Infliximab plus methotrexate is superior to methotrexate alone in the treatment of psoriatic arthritis in methotrexate-naive patients: the RESPOND study Impact of Adalimumab on Symptoms of Psoriatic Arthritis in Patients with Moderate to Severe Psoriasis: A Pooled Analysis of Randomized Clinical Trials Comparison of effectiveness and safety of infliximab, etanercept, and adalimumab in psoriatic arthritis patients who experienced an inadequate response to previous disease-modifying antirheumatic drugs Infliximab improves signs and symptoms of psoriatic arthritis: results of the IMPACT 2 trial. Efficacy and safety of infliximab for the treatment of psoriatic arthritis A prospective, randomised, placebo-controlled study to identify biomarkers associated with active treatment in psoriatic arthritis: effects of adalimumab treatment on synovial tissue 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. Continued inhibition of radiographic progression in patients with psoriatic arthritis following 2 years of treatment with etanercept. Adalimumab for the treatment of patients with moderately to severely active psoriatic arthritis: results of a double-blind, randomized, placebo-controlled trial. How vague is vague? A simulation study of the impact of the use of vague prior distributions in MCMC using WinBUGS. Comparison of two etanercept regimens for treatment of psoriasis and psoriatic arthritis: PRESTA randomised double blind multicentre trial Risk factors for radiographic progression in psoriatic arthritis: subanalysis of the randomized controlled trial ADEPT Infliximab inhibits progression of radiographic damage in patients with active psoriatic arthritis through one year of treatment: Results from the induction and maintenance psoriatic arthritis clinical trial 2. The Infliximab Multinational Psoriatic Arthritis Controlled Trial (IMPACT): results of radiographic analyses after 1 year Minimally Important Difference of Health Assessment Questionnaire in Psoriatic Arthritis: Relating Thresholds of Improvement in Functional Ability to Patient-rated Importance and Satisfaction Use of etanercept for psoriatic arthritis in the dermatology clinic: The Experience Diagnosing, Understanding Care, and Treatment with Etanercept (EDUCATE) study Abatacept in the treatment of patients with psoriatic arthritis: results of a six-month, multicenter, randomized, double-blind, placebo-controlled, phase II trial. Infliximab improves health related quality of life and physical function in patients with psoriatic arthritis Reductions in healthcare resource utilization in psoriatic arthritis patients receiving etanercept therapy: results from the educate trial. Two-year efficacy and safety of infliximab treatment in patients with active psoriatic arthritis: findings of the Infliximab Multinational Psoriatic Arthritis Controlled Trial (IMPACT). A Norwegian DMARD register: prescriptions of DMARDs and biological agents to patients with inflammatory rheumatic diseases. Efficacy and tolerability of anti-tumour necrosis factor therapy in psoriatic arthritis patients: results from the South Swedish Arthritis Treatment Group register Effect of infliximab therapy on employment, time lost from work, and productivity in patients with psoriatic arthritis. Infliximab monotherapy in Japanese patients with moderate-to-severe plaque psoriasis and psoriatic arthritis. A randomized, double-blind, placebo-controlled multicenter trial. Adalimumab improves joint-related and skin-related functional impairment in patients with psoriatic arthritis: patient-reported outcomes of the Adalimumab Effectiveness in Psoriatic Arthritis Trial 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. Adalimumab in Japanese patients with moderate to severe chronic plaque psoriasis: efficacy and safety results from a Phase II/III randomized controlled study. Adalimumab for treatment of moderate to severe psoriasis and psoriatic arthritis.
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 Background : Psoriatic arthritis often affects patients with psoriasis . Objective : To examine the effect of adalimumab on psoriatic arthritis in patients with moderate to severe psoriasis . Methods : Data from patients with psoriasis and a reported history of comorbid psoriatic arthritis in 3 r and omized , placebo-controlled psoriasis trials of  adalimumab were analyzed . Results : Adalimumab ( n = 274 ) reduced the risk of psoriatic arthropathy adverse events by 75 % versus placebo ( 1.1 vs. 4.8 % ; p = 0.025 ) . Psoriasis/psoriatic arthritis-related pain was significantly reduced ( –31.3 vs. –5.6 visual analog scale units ; p < 0.0001 ) . At week 16 , adalimumab-treated patients were more likely to respond ( 56.9 vs. 4.5 % ; p < 0.001 ) and responded for a greater percentage of follow-up time ( 39.3 vs. 2.9 % ; p < 0.0001 ) than placebo-treated patients ( regression model for PASI 75 and ACR 20 responses ) . Conclusion : Adalimumab treatment of moderate to severe psoriasis reduced symptoms of comorbid psoriatic arthritis The aim of this study is to compare effectiveness and safety of Infliximab ( INF ) , Etanercept ( ETN ) , and Adalimumab ( ADA ) in patients with psoriatic arthritis ( PsA ) with inadequate response to a previous disease-modifying antirheumatic drug ( DMARD ) . One hundred consecutive PsA patients with inadequate response to a previous DMARD entered this study . Clinical and laboratory assessment at baseline ( T0 ) and 12 ( T12 ) months were performed and included physical examination , vital signs , global Psoriasis Area and Severity Index ( PASI ; extension of psoriasis ) , tender joints count ( TJC ) , swollen joint count , health assessment question naire ( HAQ ; question naire for measuring disability ) , and monitoring of adverse events ( AEs ) . After enrolment , all patients were r and omly given INF 5 mg/Kg every 6–8 weeks , ETN 50 mg weekly , or ADA 40 mg every other week . Baseline therapy with DMARD remained unchanged . Effectiveness was defined as percentage of ACR20 responders and as clinical remission and /or minimal disease activity at 12 months treatment . INF , ETN , and ADA all effectively controlled signs and symptoms of PsA. All variables tested showed at T12 for each treatment a significant variation from the baseline value . In particular , patients on INF and ADA showed the greatest improvement in terms of PASI , while patients on ETN showed the greatest improvement on TJC and HAQ . ACR response rates were 72 % of patients on ETN , 70 % of those on ADA , and 75 % of those patients on INF . Occurrence of AEs was reported in 15 % of the cases . Only two AEs in patients on INF were considered drug related , pneumonitis and thrombocytopenia , respectively . All tumor necrosis factor-α blockers significantly controlled signs and symptoms of PsA. An increased knowledge of the different profiles of these agents may help in optimizing their use 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 DESIGN AND INTERVENTION This trial was an international multicenter phase III , double-blind , placebo-controlled , r and omized , parallel group study . Patients with active PsA were r and omly allocated to infusions of either 5 mg/kg infliximab or placebo at baseline and then at 2 , 6 , 14 and 22 weeks . R and omization was stratified by baseline methotrexate use . Dactylitis in the h and s and feet and enthesitis in the feet were assessed . Antinuclear-antibody ( ANA ) and antidouble-str and ed-DNA-antibody titers and the frequency of antibodies to infliximab were measured at baseline and at week 22 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 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 Clinical and radiographic responses were evaluated in patients with psoriatic arthritis ( PsA ) treated for up to 2 years with etanercept .  METHODS Patients were previously r and omized to receive placebo or etanercept  in a double-blind study and chose to participate in the current open-label extension phase . All patients received etanercept 25 mg twice weekly . Radiographic progression was determined at baseline , 1 year , and 2 years using the Sharp method modified to include joints frequently affected in PsA. Arthritis and psoriasis responses were determined using American College of Rheumatology 20 % ( ACR20 ) improvement criteria , PsA response criteria ( PsARC ) , and the psoriasis area severity index ( PASI ) . RESULTS Of 205 patients r and omized , 169 entered open-label , and 141 [ 71 r and omized to receive placebo ( placebo/etanercept ) and 70 r and omized to receive etanercept ( etanercept/etanercept ) ]  had radiographic data available for analysis at 2 years . ACR20 criteria , PsARC , and PASI 50 criteria were met by 64 % , 84 % , and 62 % , respectively , of etanercept/etanercept patients at the end of the 48-week open-label period . Placebo/etanercept patients achieved comparable results within 12 weeks that were sustained at 48 weeks ( 63 % , 80 % , and 73 % ) . Radiographic progression was inhibited in the etanercept/ etanercept patients ( mean adjusted change in total Sharp score of -0.38 from baseline to 2 yrs ) . In placebo/etanercept patients , disease progression was inhibited once patients began receiving etanercept ( mean adjusted change of -0.22 from 1 year to 2 years ) . Adverse event rates were similar to those observed during r and omized phase , with only one serious adverse event deemed possibly related to etanercept . CONCLUSION These data demonstrate a sustained benefit of etanercept treatment , including inhibition of radiographic progression , in patients with 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 There has been a recent growth in the use of Bayesian methods in medical research . The main reasons for this are the development of computer intensive simulation based methods such as Markov chain Monte Carlo ( MCMC ) , increases in computing power and the introduction of powerful software such as WinBUGS . This has enabled increasingly complex models to be fitted . The ability to fit these complex models has led to MCMC methods being used as a convenient tool by frequentists , who may have no desire to be fully Bayesian . Often research ers want ' the data to dominate ' when there is no prior information and thus attempt to use vague prior distributions . However , with small amounts of data the use of vague priors can be problematic . The results are potentially sensitive to the choice of prior distribution . In general there are fewer problems with location parameters . The main problem is with scale parameters . With scale parameters , not only does one have to decide the distributional form of the prior distribution , but also whether to put the prior distribution on the variance , st and ard deviation or precision . We have conducted a simulation study comparing the effects of 13 different prior distributions for the scale parameter on simulated r and om effects meta- analysis data . We varied the number of studies ( 5 , 10 and 30 ) and compared three different between- study variances to give nine different simulation scenarios . One thous and data sets were generated for each scenario and each data set was analysed using the 13 different prior distributions . The frequentist properties of bias and coverage were investigated for the between- study variance and the effect size . The choice of prior distribution was crucial when there were just five studies . There was a large variation in the estimates of the between- study variance for the 13 different prior distributions . With a large number of studies the choice of prior distribution was less important . The effect size estimated was not biased , but the precision with which it was estimated varied with the choice of prior distribution leading to varying coverage intervals and , potentially , to different statistical inferences . Again there was less of a problem with a larger number of studies . There is a particular problem if the between- study variance is close to the boundary at zero , as MCMC results tend to produce upwardly biased estimates of the between- study variance , particularly if inferences are based on the posterior mean . The choice of ' vague ' prior distribution can lead to a marked variation in results , particularly in small studies . Sensitivity to the choice of prior distribution should always be assessed 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 Introduction To identify independent predictors of radiographic progression in psoriatic arthritis ( PsA ) for patients treated with adalimumab or placebo in the Adalimumab Effectiveness in PsA Trial ( ADEPT ) . Methods Univariate analyses and multivariate linear regression analyses assessed risk for radiographic progression ( change in modified total Sharp score , ΔmTSS > 0.5 ) from baseline to week 24 for C-reactive protein ( CRP ) and other baseline variables , and for 24-week time-averaged CRP ( univariate analysis only ) . Subanalyses determined mean ΔmTSS for CRP subgroups . Analyses were post hoc , with observed data . Results One hundred and forty-four adalimumab-treated patients and 152 placebo-treated patients were assessed . Mean CRP was 64 % lower by week 2 with adalimumab and essentially unchanged with placebo . Univariate analyses indicated that elevated CRP at baseline and time-averaged CRP were strongly associated with radiographic progression  for placebo-treated patients but not for adalimumab-treated patients . Multivariate analysis confirmed that elevated baseline CRP was the only strong independent risk factor for radiographic progression ( for CRP ≥1.0 mg/dl : odds ratio = 3.28 , 95 % confidence interval = 1.66 to 6.51 , P < 0.001 ) . Adalimumab treatment reduced risk of progression approximately fivefold . The difference between mean ΔmTSS  for adalimumab versus placebo was greatest for patients with baseline CRP ≥2.0 mg/dl ( -0.5 vs. 2.6 ) . Conclusions Systemic