Infliximab plus methotrexate is superior to methotrexate alone in the treatment of psoriatic arthritis in methotrexate-naive patients: the RESPOND study Infliximab improves signs and symptoms of psoriatic arthritis: results of the IMPACT 2 trial. Cost‐effectiveness analysis of a psoriasis care instruction programme with dithranol compared with UVB phototherapy and inpatient dithranol treatment The development of candidate composite disease activity and responder indices for psoriatic arthritis (GRACE project) A prospective, randomised, placebo-controlled study to identify biomarkers associated with active treatment in psoriatic arthritis: effects of adalimumab treatment on synovial tissue Combination of direct and indirect evidence in mixed treatment comparisons. Etanercept in the treatment of psoriatic arthritis and psoriasis: a randomised trial Safety and efficacy of adalimumab in treatment of patients with psoriatic arthritis who had failed disease modifying antirheumatic drug therapy. Adalimumab for the treatment of patients with moderately to severely active psoriatic arthritis: results of a double-blind, randomized, placebo-controlled trial. Comparison of two etanercept regimens for treatment of psoriasis and psoriatic arthritis: PRESTA randomised double blind multicentre trial Psoriatic arthritis (PA): a clinical, immunological and radiological study of 180 patients. Efficacy and tolerability of anti-tumour necrosis factor therapy in psoriatic arthritis patients: results from the South Swedish Arthritis Treatment Group register Indirect comparisons of competing interventions. Sustained benefits of infliximab therapy for dermatologic and articular manifestations of psoriatic arthritis: results from the infliximab multinational psoriatic arthritis controlled trial (IMPACT). Etanercept treatment of psoriatic arthritis: safety, efficacy, and effect on disease progression. Golimumab, a new human tumor necrosis factor alpha antibody, administered every four weeks as a subcutaneous injection in psoriatic arthritis: Twenty-four-week efficacy and safety results of a randomized, placebo-controlled study.
Objective To compare the efficacy and safety of treatment with infliximab plus methotrexate with methotrexate alone in methotrexate-naive patients with active psoriatic arthritis ( PsA ) . Methods In this open-label study , patients 18 years and older with active PsA who were naive to methotrexate and not receiving disease-modifying therapy ( N=115 ) were r and omly assigned ( 1:1 ) to receive either infliximab ( 5 mg/kg ) at weeks 0 , 2 , 6 and 14 plus methotrexate ( 15 mg/week ) ; or methotrexate ( 15 mg/week ) alone . The primary assessment was American College of Rheumatology ( ACR ) 20 response at week 16 . Secondary outcome measures included psoriasis area and severity index ( PASI ) , disease activity score in 28 joints ( DAS28 ) and dactylitis and enthesitis assessment s. Results At week 16 , 86.3 % of patients receiving infliximab plus methotrexate and 66.7 % of those receiving methotrexate alone achieved an ACR20 response ( p<0.02 ) . Of patients whose baseline PASI was 2.5 or greater , 97.1 % receiving infliximab plus methotrexate compared with 54.3 % receiving methotrexate alone experienced a 75 % or greater improvement in PASI ( p<0.0001 ) . Improvements in C-reactive protein levels , DAS28 response and remission rates , dactylitis , fatigue and morning stiffness duration were also significantly greater in the group receiving infliximab . In the infliximab plus methotrexate group , 46 % ( 26/57 ) had treatment-related adverse events ( AE ) and two patients had serious AE , compared with 24 % with AE ( 13/54 ) and no serious AE in the methotrexate-alone group . Conclusions Treatment with infliximab plus methotrexate in methotrexate-naive patients with active PsA demonstrated significantly greater ACR20 response rates and PASI75 improvement compared with methotrexate alone and was generally well tolerated . This trial is registered in the US National Institutes of Health clinical trials.gov data base , identifier NCT00367237 OBJECTIVES To evaluate further in a phase III , double blind trial the efficacy of infliximab in patients with active psoriatic arthritis ( PsA ) , as observed in the smaller IMPACT trial . METHODS 