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: To evaluate the efficacy and safety of adalimumab in patients with active nonpsoriatic peripheral spondyloarthritis ( SpA ) Objective The aim of this study was to assess the efficacy and safety of adalimumab ( ADA ) , a recombinant human monoclonal antibody against tumour necrosis factor α ( TNF ) , for the induction of clinical remission in anti-TNF naïve patients with moderately to severely active ulcerative colitis . Methods This 8-week , multicentre , r and omised , double-blind , placebo-controlled study ( NCT00385736 ) , conducted at 94 centres in North America and Europe , enrolled ambulatory adult patients with Mayo score of ≥6 points and endoscopic subscore of ≥2 points despite treatment with corticosteroids and /or immunosuppressants . Under the original study protocol , 186 patients were r and omised ( 1:1 ) to subcutaneous treatment with ADA160/80 ( 160 mg at week 0 , 80 mg at week 2 , 40 mg at weeks 4 and 6 ) or placebo . Subsequently , at the request of European regulatory authorities , the protocol was amended to include a second induction group ( ADA80/40 : 80 mg at week 0 , 40 mg at weeks 2 , 4 and 6 ) . The primary efficacy endpoint was clinical remission ( Mayo score ≤2 with no individual subscore > 1 ) at week 8 , assessed in 390 patients r and omised ( 1:1:1 ) to ADA160/80 , ADA80/40 , or placebo . Safety was assessed in all enrolled patients . Patients , study site personnel , investigators , and the sponsor were blinded to treatment assignment . Results At week 8 , 18.5 % of patients in the ADA160/80 group ( p=0.031 vs placebo ) and 10.0 % in the ADA80/40 group ( p=0.833 vs placebo ) were in remission , compared with 9.2 % in the placebo group . Serious adverse events occurred in 7.6 % , 3.8 % and 4.0 % of patients in the placebo , ADA80/40 , and ADA160/80 groups , respectively . There were two malignancies in the placebo group , none in the ADA groups . There were no cases of tuberculosis and no deaths . Conclusions ADA160/80 was safe and effective for induction of clinical remission in patients with moderately to severely active ulcerative colitis failing treatment with corticosteroids and /or immunosuppressants . Clinical trial NCT00385736 Background Observational studies in daily practice are an essential complement to pivotal r and omised controlled trials because their findings refer to larger and more diverse patient population s with common comorbidities , complex medical history , concomitant medications and longer follow‐up periods . Objectives To evaluate long‐term clinical outcomes of the anti‐TNF‐α monoclonal antibody , adalimumab , in patients with psoriasis ( PsO ) or psoriatic arthritis ( PsA ) referring to an Italian dermatological centre . Methods Single‐centre retrospective real‐world investigation with an observation period of up to 9 years . Results We review ed the records of 316 patients ( 117 with PsO and 199 with PsA ) treated with adalimumab and followed for up to 9 years . Safety and efficacy of adalimumab were consistent with those described in r and omised controlled trials ( RCTs ) and other observational studies . A rapid and sustained improvement of skin lesions ( evaluated as Psoriasis Area and Severity Index ( PASI ) 75 , PASI 90 and PASI 100 response rates ) was observed in the majority of patients , including those with body mass index ( BMI ) > 30 and with prior experience of biologic therapies ( including other anti‐TNFs ) . The safety profile  of adalimumab was confirmed also in elderly patients ( > 65 years ) . Conclusion Our real‐life experience shows that the long‐term treatment with adalimumab is effective and well tolerated in psoriatic patients , including overweight/obese , elderly and anti‐TNF‐experienced subjects Objective . To examine the clinical and ultrasonographic ( US ) outcomes of reducing methotrexate ( MTX ) dosage upon initiating adalimumab ( ADA ) in MTX-inadequate responders with moderately to severely active rheumatoid arthritis ( RA ) . Methods . MUSICA ( NCT01185288 ) was a double-blind , r and omized , parallel-arm study of 309 patients with RA receiving MTX ≥ 15 mg/week for ≥ 12 weeks before screening . Patients were r and omized to high dosage  (  20 mg/week ) or low dosage ( 7.5 mg/week ) MTX ; all patients received 40 mg open-label ADA every other week for 24 weeks . The primary endpoint was Week 24 mean 28-joint Disease Activity Score based on C-reactive protein ( DAS28-CRP ) to test for noninferiority of low-dosage MTX using a 15 % margin . US images were scored using a 10-joint semiquantitative system incorporating OMERACT definitions for pathology , assessing synovial hypertrophy , vascularity , and bony erosions . Results . Rapid improvement in clinical indices was observed in both groups after