Comparison of sulfasalazine and placebo in the treatment of ankylosing spondylitis. A Department of Veterans Affairs Cooperative Study. Treatment of ankylosing spondylitis by inhibition of tumor necrosis factor alpha. Sulfasalazine in the prevention of anterior uveitis associated with ankylosing spondylitis Clinical Efficacy of Etanercept Versus Sulfasalazine in Ankylosing Spondylitis Subjects with Peripheral Joint Involvement The role of etanercept in ankylosing spondylitis. No efficacy of subcutaneous methotrexate in active ankylosing spondylitis: a 16-week open-label trial Efficacy of sulfasalazine in patients with inflammatory back pain due to undifferentiated spondyloarthritis and early ankylosing spondylitis: a multicentre randomised controlled trial. Clinical efficacy and safety of etanercept versus sulfasalazine in patients with ankylosing spondylitis: a randomized, double-blind trial. Correlation Between Mobility Restrictions and Radiologic Changes in Ankylosing Spondylitis Increased efficacy of infliximab associated with methotrexate in ankylosing spondylitis. [Sulfasalazine in the treatment of ankylosing spondylitis]. Efficacy and safety of infliximab in patients with ankylosing spondylitis: results of a randomized, placebo-controlled trial (ASSERT). Defining disease activity in ankylosing spondylitis: is a combination of variables (Bath Ankylosing Spondylitis Disease Activity Index) an appropriate instrument? A 2-year comparative open label randomized study of efficacy and safety of etanercept and infliximab in patients with ankylosing spondylitis Efficacy and safety of adalimumab in patients with non-radiographic axial spondyloarthritis: results of a randomised placebo-controlled trial (ABILITY-1) Which is the active moiety of sulfasalazine in ankylosing spondylitis? A randomized, controlled study. Baseline radiographic damage, elevated acute-phase reactant levels, and cigarette smoking status predict spinal radiographic progression in early axial spondylarthritis. Two Exercise Interventions for the Management of Patients with Ankylosing Spondylitis: A Randomized Controlled Trial Radiographic progression in patients with ankylosing spondylitis after 2 years of treatment with the tumour necrosis factor α antibody infliximab Supervised training and home-based rehabilitation in patients with stabilized ankylosing spondylitis on TNF inhibitor treatment: a controlled clinical trial with a 12-month follow-up Sulindac in ankylosing spondylitis. Double-blind evaluation of sulindac and indomethacin. Both structural damage and inflammation of the spine contribute to impairment of spinal mobility in patients with ankylosing spondylitis ASDAS, a highly discriminatory ASAS-endorsed disease activity score in patients with ankylosing spondylitis Etanercept in the Longterm Treatment of Patients With Ankylosing Spondylitis Self- and manual mobilization improves spine mobility in men with ankylosing spondylitis — a randomized study
OBJECTIVE To determine whether sulfasalazine ( SSZ ) at a dosage of 2,000 mg/day is effective for the treatment of active ankylosing spondylitis ( AS ) that is not controlled with nonsteroidal antiinflammatory drug therapy . METHODS Two hundred sixty-four patients with AS were recruited from 15 clinics , r and omized ( double-blind ) to SSZ or placebo treatment , and followed up for 36 weeks . Treatment response was based on morning stiffness , back pain , and physician and patient global assessment s. RESULTS While longitudinal analysis revealed a trend favoring SSZ in the middle of treatment , no difference was seen at the end of treatment . Response rates were 38.2 % for SSZ and 36.1 % for placebo ( P = 0.73 ) . The Westergren erythrocyte sedimentation rate declined more with SSZ treatment than with placebo ( P < 0.0001 ) . AS patients with associated peripheral arthritis showed improvement that favored SSZ ( P = 0.02 ) . Adverse reactions were fewer than expected and were mainly due to nonspecific gastrointestinal complaints . CONCLUSION SSZ at a dosage of 2,000 mg/day does not seem to be more effective than placebo in the treatment of AS patients with chronic , longst and ing disease .  SSZ is well tolerated and may be more effective than placebo in the treatment of AS patients with peripheral joint involvement . This effect is more pronounced in treatment of the peripheral arthritis in this subgroup of AS patients 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 Purpose : To assess the effects of sulfasalazine in preventing recurrences and reducing the severity of anterior uveitis associated with ankylosing spondylitis and chronic intestinal inflammation . Methods : Twenty-two patients with anterior uveitis associated with ankylosing spondylitis were studied . Ten patients were r and omised to receive oral sulfasalazine ( group 1 ) and 12 patients r and omised to no treatment ( group 2 ) ; all were followed for 3 