Wyeth presents on two Ph IV AS trials of Enbrel

US drug major Wyeth presented new data from two studies of its Enbrel (etanercept) in ankylosing spondylitis at the American College of Rheumatology meeting in San Francisco.

The first study was a randomized, double-blind clinical trial designed to compare the efficacy of Enbrel with sulphasalazine over 16 weeks in nearly 600 patients with active AS who had failed one or more non-steroidal anti-inflammatory drugs taken for at least three months. At week 16, nearly 76% of the 378 patients treated with Enbrel achieved an Assessment in Ankylosing Spondylitis score 20% response, compared with 51% of the 187 subjects who received sulphasalazine (p<0.001). Also at 16 weeks, nearly 60% of patients receiving Enbrel therapy achieved ASAS 40, versus nearly 33% of those treated with sulphasalazine (p<0.001). Overall, patients treated with Enbrel achieved an average 48% improvement in physical function, as measured by the Bath Ankylosing Spondylitis Functional Index, and these results were sustained through 16 weeks. People treated with sulphasalazine achieved an average 28% improvement during the same time period (p<0.001).

A second study was designed to assess whether long-term safety, clinical efficacy and patient-reported outcomes were sustained in AS subjects receiving Enbrel from week 108 to week 264. This Phase IV, open-label extension study consisted of patients with AS who completed a 12-week randomized, placebo-controlled study followed by a 96-week open-label study. 75% (n=44) were ASAS 20 responders at week 264 and 66% (n= 39) achieved a 50% improvement in their BASDAI score at the end of the study. The trial also showed that improvements in patient-reported outcomes (patient global assessment, back pain and morning stiffness) were sustained through 264 weeks of treatment.