addition of ADA . The difference in mean DAS28-CRP ( 0.37 , 95 % CI 0.07–0.66 ) comparing low-dosage ( 4.12 , 95 % CI 3.88–4.34 ) versus high-dosage MTX ( 3.75 , 95 % CI 3.52–3.97 ) was statistically significant and non-inferiority was not met . Statistically significant differences were not detected for most clinical , functional , and US outcomes . Pharmacokinetic and safety profiles were similar . Conclusion . In MUSICA , Week 24 mean DAS28-CRP , the primary endpoint , did not meet non-inferiority for the low-dosage MTX group . Although the differences between the 2 MTX dosage groups were small , our study findings did not support routine MTX reduction in MTX inadequate responders initiating ADA Background Infliximab ( IFX ) is one of the treatments of choice for corticosteroid-refractory and corticosteroid-dependent ulcerative colitis ( UC ) . A high serum trough level of  IFX ( TL ) is reported to be associated with sustained efficacy during maintenance treatment . As part of a phase 3 r and omized controlled trial of IFX in UC , we assessed the predictive value of the first TL at week 2 for short- and long-term response . Methods Patients received intravenous IFX 5 mg/kg or placebo at weeks 0 , 2 , and 6 . Patients with evidence of a response by week 8 continued treatment at weeks 14 and 22 .  TL was measured by enzyme-linked immunosorbent assay . Post hoc analysis was then performed for TL and clinical outcomes . Results Clinical response rate at week 8 , the primary end point , was significantly higher in the IFX group than placebo ( p = 0.005 ) . The incidence of adverse events between groups was similar . Week 2 TL was significantly associated with a 14-week clinical activity index ( CAI ) remission . In multiple logistic regression analysis , the week 2 TL-to-CAI ratio ( TL/CAI , odds ratio 8.07 ; 95 % confidence interval 2.84–27.07 , p < 0.001 ) was an independent factor correlating with 14-week CAI remission . The week 2 TL and TL/CAI were also significantly associated with 30-week mucosal healing . Conclusions IFX was confirmed to be effective and safe in this population . Our results suggest that the first TL at week 2 , in combination with clinical evaluation , is useful for predicting both short- and long-term outcomes , allowing an earlier decision between continuing IFX or switching to other options We prospect ively evaluated whether obesity impacts achievement of minimal disease activity ( MDA ) in subjects with psoriatic arthritis ( PsA ) Abstract Background This phase 3 trial is the first to evaluate the efficacy and safety of treatment with the systemic TNF‐α inhibitor , adalimumab , for Chinese patients with moderate‐to‐severe plaque psoriasis . Methods In the 12‐week , double‐blind , placebo‐controlled Period A , patients were r and omized 4 : 1 to receive adalimumab 40 mg every‐other‐week ( following a single 80 mg dose ) , or placebo every‐other‐week . In the subsequent 12‐week , open‐label , Period B , all patients received adalimumab 40 mg every‐other‐week starting at week 13 , following a single , blinded dose at week 12 of adalimumab 80 mg or matching placebo ( for patients receiving placebo or adalimumab in Period A respectively ) . In Period A , efficacy was analysed for all r and omized patients and safety for all patients receiving ≥1 dose of the study drug . Results For the 425 patients in this study ( 87 placebo ; 338 adalimumab ) , a higher percentage r and omized to adalimumab achieved the primary endpoint of ≥75 % improvement from baseline in PASI score ( PASI 75 ) at week 12 : placebo 11.5 % ( 10/87 ) ; adalimumab 77.8 % ( 263/338 ; P < 0.001 ) . Physician 's Global Assessment of clear to minimal was achieved at week 12 by 14.9 % placebo ( 13/87 ) and 80.5 % adalimumab ( 272/338 ; P < 0.001 ) . For patients who received adalimumab at any time during the study ( All‐adalimumab Population ) , treatment‐emergent adverse events ( AEs ) were reported by 63.4 % ; the most common was upper respiratory infection ( 16.1 % ) . Serious AEs were reported by 3.5 % of the All‐adalimumab Population , and serious infectious AEs by 1.2 % , which include lung infection , pneumonia and tuberculosis [ 2 ( 0.5 % ) patients each ] . There was one death ( chronic heart failure ) . Conclusion In these Chinese patients with moderate‐to‐severe psoriasis , a significantly greater percentage treated with adalimumab compared with placebo achieved efficacy endpoints at week 12 and efficacy was sustained to week 24 . Safety results were consistent with the known adalimumab safety profile ; no new safety signals were identified in the 24 weeks of treatment Introduction The aim of this study was to investigate patient reported outcomes ( PROs ) of functional ability and health related quality of life ( HRQoL ) in patients with early ( rheumatoid ) arthritis during one year of remission steered treatment . Methods In this study , 610 patients with early rheumatoid arthritis ( RA ) or undifferentiated arthritis ( UA ) were treated with methotrexate ( MTX ) and tapered high dose of prednisone .  