years  . Blood-aqueous barrier permeability was determined by fluorophotometry and bowel biopsies were taken . Results : A statistically significant difference was observed between the two groups regarding the number of recurrences of uveitis ( p = 0.016 ) . The blood-aqueous barrier permeability was significantly higher during acute attacks in group 2 ( group 1 : 31.3 ± 26.4 × 10−4 min−1 vs group 2 : 66.2 ± 28.5 × 10−4 min−1 ; p = 0.019 ) but not during the disease-free period . We observed a higher incidence of chronic intestinal inflammation at the end of the study in group 2 ( group 1 : 3/8 vs group 2 : 7/9 , p = 0.153 ) . No relation was observed between blood-aqueous barrier permeability and the number of recurrences . The number of patients with severe persistent posterior synechiae at the end of the study was higher in group 2 ( group 1 : 4 patients before and 4 patients at the end ; group 2 : 4 patients before and 8 patients at the end ; p = 0.65 ) . Conclusion : Sulfasalazine may be beneficial in preventing recurrences and reducing the severity of anterior uveitis associated with ankylosing spondylitis 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 Ankylosing spondylitis is a chronic inflammatory disease that leads to significant loss of function and disability in patients . Current conventional therapies have not demonstrated improvement in axial symptoms and progressive ankylosis of the spine . The use of new biologic agents that block the actions of tumor necrosis factor-alpha have , for the first time , reported significant improvement in axial symptoms and reduction in spinal inflammation in short-term studies . Future studies with larger numbers of patients over long periods of time will eventually determine the long-term success and safety of these agents Objective : To examine the potential therapeutic effect of methotrexate 20 mg given weekly as subcutaneous injections to 20 patients with ankylosing spondylitis refractory to non-steriodal antirheumatic drugs . Patients and methods : 20 patients with ankylosing spondylitis , a mean Bath Ankylosing Spondylitis Disease Activity Index ( BASDAI ) score of 5.6 ( range 4–9.3 ) and predominantly axial manifestations were treated with weekly 15 mg methotrexate subcutaneously for 4 weeks , which was then increased to 20 mg subcutaneously for the next 12 weeks . Clinical outcome assessment s included , among others , BASDAI score physical function , spinal mobility , patients ’ and physicians ’ global assessment ( visual analogue scale ) , peripheral joint assessment , quality of life ( Short Form 36 ) and C reactive protein . The primary end point of the study was a 20 % improvement on the ASsessment s in Ankylosing Spondylitis ( ASAS 20 ) scale . Results : Using an intention-to-treat analysis , ASAS 20 was achieved in only 25 % of patients . An ASAS 40 response was achieved in 10 % of patients , and no patient reached an ASAS 70 response or the ASAS criteria for partial remission . For the mean BASDAI score , no change was observed between baseline and week 16 ( baseline 5.6 v week 16 , 5.6 ) . No improvement was observed in any of the clinical parameters or C reactive protein , except a small but non-significant decrease in the number of swollen joints . Conclusions : In this open study , methotrexate did not show any benefit for axial manifestations in patients with active ankylosing spondylitis beyond the expected placebo response OBJECTIVES To assess the effect of sulfasalazine ( SSZ ) on inflammatory back pain ( IBP ) due to active undifferentiated spondyloarthritis ( uSpA ) or ankylosing spondylitis in patients with symptom duration < 5 years . METHODS Patients with IBP and a Bath Ankylosing Spondylitis Disease Activity Index ( BASDAI ) > 3 from 12 centres were r and omly assigned to 24 weeks ' treatment with SSZ 2 g/day or placebo . The primary outcome variable was the change in BASDAI over 6 months . Secondary outcomes included measures of spinal pain , physical function and inflammation . RESULTS 230 patients ( 50 % men , age range 18 - 64 years , 67 % human leucocyte antigen B27 positive ) were treated with either SSZ 2x1 g/day or placebo for 6 months . Enthesitis was found in 50 % , and peripheral arthritis in 47 % of the patients . The mean ( SD ) BASDAI dropped markedly in both groups : by 3.7 ( 2.7 ) and 3.8 ( 2.4 ) , respectively , as did most secondary outcome measures . No noticeable difference in treatment was observed between groups . Patients with IBP and no peripheral arthritis had significantly ( p = 0.03 ) more benefit with SSZ ( BASDAI 5.1 ( 1.3 ) to 2.8 ( 2.3 ) ) than with placebo ( 5.2 ( 1.6 ) to 3.8 ( 2.4 ) ) . Spinal pain ( p = 0.03 ) and morning stiffness ( p = 0.05 ) improved with SSZ in these patients , but other secondary outcomes were not markedly different . CONCLUSION SSZ was no better than placebo for the treatment of the signs and symptoms of