200 patients with active PsA unresponsive to previous treatment were r and omised to infusions of infliximab 5 mg/kg or placebo at weeks 0 , 2 , 6 , 14 , and 22 . Patients with inadequate response entered early escape at week 16 . The primary measure of clinical response was ACR20 . Other measures included Psoriatic Arthritis Response Criteria ( PsARC ) , Psoriasis Area and Severity Index ( PASI ) , and dactylitis and enthesopathy assessment s. RESULTS At week 14 , 58 % of patients receiving infliximab and 11 % of those receiving placebo achieved an ACR20 response and 77 % of infliximab patients and 27 % of placebo patients achieved PsARC ( both p<0.001 ) . Among the 85 % of patients with at least 3 % body surface area psoriasis involvement at baseline , 53/83 ( 64 % ) patients receiving infliximab had at least 75 % improvement in PASI compared with 2/87 ( 2 % ) patients receiving placebo at week 14 ( p<0.001 ) . These therapeutic effects were maintained through the last evaluation ( week 24 ) . Fewer infliximab patients than placebo patients had dactylitis at week 14 ( 18 % v 30 % ; p = 0.025 ) and week 24 ( 12 % v 34 % ; p<0.001 ) . Fewer infliximab patients ( 22 % ) than placebo patients ( 34 % ) had active enthesopathy at week 14 ( p = 0.016 ) ; corresponding figures at week 24 were 20 % and 37 % ( p = 0.002 ) . Infliximab was generally well tolerated , with a similar incidence of adverse events in each group . CONCLUSIONS Infliximab 5 mg/kg through 24 weeks significantly improved active PsA , including dactylitis and enthesopathy , and associated psoriasis Background This study was part of a large national cost‐effectiveness analysis , and was funded by the National Fund for Investigational Medicine of the Health Care Insurance Board . Objective To develop new composite disease activity indices for psoriatic arthritis ( PsA ) . Methods Data from routine clinic visits at multiple centres were collected in a systematic manner . Data included all domains identified as important in r and omised controlled trials in PsA. Decisions to change treatment were used as surrogates for high disease activity . New indices were developed by multiple linear regression ( psoriatic arthritis disease activity score : PASDAS ) and empirically , utilising physician-defined cut-offs for disease activity ( arithmetic mean of desirability functions : AMDF ) . These were compared with existing composite measures : Composite Psoriatic arthritis Disease Activity Index ( CPDAI ) , Disease Activity for PSoriatic Arthritis ( DAPSA ) , and Disease Activity Score for rheumatoid arthritis ( DAS28 ) . Results 161/503 ( 32 % ) subjects had treatment changes . Although all measures performed well , compared with existing indices , PASDAS was better able to discriminate between high and low disease activity ( area under receiver operating curves ( ROC ) ) curve with 95 % CI : PASDAS 0.773 ( 0.723 , 0.822 ) ; AMDF 0.730 ( 0.680 , 0.780 ) ; CPDAI 0.719 ( 0.668 , 0.770 ) ; DAPSA 0.710 ( 0.654 , 0.766 ) ; DAS28 0.736 ( 0.680 , 0.792 ) . All measures were able to discriminate between disease activity states in patients with oligoarthritis , although area under the receiver operating curves ( AUC ) were generally smaller . In patients with severe skin disease ( psoriasis area and severity index > 10 ) both nonparametric and AUC curve statistics were nonsignificant for all measures . Conclusions Two new composite measures to assess disease activity in PsA have been developed . Further testing in other data sets , including comparison with existing measures , is required to vali date these instruments Objective : To determine which of the changes in synovial tissue correlates best with clinical response associated with effective therapy ( adalimumab ) to facilitate the planning of future studies with therapeutic agents for psoriatic arthritis ( PsA ) . Methods : A total of 24 patients with active PsA were r and omised to receive adalimumab ( n = 12 ) or placebo ( n = 12 ) for 4 weeks . Synovial biopsies were obtained before and after 4 weeks of treatment . Immunohistochemical analysis was performed to characterise the cell infiltrate , expression of cytokines and matrix metalloproteinases ( MMPs ) and vascularity . Sections were analysed by digital image analysis . Statistical analysis was performed using covariance analysis . Results : The mean Disease Activity Score in 28 joints ( DAS28 ) after 4 weeks was 1.92 units lower ( 95 % confidence interval ( CI ) 1.07 to 2.77 ) after adalimumab therapy compared with placebo . Paired pretreatment and post-treatment synovial sample s were available from 19 patients . Many cell types were reduced after adalimumab treatment compared to placebo . After applying a ranked analysis of covariance ( ANCOVA ) model to correct for baseline imbalances , a significant effect of treatment was observed on CD3-positive cells : there was a median reduction of 248 cells/mm2 after adalimumab versus placebo treatment ( p = 0.035 ) . In addition , the expression of MMP13 was significantly reduced after active treatment : the integrated optical density (IOD)/mm2 was 18 190 lower after adalimumab treatment as compared to placebo ( p = 0.033 ) . Conclusion : Adalimumab therapy in PsA is associated with a marked reduction in T cell infiltration and MMP13 expression in synovial tissue , suggesting that these parameters could be used as biomarkers that are sensitive to change after active treatment in small proof of concept studies in Mixed treatment comparison ( MTC ) meta- analysis is a generalization of st and ard pairwise meta- analysis for A vs B trials , to data structures that include , for example , A vs B , B vs C , and A vs C trials . There are two roles for MTC : one is to strengthen inference concerning the relative efficacy of two treatments , by including both ' direct ' and ' indirect ' comparisons . The other is to facilitate simultaneous inference regarding all treatments , in order for example to select the best treatment . In this paper , we present a range of Bayesian hierarchical models using the Markov chain Monte Carlo software WinBUGS . These are multivariate r and om effects models that allow for variation in true treatment effects across trials . We consider models where the between-trials variance is homogeneous across treatment comparisons as well as heterogeneous variance models . We also compare models with fixed ( unconstrained ) baseline study effects with models with r and om baselines drawn from a common distribution . These models are applied to an illustrative data set and posterior parameter distributions are compared . We discuss model critique and model selection , illustrating the role of Bayesian deviance analysis , and node-based model criticism . The assumptions underlying the MTC models and their parameterization are also discussed BACKGROUND Etanercept , a tumour-necrosis-factor inhibitor , has shown efficacy in the treatment of rheumatoid arthritis . Psoriatic arthritis and psoriasis are disease states in which tumour necrosis factor , a proinflammatory cytokine , is present in increased concentrations in joints and in the skin . Therefore , psoriatic arthritis and psoriasis may be appropriate therapeutic targets for etanercept . METHODS This r and omised , double-blind , placebo-controlled , 12 week study assessed the efficacy and safety of etanercept ( 25 mg twice-weekly subcutaneous injections ) or placebo in 60 patients with psoriatic arthritis and psoriasis . Psoriatic arthritis endpoints included the proportion of patients who met the Psoriatic Arthritis Response Criteria ( PsARC ) and who met the American College of Rheumatology preliminary criteria for improvement ( ACR20 ) . Psoriasis endpoints included improvement in the psoriasis area and severity index ( PASI ) and improvement in prospect ively-identified individual target lesions . FINDINGS In this 12 week study , 26 ( 87 % ) of etanercept-treated patients met the PsARC , compared with seven ( 23 % ) of placebo-controlled patients . The ARC20 was achieved by 22 ( 73 % ) of etanercept-treated patients compared with four ( 13 % ) of placebo-treated patients . Of the 19 patients in each treatment group who could be assessed for psoriasis ( > or = 3 % body surface area ) , five ( 26 % ) of etanercept-treated patients achieved a 75 % improvement in the PASI , compared with none of the placebo-treated patients ( p=0.015 ) . The median PASI improvement was 46 % in etanercept-treated patients versus 9 % in placebo-treated patients ; similarly , median target lesion