Outcomes of a multicentre randomised clinical trial of etanercept to treat ankylosing spondylitis Clinical Efficacy of Etanercept Versus Sulfasalazine in Ankylosing Spondylitis Subjects with Peripheral Joint Involvement Clinical efficacy and safety of etanercept versus sulfasalazine in patients with ankylosing spondylitis: a randomized, double-blind trial. [A multicenter, double-blind, placebo-controlled, randomized, phase III clinical study of etanercept in treatment of ankylosing spondylitis]. Recombinant human tumor necrosis factor receptor (etanercept) for treating ankylosing spondylitis: a randomized, controlled trial. Efficacy and safety of up to 192 weeks of etanercept therapy in patients with ankylosing spondylitis. A 2-year comparative open label randomized study of efficacy and safety of etanercept and infliximab in patients with ankylosing spondylitis [A multicenter, double-blind, randomized, placebo-controlled clinical trial of etanercept treatment of Chinese patients with active ankylosing spondylitis]. Etanercept in the Longterm Treatment of Patients With Ankylosing Spondylitis Improvement in patient-reported outcomes for patients with ankylosing spondylitis treated with etanercept 50 mg once-weekly and 25 mg twice-weekly. Sustained efficacy and safety, including patient-reported outcomes, with etanercept treatment over 5 years in patients with ankylosing spondylitis. Six-month results of a double-blind, placebo-controlled trial of etanercept treatment in patients with active ankylosing spondylitis. Treatment of ankylosing spondylitis by inhibition of tumor necrosis factor alpha. Low doses of etanercept can be effective to maintain remission in ankylosing spondylitis patients Etanercept 50 mg once weekly is as effective as 25 mg twice weekly in patients with ankylosing spondylitis Efficacy of etanercept on rheumatic signs and pulmonary function tests in advanced ankylosing spondylitis: results of a randomised double-blind placebo-controlled study (SPINE) Radiographic progression of ankylosing spondylitis after up to two years of treatment with etanercept.
Objective : A double blind , r and omised , placebo controlled study to evaluate the safety and efficacy of etanercept to treat adult patients with ankylosing spondylitis ( AS ) . Methods : Adult patients with AS at 14 European sites were r and omly assigned to 25 mg injections of etanercept or placebo twice weekly for 12 weeks . The primary efficacy end point was an improvement of at least 20 % in patient reported symptoms , based on the multicomponent Assessment s in Ankylosing Spondylitis ( ASAS ) response criteria ( ASAS 20 ) . Secondary end points included ASAS 50 and ASAS 70 responses and improved scores on individual components of ASAS , the Bath Ankylosing Spondylitis Disease Activity Index ( BASDAI ) , acute phase reactants , and spinal mobility tests . Safety was evaluated during scheduled visits . Results : Of 84 patients enrolled , 45 received etanercept and 39 received placebo . Significantly more etanercept patients than placebo patients responded at the ASAS 20 level as early as week 2 , and sustained differences were evident up to week 12 . Significantly more etanercept patients reported ASAS 50 responses at all times and ASAS 70 responses at weeks 2 , 4 , and 8 ; reported lower composite and fatigue BASDAI scores ; had lower acute phase reactant levels ; and had improved spinal flexion .  Etanercept was well tolerated . Most adverse events were mild to moderate ; the only between-group difference was injection site reactions , which occurred significantly more often in etanercept patients . Conclusions : Etanercept is a well tolerated and effective treatment for reducing clinical symptoms and signs of AS Objective . Etanercept , a fully human tumor necrosis factor soluble receptor , is effective in treatment of ankylosing spondylitis ( AS ) . Current guidelines suggest sulfasalazine ( SSZ ) treatment as initial therapy for the management of patients with AS with peripheral arthritis versus therapy with biologics . We compared the efficacy of etanercept with SSZ in patients with AS with peripheral joint involvement . Methods . The efficacy of etanercept 50 mg once weekly was compared with that of SSZ up to 3 g daily in subjects with ≥ 1 swollen peripheral joint at baseline , using data from a 16-week r and omized double-blind study in subjects with AS .  