uSpA ; however , SSZ was more effective than placebo in the subgroup of patients with IBP and no peripheral arthritis 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 Study Design . In 151 adult patients with ankylosing spondylitis who participated in an inpatient rehabilitation program of 3–4 weeks , 10 different range of motion  ( ROM ) values were measured , and their lumbar spine and sacroiliac joints were radiographed . Objectives . To determine whether a correlation obtained between restriction of ROM and progression of radiologic findings in ankylosing spondylitis , together with a high enough reliability level in measurements . Summary of Background Data . A significant correlation was observed between the restriction of eight ROMs : the  Schober test , thoracolumbar rotation , thoracolumbar flexion , cervical rotation , occiput-wall distance , chin-chest distance , chest expansion , finger-floor distance , and overall radiologic changes in both lumbar spine and sacroiliac joints ; straight leg raise did not correlate , and vital capacity only with sacroiliac joint changes . Spearman 's correlation coefficients for ROMs were slightly higher to lumbar spine changes than to sacroiliac joint changes . A corresponding correlation was also observed between spinal mobility restrictions and six detailed changes in lumbar roentgenogram : syndesmophytes , apophyseal arthritis , sclerotic anterior borders of vertebrae , straightened anterior surface of vertebrae , and ossification of interspinous and anterior longitudinal ligaments . Other detailed lumbar spine findings did not correlate . As assessed by erythrocyte sedimentation rate values the disease activity increased in the course of radiologic progression , decreasing again , however , to the end stage . Methods . Conventional methods with a tape and ( Myrin ) inclinometer were used to measure thoracolumbar flexion , cervical rotation , occiput-wall distance , chin-chest distance , finger-floor distance , chest expansion , vital capacity , and straight leg raise . In addition , a new method of thoracolumbar rotation and a new modification of the Schober test were introduced . Thirty-nine patients were r and omized for a reliability assessment using repeated measurements of ROMs . Radiologic changes were evaluated ( in a masked fashion ) using the method of Dale and Vinje . Results . The reliability of all ROMs was good ( except for interraler intraclass correlation coefficients of chest expansion : 0.53 ) . Conclusions : The clear correlation between radiologic sacroiliac joint and lumbar spine progression and eight ROMs showed that these are useful noninvasive measurements of disease progression and severity in ankylosing spondylitis that can be used in daily practice OBJECTIVES The aims of this study were to assess the efficacy of infliximab ( IFX ) combined with methotrexate ( MTX ) versus IFX alone in the treatment of ankylosing spondylitis ( AS ) . METHODS The study was a 30weeks open label and prospect i ve study of parallel groups in 19 patients with active AS . These patients had shown incomplete therapeutic response to st and ard therapy ( full dose of non-steroidal anti-inflammatory drugs : NSAIDs ) and disease modifying antirheumatic drugs : DMARDs ( MTX or sulfasalazine : SLZ ) for a period of at least 12 weeks and were treated with IFX ( 5mg/kg ) . Patients were divided into two treatment groups according to the previous treatment : in Group A , 9 patients previously treated with 7.5mg/week of MTX  were treated with IFX in addition to MTX ( IFX+MTX ) ; in Group B , 10 patients previously treated only with NSAIDs  were treated with IFX ( 5mg/kg ) as monotherapy ( IFX ) . The primary outcome was improvement in disease activity shown by the BASDAI50 at week 30 ; the secondary outcome included comparison of the proportions of subjects in each group achieving response criteria proposed by the ASAS group . BASDAI , BASFI , ESR , CRP , pain , inflammation and Patient Global Assessment were also recorded . RESULTS Both groups were similar in sex ratio , clinical forms and B27 . Differences between groups occurred only in the disease duration and age of the patient . At 14 and 30 weeks only 50 % and 10 % respectively of the patients from the IFX group achieved BASDAI50 response compared to 89 % of patients from the IFX+MTX group . The difference between groups at 30 weeks was statistically significant ( p=0.001 ; percentage of difference : 79 % ; 95 % confidence interval ( CI ) : 26 - 93 % : ) . ASAS50 was reached in 67 % and 55.6 % of patients from the IFX+MTX group at 14 and 30 weeks respectively , compared with 30 % and 0 % of patients from the IFX group The difference between groups at 30 weeks was statistically significant ( p=0.011 ; percentage of difference : 57 % ; 95 % CI : 8 - 84.7 % ) . CONCLUSION Infliximab in combination with MTX seems to increase the efficacy of the