Patients in early remission ( Disease Activity Score ( DAS ) < 1.6 after 4 months ) tapered prednisone to zero and when in persistent remission , also tapered MTX . Patients not in early remission were r and omized to either MTX + hydroxychloroquine + sulphasalazine + prednisone ( arm 1 ) or to MTX + adalimumab ( arm 2 ) . Every 4 months , patients filled out the Health Assessment Question naire ( HAQ ) and the McMaster Toronto Arthritis Patient Preference Question naire ( MACTAR ) , the Short Form 36 ( SF-36 ) and visual analogue scales ( VAS ) . Change scores were compared between treatment groups . The association with achieving remission was analyzed using linear mixed models . Results During year 1 , patients who achieved early remission had the most improvement in PROs with scores comparable to the general population . Patients in the r and omization arms showed less improvement . Scores were comparable between the arms . There was a significant association between achieving remission and scores of HAQ , MACTAR and physical HRQoL. Conclusions In early arthritis , PROs of functional ability and HRQoL after one year of remission steered treatment reach normal values in patients who achieved early remission . In patients not in early remission , who were r and omized to two strategy arms , PROs improved less , with similar scores in both treatment arms . Trial registration sIS RCT N11916566 and EudraCT2006 - 006186 - OBJECTIVE Adipose tissue has immunomodulating effects in rheumatoid arthritis ( RA ) , although the exact role is , at present , unclear . The purpose of this study was to determine whether body mass index ( BMI ) affects response to  infliximab  in RA patients investigated prospect ively . METHODS In 89 patients with active RA , the BMI was calculated before initiation of infliximab treatment  ( 3 mg/kg intravenously ) . After 16 weeks of treatment , changes in disease activity were assessed with the Disease Activity Score in 28 joints ( DAS28 ) . RESULTS The mean ± SD BMI was 26 ± 5 kg/m(2 ) ( range 17 - 42 ) . The BMI correlated positively with the DAS28 at baseline ( r = 0.34 , P = 0.001 ) . 
    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: To evaluate the efficacy and safety of adalimumab in patients with active nonpsoriatic peripheral spondyloarthritis ( SpA ) Objective The aim of this study was to assess the efficacy and safety of adalimumab ( ADA ) , a recombinant human monoclonal antibody against tumour necrosis factor α ( TNF ) , for the induction of clinical remission in anti-TNF naïve patients with moderately to severely active ulcerative colitis . Methods This 8-week , multicentre , r and omised , double-blind , placebo-controlled study ( NCT00385736 ) , conducted at 94 centres in North America and Europe , enrolled ambulatory adult patients with Mayo score of ≥6 points and endoscopic subscore of ≥2 points despite treatment with corticosteroids and /or immunosuppressants . Under the original study protocol , 186 patients were r and omised ( 1:1 ) to subcutaneous treatment with ADA160/80 ( 160 mg at week 0 , 80 mg at week 2 , 40 mg at weeks 4 and 6 ) or placebo . Subsequently , at the request of European regulatory authorities , the protocol was amended to include a second induction group ( ADA80/40 : 80 mg at week 0 , 40 mg at weeks 2 , 4 and 6 ) . The primary efficacy endpoint was clinical remission ( Mayo score ≤2 with no individual subscore > 1 ) at week 8 , assessed in 390 patients r and omised ( 1:1:1 ) to ADA160/80 , ADA80/40 , or placebo . Safety was assessed in all enrolled patients . Patients , study site personnel , investigators , and the sponsor were blinded to treatment assignment . Results At week 8 , 18.5 % of patients in the ADA160/80 group ( p=0.031 vs placebo ) and 10.0 % in the ADA80/40 group ( p=0.833 vs placebo ) were in remission , compared with 9.2 % in the placebo group . Serious adverse events occurred in 7.6 % , 3.8 % and 4.0 % of patients in the placebo , ADA80/40 , and ADA160/80 groups , respectively . There were two malignancies in the placebo group , none in the ADA groups . There were no cases of tuberculosis and no deaths . Conclusions ADA160/80 was safe and effective for induction of clinical remission in patients with moderately to severely active ulcerative colitis failing treatment with corticosteroids and /or immunosuppressants . Clinical trial NCT00385736 Background Observational studies in daily practice are an essential complement to pivotal r and omised controlled trials because their findings refer to larger and