Efficacy data at baseline, week 24 and at week 48 in the etanercept versus sulfasalazine treatment group
| Parameters assessed | Time | Etanercept group (n=40) | Sulfasalazine group (n=36) | p Value* |
|---|---|---|---|---|
| BASDAI (0–10), mean (±SD) | Baseline† | 5.5 (1.3) | 6.0 (1.2) | |
| Week 24 | 2.6 (2.3) | 4.4 (2.2) | 0.002 | |
| Week 48 | 2.5 (2.0) | 4.4 (2.4) | 0.001 | |
| BASFI (0–10), mean (±SD) | Baseline† | 4.3 (2.3) | 4.3 (1.8) | |
| Week 24 | 1.9 (2.2) | 3.1 (2.2) | 0.005 | |
| Week 48 | 2.0 (2.1) | 3.3 (2.2) | 0.001 | |
| Patient global (0–10), mean (±SD) | Baseline† | 6.7 (2.1) | 7.1 (1.6) | |
| Week 24 | 2.6 (2.6) | 5.1 (2.5) | <0.001 | |
| Week 48 | 2.6 (2.2) | 4.9 (3.0) | <0.001 | |
| Physician global (0–10), mean (±SD) | Baseline† | 6.4 (1.2) | 6.1 (1.5) | |
| Week 24 | 1.8 (1.9) | 3.8 (2.5) | <0.001 | |
| Week 48 | 1.8 (1.8) | 4.1 (2.9) | <0.001 | |
| Joint count (0–64), mean (±SD) | Baseline† | 2.3 (5.8) | 1.3 (1.7) | |
| Week 24 | 0.3 (1.3) | 0.4 (2.0) | 0.70 | |
| Week 48 | 0.2 (0.7) | 0.3 (1.5) | 0.48 | |
| Enthesitis score (0–17), mean (±SD) | Baseline† | 4.4 (4.6) | 3.4 (3.4) | |
| Week 24 | 1.6 (4.1) | 2.6 (3.6) | 0.01 | |
| Week 48 | 1.8 (4.2) | 1.4 (2.9) | 0.70 | |
| BASMI (0–10), mean (±SD) | Baseline† | 1.9 (1.7) | 1.7 (1.4) | |
| Week 24 | 1.7 (1.6) | 1.9 (1.6) | 0.28 | |
| Week 48 | 1.6 (1.8) | 1.9 (1.7) | 0.32 | |
| EQ-5D (0–1), mean (±SD) | Baseline† | 0.6 (0.3) | 0.6 (0.3) | |
| Week 24 | 0.9 (0.2) | 0.7 (0.2) | 0.01 | |
| Week 48 | 0.8 (0.2) | 0.7 (0.3) | 0.047 | |
| AS-QoL (0–18), mean (±SD) | Baseline† | 9.7 (4.5) | 9.3 (3.6) | |
| Week 24 | 4.1 (4.3) | 7.4 (5.0) | <0.001 | |
| Week 48 | 4.4 (4.8) | 7.5 (5.4) | <0.001 | |
| CRP (ref 5 mg/l), mean (±SD) | Baseline† | 11.9 (13.2) | 10.6 (14.9) | |
| Week 24 | 4.2 (3.5) | 8.5 (11.8) | 0.07 | |
| Week 48 | 4.3 (3.7) | 8.7 (12.5) | 0.13 |
↵* p Values for comparison of changes in the parameters between both groups by analysis of covariance.
↵† No significant differences at baseline between etanercept and sulfasalazine. Every mean value refers to the complete intention-to-treat population (etanercept, n=40; sulfasalazine, n=36).
ASQoL, ankylosing spondylitis quality of life questionnaire; BASDAI, Bath ankylosing spondylitis disease activity index; BASFI, Bath ankylosing spondylitis disease functional index; BASMI, Bath ankylosing spondylitis metrology index; CRP, C-reactive protein (reference range <5mg/l); EQ-5D, EuroQoL index.