therapeutic response in active AS patients , but more wide-ranging studies are necessary , mainly long-term studies Ninety-five patients with ankylosing spondylitis received either sulphasalazine ( less than or equal to 3 g/day ) or placebo for 24 weeks . The patients who received sulphasalazine showed significantly improved clinical parameters [ duration of morning stiffness ( p less than 0.05 ) , the number of painful and swollen joints ( less than 0.05 ) ] and laboratory parameters [ erythrocyte sedimentation rate ( p less than 0.001 ) , haptoglobin ( p less than 0.05 ) , IgG ( p less than 0.05 ) , IgA ( p less than 0.001 ) , IgM ( p less than 0.05 ) ] . No statistically significant differences were seen in the patients receiving placebo . The results suggest that sulphasalazine is effective for the treatment of patients with ankylosing spondylitis . In these patients , there was also a diminution of the daily dosage of nonsteroidal antiinflammatory drugs . In the majority of patients , clinical and laboratory improvements were expressed more pronouncedly in the peripheral form of ankylosing spondylitis than in the axial form , but statistically no significant differences were found between the two groups OBJECTIVE 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 success in reducing AS disease activity in a limited number of clinical trials . The objective of this multicenter , r and omized , placebo-controlled study was to evaluate the efficacy and safety of infliximab in patients with AS . METHODS Patients were r and omly assigned to receive infusions of placebo or 5 mg/kg infliximab at weeks 0 , 2 , 6 , 12 , and 18 . Efficacy was assessed using the ASsessment in Ankylosing Spondylitis ( ASAS ) International Working Group criteria , the Bath Ankylosing Spondylitis Disease Activity Index ( BASDAI ) , night pain , patient 's global assessment , the Bath Ankylosing Spondylitis Functional Index ( BASFI ) , the Bath Ankylosing Spondylitis Metrology Index ( BASMI ) , chest expansion , the M and er enthesis index , the total swollen joint index , the C-reactive protein level , and the Short Form 36 ( SF-36 ) health survey question naire . The primary end point in this study was the proportion of patients with a 20 % improvement response according to the ASAS International Working Group criteria ( ASAS20 responders ) at week 24 . RESULTS Of the 357 patients screened , 201 were assigned to receive 5 mg/kg infliximab and 78 were assigned to receive placebo . After 24 weeks , 61.2 % of patients in the infliximab group were ASAS20 responders compared with 19.2 % of patients in the placebo group ( P < 0.001 ) . Clinical benefit was observed in patients receiving infliximab as early as week 2 and was maintained over the 24-week study period . Patients receiving infliximab also showed significant improvements in the BASDAI , BASFI , BASMI , chest expansion , and physical component summary score of the SF-36 . Adverse events were reported by 82.2 % of patients receiving infliximab and by 72.0 % of patients receiving placebo ; however , most adverse events in both treatment groups were mild or moderate in severity . CONCLUSION Infliximab was well tolerated and effective in a large cohort of patients with AS during a 24-week study period OBJECTIVE Disease activity has been defined using a self-administered instrument , focusing on fatigue , axial pain , peripheral pain , enthesopathy and morning stiffness [ Bath Ankylosing Spondylitis Disease Activity Index ( BASDAI ) ] . This vali date d instrument is simple and takes 40 s to complete , but whether the index is an accurate expression of the component parts , or whether additional weighting would enhance its efficacy , is unclear . METHODS Four hundred and seventy-three patients with ankylosing spondylitis received placebo or active non-steroidal anti-inflammatory drug ( NSAID ) for 6 weeks , and changes between entry and completion were captured by BASDAI and the individual components . Principle component analysis ( PCA ) was used to explore the best combinations of variables in decreasing order of explained total dispersion and to assess whether a single sum ( or algebraic expression ) best defined disease activity status . RESULTS At entry , the correlation between BASDAI and the first axis was 0.99 , 0.11 with the second , and zero thereafter . Data at study end and relating to change revealed a 100 % correlation ( R = 1 ) between the first axis and the sum , with zero for the remainder . CONCLUSIONS The data support BASDAI as being a valid and appropriate composite to define disease activity in ankylosing spondylitis . Developed as a simple sum of its components , BASDAI has excellent content validity 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 Purpose To evaluate the efficacy and safety of adalimumab in patients with non-radiographic axial spondyloarthritis ( nr-axSpA ) . Methods Patients