inflammation in PsA , as indicated by elevated baseline CRP , was the only strong independent predictor of radiographic progression . This association was observed predominantly for placebo-treated patients . Adalimumab treatment substantially reduced the overall risk of radiographic progression , and provided greatest radiographic benefit for patients with the greatest CRP concentrations at baseline . Trial Registration Trial registration : NCT00195689 OBJECTIVE To evaluate the effect of infliximab on progression of structural damage over 1 year in patients with active psoriatic arthritis ( PsA ) enrolled in the Induction and Maintenance Psoriatic Arthritis Clinical Trial 2 . METHODS In this double-blind , placebo-controlled study , 200 patients with active PsA were r and omly assigned ( 1:1 ratio ) to receive infusions of infliximab ( 5 mg/kg ) or placebo at weeks 0 , 2 , and 6 , and every 8 weeks thereafter through week 54 . At week 24 , patients initially assigned to receive placebo crossed over to receive infliximab ( 5 mg/kg ) . Based on predefined criteria , patients r and omized to receive placebo could enter early escape by receiving infliximab ( 5 mg/kg ) starting at week 16 , and patients r and omized to receive infliximab could have the dose increased to 10 mg/kg starting at week 38 . Patients were analyzed according to the treatment they were r and omized to receive . Radiographs of h and s and feet were obtained at baseline and at weeks 24 and 54 . Two readers blinded to treatment assignment and radiograph sequence independently evaluated erosions and joint space narrowing using the Sharp/van der Heijde scoring method modified for PsA. RESULTS At week 24 , patients r and omized to receive infliximab 5 mg/kg had significantly less radiographic progression compared with patients r and omized to receive placebo , with mean + /- SD changes from baseline in the total Sharp/van der Heijde score of -0.70 + /- 2.53 and 0.82 + /- 2.62 , respectively ( P < 0.001 ) . At week 54 , mean + /- SD changes from baseline in the total Sharp/van der Heijde score were -0.94 + /- 3.40 in patients r and omized to receive infliximab and 0.53 + /- 2.60 in those receiving placebo/infliximab ( P = 0.001 ) . CONCLUSION Infliximab significantly inhibits radiographic progression in patients with PsA as early as 6 months after starting treatment , and the beneficial effect continues through 1 year of infliximab therapy Objective : Infliximab is effective in improving signs and symptoms of joint/skin involvement , functional status , and quality of life in patients with psoriatic arthritis ( PsA ) . Using IMPACT trial data , we assessed the effect of infliximab ( IFX ) on structural damage in PsA. Methods : Patients with active PsA were r and omly assigned to receive placebo ( PBO/IFX ) or infliximab 5 mg/kg ( IFX/IFX ) at weeks 0 , 2 , 6 , and 14 , with the primary endpoint at week 16 . The PBO group received infliximab loading doses at weeks 16 , 18 , and 22 . Thereafter , all patients received infliximab 5 mg/kg every 8 weeks through week 50 . H and /feet radiographs were obtained at weeks 0 and 50 . Total radiographic scores were determined using the PsA modified van der Heijde-Sharp ( vdH-S ) score . Projected annual rate of progression was calculated by dividing x ray score by disease duration ( years ) . Results : As reported previously , 65 % of infliximab treated patients versus 10 % of PBO treated patients achieved an ACR20 response at week 16 ( p<0.001 ) . At week 50 , 69 % of patients achieved an ACR20 response . Radiographs ( baseline and week 50 ) were available for 72/104 patients . At baseline , estimated mean annual rate of progression was 5.8 modified vdH-S points/year . Mean ( median ) changes from baseline to week 50 in the total modified vdH-S score were −1.95 ( −0.50 ) for PBO/IFX and −1.52 ( −0.50 ) for IFX/IFX patients ( p = NS ) . At week 50 , 85 % and 84 % of patients in the PBO/IFX and IFX/IFX groups had no worsening in the total modified vdH-S score . Conclusion : Infliximab inhibits radiographic progression in patients with PsA through week 50 Objective . To evaluate changes in function as measured by Health Assessment Question naire Disability Index ( HAQ-DI ) and the meaningfulness of the changes , in importance and satisfaction , in patients with psoriatic arthritis ( PsA ) . Methods . HAQ-DI was assessed at baseline and at Weeks 4 , 12 , and 24 in a r and omized double-blind study of 205 patients with active PsA receiving etanercept 25 mg twice weekly or placebo .  