |
|---|---|---|
| No statistically significant differences were found between treatment groups in any of the baseline characteristics using non-parametric tests (Mann-Whitney U test). | ||
| BASDAI, Bath Ankylosing Spondylitis Disease Activity Index 0–10; BASFI, Bath Ankylosing Spondylitis Functional Index 0–10; VAS, visual analogue scale; EMS, early morning stiffness; CRP, C reactive protein; ASQoL, Ankylosing Spondylitis Quality of Life Index; NSAIDs, non-steroidal anti-inflammatory drugs; DMARDS, disease modifying antirheumatic drugs. | ||
| Male:female | 23:5 | 11:3 |
| Age (years), mean | 41 (28–74) | 39 (30–56) |
| Disease duration (years) | 8 (0–41) | 10 (0–35) |
| HLA-B27 positive (%) | 96 | 86 |
| BASDAI | 6.9 (2.11–9.26) | 6.4 (3–10) |
| BASFI | 6.7 (1.9–9.63) | 6.0 (3.8–10) |
| VAS (mm): | ||
| Pain day | 57.5 (17–96) | 66 (24–100) |
| Pain night | 63.5 (11–100) | 76.5 (33–100) |
| Enthesopathy | 75 (0–100) | 73 (9–100) |
| EMS (min) | 60 (15–120) | 75 (10–120) |
| CRP (mg/l) | 30.5 (10–153) | 30 (13–60) |
| ASQoL | 14 (2–18) | 13.5 (8–18) |
| Concomitant drugs, No (%) of patients): | ||
| NSAIDs | 25 (89) | 12 (86) |
| Oral corticosteroids | 5 (18) | 3 (25) |
| DMARDs | 10 (36) | 4 (21) |