fulfilled Assessment of Spondyloarthritis international Society ( ASAS ) criteria for axial spondyloarthritis , had a Bath Ankylosing Spondylitis Disease Activity Index ( BASDAI ) score of ≥ 4 , total back pain score of ≥ 4 ( 10 cm visual analogue scale ) and inadequate response , intolerance or contraindication to non-steroidal anti-inflammatory drugs ( NSAIDs ) ; patients fulfilling modified New York criteria for ankylosing spondylitis were excluded . Patients were r and omised to adalimumab ( N=91 ) or placebo ( N=94 ) . The primary endpoint was the percentage of patients achieving ASAS40 at week 12 . Efficacy assessment s included BASDAI and Ankylosing Spondylitis Disease Activity Score ( ASDAS ) . MRI was performed at baseline and week 12 and scored using the Spondyloarthritis Research Consortium of Canada ( SPARCC ) index . Results Significantly more patients in the adalimumab group achieved ASAS40 at week 12 compared with patients in the placebo group ( 36 % vs 15 % , p<0.001 ) . Significant clinical improvements based on other ASAS responses , ASDAS and BASDAI were also detected at week 12 with adalimumab treatment , as were improvements in quality of life measures . Inflammation in the spine and sacroiliac joints on MRI significantly decreased after 12 weeks of adalimumab treatment . Shorter disease duration , younger age , elevated baseline C-reactive protein or higher SPARCC MRI sacroiliac joint scores were associated with better week 12 responses to adalimumab . The safety profile was consistent with what is known for adalimumab in ankylosing spondylitis and other diseases . Conclusions In patients with nr-axSpA  , adalimumab treatment result ed in effective control of disease activity , decreased inflammation and improved quality of life  compared with placebo . Results from ABILITY-1 suggest that adalimumab has a positive benefit – risk profile in active nr-axSpA patients with inadequate response to NSAIDs OBJECTIVE To compare the efficacy of sulfasalazine ( SSZ ) with its two moieties , 5-aminosalicylic acid ( ASA ) and sulfapyridine ( SP ) , in patients with active ankylosing spondylitis ( AS ) . METHODS A 26-week r and omized , observer-blinded , 2-center , controlled study of treatment with either SSZ , ASA , or SP was conducted in 90 patients with active AS . Patients were evaluated at baseline and at monthly intervals , using several clinical and laboratory measures of disease activity . A global assessment of treatment efficacy was made by both patients and observers at the end of the study period . RESULTS There were no significant changes in any of the parameters of disease activity in the ASA treatment group . Levels of serum IgG , IgA , and IgM fell significantly during treatment with SP , but none of the other changes reached statistical significance . Plasma viscosity and IgG and IgA levels fell significantly during treatment with SSZ , as did nocturnal spinal pain and overall spinal pain . Patients and observers reported a favorable outcome after treatment with SSZ or SP significantly more often than with ASA treatment . CONCLUSION SP appears to be the active moiety in AS , although there was a trend suggesting a better outcome in the SSZ group compared with the SP group , perhaps suggesting the importance of a common sulfonamide structure for efficacy OBJECTIVE To assess prospect ively the rates and to explore predictors of spinal radiographic progression over 2 years in a cohort of patients with early axial spondylarthritis ( SpA ) . METHODS Two hundred ten patients with axial SpA from the German Spondyloarthritis Inception Cohort were selected for this analysis based on the availability of radiographs at baseline and after 2 years of followup . Spinal radiographs were scored by 2 trained readers in a blinded , r and omly selected order according to the modified Stoke Ankylosing Spondylitis Spine Score ( mSASSS ) . Spinal radiographic progression was defined as worsening of the mean mSASSS by ≥2 units over 2 years . RESULTS Among the patients with axial SpA , 14.3 % showed spinal radiographic progression after 2 years ( 20 % of those with AS and 7.4 % of those with nonradiographic axial SpA ) . The following parameters were independently associated with spinal radiographic progression : presence of syndesmophytes at baseline ( odds ratio [ OR ] 6.29 , P < 0.001 ) , elevated levels of markers of systemic inflammation ( for the erythrocyte sedimentation rate , OR 4.04 , P = 0.001 ; for C-reactive protein level time-averaged over 2 years , OR 3.81 , P = 0.001 ) , and cigarette smoking ( OR 2.75 , P = 0.012 ) . These associations were confirmed by multivariate logistic regression analysis . No clear association with spinal radiographic progression was observed for HLA-B27 status , sex , age , disease duration , Bath Ankylosing Spondylitis Disease Activity Index , Bath Ankylosing Spondylitis Functional Index , presence of