Concurrently , patients rated the importance of and satisfaction with their change in function on a 7-point scale ( 1 = not at all important/satisfied ; 7 = extremely important/satisfied ) . Mean HAQ-DI improvement corresponding to ratings of minimally ( 2–3 ) or very ( 6–7 ) important or satisfied was determined using a posthoc linear mixed-model analysis . Patient importance ratings were used as an anchor to estimate minimally important difference ( MID ) for HAQ-DI ; distribution-based estimates were also calculated . Results . A total of 161 patients ( 69 placebo ; 92 etanercept ) had ≥ 1 HAQ-DI scores showing improvement from baseline and a corresponding importance or satisfaction rating . HAQ-DI improvements corresponding to importance scale ratings of 2 or 3 were 0.335 ( 95 % CI 0.214 , 0.455 ) and 0.360 ( 95 % CI 0.263 , 0.456 ) , respectively , suggesting an MID of about 0.35 . HAQ-DI improvements corresponding to satisfaction scale ratings of 2 and 3 were 0.293 ( 95 % CI 0.230 , 0.357 ) and 0.360 ( 95 % CI 0.307 , 0.413 ) . For a given change in HAQ-DI , nearly two-thirds of patients indicated a lower rating for satisfaction than for importance . This trial was registered in the Clinical Trials.gov registry ( NCT00317499 ) . Conclusion . Our study suggests the MID for HAQ-DI in PsA is about 0.35 . The results may also provide insight into patient satisfaction with changes in function and expectations for therapy Objective : To assess the efficacy and tolerability of etanercept to treat psoriatic arthritis . Material s and methods : A total of 1122 patients who had active psoriatic arthritis were enrolled in a Phase 4 , non‐r and omized , open‐label , single‐arm , 24‐week study . These patients had clinical ly stable , plaque psoriasis involving ⩾10 % body surface area and joint disease ( either ⩾two swollen and ⩾two tender/painful joints for ⩾3 months , or ⩾one joint with sacroiliitis or spondylitis ) . They received etanercept therapy 50 mg subcutaneously once weekly for 24 weeks . Results : After 24 weeks of treatment , 865 patients ( 77.1 % ; 95 % CI : 74.64–79.55 % ) achieved a ‘ mild or better ’ score on the physician global assessment of psoriasis and were improved from baseline . Mean improvement in body surface area involvement was 16.9 percentage points ( 15.89–17.91 ) . Patient global assessment of psoriasis , joint pain , and joint disease scores were improved by means of 2.2 ( 2.15–2.34 ) , 2.7 ( 2.53–2.84 ) , and 1.5 ( 1.39–1.55 ) , respectively . Thirty‐five patients ( 3.1 % ) experienced at least one serious adverse event . No patient died during the study . Conclusions : These results support the effectiveness and tolerability  of etanercept treatment in patients with psoriatic arthritis being treated at dermatology clinics OBJECTIVE To assess the safety and efficacy of abatacept , a selective T cell costimulation modulator , in patients with psoriatic arthritis ( PsA ) . METHODS In this 6-month , multicenter , r and omized , double-blind , placebo-controlled , phase II study , 170 PsA patients with a psoriasis target lesion ( TL ) ≥2 cm who had previously taken disease-modifying antirheumatic drugs ( DMARDs ) , including anti-tumor necrosis factor ( anti-TNF ) agents , were r and omized ( 1:1:1:1 ) to receive placebo or abatacept at doses of 3 mg/kg , 10 mg/kg , or 30/10 mg/kg ( 2 initial doses of 30 mg/kg , followed by 10 mg/kg ) on days 1 , 15 , and 29 and then once every 28 days thereafter . The primary end point was the American College of Rheumatology 20 % criteria for improvement ( ACR20 response ) on day 169 . Other key end points were magnetic resonance imaging ( MRI ) scores for joint erosion , osteitis , and synovitis , scores on the Health Assessment Question naire ( HAQ ) and the Short Form-36 ( SF-36 ) health survey , the investigator 's global assessment of psoriasis , the TL score , and the Psoriasis Area and Severity Index ( PASI ) score . RESULTS Proportions of patients achieving an ACR20 response were 19 % , 33 % , 48 % , and 42 % in the placebo , the abatacept 3 mg/kg , the abatacept 10 mg/kg , and the abatacept 30/10 mg/kg groups , respectively . Compared with placebo , improvements were significantly higher for the abatacept 10 mg/kg ( P = 0.006 ) and 30/10 mg/kg ( P = 0.022 ) groups , but not for 3 mg/kg group ( P = 0.121 ) . All abatacept regimens result ed in improved MRI , HAQ , and SF-36 scores , with 10 mg/kg showing the greatest improvements . Improvements in the TL and PASI scores were observed in all abatacept arms ; a response according to the investigator 's global assessment was seen only with 3 mg/kg of abatacept . The safety profiles were similar among the treatment arms . CONCLUSION The results of this study suggest that 10 mg/kg of abatacept , the approved dosage for rheumatoid arthritis and juvenile idiopathic arthritis , may be an effective treatment option for Objectives : To evaluate the effect of infliximab on health related quality of life ( HRQoL ) and physical function in patients with active psoriatic arthritis ( PsA ) in the IMPACT 2 trial . Methods : 200 patients with PsA unresponsive to conventional treatment were r and omised to intravenous 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 .  