Efficacy was assessed by the Assessment in AS criteria and the Bath AS Disease Activity , Functional , and Metrology indices . The last observation carried forward method was used for imputation of missing values . Results . Of 566 subjects included in original study , 181 ( etanercept 121 ; SSZ 60 ) had ≥ 1 swollen peripheral joint and 364 ( etanercept 250 ; SSZ 124 ) had none at baseline . AS patients treated with etanercept showed significantly greater improvement than those treated with SSZ in all joint assessment s regardless of swollen joint involvement . Conclusion . In this analysis , etanercept was significantly more effective than SSZ for management of patients with AS and peripheral joint involvement OBJECTIVE Etanercept , a fully human tumor necrosis factor ( TNF ) receptor , is an effective treatment in patients with ankylosing spondylitis ( AS ) .  Sulfasalazine is frequently used for the treatment of both axial symptoms and peripheral symptoms of AS , and it has been the recommended therapy before the use of an anti-TNF agent when peripheral arthritis is present . Until now , no clinical trial has compared the efficacy and safety of a TNF blocker with that of sulfasalazine . This study was undertaken to compare the efficacy and safety of etanercept with that of sulfasalazine after 16 weeks of treatment in patients with axial and peripheral manifestations of AS . METHODS In this r and omized , double-blind study , patients received etanercept 50 mg once weekly ( n=379 ) or sulfasalazine titrated to a maximum of 3 gm/day ( n=187 ) for 16 weeks . The primary end point was the proportion of patients who achieved the Assessment of SpondyloArthritis international Society criteria for 20 % improvement ( ASAS20 ) at 16 weeks . Last observation carried forward was predefined for imputation of missing values . RESULTS The mean age of the patients was 41 years , 74 % were male , and the mean disease duration was 7.6 years . The proportion of ASAS20 responders at week 16 was greater among patients treated with etanercept compared with those treated with sulfasalazine ( 75.9 % versus 52.9 % ; P<0.0001 ) . As early as week 2 of treatment , etanercept was found to be more effective than sulfasalazine ( P<0.0001 ) in ameliorating both the axial symptoms and peripheral manifestations . Serious adverse events rarely occurred , and the rate of serious adverse events did not differ between groups . CONCLUSION In this population of patients with AS , etanercept was significantly more effective than sulfasalazine in improving the signs and symptoms of AS in the axial skeleton and peripheral joints 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 , r and omized 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 OBJECTIVE To determine the safety and efficacy of etanercept in a multicenter , r and omized , placebo-controlled , double-blind trial of adults with moderate to severe active ankylosing spondylitis ( AS ) . METHODS Patients ( n = 277 ) were treated with either etanercept 25 mg ( n = 138 ) or placebo ( n = 139 ) subcutaneously twice weekly for 24 weeks . The primary outcome measures were the percentages of patients achieving the Assessment s in Ankylosing Spondylitis 20 % response ( ASAS20 ) at weeks 12 and 24 . Other outcome measures included the percentage of patients achieving higher ASAS responses , and the safety of etanercept in patients with AS . All outcome measures were assessed at 2 , 4 , 8 , 12 , and 24 weeks . RESULTS Treatment with etanercept result ed in dramatic improvement . The ASAS20 was achieved by 59 % of patients in the etanercept group and by 28 % of patients in the placebo group ( P < 0.0001 ) at week 12 , and by 57 % and 22 % of patients , respectively , at week 24 ( P < 0.0001 ) . All individual ASAS components , acute-phase reactant levels , and spinal mobility measures were also significantly improved . The safety profile of etanercept was similar to that reported in studies of patients with rheumatoid arthritis or psoriatic arthritis . The only adverse events that occurred significantly more often in the etanercept group were injection-site reactions , accidental injuries , and upper respiratory tract infections . CONCLUSION Etanercept is a highly effective and well tolerated treatment in patients with active AS OBJECTIVE Evaluate long-term safety and efficacy of etanercept treatment in patients with ankylosing spondylitis ( AS ) . METHODS Patients with AS who previously participated in a r and omised controlled trial ( RCT ) of etanercept  were eligible to enroll in a 168-week open-label extension ( OLE ) . Safety end points included rates of adverse events ( AE ) , serious adverse events ( SAE ) , infections , serious infections and death . Efficacy end points included Assessment in Ankylosing Spondylitis ( ASAS20 ) response , ASAS 5/6 response and partial remission rates . RESULTS A total of 257 of 277 patients ( 92 % ) enrolled in the OLE . After up to 