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 evaluate the safety and efficacy of long-term treatment of psoriasis with etanercept , 50 mg twice weekly . DESIGN , SETTING , AND PATIENTS A phase 3 , r and omized , double-blind trial with an open-label extension . A total of 618 adult patients with moderate to severe plaque psoriasis were studied at 39 medical centers in the United States and Canada from May 23 , 2003 , through June 22 , 2005 . INTERVENTIONS Patients were r and omized to receive  placebo or etanercept for 12 weeks . Beginning with week 13 , all patients ( N=591 ) received etanercept . MAIN OUTCOME MEASURES Exposure-adjusted adverse event rates were calculated . Efficacy measures included efficacy and patient global assessment of psoriasis . RESULTS Exposure-adjusted rates of adverse events , serious adverse events , infections , and serious infections were similar for placebo and etanercept treatments . Nonneutralizing antibodies to etanercept , observed in 18.3 % of patients , had no apparent effect on safety or efficacy . Patients responded within 2 weeks to etanercept , with statistically significant differences in the Psoriasis Area and Severity Index and Dermatology Life Quality Index between the etanercept and placebo groups at week 12 . At week 24 , after 12 weeks of open-label etanercept treatment , patients in the original placebo group had clinical benefits comparable to those of patients in the original etanercept group . As both groups progressed through the open-label period , the Psoriasis Area and Severity Index response peaked at week 48 . At week 96 , 51.6 % of the original placebo-treated patients and 51.1 % of the original etanercept-treated patients had improvements from baseline in the Psoriasis Area and Severity Index of at least 75 % . CONCLUSIONS Extended exposure to 50 mg of etanercept twice weekly result ed in exposure-adjusted rates of adverse events and infections similar to those in patients receiving placebo . Improvements in physician- and patient-reported measures of psoriasis severity were observed for up to 96 weeks of continuous etanercept therapy . Trial Registration clinical trials.gov Identifier NCT00111449 Objective Evaluate ustekinumab , an anti-interleukin (IL)-12 and IL-23 antibody , effects on radiographic progression in psoriatic arthritis ( PsA ) . Methods We conducted preplanned integrated analyses of combined radiographic data from PSUMMIT-1 and PSUMMIT-2 phase 3 , r and omised , controlled trials . Patients had active PsA despite prior conventional and /or biologic disease-modifying antirheumatic drugs ( ≥5/66 swollen , ≥5/68 tender joints , C-reactive protein ≥3.0 mg/L , documented plaque psoriasis ) . Patients ( PSUMMIT-1 , n=615 ; PSUMMIT-2 , n=312 ) were r and omised  to ustekinumab 45 mg , 90 mg , or placebo , at weeks ( wk ) 0 , 4 and every ( q ) 12 wks . At wk 16 , patients with < 5 % improvement in tender/swollen joint counts entered blinded early escape . All other placebo patients received ustekinumab 45 mg at wk 24 and wk 28 , then q 12 wks . Radiographs of h and s/feet at wks 0/24/52 were assessed using PsA-modified van der Heijde-Sharp ( vdH-S ) scores ; combined PSUMMIT-1 and PSUMMIT-2 changes in total vdH-S scores from wk 0 to wk 24 comprised the prespecified primary radiographic analysis . Treatment effects were assessed using analysis of variance on van der Waerden normal scores ( factors = treatment , baseline methotrexate usage , and study ) . Results Integrated data analysis results indicated that ustekinumab-treated patients ( regardless of dose ) demonstrated significantly less radiographic progression at wk 24 than did placebo recipients ( wk 0–24 total vdH-S score mean changes : 0.4-combined/individual ustekinumab dose groups , 1.0-placebo ; all p<0.02 ) . From wk 24 to wk 52 , inhibition of radiographic progression was maintained for ustekinumab-treated patients , and progression was substantially reduced among initial placebo recipients who started ustekinumab at wk 16 or wk 24 ( wk 24 – wk 52 , total vdH-S score mean change : 0.08 ) . Conclusions Ustekinumab 45 and 90 mg treatments significantly inhibited radiographic progression of joint damage in patients with active BACKGROUND Previous studies of infliximab in psoriasis have demonstrated rapid improvement with induction therapy and sustained response with regularly administered maintenance therapy . OBJECTIVE The efficacy and safety of continuous ( every-8-week ) and intermittent ( as-needed ) maintenance regimens were compared . METHODS Patients with moderate-to-severe psoriasis ( n = 835 ) were r and omized to induction therapy ( weeks 0 , 2 , and 6 ) with infliximab 3 mg/kg or 5 mg/kg or placebo . Infliximab-treated patients were r and omized again at week 14 to continuous or intermittent maintenance regimens at their induction dose . RESULTS At week 10 , 75.5 % and 70.3 % of patients in the infliximab 5 mg/kg and 3 mg/kg groups , respectively , achieved PASI 75 ; 45.2 % and 37.1 % achieved PASI 90 ( vs 1.9 % [ PASI 75 ] and 0.5 % [ PASI 90 ] for placebo ; P < .001 ) . Through week 50 , PASI responses were better maintained with continuous compared with intermittent therapy within each dose , and with 5 mg/kg compared with 3 mg/kg continuous therapy . LIMITATIONS Longer term ( > 1 year ) maintenance therapy and further study of  infliximab serum concentrations over this period , in both PASI 75 responders and non-responders , would be preferable . CONCLUSIONS Through week 50 , response was best maintained with continuous infliximab therapy . Infliximab was generally well-tolerated in most patients OBJECTIVES To study the clinical spectrum of psoriasis and the incidence in the general population and to identify risk factors associated with the occurrence of psoriasis . DESIGN Prospect i ve cohort study with nested case-control analysis . SETTING The data source was the United Kingdom General Practice Research Data base containing computerized clinical information entered by general practitioners ( GPs ) . PATIENTS The study population comprised patients receiving a first-ever diagnosis of psoriasis between January 1 , 1996 , and December 31 , 1997 , and free of cancer . INTERVENTIONS Diagnosis of psoriasis was vali date d in a r and om sample of 14 % of all ascertained cases requesting confirmation by the GPs . Nested case-control analysis included 3994 cases of psoriasis and a r and om sample of 10 000 controls frequency matched to cases by age , sex , and calendar year . MAIN OUTCOME MEASURES Incidence rate of psoriasis and estimates of the odds ratio ( OR ) and 95 % confidence interval ( CI ) for psoriasis as associated with selected risk factors . RESULTS The incidence rate of psoriasis was 14 per 10 000 person-years . Patients with antecedents of skin disorders and skin infection within the last year carried the highest risk of developing psoriasis ( OR , 3.6 [ 95 % CI , 3.2 - 4.1 ] , and OR , 2.1 [ 95 % CI , 1.8 - 2.4 ] , respectively ) . Also , smoking was found to be an independent risk factors for psoriasis ( OR , 1.4 [ 95 % CI , 1.3 - 1.6 ] ) . We did not find an association between risk of psoriasis and antecedents of stress , diabetes , hypertension , hyperlipidemia , cardiovascular disease , or rheumatoid arthritis . CONCLUSIONS The incidence rate in our study was higher than those published in other studies , probably owing to our case definition that considered cases recorded by the GPs independently of a specialist confirmation . Our results confirm the association between psoriasis , skin disorders , and smoking 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 In two previous phase 3 studies , up to 60 weeks of etanercept therapy significantly improved the symptoms of psoriasis and was well tolerated . OBJECTIVE To evaluate the long-term safety of etanercept in an open-label extension study for up to 72 weeks in patients with moderate-to-severe plaque psoriasis . METHODS A total of 912 patients received 50 mg subcutaneous etanercept once weekly ( OW ) for the first 12 weeks of this extension study . Thereafter , eligible patients could maintain the 50 mg QW dose ( n = 321 ) or escalate to 50 mg twice weekly ( BIW ; n = 591 ) anytime thereafter based on one of three predetermined criteria . RESULTS Etanercept was well tolerated during 1056 patient-years of exposure ; no difference was observed between the 50 mg QW and 50 mg BIW dosages in rates of adverse events and infections . Improvement in skin disease was maintained throughout the study . Patients who stopped and then restarted etanercept also showed improvement in psoriasis . CONCLUSION Psoriatic patients continued to benefit from open-label etanercept treatment , both continuous and interrupted therapy , which was generally well tolerated after a combined 2.5 years of experience Objective . To assess longer-term outcomes , including enthesitis and dactylitis , in patients with active psoriatic arthritis ( PsA ) , in a study of golimumab treatment . Methods . Adult patients with active PsA were r and omized 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 . All patients received golimumab 50 mg or 100 mg from Week 24 onward . Entheses tenderness was scored in 15 body sites using the PsA-modified Maastricht Ankylosing Spondylitis Enthesitis Score ( MASES ) . Dactylitis was assessed in 20 digits of the h and s and feet . Results . Among the 405 r and omized patients , 77 % presented with enthesitis and 34 % dactylitis at baseline . At Week 24 of the placebo-controlled study phase , significant differences were observed between golimumab 50 mg and /or 100 mg and placebo for mean percent improvement in the PsA-modified MASES [ 46 % ( p < 0.001 ) and 52 % ( p < 0.00 