HRQoL was assessed using the Short Form-36 ( SF-36 ) at weeks 0 , 14 , and 24 . Functional disability was assessed using the Health Assessment Question naire ( HAQ ) at every visit through week 24 . Associations between changes in quality of life ( SF-36 ) and articular ( American College of Rheumatology ( ACR ) ) and dermatological ( Psoriasis Area and Severity Index ( PASI ) ) responses were examined . Results : Mean percentage improvement from baseline in HAQ was 48.6 % in the infliximab group compared with worsening of 18.4 % in the placebo group at week 14 ( p<0.001 ) . Furthermore , 58.6 % and 19.4 % of infliximab and placebo treated patients , respectively , achieved a clinical ly meaningful improvement in HAQ ( that is , ⩾0.3 unit decrease ) at week 14 ( p<0.001 ) . Increases in physical and mental component summary ( PCS and MCS ) scores and all eight scales of the SF-36 in the infliximab group were greater than those in the placebo group at week 14 ( p⩽0.001 ) . These benefits were sustained through week 24 . Patients achieving ACR20 and PASI75 responses had the greatest improvements in PCS and MCS scores . Conclusions : In patients with PsA  , infliximab 5 mg/kg significantly improved HRQoL and physical function compared with placebo through 24 weeks The Experience Diagnosing , Underst and ing Care , and Treatment with Enbrel ( EDUCATE ) trial is a phase IV , 24-week , multicenter , open-label study of etanercept 50 mg weekly in the treatment of psoriatic arthritis ( PsA ) in community dermatology clinics . In this study , patients with active PsA and moderate to severe plaque psoriasis have measurable uses of healthcare re sources at baseline , reflecting a burden of illness . Etanercept significantly reduced healthcare re source utilization , absenteeism , and caregiver assistance in PsA patients after 24 weeks of treatment . These results could translate into savings on both direct and indirect costs and improvements in health-related quality of life for patients with OBJECTIVE To investigate longterm efficacy/safety of infliximab over 2 years in patients with active psoriatic arthritis ( PsA ) . METHODS Initially , 104 patients were r and omized to receive blinded infusions of infliximab 5 mg/kg or placebo at Weeks 0 , 2 , 6 , and 14 . At Week 16 , all patients received infliximab 5 mg/kg every 8 weeks through Week 46 . Seventy-eight of the 87 patients completing the first year continued into the open-label longterm extension and received infliximab 5 mg/kg at Weeks 54 , 62 , 70 , 78 , 86 , and 94 . The primary efficacy endpoint for the study extension was the proportion of patients with at least 20 % improvement in the American College of Rheumatology response criteria ( ACR20 ) at Week 98 . Radiographic progression was assessed by the PsA-modified van der Heijde-Sharp score in patients with radiographs available at baseline and Week 98 ( n = 43 ) . RESULTS At Week 98 , 62 % ( 48/78 ) of infliximab-treated patients achieved an ACR20 response ; 45 % ( 35/78 ) and 35 % ( 27/78 ) of patients achieved ACR50 and ACR70 responses , respectively . Among patients with baseline Psoriasis Area and Severity Index scores > or= 2.5 , 64 % ( 16/25 ) achieved > 75 % improvement from baseline to Week 98 . The average estimated annual radiographic progression with infliximab treatment was significantly reduced versus the estimated baseline rate of progression . No new safety issues were observed during the second year of the study . CONCLUSION Therapy with infliximab 5 mg/kg through Week 94 produced sustained improvement in joint and skin symptoms , inhibited radiographic progression , and continued to exhibit a favorable benefit-risk ratio in this population with treatment-refractory Information concerning the effectiveness of drug therapy can not be obtained only from r and omized controlled clinical trials , due to limitations such as a short time frame and narrow inclusion and exclusion criteria . Therefore , complementary longitudinal observational studies performed in a real life setting are required .  