192 weeks of treatment with etanercept , the most common AEs were injection site reactions , headaches and diarrhoea . The exposure-adjusted rate of SAEs was 0.08 per patient-year . The rate of infections was 1.1 per patient-year , and the rate for serious infections was 0.02 per patient-year . No deaths were reported . Of patients who received  etanercept  in both the RCT and OLE and were still in the trial , 71 % were ASAS20 responders at week 96 , and 81 % were responders at week 192 . ASAS 5/6 response rates were 61 % at week 96 and 60 % at week 144 , and partial remission response rates were 41 % at week 96 and 44 % at week 192 . Placebo patients who switched to etanercept in the OLE showed similar patterns of efficacy maintenance . CONCLUSIONS Etanercept was well tolerated for up to 192 weeks in patients with AS , with no unexpected AEs or SAEs observed . No deaths were reported . Improvements in the signs and symptoms of AS were maintained for up to 192 weeks The signs and symptoms of ankylosing spondylitis ( AS ) respond inadequately to nonsteroidal antiinflammatory drugs , corticosteroids , and disease modifying antirheumatic drugs in quite a number of patients . Tumor necrosis factor inhibitors have demonstrated to be of value in reducing AS disease activity in clinical trials . The efficacy and safety of both etanercept and infliximab in patients with ankylosing spondylitis were compared in a 2-year open label r and omised study . Our results are consistent with a significant more rapid clinical improvement in the infliximab treated group . Treatment with both etanercept and infliximab at the end of the study was effective , safe , and well tolerated 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 Objective . To evaluate the 2-year efficacy and safety of etanercept in patients with ankylosing spondylitis ( AS ) . Methods . A 96-week open-label extension study , which followed a 12-week double-blind placebo-controlled trial , was design ed to provide longterm efficacy and safety data , including radiographic outcomes , for patients treated with etanercept 25 mg twice weekly ( NCT00421980 ) . In all , 81 patients were enrolled ( 96 % of the participants from the double-blind study ) . Key efficacy measures included improvement using the Assessment in Ankylosing Spondylitis 20 % ( ASAS20 ) criteria , the Bath Ankylosing Spondylitis Functional Index ( BASFI ) , and the Bath Ankylosing Spondylitis Disease Activity Index ( BASDAI ) . Radiographic progression was evaluated using the modified Stoke Ankylosing Spondylitis Spine Score ( mSASSS ) method . Paired t tests were used to test within-group changes from baseline . Results . The percentage of responders , by ASAS20 criteria , remained relatively constant in patients who received etanercept during the 12-week double-blind study ( 60 % at Week 0 and 83 % at Week 96 of the open-label extension ) ; more patients from the placebo group became responders after being switched to etanercept ( 23 % and 74 % , respectively ) . A similar trend was also observed using the ASAS40 and ASAS5/6 criteria , the BASFI , and the BASDAI . Most patients had no change from baseline in mSASSS values .  Etanercept was well tolerated ; the most frequent adverse events were injection site reactions ( n = 30 ; 37.0 % ) and headache ( n = 18 ; 22.2 % ) , and the most frequent infections were upper respiratory tract infections ( n = 43 ; 53.1 % ) and flu syndrome ( n = 22 ; 27.2 % ) . Conclusion . For 2 years , etanercept was clinical ly effective and well tolerated , with no unexpected safety findings OBJECTIVES The objective of this study was to assess the humanistic impact of ankylosing spondylitis ( AS ) , and compare the effect of etanercept 50 mg once-weekly ( QW ) , etanercept 25 mg twice-weekly ( BIW ) and placebo on patient-reported outcomes ( PROs ) . METHODS In a 12-week , double-blind , placebo-controlled multicenter study , 356 patients with active AS received etanercept 50 mg QW , etanercept 25 mg BIW or placebo  ( 3:3:1 r and omization , respectively ) . PROs were assessed using Bath Ankylosing Spondylitis Functional Index , Bath Ankylosing Spondylitis Activity Index fatigue item , EuroQOL-5D ( EQ-5D ) utility , EQ-5D visual analog scale and the Medical Outcomes Short Form Question naire ( SF-36 ) scores at baseline and at regular intervals . Mean changes from baseline in PROs were analysed using analysis of covariance to assess differences between etanercept and placebo , or between the two etanercept groups . RESULTS Consistent with earlier reports , AS was associated with quality of life ( QOL ) impairment and functional limitations , similar to or worse than