This meta- analysis shows that ETN monotherapy is effective in improving physical function and reducing disease activity in patients with AS .
Compared with SSZ , ETN markedly decreased the BASDAI and CRP levels .
Etanercept ( ETN ) has been widely applied in the treatment of ankylosing spondylitis ( AS ) .
As the use of ETN has increased , associated adverse effects have been reported frequently .
Previous meta-analyses have focused on comparing the differences in clinical outcomes between ETN and placebo ( PBO ) .
The present meta- analysis evaluated r and omised controlled trials ( RCTs ) to compare the effects of ETN and a PBO or sulfasalazine ( SSZ ) in patients with AS .
[A multicenter, double-blind, randomized, placebo-controlled clinical trial of etanercept treatment of Chinese patients with active ankylosing spondylitis].
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 r and omly 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 Assessment s 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 tolerated
This meta- analysis shows that ETN monotherapy is effective in improving physical function and reducing disease activity in patients with AS .
Compared with SSZ , ETN markedly decreased the BASDAI and CRP levels .
Etanercept ( ETN ) has been widely applied in the treatment of ankylosing spondylitis ( AS ) .
As the use of ETN has increased , associated adverse effects have been reported frequently .
Previous meta-analyses have focused on comparing the differences in clinical outcomes between ETN and placebo ( PBO ) .
The present meta- analysis evaluated r and omised controlled trials ( RCTs ) to compare the effects of ETN and a PBO or sulfasalazine ( SSZ ) in patients with AS .