OP0005 ETANERCEPT (ENBREL^®) IMPROVES SIGNS AND SYMPTOMS OF ANKYLOSING SPONDYLITIS: RESULTS OF A PHASE 3 MULTICENTER CLINICAL TRIAL**
J Davis, D van der Heijde, J Braun, M Dougados, J Cush, D Clegg, W Tsuji

In prior studies, Etanercept therapy was shown to be safe and efficacious in patients with ankylosing spondylitis (AS). In this study, Davis et al. investigate the use of etanercept in ankylosing spondylitis in a larger, Phase III, multicentered, placebo-controlled clinical trial.

Methods: Patients with active AS were randomized to receive either etanercept 25mg sc 2x weekly (n=138) or placebo (n=139). Use of concomitant DMARD therapy was considered when randomizing patients. The primary endpoint measured was the Ankylosing Spondylitis Response Criteria (ASAS 20) at 12 to 24 weeks.

Results: Improvements were noted as early as week 2. At 12 weeks, 60% of patients in the etanercept group met ASAS 20 criteria versus 27% of patients in the placebo group (p<0.0001). Improvement was maintained through week 24 with 58% of patients treated with etanercept meeting ASAS 20 criteria compared with 23% of patients receiving placebo. Statistically significant improvement was achieved in both etanercept groups in all of the individual components of the ASAS response criteria. Adverse events were similar to those seen in patients with RA.

**There was another abstract (OP0097 A MULTICENTRE, PLACEBO-CONTROLLED TRIAL OF ENBREL IN ANKYLOSING SPONDYLITIS, Calin et al) presented which also assessed the effectiveness of etanercept in patients with AS. The trial consisted of 84 patients and had a similar design. They reported similar efficacy as in the study above. A significantly greater percentage of patients receiving etanercept (60%) achieved an ASAS response at 12 weeks compared to the patients receiving placebo (23.1%). Additionally, they found that 70% of patients receiving etanercept had a BASDAI >40 compared to no patients in the placebo group.

Conclusion: Treatment of Etanercept in patients with AS is safe efficacious with significant improvement noted as early as 2 weeks continuing through 24 weeks.

Editorial Comment: These studies extend the previously published results (see archived news) to larger patient population demonstrating the remarkable effectiveness of etanercept in Ankylosing Spondylitis.

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