human
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: 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 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 assess long-term golimumab efficacy/safety in patients with active psoriatic arthritis ( PsA ) . Methods Adult PsA patients ( ≥3 swollen , ≥3 tender joints , active psoriasis ) were r and omly assigned to subcutaneous injections of placebo , golimumab 50 mg or 100 mg every 4 weeks ( q4wks ) through week 20 . All patients received golimumab 50 or 100 mg beginning week 24 . Findings through 2 years are reported . Efficacy evaluations included ≥20 % improvement in American College of Rheumatology ( ACR20 ) response , good/moderate response in Disease Activity Scores incorporating 28 joints and C-reactive protein ( DAS28-CRP ) , ≥75 % improvement in Psoriasis Area and Severity Index ( PASI75 ) and changes in PsA-modified Sharp/van der Heijde scores ( SHS ) . Results Golimumab treatment through 2 years was effective in maintaining clinical response ( response rates : ACR20 63%–70 % , DAS28-CRP 77%–86 % , PASI75 56%–72 % ) and inhibiting radiographic progression ( mean change in PsA-modified SHS in golimumab-treated patients : −0.36 ) , with no clear difference between doses . No new safety signals were identified through 2 years . With the study 's tuberculosis screening and prophylactic measures , no patient developed active tuberculosis through 2 years . Conclusions Golimumab 50 and 100 mg for up to 2 years yielded sustained clinical and radiographic efficacy when administered to patients with active PsA. Increasing the golimumab dose from 50 to 100 mg q4wks added limited benefit . Golimumab safety through up to 2 years was consistent with other antitumour necrosis factor α agents used to treat PsA. Treatment of patients with latent tuberculosis identified at baseline appeared to be effective in inhibiting the development of active tuberculosis Background Psoriatic Arthritis ( PsA ) is estimated to occur in 10 - 15 % of people with psoriasis and accounts for 13 % of people attending early arthritis clinics . With an increasing awareness of the poor outcomes associated with PsA and the availability of new effective , but costly , treatments , there is an urgent need to research the optimal treatment for patients with PsA. The aim of the TICOPA study is to establish whether , in treatment naive early PsA patients , “ tight control ” intensive management with protocol driven therapies and pre-defined objective targets for treatment can improve clinical outcome compared to st and ard care alone . Methods / design TICOPA is a UK multicentre , open-label , r and omised controlled , parallel group trial of 206 patients with early PsA. Patients will be r and omised on a 1:1 basis to receive either st and ard care ( 12 weekly review ) or intensive management ( 4 weekly review ) for a period of 48 weeks . Patients assigned to the intensive management group will follow a strict treatment protocol whereby dose continuation/escalation is determined through the objective assessment of the minimal disease activity ( MDA ) criteria . Patients assigned to the st and ard care group will have treatment prescribed as felt appropriate by the treating clinician , with no set protocol . The primary objective of the trial is to compare intensive management with st and ard care  in terms of the proportion of patients achieving an ACR 20 response at 48 weeks post-r and omisation , in order to determine whether intensive management has superior clinical efficacy . Key secondary outcomes include ACR 50 and 70 , PASI 75 and X-ray Van der Heijde score at 48 weeks post-r and omisation along with cost-effectiveness at 12 , 24 and 28 weeks . Discussion The TICOPA trial will provide direct evidence as to whether the use of early and intensive treatment in PsA in routine clinical care leads to an improvement in patients ’ disease activity and a reduction in radiological joint damage . Trial registration IS RCT N30147736 , Objective : To evaluate the efficacy and safety of infliximab through 1 year in patients with psoriatic arthritis ( PsA ) enrolled in the IMPACT 2 trial . Methods : In this double blind , placebo controlled , phase III study , 200 patients with active PsA were r and omised to receive infusions of infliximab 5 mg/kg or placebo at weeks 0 , 2 , 6 , and every 8 weeks thereafter through 1 year . Patients with persistent disease activity