Secondary efficacy outcomes from baseline to week 28
| Efficacy measures | IFX+NPX N=105 | PBO+NPX N=51 | p Value for treatment group difference | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Baseline, mean | Week 28, mean | Change from baseline, mean (SD) | % Change | Baseline, mean | Week 28, mean | Change from baseline, mean (SD) | % Change | ||
| PhGADA (100 mm VAS) | 66.6 | 15.6 | –51.3 (23.00) | –76.5 | 63.3 | 30.6 | –33.0 (22.44) | –51.7 | <0.001 |
| PtGADA (100 mm VAS) | 73.5 | 18.8 | –54.5 (25.71) | –74.4 | 72.3 | 34.4 | –38.1 (29.02) | –52.4 | <0.001 |
| Patient's total back pain (100 mm VAS) | 76.7 | 18.6 | –58.0 (25.61) | –75.7 | 76.6 | 30.8 | –45.2 (29.27) | –59.8 | 0.005 |
| Patient's nocturnal pain (100 mm VAS) | 70.6 | 16.7 | –54.0 (26.03) | –76.4 | 69.3 | 31.4 | –37.4 (30.66) | –54.7 | <0.001 |
| EQ-5D index score* | 0.38 | 0.75 | 0.37 (0.303) | 95.4 | 0.33 | 0.60 | 0.27 (0.313) | 81.6 | 0.003 |
| EQ-5D global health status* | 46.8 | 76.8 | 30.0 (29.23) | 64.2 | 40.0 | 58.9 | 18.5 (23.11) | 47.0 | <0.001 |
| SF-36 physical component* | 34.0 | 46.6 | 12.6 (10.31) | 42.5 | 32.4 | 40.3 | 8.6 (8.93) | 29.4 | 0.003 |
| SF-36 mental component* | 40.0 | 49.0 | 9.0 (10.96) | 33.5 | 37.7 | 45.7 | 7.6 (11.10) | 27.1 | 0.16 |
| BASMI | 3.1 | 2.0 | –1.1 (1.13) | –34.6 | 3.1 | 2.5 | –0.6(0.72) | –18.7 | <0.001 |
| ESR (mm/h) | 23.0 | 7.1 | –16.0 (16.11) | –54.7 | 28.3 | 19.0 | –9.4 (13.18) | –13.0 | <0.001 |
| CRP (mg/dL) | 2.02 | 0.91 | –1.24 (6.209) | –55.1 | 1.65 | 1.15 | –0.55 (1.315) | –30.5 | 0.59 |
| 66-joint swollen joint count, mean (SD) | 1.49 | 0.15 | –1.44 (4.131) | –89.6 | 0.78 | 0.40 | –0.42 (0.917) | –49.0 | 0.06 |
| 68-joint tender joint count, mean (SD) | 4.06 | 0.94 | –3.29 (6.385) | –76.9 | 3.80 | 1.07 | –2.93 (5.101) | –72.0 | 0.73 |
| Patients who met criterion at week 28, % | Patients who met criterion at week 28, % | ||||||||
| BASDAI≥50% improvement | 77.3 | 51.1 | 0.003 | ||||||
| BASDAI<3 | 76.3 | 53.3 | 0.01 | ||||||
*An increase in scores indicates improvement on these measures. For all other measures, a decrease in score indicates improvement.
BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BASMI, Bath Ankylosing Spondylitis Metrology Index; CRP, C-reactive protein; ESR, erythrocyte sedimentation rate; EQ-5D, EuroQoL 5D Health Questionnaire; IFX, infliximab; NPX, naproxen; PBO, placebo; PhGADA, Physician Global Assessment of Disease Activity; PtGADA, Patient Global Assessment of Disease Activity; SF-36, Short Form 36 Health Survey; VAS, visual analogue scale.