Treatment Of Ankylosing Spondylitis With A Recombinant Human Tumor Necosis Factor-Fc Fusion Protein: A Short-Term Clinical Study

Objective To evaluate the short-term efficacy and safety profile of a recombinant human tumor necrosis factor receptor-Fc fusion protein in ankylosing spondylitis (AS).Mathods This was a retrospective study. Subjects eligible for this study were adults with a diagnosis of definite AS. All patients were assigned to receive once-weekly subcutaneous injections of etanercept (50mg) and all of them were followed up to 12 weeks. The primary endpoint was proportion of ASAS20 responders. The secondary endpoints were the proportion of subjects achieving an BASDAI 20%, BASDAI 50% and BASDAI 70% improvement. Other secondary endpoints, related to reducing signs and symptoms of AS and improving range of motion and physical function, were evaluated.Results 39 of all 40 patients (82.5% males, median age 32yr, median disease duration 5.7yr, 100%HLA-B27+) completed the treatment. The proportion of ASAS 20 responders at 12th week was 82.1%. The proportion of subjects achieving an BASDAI 20%, BASDAI 50% and BASDAI 70% improvement at 12th week was 94.9%, 76.9%, 41% respectively. Results for other secondary efficacy endpoints showed that etanercept could provide substantial benefits to patients with AS by reducing clinical signs and symptoms and improving range of motion, physical function, and quality of life. 30.8% of subjects reported treatment-related adverseevents. The most frequently occurred were elevation of liver enzymes, upperrespiratory tract infection and injection site reaction. Most treatment-related adverseevents were mild in severity.Conclusion Etanercept demonstrated consistent evidence of efficacy and was welltolerated in the treatment of active AS.