more diverse patient population s with common comorbidities , complex medical history , concomitant medications and longer follow‐up periods . Objectives To evaluate long‐term clinical outcomes of the anti‐TNF‐α monoclonal antibody , adalimumab , in patients with psoriasis ( PsO ) or psoriatic arthritis ( PsA ) referring to an Italian dermatological centre . Methods Single‐centre retrospective real‐world investigation with an observation period of up to 9 years . Results We review ed the records of 316 patients ( 117 with PsO and 199 with PsA ) treated with adalimumab and followed for up to 9 years . Safety and efficacy of adalimumab were consistent with those described in r and omised controlled trials ( RCTs ) and other observational studies . A rapid and sustained improvement of skin lesions ( evaluated as Psoriasis Area and Severity Index ( PASI ) 75 , PASI 90 and PASI 100 response rates ) was observed in the majority of patients , including those with body mass index ( BMI ) > 30 and with prior experience of biologic therapies ( including other anti‐TNFs ) . The safety profile  of adalimumab was confirmed also in elderly patients ( > 65 years ) . Conclusion Our real‐life experience shows that the long‐term treatment with adalimumab is effective and well tolerated in psoriatic patients , including overweight/obese , elderly and anti‐TNF‐experienced subjects Objective . To examine the clinical and ultrasonographic ( US ) outcomes of reducing methotrexate ( MTX ) dosage upon initiating adalimumab ( ADA ) in MTX-inadequate responders with moderately to severely active rheumatoid arthritis ( RA ) . Methods . MUSICA ( NCT01185288 ) was a double-blind , r and omized , parallel-arm study of 309 patients with RA receiving MTX ≥ 15 mg/week for ≥ 12 weeks before screening . Patients were r and omized to high dosage  (  20 mg/week ) or low dosage ( 7.5 mg/week ) MTX ; all patients received 40 mg open-label ADA every other week for 24 weeks . The primary endpoint was Week 24 mean 28-joint Disease Activity Score based on C-reactive protein ( DAS28-CRP ) to test for noninferiority of low-dosage MTX using a 15 % margin . US images were scored using a 10-joint semiquantitative system incorporating OMERACT definitions for pathology , assessing synovial hypertrophy , vascularity , and bony erosions . Results . Rapid improvement in clinical indices was observed in both groups after addition of ADA . The difference in mean DAS28-CRP ( 0.37 , 95 % CI 0.07–0.66 ) comparing low-dosage ( 4.12 , 95 % CI 3.88–4.34 ) versus high-dosage MTX ( 3.75 , 95 % CI 3.52–3.97 ) was statistically significant and non-inferiority was not met . Statistically significant differences were not detected for most clinical , functional , and US outcomes . Pharmacokinetic and safety profiles were similar . Conclusion . In MUSICA , Week 24 mean DAS28-CRP , the primary endpoint , did not meet non-inferiority for the low-dosage MTX group . Although the differences between the 2 MTX dosage groups were small , our study findings did not support routine MTX reduction in MTX inadequate responders initiating ADA Background Infliximab ( IFX ) is one of the treatments of choice for corticosteroid-refractory and corticosteroid-dependent ulcerative colitis ( UC ) . A high serum trough level of  IFX ( TL ) is reported to be associated with sustained efficacy during maintenance treatment . As part of a phase 3 r and omized controlled trial of IFX in UC , we assessed the predictive value of the first TL at week 2 for short- and long-term response . Methods Patients received intravenous IFX 5 mg/kg or placebo at weeks 0 , 2 , and 6 . Patients with evidence of a response by week 8 continued treatment at weeks 14 and 22 .  TL was measured by enzyme-linked immunosorbent assay . Post hoc analysis was then performed for TL and clinical outcomes . Results Clinical response rate at week 8 , the primary end point , was significantly higher in the IFX group than placebo ( p = 0.005 ) . The incidence of adverse events between groups was similar . Week 2 TL was significantly associated with a 14-week clinical activity index ( CAI ) remission . In multiple logistic regression analysis , the week 2 TL-to-CAI ratio ( TL/CAI , odds ratio 8.07 ; 95 % confidence interval 2.84–27.07 , p < 0.001 ) was an independent factor correlating with 14-week CAI remission . The week 2 TL and TL/CAI were also significantly associated with 30-week mucosal healing . Conclusions IFX was confirmed to be effective and safe in this population . Our results suggest that the first TL at week 2 , in combination with clinical evaluation , is useful for predicting both short- and long-term outcomes , allowing an earlier decision between continuing IFX or switching to other options We prospect ively evaluated whether obesity impacts achievement of