improvements were 50 % and 0 , respectively . Etanercept was well tolerated . INTERPRETATION Etanercept offers patients with psoriatic arthritis and psoriasis a new therapeutic option for control of their disease OBJECTIVE To demonstrate the safety and efficacy of adalimumab for the treatment of active psoriatic arthritis ( PsA ) in patients with an inadequate response to disease modifying antirheumatic drugs ( DMARD ) . METHODS In a placebo controlled , double-blind , r and omized , multicenter study , patients were treated for 12 weeks with subcutaneous injections of adalimumab 40 mg every other week ( eow ) or placebo , followed by a period of open-label treatment with adalimumab 40 mg eow . The primary efficacy endpoint was the percentage of patients who met the American College of Rheumatology ( ACR20 ) core criteria at Week 12 . Secondary efficacy measures included the modified Psoriatic Arthritis Response Criteria ( PsARC ) and assessment s of disability , psoriatic lesions , and quality of life . For missing data , nonresponder imputation was used for ACR and PsARC scores and last observation carried forward for other measures . RESULTS A total of 100 patients received study drug ( 51  adalimumab  , 49 placebo )  . At Week 12 , an ACR20 response was achieved by 39 % of adalimumab patients versus 16 % of placebo patients ( p = 0.012 ) , and a PsARC response was achieved by 51 % with adalimumab versus 24 % with placebo ( p = 0.007 ) . At Week 12 , measures of skin lesions and disability were statistically significantly improved with adalimumab . After Week 12 , open-label adalimumab provided continued improvement for adalimumab patients and initiated rapid improvement for placebo patients , with ACR20 response rates of 65 % and 57 % , respectively , observed at Week 24 . Serious adverse events had similar frequencies during therapy with placebo ( 4.1 % ) , blinded adalimumab ( 2.0 % ) , and open-label adalimumab ( 3.1 % ) . No serious infections occurred during adalimumab therapy . CONCLUSION In this study of patients who had active PsA and a previous , inadequate response to DMARD therapy , adalimumab was well tolerated and significantly reduced the signs , symptoms , and disability of PsA during 12 weeks of blinded and 12 weeks of open-label therapy . Adalimumab also improved psoriasis in these patients OBJECTIVE Adalimumab , a fully human , anti-tumor necrosis factor monoclonal antibody , was evaluated for its safety and efficacy compared with placebo in the treatment of active psoriatic arthritis ( PsA ) . METHODS Patients with moderately to severely active PsA and a history of inadequate response to nonsteroidal antiinflammatory drugs were r and omized to receive 40 mg adalimumab or placebo subcutaneously every other week for 24 weeks . Study visits were at baseline , weeks 2 and 4 , and every 4 weeks thereafter . The primary efficacy end points were the American College of Rheumatology 20 % improvement ( ACR20 ) response at week 12 and the change in the modified total Sharp score of structural damage at week 24 . Secondary end points were measures of joint disease , disability , and quality of life in all patients , as well as the severity of skin disease in those patients with psoriasis involving at least 3 % of body surface area . RESULTS At week 12 , 58 % of the adalimumab-treated patients ( 87 of 151 ) achieved an ACR20 response , compared with 14 % of the placebo-treated patients ( 23 of 162 ) ( P < 0.001 ) . At week 24 , similar ACR20 response rates were maintained and the mean change in the modified total Sharp score was -0.2 in patients receiving adalimumab and 1.0 in those receiving placebo ( P < 0.001 ) . Among the 69 adalimumab-treated patients evaluated with the Psoriasis Area and Severity Index ( PASI ) , 59 % achieved a 75 % PASI improvement response at 24 weeks , compared with 1 % of the 69 placebo-treated patients evaluated ( P < 0.001 ) . Disability and quality of life measures were also significantly improved with adalimumab treatment compared with placebo . Adalimumab was generally safe and well-tolerated . CONCLUSION Adalimumab significantly improved joint and skin manifestations , inhibited structural changes on radiographs , lessened disability due to joint damage , and improved quality of life in