[A multicenter, double-blind, placebo-controlled, randomized, phase III clinical study of etanercept in treatment of ankylosing spondylitis].

ABSTRACT

OBJECTIVE: To evaluate the short-term efficacy and safety of etanercept treatment in Chinese patients with active ankylosing spondylitis (AS). METHODS: This was a 12-week multicenter, double-blind, placebo-controlled, randomized phase III clinical study. The first part was a 6-week placebo-controlled period followed by a 6-week open-label period. The primary efficacy endpoint was the percentage of subjects achieving a 20% improvement in assessment in ankylosing spondylitis (ASAS) (ASAS 20). The secondary efficacy endpoints were the percentage of patients achieving a 40% improvement in ASAS (ASAS 40), achieving a 50% improvement in ASAS (ASAS 50), achieving a 70% improvement in ASAS (ASAS 70), and ASAS 5/6 responses at all visits, and the improvement in subject global assessment, physician global assessment, nocturnal and total back pain, bath AS functional index (BASFI), bath AS disease activity index (BASDAI), spinal mobility, joint assessment and quality of life assessment. All subjects in the study were evaluated for safety. RESULTS: The primary endpoint, ASAS 20 at week 6, was achieved by 86.5% (64/74) patients in the etanercept group compared to 29.5% (23/78) patients in the placebo group (P < 0.001). As early as week 2, the percentages of patients achieving the ASAS 20 between the two groups were significantly different. Furthermore, the majority of secondary efficacy end points were also significantly improved. Most of adverse events (AE) were mild in nature, the commonest adverse events were elevated liver function levels, injection site reactions and nasopharyngitis. No death or serious AE were observed. CONCLUSION: Etanercept can improve symptoms fastly, significantly and safely in Chinese patients with active AS.