Intention to treat analysis of clinical outcomes at all end points. Values are given median (range)
| Variable | Infliximab + methotrexate group (n = 28) | Placebo + methotrexate group (n = 14) | INF v placebo p Value | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Baseline | Week 4 | Week 10 | Week 30 | Baseline | Week 4 | Week 10 | Week 30 | Week 30 | |
| *p<0.005, Wilcoxon signed rank test comparing baseline data with week 30 within groups. | |||||||||
| **p<0.003, Mann-Whitney U test comparing change scores (week 30 minus baseline) between groups. | |||||||||
| BASFI, Bath Ankylosing Spondylitis Functional Index 0–10; EMS, early morning stiffness; VAS, visual analogue scale; DAS, Disease Activity Score; ASQoL, Ankylosing Spondylitis Quality of Life Index; CRP, C reactive protein. | |||||||||
| BASFI | 6.68 (1.90–9.63) | 5.61 (0.32–9.60) | 4.96 (0.32–8.84) | 5.04 (0.61–9.14)* | 6.00 (3.84–10) | 4.90 (0.23–9.66) | 6.10 (0.89–9.59) | 5.68 (2.69–9.59) | 0.196 |
| EMS (min) | 60 (15–120) | 45 (0–120) | 15 (0–120) | 30 (0–120) | 75 (10–120) | 37.5 (0–120) | 45 (0–120) | 60 (5–120) | 0.298 |
| VAS (mm): | |||||||||
| Pain day | 57.5 (17–96) | 28.5 (0–100) | 20.5 (0–100) | 30 (0–100) | 66 (24–100) | 60 (6–100) | 55 (6–98) | 58.5 (17–98) | 0.043 |
| Pain night | 63.5 (11–100) | 21 (0–100) | 11 (0–93) | 22 (0–93)* | 76.5 (33–100) | 65 (12–100) | 63.5 (6–97) | 58.5 (22–97) | 0.235 |
| Enthesopathy | 75 (0–100) | 30.5 (0–83) | 16 (0–100) | 29.5 (0–100)* | 73 (9–100) | 62 (8–100) | 51 (11–98) | 46 (11–98) | 0.488 |
| Physician DAS | 63.5 (36–96) | 24.5 (4–80) | 19.5 (2–54) | 23.5 (0–65)* | 62 (29–98) | 46.5 (8–78) | 48.5 (12–78) | 57.5 (27–92) | 0.001** |
| ASQoL | 14 (2–18) | 10.5 (0–18) | 7.5 (0–17) | 8.5 (0–18)* | 13.5 (8–18) | 11.5 (0–18) | 14 (2–18) | 14.5 (5–18) | 0.144 |
| CRP (mg/l) | 30.5 (10–153) | 6 (0–104) | 5.5 (0–50) | 8.5 (0–79)* | 30 (13–60) | 22 (10–52) | 21 (7–92) | 26 (7–56) | 0.017 |