NOR-DMARD  , a Norwegian 5-center register , was established in December 2000 . All  DMARD prescriptions to patients with inflammatory arthropathies are included , and patients are followed longitudinally with a variety of assessment s. As of 2005 , 4683 DMARD regimens have been included .  Methotrexate is the most commonly used DMARD in rheumatoid arthritis and psoriatic arthritis . The proportions of patients who have received anti-TNF drugs  in rheumatoid arthritis , psoriatic arthritis , ankylosing spondylitis , juvenile arthritis and other diseases have been 22.5 , 21.6 , 53.8 , 36.9 and 9.7 % , respectively . The proportion of patients receiving anti-TNF drugs  is considerably higher in 2004 than earlier , and criteria for prescribing anti-TNF drugs appear to be trending toward patients with less severe and active disease . Confounding by indication or channeling bias represents a challenge for the group comparisons of longitudinal effectiveness data , but can be addressed by modern statistical techniques . The NOR-DMARD register may in the future provide comparative real life effectiveness data that may also be used in cost-effectiveness analyses 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 OBJECTIVE To examine the effect of infliximab on employment status , time lost from work , and productivity in a double-blind , placebo-controlled study of patients with active psoriatic arthritis ( PsA ) . METHODS Two hundred adult patients with PsA were r and omized to intravenous infusions of either infliximab 5 mg/kg or placebo at Weeks 0 , 2 , 6 , 14 , and 22 , with early escape at Week 16 . Employment status , workdays missed , and productivity were assessed at baseline and at Week 14 . The effect of PsA on daily productivity was assessed using a visual analog scale . RESULTS At baseline , similar percentages of patients in both treatment groups were employed and similar percentages missed workdays ; the mean productivity score at baseline was similar between groups ( roughly 3 on a scale of 0 to 10 ) . At Week 14 , median productivity increased significantly in the infliximab group compared with the placebo group ( 67.5 % vs 9.2 % ; p < 0.0001 ) . Compared with the placebo group , higher proportions of patients in the infliximab group improved employment status from unemployed at baseline to employed at Week 14 ( 11.5 % vs 0 % ; p = 0.084 ) and from part-time to full-time employment ( 30.0 % vs 10.0 % ; p = 0.582 ) . Among patients employed at baseline and Week 14 , a lower proportion of patients in the infliximab group than in the placebo group had missed workdays in the 4 weeks prior to Week 14 ( p = 0.138 ) . CONCLUSION After 14 weeks of treatment , infliximab improved productivity in patients with active PsA. There was also a trend toward increased employment and reduced time lost from work for patients treated with infliximab BACKGROUND A clinical trial of infliximab in psoriasis has not yet been performed in Asian population s , although infliximab has been approved for the indications of psoriatic arthritis and plaque psoriasis in the US and the EU . OBJECTIVE This study aims to vali date the efficacy and safety of infliximab in Japanese patients with plaque psoriasis and psoriatic arthritis . METHODS Patients with moderate-to-severe psoriasis , including psoriatic arthritis , were r and omized to the induction therapy ( Weeks 0 , 2 and 6 ) with infliximab 5 mg/kg ( n=37 ) or placebo ( n=17 ) . For the maintenance therapy , infliximab was administered every 8 weeks from Week 14 to Week 62 in the infliximab group , and placebo was switched to infliximab in the placebo group starting at Week 16 . The primary efficacy endpoint was the proportion of patients who had achieved at least 75 % improvement in the psoriasis area and severity index ( PASI 75 response rate ) from baseline at Week 10 . RESULTS At Week 10 , a total of 68.6 % of patients receiving infliximab and none of those receiving placebo , achieved PASI 75 response ( p<0.001 ) . A significant improvement in PASI , PGA , DLQI , and patient 's pain assessment was seen from Week 6 through Week 14 in the infliximab group compared with the placebo group . Through Week 66 , PASI , PGA , DLQI as well as pain relief were better maintained . CONCLUSION Infliximab could provide a sustained improvement effect on skin and joint symptoms , and accordingly contributed to a sustained improvement in the QOL of patients with moderate-to-severe plaque psoriasis and psoriatic arthritis .  