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 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 OBJECTIVES : The impact of infliximab induction and maintenance therapy on health-related quality of life ( HRQL ) was evaluated in patients with ulcerative colitis ( UC ) . METHODS : In two placebo-controlled , double-blind studies ( the Active Ulcerative Colitis Trials 1 and 2 [ ACT 1 and 2 ] ) , 728 patients were r and omized to placebo or infliximab 5 mg/kg or 10 mg/kg . Infusions were administered at weeks 0 , 2 , 6 , and every 8 wk thereafter , up to week 22 ( ACT 2 ) or 46 ( ACT 1 ) . Changes in Inflammatory Bowel Disease Question naire ( IBDQ ) and Medical Outcomes Study 36-Item Short Form Health Survey physical and mental component summary ( PCS and MCS , respectively ) scores were analyzed . RESULTS : Baseline scores for the pooled patient population indicated substantial impairment in HRQL . Improvement at week 8 in the total IBDQ score was significantly greater in the infliximab 5-mg/kg ( 40 , P < 0.001 ) and 10-mg/kg ( 36 , P < 0.001 ) groups compared with the placebo group ( 28 ) . Improvement at week 8 was also significantly greater in the infliximab 5- and 10-mg/kg groups for the PCS ( 6.8 and 5.9 , respectively ) and MCS ( 5.9 and 6.4 , respectively ) compared with placebo ( PCS = 3.7 , MCS = 3.0 , P < 0.01 for all comparisons ) . Continued benefit was seen at weeks 30 and 54 with infliximab maintenance therapy ( P < 0.001 for all comparisons ) . Improvement in total IBDQ score correlated significantly ( P < 0.001 ) with improvement in both PCS and MCS scores , and Mayo score . CONCLUSIONS : Infliximab therapy substantially improved HRQL  in patients with UC . This benefit was sustained through 1 yr with maintenance infliximab therapy Background : Inflammatory bowel disease ( IBD ) is characterized by a chronic relapsing inflammation of the gastrointestinal tract . Adult IBD patients suffer from a disabling disease which greatly affects health-related quality of life ( HRQoL ) . A worse HRQoL in these patients may result in a defensive and ineffective use of medical attention and thus higher medical costs . Because of its chronic nature , IBD may also cause psychological problems in many patients which may also influence HRQoL and care-seeking behavior . An important factor reducing HRQoL is disease activity . Induction of remission and long-term remission are important goals for improving HRQoL. Furthermore , remission is associated with a decreased need for hospitalization and surgery and increased employment , which in turn improve HRQoL. Treatment strategies available for many years are corticosteroids , 5-aminosalicylates and immunnosuppressants , but these treatments did not show significant long-term improvement on HRQoL. The biologics , which induce rapid and sustained remission , may improve HRQoL. Objective : To review and evaluate the current literature on the effect of biologics on HRQoL of IBD patients . Methods : We performed a MEDLINE search and review ed the effect of different biologics on HRQoL. The following subjects and synonyms of these terms were used : inflammatory bowel disease , Crohn ’s disease , ulcerative colitis , quality of life , health-related quality of life , fatigue , different anti-TNF medication , and biologicals/biologics ( MESH ) . Studies included were limited to English- language , adult population , full-text , r and omized , double-blind , placebo-controlled in which HRQoL was measured . Results : Out of 202 identified articles , 8 r and omized controlled trials ( RCT ) met the inclusion criteria . Two RCTs on infliximab showed significant improvement of HRQoL compared to placebo which was sustained over the long term . One RCT on adalimumab showed a significant and sustained improvement of HRQoL compared to placebo . This study showed also significant decrease of fatigue in the adalimumab-treated patients . Three RCTs on certolizumab showed a significant improvement of HRQoL in the intervention group compared to placebo . Two RCTs of natalizumab treatment were found . One study showed significant and sustained improvement compared to placebo , and also scores of HRQoL comparable to that in the general population , but in the other no significant results were found . Conclusion : The biologics infliximab , adalimumab , certolizumab , and natalizumab demonstrated significant improvement of HRQoL of IBD patients compared with placebo . However , we found differences in improvement of HRQoL between the different biologics Background : Vedolizumab , a gut-selective , anti-inflammatory monoclonal antibody , has shown preliminary efficacy in ulcerative colitis ( UC ) and Crohn 's disease ( CD ) . We report long-term experience with vedolizumab for active UC and CD . Methods : After a placebo-controlled study , 38 patients with UC were r and omized to a loading regimen of vedolizumab 2 , 6 , or 10 mg/kg on days 1 , 15 , and 43 , followed by maintenance dosing every 8 weeks . Thirty-four vedolizumab-naive patients ( 15 UC ; 19 CD ) were r and omized to vedolizumab 2 , 6 , or 10 mg/kg on the same schedule . Rollover patients were treated up to 630 days and treatment-naive patients were treated up to 547 days . Results : Seventy-two patients were dosed ; 52 ( 72 % ) completed the study . In exploratory analyses , 28 of 72 ( 39 % ; UC : 21 of 53 , CD : 7 of 19 ) achieved clinical response and 42 of 72 ( 58.3 % ; UC : 38 of 53 , CD : 4 of 19 ) achieved clinical remission . Mean partial Mayo scores declined from baseline through day 155 in both treatment-naive patients with UC ( 5.4 to 1.7 , respectively ) and rollover patients with UC ( 2.3 to 1.4 , respectively ) , leveling off thereafter . Mean Crohn 's Disease Activity Index scores decreased from 295 ( baseline ) to 238 at day 43 , continued to trend downward through day 155 , and remained below baseline through day 491 . Mean Inflammatory Bowel Disease Question naire scores increased in all treatment groups . No deaths or systemic opportunistic infections were reported . Conclusion : Vedolizumab every 8 weeks for up to 78 weeks had an adverse event profile similar to that previously observed . Mean disease activity indices ( partial Mayo score and Crohn 's Disease Activity Index score ) improved with all 3 doses investigated BACKGROUND Infliximab , a chimeric monoclonal antibody directed against tumor necrosis factor alpha , is an established treatment for Crohn 's disease but not ulcerative colitis . METHODS Two r and omized , double-blind , placebo-controlled studies --the Active Ulcerative Colitis Trials 1 and 2 ( ACT 1 and ACT 2 , respectively)--evaluated the efficacy of infliximab for induction and maintenance therapy in adults with ulcerative colitis . In each study , 364 patients with moderate-to-severe active ulcerative colitis despite treatment with concurrent medications received placebo or infliximab  ( 5 mg or 10 mg per kilogram of body weight ) intravenously at weeks 0 , 2 , and 6 and then every eight weeks through week 46 ( in ACT 1 ) or week 22 ( in ACT 2 ) . Patients were followed for 54 weeks in ACT 1 and 30 weeks in ACT 2 . RESULTS In ACT 1 , 69 percent of patients who received 5 mg of infliximab and 61 percent of those who received 10 mg had a clinical response at week 8 , as compared with 37 percent of those who received placebo ( P<0.001 for both comparisons with placebo ) . A response was defined as a decrease in the Mayo score of at least 3 points and at least 30 percent , with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute rectal-bleeding subscore of 0 or 1 . In ACT 2 , 64 percent of patients who received 5 mg of infliximab and 69 percent of those who received 10 mg had a clinical response at week 8 , as compared with 29 percent of those who received placebo ( P<0.001 for both comparisons with placebo ) . In both studies , patients who received infliximab were more likely to have a clinical response at week 30 ( P < or = 0.002 for all comparisons ) . In ACT 1 , more patients who received 5 mg or 10 mg of infliximab had a clinical response at week 54 ( 45 percent and 44 percent , respectively ) than did those who received placebo ( 20 percent , P<0.001 for both comparisons ) . CONCLUSIONS Patients with moderate-to-severe active ulcerative colitis treated with infliximab at weeks 