    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 evaluate the safety and efficacy of long-term treatment of psoriasis with etanercept , 50 mg twice weekly . DESIGN , SETTING , AND PATIENTS A phase 3 , r and omized , double-blind trial with an open-label extension . A total of 618 adult patients with moderate to severe plaque psoriasis were studied at 39 medical centers in the United States and Canada from May 23 , 2003 , through June 22 , 2005 . INTERVENTIONS Patients were r and omized to receive  placebo or etanercept for 12 weeks . Beginning with week 13 , all patients ( N=591 ) received etanercept . MAIN OUTCOME MEASURES Exposure-adjusted adverse event rates were calculated . Efficacy measures included efficacy and patient global assessment of psoriasis . RESULTS Exposure-adjusted rates of adverse events , serious adverse events , infections , and serious infections were similar for placebo and etanercept treatments . Nonneutralizing antibodies to etanercept , observed in 18.3 % of patients , had no apparent effect on safety or efficacy . Patients responded within 2 weeks to etanercept , with statistically significant differences in the Psoriasis Area and Severity Index and Dermatology Life Quality Index between the etanercept and placebo groups at week 12 . At week 24 , after 12 weeks of open-label etanercept treatment , patients in the original placebo group had clinical benefits comparable to those of patients in the original etanercept group . As both groups progressed through the open-label period , the Psoriasis Area and Severity Index response peaked at week 48 . At week 96 , 51.6 % of the original placebo-treated patients and 51.1 % of the original etanercept-treated patients had improvements from baseline in the Psoriasis Area and Severity Index of at least 75 % . CONCLUSIONS Extended exposure to 50 mg of etanercept twice weekly result ed in exposure-adjusted rates of adverse events and infections similar to those in patients receiving placebo . Improvements in physician- and patient-reported measures of psoriasis severity were observed for up to 96 weeks of continuous etanercept therapy . Trial Registration clinical trials.gov Identifier NCT00111449 Objective Evaluate ustekinumab , an anti-interleukin (IL)-12 and IL-23 antibody , effects on radiographic progression in psoriatic arthritis ( PsA ) . Methods We conducted preplanned integrated analyses of combined radiographic data from PSUMMIT-1 and PSUMMIT-2 phase 3 , r and omised , controlled trials . Patients had active PsA despite prior conventional and /or biologic disease-modifying antirheumatic drugs ( ≥5/66 swollen , ≥5/68 tender joints , C-reactive protein ≥3.0 mg/L , documented plaque psoriasis ) . Patients ( PSUMMIT-1 , n=615 ; PSUMMIT-2 , n=312 ) were r and omised  to ustekinumab 45 mg , 90 mg , or placebo , at weeks ( wk ) 0 , 4 and every ( q ) 12 wks . At wk 16 , patients with < 5 % improvement in tender/swollen joint counts entered blinded early escape . All other placebo patients received ustekinumab 45 mg at wk 24 and wk 28 , then q 12 wks . Radiographs of h and s/feet at wks 0/24/52 were assessed using PsA-modified van der Heijde-Sharp ( vdH-S ) scores ; combined PSUMMIT-1 and PSUMMIT-2 changes in total vdH-S scores from wk 0 to wk 24 comprised the prespecified primary radiographic analysis . Treatment effects were assessed using analysis of variance on van der Waerden normal scores ( factors = treatment , baseline methotrexate usage , and study ) . Results Integrated data analysis results indicated that ustekinumab-treated patients ( regardless of dose ) demonstrated significantly less radiographic progression at wk 24 than did placebo recipients ( wk 0–24 total vdH-S score mean changes : 0.4-combined/individual ustekinumab dose groups , 1.0-placebo ; all p<0.02 ) . From wk 24 to wk 52 , inhibition of radiographic progression was maintained for ustekinumab-treated patients , and progression was substantially reduced among initial placebo recipients who started ustekinumab at wk 16 or wk 24 ( wk 24 – wk 52 , total vdH-S score mean change : 0.08 ) . Conclusions Ustekinumab 45 and 90 mg treatments significantly inhibited radiographic progression of joint damage in patients with active BACKGROUND Previous studies of infliximab in psoriasis have demonstrated rapid improvement with induction therapy and sustained response with regularly administered maintenance therapy . OBJECTIVE The efficacy and safety of continuous ( every-8-week ) and intermittent ( as-needed ) maintenance regimens were compared . METHODS Patients with moderate-to-severe psoriasis ( n = 835 ) were r and omized to induction therapy ( weeks 0 , 2 , and 6 ) with infliximab 3 mg/kg or 5 mg/kg or placebo . Infliximab-treated patients were r and omized again at week 14 to continuous or intermittent maintenance regimens at their induction dose . RESULTS At week 10 , 75.5 % and 70.3 % of patients in the infliximab 5 mg/kg and 3 mg/kg groups , respectively , achieved PASI 75 ; 45.2 % and 37.1 % achieved PASI 90 ( vs 1.9 % [ PASI 75 ] and 0.5 % [ PASI 90 ] for placebo ; P < .001 ) . Through week 50 , PASI responses were better maintained with continuous compared with intermittent therapy within each dose , and with 5 mg/kg compared with 3 mg/kg continuous therapy . LIMITATIONS Longer term ( > 1 year ) maintenance therapy and further study of  infliximab serum concentrations over this period , in both PASI 75 responders and non-responders , would be preferable . CONCLUSIONS Through week 50 , response was best maintained with continuous infliximab therapy . Infliximab was generally well-tolerated in most patients OBJECTIVES To study the clinical spectrum of psoriasis and the incidence in the general population and to identify risk factors associated with the occurrence of psoriasis . DESIGN Prospect i ve cohort study with nested case-control analysis . SETTING The data source was the United Kingdom General Practice Research Data base containing computerized clinical information entered by general practitioners ( GPs ) . PATIENTS The study population comprised patients receiving a first-ever diagnosis of psoriasis between January 1 , 1996 , and December 31 , 1997 , and free of cancer . INTERVENTIONS Diagnosis of psoriasis was vali date d in a r and om sample of 14 % of all ascertained cases requesting confirmation by the GPs . Nested case-control analysis included 3994 cases of psoriasis and a r and om sample of 10 000 controls frequency matched to cases by age , sex , and calendar year . MAIN OUTCOME MEASURES Incidence rate of psoriasis and estimates of the odds ratio ( OR ) and 95 % confidence interval ( CI ) for psoriasis as associated with selected risk factors . RESULTS The incidence rate of psoriasis was 14 per 10 000 person-years . Patients with antecedents of skin disorders and skin infection within the last year carried the highest risk of developing psoriasis ( OR , 3.6 [ 95 % CI , 3.2 - 4.1 ] , and OR , 2.1 [ 95 % CI , 1.8 - 2.4 ] , respectively ) . Also , smoking was found to be an independent risk factors for psoriasis ( OR , 1.4 [ 95 % CI , 1.3 - 1.6 ] ) . We did not find an association between risk of psoriasis and antecedents of stress , diabetes , hypertension , hyperlipidemia , cardiovascular disease , or rheumatoid arthritis . CONCLUSIONS The incidence rate in our study was higher than those published in other studies , probably owing to our case definition that considered cases recorded by the GPs independently of a specialist confirmation . Our results confirm the association between psoriasis , skin disorders , and smoking 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 In two previous phase 3 studies , up to 60 weeks of etanercept therapy significantly improved the symptoms of psoriasis and was well tolerated . OBJECTIVE To evaluate the long-term safety of etanercept in an open-label extension study for up to 72 weeks in patients with moderate-to-severe plaque psoriasis . METHODS A total of 912 patients received 50 mg subcutaneous etanercept once weekly ( OW ) for the first 12 weeks of this extension study . Thereafter , eligible patients could maintain the 50 mg QW dose ( n = 321 ) or escalate to 50 mg twice weekly ( BIW ; n = 591 ) anytime thereafter based on one of three predetermined criteria . RESULTS Etanercept was well tolerated during 1056 patient-years of exposure ; no difference was observed between the 50 mg QW and 50 mg BIW dosages in rates of adverse events and infections . Improvement in skin disease was maintained throughout the study . Patients who stopped and then restarted etanercept also showed improvement in psoriasis . CONCLUSION Psoriatic patients continued to benefit from open-label etanercept treatment , both continuous and interrupted therapy , which was generally well tolerated after a combined 2.5 years of experience Objective . To assess longer-term outcomes , including enthesitis and dactylitis , in patients with active psoriatic arthritis ( PsA ) , in a study of golimumab treatment . Methods . Adult patients with active PsA were r and omized 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 . All patients received golimumab 50 mg or 100 mg from Week 24 onward . Entheses tenderness was scored in 15 body sites using the PsA-modified Maastricht Ankylosing Spondylitis Enthesitis Score ( MASES ) . Dactylitis was assessed in 20 digits of the h and s and feet . Results . Among the 405 r and omized patients , 77 % presented with enthesitis and 34 % dactylitis at baseline . At Week 24 of the placebo-controlled study phase , significant differences were observed between golimumab 50 mg and /or 100 mg and placebo for mean percent improvement in the PsA-modified MASES [ 46 % ( p < 0.001 ) and 52 % ( p < 0.00 
    Output:
    