cancer , congestive heart failure , diabetes or depression . Treatment with etanercept 50 mg QW or 25 mg BIW significantly improved QOL and functional status compared with placebo . High proportions of patients achieved clinical ly meaningful improvements in all PRO measures , including physical function , fatigue , pain , psychosocial domains and general health status . Improvements were similar with the two etanercept dose regimens . CONCLUSIONS The more convenient etanercept 50 mg QW dose regimen significantly improves function and QOL in patients with AS , similarly to the st and ard dosing of 25 mg BIW , supporting its use for AS therapy OBJECTIVES To assess long-term safety and clinical efficacy of etanercept 25 mg subcutaneously twice weekly up to 5 years in subjects with ankylosing spondylitis ( AS ) . METHODS An open-label ( OL ) , multicentre , phase 4 , 156-week extension study of subjects with AS who had completed a 12-week r and omised , placebo-controlled study ( N=84 ; n=45 etanercept , n=39 placebo ) followed by a 96-week OL study ( n=81 ; n=42 etanercept/etanercept ; n=39 placebo/etanercept ) ; 59 subjects who completed the 96-week OL extension enrolled in the current OL trial and continued etanercept 25 mg BIW for an additional 156 weeks ( total duration : 264 weeks , original etanercept group ; 252 weeks , original placebo group ) . Safety was based on spontaneous reports of adverse events ( AEs ) . Last observation carried forward was used for imputation of missing values . RESULTS Thirty-seven of 59 subjects ( 63 % ) completed 5 years of etanercept treatment . Serious non infectious AEs and serious infections occurred at a rate of 0.17 and 0.03 events per subject years , respectively ; inflammatory bowel disease and uveitis ( including iritis and iridiocyclitis ) occurred at 0.01 and 0.14 , respectively . No cases of tuberculosis or opportunistic infections were reported . Assessment in Ankylosing Spondylitis ( ASAS ) responses and improvements in Bath Ankylosing Spondylitis Functional Index and spinal mobility were sustained from week 108 through week 264 . CONCLUSIONS Etanercept was well tolerated with no new safety signals detected in subjects with AS over 5 years . Clinical efficacy and improvements in function and mobility seen during the double-blind and first OL study were sustained . These results support etanercept therapy for the long-term management of this chronic disease OBJECTIVE There is increasing evidence that tumor necrosis factor alpha ( TNFalpha ) is central ly involved in the pathogenesis of ankylosing spondylitis ( AS ) and other spondylarthritides . This study was design ed to investigate the efficacy of anti-TNFalpha therapy with etanercept , a 75-kd receptor fusion protein , in active AS . METHODS This multicenter trial had 2 phases : an initial placebo-controlled period of 6 weeks ' duration and an observational phase lasting 24 weeks . Thirty patients with active AS were included . They were r and omized into 2 groups , which received either etanercept ( 25 mg twice weekly ) ( n = 14 ) or placebo ( n = 16 ) for 6 weeks . Then both groups were treated with etanercept . Nonsteroidal antiinflammatory drug ( NSAID ) treatment could be continued , but disease-modifying antirheumatic drugs ( DMARDs ) and steroids had to be withdrawn prior to the study . All patients received etanercept for a total of 12 weeks and were followed up for at least 24 weeks . The Bath AS Disease Activity Index ( BASDAI ) , Bath AS Functional Index , Bath AS Metrology Index , pain level on a numeric rating scale , quality of life by the Short Form 36 , and C-reactive protein ( CRP ) level were assessed . The primary outcome parameter was a > or=50 % improvement in the BASDAI . RESULTS Treatment with etanercept result ed in at least a 50 % regression of disease activity in 57 % of these patients at week 6 , versus 6 % of the placebo-treated patients ( P = 0.004 ) . After the placebo-treated patients switched to etanercept , 56 % improved . The mean + /- SD BASDAI improved from 6.5 + /- 1.2 at baseline to 3.5 + /- 1.9 at week 6 in the etanercept group , with no improvement in the placebo group ( P = 0.003 between groups ) . Similarly , pain , function , mobility , and quality of life improved with etanercept but not with placebo at week 6 ( P < 0.05 ) . Mean CRP levels decreased significantly with etanercept but not with placebo ( P = 0.001 ) . There was ongoing improvement in all parameters in both groups until week 12 and week 18 , respectively ( i.e. , throughout the period of etanercept treatment ) . Disease relapses occurred a mean + /- SD of 6.2 + /- 3.0 weeks after cessation of etanercept . No severe adverse events , including major infections , were observed during the trial . CONCLUSION This study shows that on a short-term basis ( 3 months ) , treatment with etanercept is clearly efficacious in patients with active AS who are receiving NSAID therapy but not DMARDs or steroids .  