minimal disease activity ( MDA ) in subjects with psoriatic arthritis ( PsA ) Abstract Background This phase 3 trial is the first to evaluate the efficacy and safety of treatment with the systemic TNF‐α inhibitor , adalimumab , for Chinese patients with moderate‐to‐severe plaque psoriasis . Methods In the 12‐week , double‐blind , placebo‐controlled Period A , patients were r and omized 4 : 1 to receive adalimumab 40 mg every‐other‐week ( following a single 80 mg dose ) , or placebo every‐other‐week . In the subsequent 12‐week , open‐label , Period B , all patients received adalimumab 40 mg every‐other‐week starting at week 13 , following a single , blinded dose at week 12 of adalimumab 80 mg or matching placebo ( for patients receiving placebo or adalimumab in Period A respectively ) . In Period A , efficacy was analysed for all r and omized patients and safety for all patients receiving ≥1 dose of the study drug . Results For the 425 patients in this study ( 87 placebo ; 338 adalimumab ) , a higher percentage r and omized to adalimumab achieved the primary endpoint of ≥75 % improvement from baseline in PASI score ( PASI 75 ) at week 12 : placebo 11.5 % ( 10/87 ) ; adalimumab 77.8 % ( 263/338 ; P < 0.001 ) . Physician 's Global Assessment of clear to minimal was achieved at week 12 by 14.9 % placebo ( 13/87 ) and 80.5 % adalimumab ( 272/338 ; P < 0.001 ) . For patients who received adalimumab at any time during the study ( All‐adalimumab Population ) , treatment‐emergent adverse events ( AEs ) were reported by 63.4 % ; the most common was upper respiratory infection ( 16.1 % ) . Serious AEs were reported by 3.5 % of the All‐adalimumab Population , and serious infectious AEs by 1.2 % , which include lung infection , pneumonia and tuberculosis [ 2 ( 0.5 % ) patients each ] . There was one death ( chronic heart failure ) . Conclusion In these Chinese patients with moderate‐to‐severe psoriasis , a significantly greater percentage treated with adalimumab compared with placebo achieved efficacy endpoints at week 12 and efficacy was sustained to week 24 . Safety results were consistent with the known adalimumab safety profile ; no new safety signals were identified in the 24 weeks of treatment Introduction The aim of this study was to investigate patient reported outcomes ( PROs ) of functional ability and health related quality of life ( HRQoL ) in patients with early ( rheumatoid ) arthritis during one year of remission steered treatment . Methods In this study , 610 patients with early rheumatoid arthritis ( RA ) or undifferentiated arthritis ( UA ) were treated with methotrexate ( MTX ) and tapered high dose of prednisone .  Patients in early remission ( Disease Activity Score ( DAS ) < 1.6 after 4 months ) tapered prednisone to zero and when in persistent remission , also tapered MTX . Patients not in early remission were r and omized to either MTX + hydroxychloroquine + sulphasalazine + prednisone ( arm 1 ) or to MTX + adalimumab ( arm 2 ) . Every 4 months , patients filled out the Health Assessment Question naire ( HAQ ) and the McMaster Toronto Arthritis Patient Preference Question naire ( MACTAR ) , the Short Form 36 ( SF-36 ) and visual analogue scales ( VAS ) . Change scores were compared between treatment groups . The association with achieving remission was analyzed using linear mixed models . Results During year 1 , patients who achieved early remission had the most improvement in PROs with scores comparable to the general population . Patients in the r and omization arms showed less improvement . Scores were comparable between the arms . There was a significant association between achieving remission and scores of HAQ , MACTAR and physical HRQoL. Conclusions In early arthritis , PROs of functional ability and HRQoL after one year of remission steered treatment reach normal values in patients who achieved early remission . In patients not in early remission , who were r and omized to two strategy arms , PROs improved less , with similar scores in both treatment arms . Trial registration sIS RCT N11916566 and EudraCT2006 - 006186 - OBJECTIVE Adipose tissue has immunomodulating effects in rheumatoid arthritis ( RA ) , although the exact role is , at present , unclear . The purpose of this study was to determine whether body mass index ( BMI ) affects response to  infliximab  in RA patients investigated prospect ively . METHODS In 89 patients with active RA , the BMI was calculated before initiation of infliximab treatment  ( 3 mg/kg intravenously ) . After 16 weeks of treatment , changes in disease activity were assessed with the Disease Activity Score in 28 joints ( DAS28 ) . RESULTS The mean ± SD BMI was 26 ± 5 kg/m(2 ) ( range 17 - 42 ) . The BMI correlated positively with the DAS28 at baseline ( r = 0.34 , P = 0.001 ) . 
    Output:
    