patients with moderately to severely active Objectives To compare the efficacy over 12 weeks of two different etanercept regimens in treating the skin manifestations of psoriasis in patients who also have psoriatic arthritis and to evaluate efficacy and safety over an additional 12 weeks of open label etanercept treatment . Design R and omised double blind multicentre outpatient study . Setting 98 outpatient facilities in Europe , Latin America , and the Asia Pacific region . Participants 752 patients with both psoriasis ( evaluated by dermatologists ) and psoriatic arthritis ( evaluated by rheumatologists ) . Interventions During the blinded portion of the study , participants were r and omised to receive etanercept 50 mg twice weekly ( n=379 ) or 50 mg once weekly ( n=373 ) for 12 weeks by subcutaneous injection . All participants then received open label etanercept 50 mg once weekly for 12 additional weeks , while remaining blinded to the regimen . Main outcome measures The primary efficacy end point was the proportion of participants achieving “ clear ” or “ almost clear ” on the physician ’s global assessment of psoriasis at week 12 . Secondary efficacy analyses included psoriasis area and severity index , American College of Rheumatology responses , psoriatic arthritis response criteria , and improvement in joint and tendon disease manifestations . Results At week 12 , 46 % ( 176/379 ) of participants receiving etanercept 50 mg twice weekly achieved a physician ’s global assessment of psoriasis of “ clear ” or “ almost clear ” compared with 32 % ( 119/373 ) in the group treated with 50 mg once weekly ( P<0.001 ) . In contrast , an equally high percentage of participants in both groups achieved psoriatic arthritis response criteria ( 77 % ( 284/371 ) in the twice weekly/once weekly group versus 76 % ( 282/371 ) in the once weekly/once weekly group ) . Participants treated with 50 mg twice weekly/once weekly had greater mean reductions from baseline in the psoriasis area and severity index at week 12 compared with those who received 50 mg once weekly/once weekly ( 71 % v 62 % , P<0.001 ) , with less difference at week 24 ( 78 % v 74 % , P<0.110 ) . Joint and tendon disease manifestations improved from baseline in both groups to a similar extent . No new safety signals were seen in either etanercept treatment group , and no significant difference in the safety profiles was observed . Conclusions In participants with active psoriasis and psoriatic arthritis , initial treatment of the psoriasis with etanercept 50 mg twice weekly may allow for more rapid clearance of skin lesions than with 50 mg once weekly . A regimen of 50 mg once weekly seems to be appropriate for treatment of joint and tendon rheumatic symptoms . The choice of regimen should be determined by the clinical needs of the individual patient . Trial registration Clinical trials NCT00245960 We carried out a prospect i ve study of the clinical , laboratory and radiological features of 180 patients with psoriatic arthritis . We initially classified our patients into five groups as described in the publications of Moll and Wright . Thirty-seven per cent had oligoarthritis , 36 % polyarthritis , 23 % spondarthritis ( sacroiliitis and /or spondylitis ) and 4 % had the mutilans form . The distal joint arthritis type did not exist as an entity and the distal interphalangeal ( DIP ) joints were affected in all groups . The spondarthritis form includes patients with exclusively axial manifestations and also those who in addition have peripheral arthritis ( oligoarthritis , polyarthritis , DIP arthritis ) . Only 53 % of our patients had nail involvement . We found an increase of IgA levels in patients with axial disease . This suggests a relationship between ankylosing spondylitis and psoriatic spondylitis . The HLA-B17/Cw6 association increased in the oligoarticular form . The increase of antigen B17 correlated with the spondarthritic and oligoarthritis forms whereas Cw6 was more important in the oligoarthritis form . An increase of the HLA-B27/Cw1 association and the spondarthritic form was also found . Moreover , we detected a greater incidence of the HLA-B27 antigen in patients with bilateral sacroiliitis ( 85 % ) than in patients with unilateral sacroiliitis ( 22 % ) . Our