After cessation of therapy , almost all patients experienced a relapse within a few weeks . Thus , it seems probable that etanercept must be administered continuously in most AS patients to achieve permanent inhibition of the inflammatory process BACKGROUND There are few effective treatments for ankylosing spondylitis , which causes substantial morbidity . Because of the central role of tumor necrosis factor alpha in the spondyloarthritides , we performed a r and omized , double-blind , placebo-controlled trial of etanercept , a recombinant human tumor necrosis factor receptor (p75):Fc fusion protein , in patients with ankylosing spondylitis . METHODS Forty patients with active , inflammatory ankylosing spondylitis were r and omly assigned to receive twice-weekly subcutaneous injections of etanercept ( 25 mg ) or placebo for four months . The primary end point was a composite of improvements in measures of morning stiffness , spinal pain , functioning , the patient 's global assessment of disease activity , and joint swelling . Patients were allowed to continue taking nonsteroidal antiinflammatory drugs , oral corticosteriods ( < or = 10 mg per day ) , and disease-modifying antirheumatic drugs at stable doses during the trial . RESULTS Treatment with etanercept result ed in significant and sustained improvement . At four months , 80 percent of the patients in the etanercept group had a treatment response , as compared with 30 percent of those in the placebo group ( P=0.004 ) . Improvements over base-line values for various measures of disease activity , including morning stiffness , spinal pain , functioning , quality of life , enthesitis , chest expansion , erythrocyte sedimentation rate , and C-reactive protein , were significantly greater in the etanercept group . Longitudinal analysis showed that the treatment response was rapid and did not diminish over time . Etanercept was well tolerated , with no significant differences in rates of adverse events between the two groups . CONCLUSIONS Treatment with etanercept for four months result ed in rapid , significant , and sustained improvement in patients with ankylosing spondylitis We wanted to do a prospect i ve open-label study to evaluate if ankylosing spondylitis ( AS ) patients in clinical remission with twice weekly etanercept ( ETN ) 25 mg therapy could be changed to weekly regimen or even to every other week regimen without increased dose for injection . Thirty-eight AS patients self-administered 25 mg of ETN ( Wyett ) subcutaneously . According to the protocol , patients who were in clinical partial remission with twice weekly ETN 25 mg at week 12 and 16 changed to a weekly regimen without a change of the dose . If clinical remission , despite the reduction of the dose , persists at week 24 and 28 , patients changed to an every-other-week regimen , continuing with this administration schedule for the entire duration of the study if at week 36 and 46 clinical remission was maintained . At the end of the study , 18 patients ( 47 % ) were still in remission , 4 ( 10 % ) with a weekly regimen , and 14 ( 37 % ) with an every-other-weekly regimen . Our study indicates that a consistent percentage of subjects with AS , treated with ETN 25 mg twice weekly , achieved clinical remission within the first 3 months of therapy , and also , a substantial percentage of these patients maintains the partial remission with an every other week regimen Objective : To compare the efficacy , pharmacokinetics and safety of etanercept 50 mg once weekly with 25 mg twice weekly and placebo in patients with ankylosing spondylitis . Methods : A 12-week , double-blind , placebo-controlled study compared the effects of etanercept 50 mg once weekly , etanercept 25 mg twice weekly and placebo in 356 patients with active ankylosing spondylitis ( 3:3:1 r and omisation , respectively ) . The primary end point was the proportion of patients achieving a response at week 12 based on the Assessment in Ankylosing Spondylitis Working Group criteria ( ASAS 20 ) . The pharmacokinetics of etanercept 50 mg once weekly and 25 mg twice weekly were analysed . Results : Baseline characteristics and disease activity were similar among the three groups : etanercept 50 mg once weekly , etanercept 25 mg twice weekly and placebo . The percentage of patients discontinuing therapy was 9.0 % , 9.3 % and 13.7 % for the three