0 , 2 , and 6 and every eight weeks thereafter were more likely to have a clinical response at weeks 8 , 30 , and 54 than were those receiving placebo . ( Clinical Trials.gov numbers , NCT00036439 and NCT00096655 . OBJECTIVE : The aim of this study was to compare the treatment efficacies of subcutaneous interferon-α-2A ( IFN-α-2A ) injections versus prednisolone enemas in active left-sided ulcerative colitis in an open-labeled , r and omized study . METHODS : Sixteen ulcerative colitis patients received IFN-α-2A subcutaneously  ( dosage : first wk , 9 MIU three times weekly [ t.i.w . ] ; second wk , 6 MIU t.i.w . ; wk 3–12 , 3 MIU t.i.w . ) , and 16 received prednisolone enemas for 30 days ( 100 ml once daily , 0.25 mg of prednisolone/ml ) . The Powell-Tuck Index , Inflammatory Bowel Disease Question naire ( IBDQ ) score , and rectal histological activities were assessed before and after treatment . Thirteen patients in the IFN-α-2A group and all 16 in the prednisolone enema group completed the treatment . RESULTS : IFN-α-2A treatment showed significant improvements in the Powell-Tuck Index ( p = 0.0002 ) , IBDQ score ( p = 0.002 ) , and rectal histological activity scores ( p = 0.0 
    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 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 OBJECTIVES : The impact of infliximab induction and maintenance therapy on health-related quality of life ( HRQL ) was evaluated in patients with ulcerative colitis ( UC ) . METHODS : In two placebo-controlled , double-blind studies ( the Active Ulcerative Colitis Trials 1 and 2 [ ACT 1 and 2 ] ) , 728 patients were r and omized to placebo or infliximab 5 mg/kg or 10 mg/kg . Infusions were administered at weeks 0 , 2 , 6 , and every 8 wk thereafter , up to week 22 ( ACT 2 ) or 46 ( ACT 1 ) . Changes in Inflammatory Bowel Disease Question naire ( IBDQ ) and Medical Outcomes Study 36-Item Short Form Health Survey physical and mental component summary ( PCS and MCS , respectively ) scores were analyzed . RESULTS : Baseline scores for the pooled patient population indicated substantial impairment in HRQL . Improvement at week 8 in the total IBDQ score was significantly greater in the infliximab 5-mg/kg ( 40 , P < 0.001 ) and 10-mg/kg ( 36 , P < 0.001 ) groups compared with the placebo group ( 28 ) . Improvement at week 8 was also significantly greater in the infliximab 5- and 10-mg/kg groups for the PCS ( 6.8 and 5.9 , respectively ) and MCS ( 5.9 and 6.4 , respectively ) compared with placebo ( PCS = 3.7 , MCS = 3.0 , P < 0.01 for all comparisons ) . Continued benefit was seen at weeks 30 and 54 with infliximab maintenance therapy ( P < 0.001 for all comparisons ) . Improvement in total IBDQ score correlated significantly ( P < 0.001 ) with improvement in both PCS and MCS scores , and Mayo score . CONCLUSIONS : Infliximab therapy substantially improved HRQL  in patients with UC . This benefit was sustained through 1 yr with maintenance infliximab therapy Background : Inflammatory bowel disease ( IBD ) is characterized by a chronic relapsing inflammation of the gastrointestinal tract . Adult IBD patients suffer from a disabling disease which greatly affects health-related quality of life ( HRQoL ) . A worse HRQoL in these patients may result in a defensive and ineffective use of medical attention and thus higher medical costs . Because of its chronic nature , IBD may also cause psychological problems in many patients which may also influence HRQoL and care-seeking behavior . An important factor reducing HRQoL is disease activity . Induction of remission and long-term remission are important goals for improving HRQoL. Furthermore , remission is associated with a decreased need for hospitalization and surgery and increased employment , which in turn improve HRQoL. Treatment strategies available for many years are corticosteroids , 5-aminosalicylates and immunnosuppressants , but these treatments did not show significant long-term improvement on HRQoL. The biologics , which induce rapid and sustained remission , may improve HRQoL. Objective : To review and evaluate the current literature on the effect of biologics on HRQoL of