peripheral arthritis , enthesitis , psoriasis , treatment with nonsteroidal antiinflammatory drugs , or treatment with disease-modifying antirheumatic drugs at baseline . CONCLUSION The presence of radiographic damage at baseline ( syndesmophytes ) , elevated levels of acute-phase reactants , and cigarette smoking were all independently associated with spinal radiographic progression in patients with early axial Fernández-de-las-Peñas C , Alonso-Blanco C , Morales-Cabezas M , Miangolarra-Page JC : Two exercise interventions for the management of patients with ankylosing spondylitis : A r and omized controlled trial . Am J Phys Med Rehabil 2005;84:407–419 . Objective : The purpose of this clinical trial was to evaluate the impact of a 4-month comprehensive protocol of strengthening and flexibility exercises developed by our research group versus conventional exercises for patients with Ankylosing Spondylitis ( AS ) on functional and mobility outcomes . Design : R and omized controlled trial . Forty-five patients diagnosed with AS according to the modified criteria of New York were allocated to control or experimental groups using a r and om numbers table . The control group was treated with a conventional protocol of physical therapy in AS , whereas the experimental group was treated with the protocol suggested by our research group . The conventional intervention consisted of 20 exercises : motion and flexibility exercises of the cervical , thoracic , and lumbar spine ; stretching of the shortened muscles ; and chest expansion exercises . The experimental protocol is based on the postural affectation of the AS and the treatment of the shortened muscle chains in these patients according to the Global Posture Reeducation ( GPR ) method . This intervention employs specific strengthening and flexibility exercises in which the shortened muscle chains are stretched and strengthened . The study lasted 4 mos . During this period , patients received a weekly group session managed by an experienced physiotherapist . Each session lasted an hour , and there were 15 total sessions . Changes in activity , mobility , and functional capacity were evaluated by an assessor blinded to the intervention , using the following previously vali date d scores from the Bath group : BASMI ( tragus to wall distance , modified Schöber test , cervical rotation , lumbar side flexion , and intermalleolar distance ) , BASDAI ( The Bath Ankylosing Spondylitis Disease Activity Index ) , and BASFI ( The Bath Ankylosing Spondylitis Functional Index ) . Results : Both groups showed an improvement ( prepost scores ) in all the outcome measures , mobility measures of the BASMI index , as well as in BASFI and BASDAI indexes . In the control group , the improvement in tragus to wall distance ( P = 0.009 ) and in lumbar side flexion ( P = 0.02 ) was statistically significant . Although the rest of the outcomes also improved , they did not reach a significant level ( P > 0.05 ) . In the experimental group , the improvement in all the clinical measures of the BASMI index ( P < 0.01 ) and in the BASFI index ( P = 0.003 ) was statistically significant . The intergroup comparison between the improvement ( prepost scores ) in both groups showed that the experimental group obtained a greater improvement than the control group in all the clinical measures of the BASMI index , except in tragus to wall distance , as well as in the BASFI index . Conclusions : The experimental protocol developed by our research group , based on the GPR method and specific strengthening and flexibility exercises of the muscle chains , offers promising results in the management of patients suffering from AS . Further trials on this topic are required Background : Anti-tumour necrosis factor ( TNF ) treatment is clinical ly efficacious in patients with active ankylosing spondylitis ( AS ) and leads to improvement of spinal inflammation , as assessed by magnetic resonance imaging . It is unclear whether anti-TNF treatment affects chronic spinal changes in AS . Objectives : To analyse the effect of infliximab on the radiographic course of AS over 2 years . Methods : Complete sets of lateral radiographs of the cervical spine and lumbar spine were available from 82 patients from two sources : 41 patients ( group 1 ) had been treated with infliximab ( 5 mg/kg/6 weeks ) as part of a recent r and omised controlled trial and 41 patients ( group 2 ) were part of the early German AS cohort ( GESPIC ) , without controlled interventions . Radiographs were obtained at baseline and after 2 years and scored by the modified Stokes AS Spinal Score ( mSASSS ) . Results : Patients in the infliximab group were older , had a longer disease duration , and more radiographic damage  at baseline . The mean ( SD ) mSASSS change was 0.4 ( 2.7 ) and 0.7 ( 2.8 ) for groups 1 and 2 , respectively ( p = NS ) . Radiographic damage at baseline was a predictor for more radiographic progression .  