respective groups . ASAS 20 response at 12 weeks was achieved by 74.2 % of patients with etanercept 50 mg once weekly and 71.3 % of those with etanercept 25 mg twice weekly , both significantly higher than the percentage of patients taking placebo ( 37.3 % , p<0.001 ) . Percentages of patients with ASAS 5/6 response ( 70.3 % , 72.0 % and 27.5 % , respectively ; p<0.001 ) and those with ASAS 40 response ( 58.1 % , 53.3 % and 21.6 % , respectively ; p<0.001 ) followed a similar pattern . Significant improvement ( p<0.05 ) was seen in measures of disease activity , back pain , morning stiffness and C reactive protein levels as early as 2 weeks . Serum etanercept exposure was similar between the etanercept groups . Incidence of treatment-emergent adverse events , including infections , was similar among all three groups , and no unexpected safety issues were identified . Conclusions : Patients with ankylosing spondylitis can expect a comparable significant improvement in clinical outcomes with similar safety when treated with etanercept 50 mg once weekly or with 25 mg twice weekly Objectives Patients with advanced ankylosing spondylitis ( AS ) experience disability because of reduced spinal mobility and pulmonary function impairment . This placebo-controlled study evaluated the effect of etanercept ( ETN ) in patients with advanced AS . Methods A multicentre r and omised double-blind placebo-controlled trial of 12 weeks ' duration was performed . Patients had definite ( modified New York criteria ) , active ( Bath AS Disease Activity Index ( BASDAI ) ≥40 ) , severe ( radiological intervertebral bridges ) AS refractory to non-steroidal anti-inflammatory drugs and were antitumour necrosis factor naive . They were treated with ETN 50 mg once weekly or identical placebo ( PBO ) . Results Of the 95 patients screened , 82 were r and omised to receive ETN ( n=39 ) or PBO ( n=43 ) . At baseline the disease was active ( mean BASDAI 61.0±13.4 , C reactive protein ( CRP ) 20.7±25.5 mg/l ) and severe ( mean Bath AS Metrology Index ( BASMI ) 5.7±1.3 , mSASSS 36.5±20.5 ) ; forced pulmonary vital capacity ( FVC ) was 3.3±0.7 l. Improvement in BASDAI ( normalised net incremental area under the curve between baseline and week 12 , primary end point ) was significantly greater in the ETN group than in the PBO group ( −19.8±16.5 vs −11.0±16.4 , p=0.019 ) . Moreover , at week 12 , ETN gave better results than PBO for the BASDAI ( −26.4±19.7 vs −14.4±19.7 ; p=0.008 ) , total back pain ( −29.2±24.0 vs −14.9±24.0 ; p=0.010 ) , BASFI ( −21.7±17.6 vs −10.1±17.6 ; p=0.004 ) , BASMI ( −0.6±0.6 vs −0.2±0.6 ; p=0.011 ) , CRP level ( −15.7±14.2 vs −1.3±14.2 ; p<0.001 ) and FVC ( + 160±280 ml vs −20±280 ml ; p=0.006 ) . Conclusions ETN has short-term efficacy for patients with advanced AS , as was previously reported for less advanced disease . The efficacy is observed for the main symptoms ( pain ) and on markers of inflammation ( CRP ) , as well as disease severity in terms of spinal mobility and pulmonary function OBJECTIVE To investigate the effect of etanercept therapy on radiographic progression in patients with ankylosing spondylitis ( AS ) . METHODS Patients with AS who had previously participated in a 24-week r and omized , double-blind , placebo-controlled trial of etanercept therapy were enrolled in a 72-week open-label extension . Radiographs of the cervical and lumbar spine from patients who received etanercept ( 25 mg twice weekly ) for up to 96 weeks were compared with radiographs from patients in a large prevalence cohort ( Outcome Assessment s in Ankylosing Spondylitis International Study [ OASIS ] ) who had not been treated with anti-tumor necrosis factor alpha ( anti-TNFalpha ) agents . Radiographs obtained at 2 time points up to 96 weeks apart from patients in both study population s were digitized and read by 2 independent readers who were blinded with regard to patient group and sequence . The primary end point was the 96-week change in the modified Stoke AS Spine Score ( mSASSS ) . RESULTS A total of 257 patients treated with etanercept were compared with 175 unselected patients from the OASIS study . There was no significant difference in the change in the mSASSS from baseline among patients who received etanercept ( mean + /- SD 0.91 + /- 2.45 ) versus those from the OASIS group ( 0.95 + /- 3.18 ) . CONCLUSION Unlike other inflammatory rheumatic diseases such as rheumatoid arthritis and psoriatic arthritis , structural progression in AS seems to be independent of TNF , despite the fact that TNF is responsible for the signs and symptoms due to inflammation in this disease
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 .