Infliximab was generally well tolerated in most patients . These results corresponded with the results of the trials in the US and the EU Objective : To evaluate the effects of adalimumab on patient-reported outcomes of joint-related and skin-related functional impairment , health-related quality of life , fatigue and pain in patients with psoriatic arthritis ( PsA ) . Methods : Patients with moderately- to severely- active PsA were treated with adalimumab , 40 mg , every other week , or placebo , in this 24-week , r and omised , controlled trial . Patient-reported outcomes included the Health Assessment Question naire Disability Index ( HAQ DI ) , Short-Form 36 Health Survey ( SF-36 ) , the Functional Assessment of Chronic Illness Therapy — Fatigue ( FACIT-Fatigue ) Scale and the Dermatology Life Quality Index ( DLQI ) . Results : Adalimumab ( n = 151 ) and placebo ( n = 162 ) groups were comparable with respect to baseline demographics and disease severity . Significant changes from baseline in HAQ DI were reported for adalimumab v placebo ( −0.4 v −0.1 , p<0.001 ) at both 12 and 24 weeks . At week 24 , significant improvements in the SF-36 domains of physical functioning , role-physical , bodily pain , general health , vitality and social functioning , as well as the physical component summary score , were observed for adalimumab versus placebo ( p<0.01 ) . These reported changes in HAQ DI and SF-36 were also clinical ly important . Significantly more patients treated with adalimumab had complete resolution of functional loss ( HAQ DI = 0 ) and dermatological-related functional limitations ( DLQI = 0 ) compared with placebo at weeks 12 and 24 ( p⩽0.001 ) . Adalimumab led to significantly greater improvements in FACIT-Fatigue scores , pain scores , and disease activity measures versus placebo at 12 and 24 weeks ( p<0.001 for all ) . Conclusions : Adalimumab improved physical-related and dermatological-related functional limitations , HRQOL , fatigue and pain in patients with PsA treated for 24 weeks 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 Incidence of psoriasis vulgaris in Asians is estimated at 0.05 - 0.3 % . Studies in North America and Europe demonstrated that adalimumab , a fully human , recombinant , immunoglobulin G(1 ) monoclonal antibody , was efficacious and well-tolerated in patients with chronic plaque psoriasis . This 24-week , placebo-controlled study evaluated the efficacy and safety of three different dosing regimens of adalimumab in Japanese patients with moderate to severe chronic plaque psoriasis ( n = 169 ) . Patients were r and omized to receive adalimumab 40 mg every other week ( eow ) , adalimumab 80-mg loading dose at week 0 followed by adalimumab 40 mg eow starting at week 2 , adalimumab 80 mg eow , or placebo eow given as s.c . injections . The primary efficacy endpoint was the percentage of patients achieving a 75 % or greater improvement in Psoriasis Area and Severity Index ( PASI 75 ) score at week 16 . At week 16 , PASI 75 response rates were significantly greater for all three adalimumab groups ( 40 mg eow : 57.9 % , P < 0.001 ; 40 mg eow plus loading dose : 62.8 % , P < 0.001 ; 80 mg eow : 81.0 % , P < 0.001 ) versus placebo ( 4.3 % ) . As early as week 4 , the 40-mg eow plus loading dose and 80-mg eow groups achieved significantly greater PASI 75 response rates compared with placebo . Injection-site reactions and hepatic events occurred in greater percentages of adalimumab-treated patients compared with placebo . Adalimumab therapy demonstrated efficacy and safety at all three dosage regimens . Rapid response rate in patients receiving 40 mg eow plus loading dose supports using an 80-mg loading dose in the treatment of psoriasis Psoriasis and psoriatic arthritis are common diseases associated with considerable morbidity and disability . Their pathophysiology comprises similar processes leading to inflammation of skin , entheses , and joints . Although traditional systemic agents can be effective , their use may be limited by lack of efficacy and concerns regarding adverse effects . The objective of this study was to assess the efficacy and safety of adalimumab , a fully human antitumor necrosis factor ( anti-TNF ) monoclonal antibody , over 16 weeks . The present authors report their personal experience in 15 patients with severe plaque psoriasis and psoriatic arthritis , refractory to other treatments , in which a decisive regression of joint/skin involvement was obtained . Psoriasis and psoriatic arthritis are chronic inflammatory disorders result ing from a combination of genetic and environmental factors
OBJECTIVE To evaluate the comparative effectiveness of available tumor necrosis factor-α inhibitors ( anti-TNFs ) for the management of psoriatic arthritis ( PsA ) in patients with an inadequate response to disease-modifying antirheumatic drugs ( DMARDs ) .