could enter early escape at week 16 , and all remaining placebo patients crossed over to infliximab at week 24 . Patients r and omised to infliximab who had no response or who lost response could escalate their dose to 10 mg/kg starting at week 38 . Clinical efficacy was assessed based on the proportion of patients achieving ACR 20 and PASI 75 responses . Major clinical response ( that is , maintenance of ACR 70 response for 24 continuous weeks ) was assessed for the first time in PsA. Results : Through 1 year of treatment , 58.9 % and 61.4 % of patients in the r and omised infliximab and placebo/infliximab groups , respectively , achieved ACR 20 ; corresponding figures for PASI 75 were 50.0 % and 60.3 % . At week 54 , major clinical response was achieved by 12.1 % of patients in the infliximab group . The safety profile of infliximab through week 54 was consistent with that seen through week 24 . Two malignancies occurred : basal cell skin cancer ( placebo ) and stage I Hodgkin ’s lymphoma ( infliximab ) . Conclusion : Infliximab maintains a high degree of clinical efficacy and continues to be well tolerated in patients with PsA through 1 year of treatment 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 OBJECTIVE Golimumab , administered subcutaneously every 4 weeks , has been shown to be effective in reducing the signs and symptoms of active  psoriatic arthritis ( PsA ) through week 24 of the GO-REVEAL study . Herein we report 1-year clinical , radiographic , and safety findings . METHODS Adult patients with active PsA ( ≥3 swollen and ≥3 tender joints ) were r and omly assigned to receive subcutaneous placebo , golimumab 50 mg , or golimumab 100 mg every 4 weeks through week 20 . At week 16 , patients with < 10 % improvement from baseline  in swollen and tender joint counts entered a blinded early escape phase , with placebo crossover to golimumab 50 mg , golimumab 50 mg increased to 100 mg , and golimumab 100 mg continued at 100 mg . Patients receiving placebo who did not enter the early escape phase crossed over to golimumab 50 mg at week 24 . Findings through 1 year are reported , including the second of 2 co primary end points ( i.e. , change from baseline to week 2 
    Output:
    
agent
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: 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 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 assess long-term golimumab efficacy/safety in patients with active psoriatic arthritis ( PsA ) . Methods Adult PsA patients ( ≥3 swollen , ≥3 tender joints , active psoriasis ) were r and omly assigned to subcutaneous injections of placebo , golimumab 50 mg or 100 mg every 4 weeks ( q4wks ) through week 20 . All patients received golimumab 50 or 100 mg beginning week 24 . Findings through 2 years are reported . Efficacy evaluations included ≥20 % improvement in American College of Rheumatology ( ACR20 ) response , good/moderate response in Disease Activity Scores incorporating 28 joints and C-reactive protein ( DAS28-CRP ) , ≥75 % improvement in Psoriasis Area and Severity Index ( PASI75 ) and changes in PsA-modified Sharp/van der Heijde scores ( SHS ) . Results Golimumab treatment through 2 years was effective in maintaining clinical response ( response rates : ACR20 63%–70 % , DAS28-CRP 77%–86 % , PASI75 56%–72 % ) and inhibiting radiographic progression ( mean change in PsA-modified SHS in golimumab-treated patients : −0.36 ) , with no clear difference between doses . No new safety signals were identified through 2 years . With the study 's tuberculosis screening and prophylactic measures , no patient developed active tuberculosis through 2 years . Conclusions Golimumab 50 and 100 mg for up to 2 years yielded sustained clinical and radiographic efficacy when administered to patients with active PsA. Increasing the golimumab dose from 50 to 100 mg q4wks added limited benefit . Golimumab safety through up to 2 years was consistent with other antitumour necrosis factor α agents used to treat PsA. Treatment of patients with latent tuberculosis identified at baseline appeared to be effective in inhibiting the development of active tuberculosis Background Psoriatic Arthritis ( PsA ) is estimated to occur in 10 - 15 % of people with psoriasis and accounts for 13 % of people attending early arthritis clinics . With an increasing awareness of the poor outcomes associated with PsA and the availability of new effective , but costly , treatments , there is an urgent need to research the optimal treatment for patients with PsA. The aim of the TICOPA study is to establish whether , in treatment naive early PsA patients , “ tight control ” intensive management with protocol driven therapies and pre-defined objective targets for treatment can improve clinical outcome compared to st and ard care alone . Methods / design TICOPA is a UK multicentre , open-label , r and omised controlled , parallel group trial of 206 patients with early PsA. Patients will be r and omised on a 1:1 basis to receive either st and ard care ( 12 weekly review ) or intensive management ( 4 weekly review ) for a period of 48 weeks . Patients assigned to the intensive management group will follow a strict treatment protocol whereby dose continuation/escalation is determined through the objective assessment of the minimal disease activity ( MDA ) criteria . Patients assigned to the st and ard care group will have treatment prescribed as felt appropriate by the treating clinician , with no set protocol . The primary objective of the trial is to compare intensive management with st and ard care  in terms of the proportion of patients achieving an ACR 20 response at 48 weeks post-r and omisation , in order to determine whether intensive management has superior clinical efficacy . Key secondary outcomes include ACR 50 and 70 , PASI 75 and X-ray Van der Heijde score at 48 weeks post-r and omisation along with cost-effectiveness at 12 , 24 and 28 weeks . Discussion The TICOPA trial will provide direct evidence as to whether the use of early and intensive treatment in PsA in routine clinical care leads to an improvement in patients ’ disease activity and a reduction in radiological joint damage . Trial registration IS RCT N30147736 , Objective : To evaluate the efficacy and safety of infliximab through 1 year in patients with psoriatic arthritis ( PsA ) enrolled in the IMPACT 2 trial . Methods : In this double blind , placebo controlled , phase III study , 200 patients with active PsA were r and omised to receive infusions of infliximab 5 mg/kg or placebo at weeks 0 , 2 , 6 , and every 8 weeks thereafter through 1 year . Patients with persistent disease activity could enter early escape at week 16 , and all remaining placebo patients crossed over to infliximab at week 24 . Patients r and omised to infliximab who had no response or who lost response could escalate their dose to 10 mg/kg starting at week 38 . Clinical efficacy was assessed based on the proportion of patients achieving ACR 20 and PASI 75 responses . Major clinical response ( that is , maintenance of ACR 70 response for 24 continuous weeks ) was assessed for the first time in PsA. Results : Through 1 year of treatment , 58.9 % and 61.4 % of patients in the r and omised infliximab and placebo/infliximab groups , respectively , achieved ACR 20 ; corresponding figures for PASI 75 were 50.0 % and 60.3 % . At week 54 , major clinical response was achieved by 12.1 % of patients in the infliximab group . The safety profile of infliximab through week 54 was consistent with that seen through week 24 . Two malignancies occurred : basal cell skin cancer ( placebo ) and stage I Hodgkin ’s lymphoma ( infliximab ) . Conclusion : Infliximab maintains a high degree of clinical efficacy and continues to be well tolerated in patients with PsA through 1 year of treatment 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 OBJECTIVE Golimumab , administered subcutaneously every 4 weeks , has been shown to be effective in reducing the signs and symptoms of active  psoriatic arthritis ( PsA ) through week 24 of the GO-REVEAL study . Herein we report 1-year clinical , radiographic , and safety findings . METHODS Adult patients with active PsA ( ≥3 swollen and ≥3 tender joints ) were r and omly assigned to receive subcutaneous placebo , golimumab 50 mg , or golimumab 100 mg every 4 weeks through week 20 . At week 16 , patients with < 10 % improvement from baseline  in swollen and tender joint counts entered a blinded early escape phase , with placebo crossover to golimumab 50 mg , golimumab 50 mg increased to 100 mg , and golimumab 100 mg continued at 100 mg . Patients receiving placebo who did not enter the early escape phase crossed over to golimumab 50 mg at week 24 . Findings through 1 year are reported , including the second of 2 co primary end points ( i.e. , change from baseline to week 2 
    Output:
    