Patients with baseline damage who were treated with infliximab showed a trend for less radiographic progression . No correlations between clinical parameters and radiographic progression were found . Conclusions : Patients with AS treated with infliximab  had less radiographic progression after 2 years . Patients with prevalent radiographic damage are prone to develop more damage over time . Infliximab may decelerate radiographic progression in such patients . Larger studies are needed to prove that anti-TNF treatment inhibits structural damage Objective : To assess the 12-month ’s follow-up effects on pain , mobility , and physical function outcomes of a supervised training and home-based rehabilitation for ankylosing spondylitis patients stabilized with TNF-inhibitor therapy . Design : Controlled clinical trial ( sequentially determined allocation ) with 12-months ’ follow-up . Setting : Patients ’ homes . Subjects : A total of 69 subjects were allocated to either a rehabilitation programme ( rehabilitation group , n = 22 ) , an educational-behavioural programme ( educational group , n = 24 ) , and to neither programme ( control group , n = 23 ) . Interventions : Rehabilitation programme included supervised training and home exercises ( stretching , strengthening , aerobic , chest , and spine/hip joint flexibility exercises ) ; educational-behavioural programme included information on ankylosing spondylitis , pain and stress mechanisms , and control . Main measures : Spinal pain intensity , Bath Ankylosing Spondylitis Metrology Index , Bath Ankylosing Spondylitis Functional Index , Bath Ankylosing Spondylitis Disease Activity Index , chest expansion , and cervical and lumbar spine active range of motion measured by a pocket goniometer . Results : At baseline , the three groups exhibited comparable demographic characteristics and basal evaluations . Intra-group changes in the rehabilitation group from baseline to 12 months yielded statistically significant gains ( p < 0.05 ) for all outcomes . At 12-months follow-up , compared with the control and educational-behavioural , the rehabilitation group exhibited significant differences in chest expansion ( p = 0.001 and p < 0.001 ) , Bath Ankylosing Spondylitis Disease Activity Index ( p = 0.012 and p = 0.050 ) , and in some goniometric measurements as cervical rotation ( p = 0.007 and p = 0.014 ) , toraco-lumbar rotation ( p = 0.009 and p = 0.050 ) , and total cervical movements ( p = 0.009 and p = 0.001 ) . Conclusion : In comparison with the educational-behavioural programme or no intervention , supervised training and home exercises improved long-term outcome in patients with ankylosing spondylitis Ankylosing spondylitis affects about 1 % of the population . In the past , evaluation of therapy in the management of this disease has been hampered by the lack of availability of objective criteria for following the condition . By using recently developed measurements of spinal mobility and other variables we have compared sulindac , a recently introduced nonsteroidal antiinflammatory drug , and indomethacin in a double-blind six-month parallel study of 30 patients .  Sulindac and indomethacin have comparable efficacy and tolerance . Advantages of sulindac include a twice-a-day dose regimen Objective To study the relationship between spinal mobility , radiographic damage of the spine and spinal inflammation as assessed by MRI in patients with ankylosing spondylitis ( AS ) . Methods In this sub analysis of the Ankylosing Spondylitis Study for the Evaluation of Recombinant Infliximab Therapy cohort , 214 patients , representing an 80 % r and om sample , were investigated . Only baseline data were used . MRI inflammation was assessed by the AS spinal MRI activity ( ASspiMRI-a ) score , structural damage by the modified Stoke AS Spine Score ( mSASSS ) and spinal mobility by the linear definition of the Bath Ankylosing Spondylitis Metrology Index ( BASMI ) . Univariate correlations were calculated on baseline values using Spearman rank correlation . Independent associations between the variables of interest were investigated by multivariate linear regression analysis . Associations with clinical disease activity , C-reactive protein , disease duration , age , gender , body mass index and HLA-B27 status were also investigated . Subanalyses were performed according to disease duration . Results BASMI correlated moderately well with mSASSS ( Spearman 's ρ=0.6 ) and weakly with ASspiMRI-a ( ρ=0.3 ) . A best-fit model for BASMI included both mSASSS ( regression coefficient (B)=0.865 , p<0.001 ) and ASspiMRI-a ( B=0.236 , p=0.018 ) . In patients with a disease duration ≤3 years , B was greater for ASspiMRI-a than for mSASSS ( 0.595 vs 0.380 ) , while in patients with a disease duration > 3 years B was greater for mSASSS than for ASspiMRI-a ( 0.924 vs 0.156 ) . Conclusion