Table 1.
Summary data for phase III pivotal trials of anti-TNFα therapies for AS
| Study | Patient no | Disease duration | Primary endpoint | Primary endpoint | Secondary endpoints | Secondary endpoints | ||
|---|---|---|---|---|---|---|---|---|
| Active | Placebo | Active | Placebo | |||||
| Davis et al (2003) | Etanercept = 138 | 10-years | ASAS 20 response at 12-weeks | 59% | 28% | BASDAI | −40.6% | −7.6% |
| Placebo = 139 | 10-years | ASAS 50 | 43% | 8% | ||||
| CRP | −68.4% | −5% | ||||||
| Van der Heijde et al 2005 | Infliximab = 201 | 8-years | ASAS 20 response at 24-weeks | 61.2% | 19.2% | ASAS 40 | 47% | 12% |
| Placebo = 78 | 13-years | ASAS partial remission | 22.4% | 1.3% | ||||
| ASAS 5/6 | 49% | 8.0% | ||||||
| BASDAI | −43.9% | −6.2% | ||||||
| BASFI | −29.8% | 0% | ||||||
| Van der Heijde et al 2006 | Adalimumab = 208 | 11-years | ASAS 20 response at 12-weeks | 58.2% | 20.6% | ASAS 40 | 39.9% | 13.1% |
| Placebo = 170 | 10-years | ASAS partial remission | 20.7% | 3.7% | ||||
| ASAS 5/6 | 48.6% | 13.1% | ||||||
| BASDAI | −41.3% | −12.7% | ||||||
| BASFI | −68.8% | −14.3% | ||||||