work revealed that PA is not a harmless disease ; 57 % of our patients had erosive arthritis while 19 % had ARA class III or IV functional impairment Background : The use of tumour necrosis factor ( TNF ) blocking agents in psoriatic arthritis ( PsA ) is increasing , and the SSATG register has followed patients with PsA for more than 5 years . The aim of the present work therefore was to present efficacy and tolerability data of TNF-blocking agents on PsA in clinical practice , and to study potential predictors for drug survival ( the length of time a patient continues to take a particular drug ) . Material s and methods : Patients ( n = 261 ) with active PsA , starting anti-TNF therapy for the first time in southern Sweden , were included . Basal characteristics , disease activity measures , and termination reason for blockers were prospect ively collected during the period April 1999 to September 2006 . Cox proportional hazard models were used to investigate predictors for treatment termination . Results : Overall , response rates at 3–12 months for global visual analogue scale ( VASglobal50 ) and pain VAS ( VASpain50 ) were about 50 % , whereas response rates for European League Against Rheumatism ( EULAR ) scoring “ overall ” and EULAR “ good ” were around 75 % and 55 % , respectively . Concomitant methotrexate ( MTX ) ( hazard ratio ( HR ) 0.64 , 95 % CI 0.39–0.95 , p = 0.03 ) , etanercept ( HR 0.49 , 95 % CI 0.28–0.86 , p = 0.01 ) , and high C-reactive protein ( CRP ) levels ( HR 0.77 , 95 % CI 0.61–0.97 , p = 0.03 ) at treatment initiation were associated with better overall drug survival . The improved drug survival of concomitant MTX appeared to be related to significantly fewer dropouts because of adverse events ( HR = 0.24 ( 0.11–0.52 ) , p<0.01 ) . The blockers were well tolerated with a rate of serious adverse events of 5–6 % per year . No unexpected serious adverse events were observed . Conclusion : Concomitant MTX and high CRP levels are associated with treatment continuation of anti-TNF therapy in patients with PsA regardless of joint distribution . The positive effect of MTX was primarily linked to fewer dropouts because of adverse events OBJECTIVES To survey the frequency of use of indirect comparisons in systematic review s and evaluate the methods used in their analysis and interpretation . Also to identify alternative statistical approaches for the analysis of indirect comparisons , to assess the properties of different statistical methods used for performing indirect comparisons and to compare direct and indirect estimates of the same effects within review s. DATA SOURCES Electronic data bases . REVIEW METHODS The Data base of Abstract s of Review s of Effects ( DARE ) was search ed for systematic review s involving meta- analysis of r and omised controlled trials ( RCTs ) that reported both direct and indirect comparisons , or indirect comparisons alone . A systematic review of MEDLINE and other data bases was carried out to identify published methods for analysing indirect comparisons . Study design s were created using data from the International Stroke Trial . R and om sample s of patients receiving aspirin , heparin or placebo in 16 centres were used to create meta-analyses , with half of the trials comparing aspirin and placebo and half heparin and placebo . Methods for indirect comparisons were used to estimate the contrast between aspirin  and  heparin . The whole process was repeated 1000 times and the results were compared with direct comparisons and also theoretical results . Further detailed case studies comparing the results from both direct and indirect comparisons of the same effects were undertaken . RESULTS Of the review s identified through DARE , 31/327 ( 9.5 % ) included indirect comparisons . A further five review s including indirect comparisons were identified through electronic search ing . Few review s carried out a formal analysis and some based analysis on the naive addition of data from the treatment arms of interest . Few method ological papers were identified . Some valid approaches for aggregate data that could be applied using st and ard software were found : the adjusted indirect comparison , meta-regression and , for binary data only , multiple logistic regression ( fixed effect models only ) . Simulation studies showed that the naive method is liable to bias and also produces over-precise answers . Several methods provide correct answers if strong but unverifiable assumptions are fulfilled . Four times as many similarly sized trials are needed for the indirect approach to have the same power as directly r and omised comparisons . Detailed case studies comparing direct and indirect comparisons of the same effect show considerable statistical discrepancies , but the direction of such discrepancy is unpredictable . CONCLUSIONS Direct evidence from good- quality RCTs should be used wherever possible . Without this evidence , it may be necessary to look for indirect comparisons from RCTs . However , the results may be susceptible to bias . When making indirect comparisons within a systematic review , an adjusted indirect comparison method should ideally be used employing the r and om effects model . If both direct and indirect comparisons are possible within a review , it is recommended that these be done separately before considering whether to pool data . There is a need to evaluate methods for the analysis of indirect comparisons for continuous data and for empirical research into how different methods of indirect comparison perform in cases where there is a large treatment effect . Further study is needed into when it is appropriate to look at indirect comparisons and when to combine both direct and indirect comparisons . Research into how evidence from indirect comparisons compares to that from non-r and omised studies may also be warranted . Investigations using individual patient data from a meta- analysis of several RCTs using different protocol s and an evaluation of the impact of choosing different binary effect measures for the inverse variance method would also be useful OBJECTIVE To investigate the efficacy and tolerability of infliximab therapy for the articular and dermatologic manifestations of active psoriatic arthritis ( PsA ) . METHODS One hundred four patients with PsA in whom prior therapy with at least 1 disease-modifying antirheumatic drug ( DMARD ) had failed were recruited into this investigator-initiated , multicenter , r and omized , double-blind , placebo-controlled clinical trial . During the initial blinded portion of the study , patients received infusions of infliximab ( 5 mg/kg ) or placebo at weeks 0 , 2 , 6 , and 14 . After week 16 , patients initially assigned to receive placebo crossed over to receive infliximab 5 mg/kg every 8 weeks through week 50 , while patients initially r and omized to infliximab continued to receive active treatment at the same dose through week 50 . The primary efficacy outcome was achievement of the American College of Rheumatology 20 % criteria for improvement in rheumatoid arthritis ( ACR20 ) at week 16 . Additional predefined clinical efficacy assessment s included the Psoriasis Area and Severity Index ( PASI ) score , the ACR50 and ACR70 criteria , the Disease Activity Score in 28 joints , the Health Assessment Question naire , ratings of enthesitis and dactylitis , and the Psoriatic Arthritis Response Criteria score . RESULTS The proportion of infliximab-treated patients who achieved an ACR20 response at week 16 ( 65 % ) was significantly higher than the proportion of placebo-treated patients who achieved this response ( 10 % ) . In addition , 46 % of infliximab-treated patients achieved an ACR50 response , and 29 % achieved an ACR70 response ; no placebo-treated patient achieved these end points . Among patients who had PASI scores of > /=2.5 at baseline , 68 % of infliximab-treated patients achieved improvement of > /=75 % in the PASI score at week 16 compared with none of the placebo-treated patients . Continued therapy with infliximab result ed in sustained improvement in articular and dermatologic manifestations of PsA through week 50 . The incidence of adverse events was similar between the treatment groups . CONCLUSION Therapy with infliximab at a dose of 5 mg/kg significantly improved the signs and symptoms of arthritis , psoriasis , dactylitis , and enthesitis in patients with active PsA that had been resistant to DMARD therapy . With continued infliximab treatment , benefits were sustained through 50 weeks . The