[A multicenter, double-blind, randomized, placebo-controlled clinical trial of
etanercept treatment of Chinese patients with active ankylosing spondylitis]. [Article in Chinese]
Author(s): Huang F, Zhang J, Zheng Y, Xu JH, Li XF, Wu HX, Chen ZW, Zhao Z, Zhang YM.
Affiliation(s): Department of Rheumatology, Chinese PLA General Hospital, Beijing, China.
Publication date & source: 2011, Zhonghua Nei Ke Za Zhi. , 50(12):1043-7
OBJECTIVE: To evaluate the efficacy and safety of etanercept 50 mg once-weekly
treatment of Chinese patients with active ankylosing spondylitis (AS).
METHODS: Four hundred patients with active AS, enrolled in six medical centers,
were randomly divided into either the treatment group or the placebo group in a
3:1 ratio. The total length of the study was 12 weeks. The first 6-week period
was a double-blind placebo controlled treatment period and the second 6-week
period was an open-labeled treatment period. During the first 6-week period, 300
patients in the treatment group received once-weekly subcutaneous injection of
etanercept (50 mg), whereas the 100 patients in the placebo group received
placebo injection. During the second 6-week period, patients in both groups
received etanercept (50 mg once weekly subcutaneous injection). The primary end
point was the percentage of patients achieving the Assessments in Ankylosing
Spondylitis (ASAS) 20% response (ASAS 20) at week 6. Other outcome measures
included the percentage of patients achieving ASAS 5/6, partial remission and
Bath AS disease activity index 50 (BASDAI 50) responses at week 12.
RESULTS: A total of 381 patients completed the trial, including 285 patients in
the etanercept group and 96 patients in the placebo group. At week 2, the
percentage of patients achieving ASAS 20 in the etanercept group was 55.7%,
whereas the placebo group was only 17.0% (P < 0.001). At week 6, 77.5% of
patients in the etanercept group achieved ASAS 20 as compared with 32.3% in the
placebo group (P < 0.001). At the end of 12 weeks, the percentage of patients in
the etanercept group achieving the ASAS 20 was 89.5%. Improvements of other
measures were also significant in the etanercept group. Etanercept was well
tolerated and no malignancy and life-threatening events were observed in this
study. Most adverse events observed were mild injection-site reactions.
CONCLUSION: Etanercept 50 mg weekly treatment of Chinese patients with active
ankylosing spondylitis is convenient, fast-acting, highly effective, and well