Spinal mobility impairment in AS is independently determined both by irreversible spinal damage and by reversible spinal inflammation . Spinal mobility impairment is more influenced by spinal inflammation in early disease , and by structural damage in later disease Objectives : To evaluate various validity aspects of four disease activity scores ( ASDAS ) for ankylosing spondylitis ( AS ) in comparison with the Bath Ankylosing Spondylitis Disease Activity Index ( BASDAI ) , its individual components and physician and patient global assessment of disease activity . Methods : The analyses were performed in two cohorts of patients with AS : ( 1 ) the NOR-DMARD data base which includes patients starting on a disease-modifying antirheumatic drug or tumour necrosis factor ( TNF ) blocker and ( 2 ) patients participating in double-blind placebo controlled r and omised clinical trials with TNF blockers in four centres . Discrimination between patients with low versus high disease activity according to various definitions and between various levels of change were analysed as the st and ardised mean difference ( difference in the group means divided by the pooled SD of the group means ) and t score . Results : The four ASDAS versions were highly discriminatory in differentiating patients with different levels of disease activity and patients with different levels of change . The ASDAS scores outperformed the BASDAI and its single components in all setting s : patient- or physician-based , reflecting status or change , with normal or raised C-reactive protein ( CRP ) , in the presence or absence of peripheral arthritis . There were no major differences between the four ASDAS scores . Based on feasibility , the ASAS membership selected the ASDAS version which included back pain , duration of morning stiffness , patient global assessment , peripheral joint complaints and CRP as the preferred version . Conclusions : The ASDAS is a vali date d , highly discriminatory instrument for assessing disease activity in AS , including patient-reported outcomes and CRP levels 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 Aims : To evaluate effects of physiotherapeutic intervention in terms of self- and manual mobilization on chest expansion , vital capacity , posture , spine mobility and experienced consequences of the disease in patients with ankylosing spondylitis . Design : A prospect i ve , r and omized controlled study . Methods : Thirty-two men , aged between 23 and 60 years , with ankylosing spondylitis were r and omized to active or no treatment for eight weeks . Physiotherapeutic intervention included individualized self- and manual mobilization for 1 hour twice a week and individually adjusted home exercises . Two blinded investigators made the assessment s of chest expansion , posture and spinal mobility before and after the treatment period . The patient filled in three and the physiotherapist one of the four Bath Ankylosing Spondylitis scales ( BAS scales ) . Results : In the treatment group chest expansion increased at the level of processus xiphoideus ( P<0.01 ) , with no difference in vital capacity compared with the control group . The posture improved in the cervical ( C7—wall distance ) ( P<0.001 ) and in the thoracic spine ( P<0.05 ) . Thoracic and lumbar spine flexion improved ( P<0.01 ) as did sagittal range of motion P<0.001 and P<0.01 , respectively . The Bath Ankylosing Spondylitis Metrology Index total scoring improved ( P<0.001 ) in the treatment group compared with the control group . The other three BAS scales showed no differences between groups . At four months follow-up of the treatment group , cervical spine posture , lumbar flexion and range of motion as well as BAS Metrology Index were still improved . Conclusion : This study shows that eight weeks of self- and manual mobilization treatment improved chest expansion , posture and spine mobility in patients with ankylosing spondylitis
There is not enough evidence to support any benefit of sulfasalazine in reducing pain , disease activity , radiographic progression , or improving physical function and spinal mobility in the treatment of AS .
A statistically significant benefit in reducing the erythrocyte sedimentation rate and easing spinal stiffness was mentioned in the previous version .
More withdrawals because of side effects occurred with sulfasalazine .
BACKGROUND Ankylosing spondylitis ( AS ) is a chronic inflammatory disease of unknown cause and affects mainly the spine , but can also affect other joints .
Disease progression may result in loss of mobility and function .
Sulfasalazine is a disease-modifying antirheumatic drug used in the treatment of AS .
However , its efficacy remains unclear .
This is an up date of a Cochrane review first published in 2005 .
OBJECTIVES To evaluate the benefits and harms of sulfasalazine for the treatment of ankylosing spondylitis ( AS ) .