benefit-to-risk ratio appeared favorable in this study population OBJECTIVE Etanercept has been shown to improve the articular and cutaneous manifestations of psoriatic arthritis ( PsA ) . In this study , we further evaluated the safety , efficacy , and effect on radiographic progression of etanercept in patients with PsA. METHODS Patients with PsA ( n = 205 ) were r and omized to receive placebo or 25 mg etanercept subcutaneously twice weekly for 24 weeks . Patients continued to receive blind-labeled therapy in a maintenance phase until all had completed the 24-week phase , then could receive open-label etanercept in a 48-week extension . Efficacy and safety were evaluated at 4 , 12 , and 24 weeks and at 12-week intervals thereafter . Radiographs of the h and s and wrists were assessed at baseline and 24 weeks , at entry to the open-label phase , and after 48 weeks in the study . RESULTS Etanercept significantly reduced the signs and symptoms of PsA and psoriasis . At 12 weeks , 59 % of etanercept patients met the American College of Rheumatology 20 % improvement criteria for joint response , compared with 15 % of placebo patients ( P < 0.0001 ) , and results were sustained at 24 and 48 weeks . At 24 weeks , 23 % of etanercept patients eligible for psoriasis evaluation achieved at least 75 % improvement in the Psoriasis Area and Severity Index , compared with 3 % of placebo patients ( P = 0.001 ) . Radiographic disease progression was inhibited in the etanercept group at 12 months ; the mean annualized rate of change in the modified total Sharp score was -0.03 unit , compared with + 1.00 unit in the placebo group ( P = 0.0001 ) . Etanercept was well tolerated . CONCLUSION Etanercept reduced joint symptoms , improved psoriatic lesions , inhibited radiographic progression , and was well tolerated in patients with OBJECTIVE To assess the efficacy and safety of golimumab in patients with active psoriatic arthritis ( PsA ) . METHODS Adult patients with PsA who had at least 3 swollen and 3 tender joints and active psoriasis were r and omly assigned to receive subcutaneous injections of placebo  ( n = 113 ) , golimumab 50 mg ( n = 146 ) , or golimumab 100 mg ( n = 146 ) every 4 weeks through week 20 . Efficacy assessment s through week 24 included the American College of Rheumatology 20 % improvement criteria ( ACR20 ) , the Psoriasis Area and Severity Index ( PASI ) in patients in whom at least 3 % of the body surface area was affected by psoriasis at baseline , the  Short Form 36 Health Survey ( SF-36 ) , the disability index of the Health Assessment Question naire ( HAQ ) , the Nail Psoriasis Severity Index ( NAPSI ) , the physician 's global assessment of psoriatic nail disease , and enthesitis ( using the PsA-modified Maastricht Ankylosing Spondylitis Enthesitis Score [ MASES ] index ) . RESULTS At week 14 , 48 % of all patients receiving golimumab , 51 % of patients receiving golimumab 50 mg , and 45 % of patients receiving golimumab 100 mg achieved an ACR20 response ( the primary end point ) , compared with 9 % of patients receiving placebo ( P < 0.001 for all comparisons ) . Among the 74 % of patients in whom at least 3 % of the body surface area was affected by psoriasis at baseline , 40 % of those in the golimumab 50 mg group and 58 % of those in the golimumab 100 mg group had at least 75 % improvement in the PASI at week 14 ( major secondary end point ) , compared with 3 % of placebo-treated patients ( P < 0.001 for both doses ) . Significant improvement was observed for other major secondary end points ( the HAQ and the SF-36 ) , the NAPSI , the physician 's global assessment of psoriatric nail disease , and the PsA-modified MASES index in each golimumab group compared with placebo . This efficacy was maintained through week 24 . Golimumab was generally well tolerated . CONCLUSION Treatment with golimumab at doses of 50 mg and 100 mg significantly improved active PsA and associated skin and nail psoriasis through week 24
Background An up date d economic evaluation was conducted to compare the cost-effectiveness of the four tumour necrosis factor (TNF)-α inhibitors adalimumab , etanercept , golimumab and infliximab in active , progressive psoriatic arthritis ( PsA ) where response to st and ard treatment has been inadequate .