IBD patients . Methods : We performed a MEDLINE search and review ed the effect of different biologics on HRQoL. The following subjects and synonyms of these terms were used : inflammatory bowel disease , Crohn ’s disease , ulcerative colitis , quality of life , health-related quality of life , fatigue , different anti-TNF medication , and biologicals/biologics ( MESH ) . Studies included were limited to English- language , adult population , full-text , r and omized , double-blind , placebo-controlled in which HRQoL was measured . Results : Out of 202 identified articles , 8 r and omized controlled trials ( RCT ) met the inclusion criteria . Two RCTs on infliximab showed significant improvement of HRQoL compared to placebo which was sustained over the long term . One RCT on adalimumab showed a significant and sustained improvement of HRQoL compared to placebo . This study showed also significant decrease of fatigue in the adalimumab-treated patients . Three RCTs on certolizumab showed a significant improvement of HRQoL in the intervention group compared to placebo . Two RCTs of natalizumab treatment were found . One study showed significant and sustained improvement compared to placebo , and also scores of HRQoL comparable to that in the general population , but in the other no significant results were found . Conclusion : The biologics infliximab , adalimumab , certolizumab , and natalizumab demonstrated significant improvement of HRQoL of IBD patients compared with placebo . However , we found differences in improvement of HRQoL between the different biologics Background : Vedolizumab , a gut-selective , anti-inflammatory monoclonal antibody , has shown preliminary efficacy in ulcerative colitis ( UC ) and Crohn 's disease ( CD ) . We report long-term experience with vedolizumab for active UC and CD . Methods : After a placebo-controlled study , 38 patients with UC were r and omized to a loading regimen of vedolizumab 2 , 6 , or 10 mg/kg on days 1 , 15 , and 43 , followed by maintenance dosing every 8 weeks . Thirty-four vedolizumab-naive patients ( 15 UC ; 19 CD ) were r and omized to vedolizumab 2 , 6 , or 10 mg/kg on the same schedule . Rollover patients were treated up to 630 days and treatment-naive patients were treated up to 547 days . Results : Seventy-two patients were dosed ; 52 ( 72 % ) completed the study . In exploratory analyses , 28 of 72 ( 39 % ; UC : 21 of 53 , CD : 7 of 19 ) achieved clinical response and 42 of 72 ( 58.3 % ; UC : 38 of 53 , CD : 4 of 19 ) achieved clinical remission . Mean partial Mayo scores declined from baseline through day 155 in both treatment-naive patients with UC ( 5.4 to 1.7 , respectively ) and rollover patients with UC ( 2.3 to 1.4 , respectively ) , leveling off thereafter . Mean Crohn 's Disease Activity Index scores decreased from 295 ( baseline ) to 238 at day 43 , continued to trend downward through day 155 , and remained below baseline through day 491 . Mean Inflammatory Bowel Disease Question naire scores increased in all treatment groups . No deaths or systemic opportunistic infections were reported . Conclusion : Vedolizumab every 8 weeks for up to 78 weeks had an adverse event profile similar to that previously observed . Mean disease activity indices ( partial Mayo score and Crohn 's Disease Activity Index score ) improved with all 3 doses investigated BACKGROUND Infliximab , a chimeric monoclonal antibody directed against tumor necrosis factor alpha , is an established treatment for Crohn 's disease but not ulcerative colitis . METHODS Two r and omized , double-blind , placebo-controlled studies --the Active Ulcerative Colitis Trials 1 and 2 ( ACT 1 and ACT 2 , respectively)--evaluated the efficacy of infliximab for induction and maintenance therapy in adults with ulcerative colitis . In each study , 364 patients with moderate-to-severe active ulcerative colitis despite treatment with concurrent medications received placebo or infliximab  ( 5 mg or 10 mg per kilogram of body weight ) intravenously at weeks 0 , 2 , and 6 and then every eight weeks through week 46 ( in ACT 1 ) or week 22 ( in ACT 2 ) . Patients were followed for 54 weeks in ACT 1 and 30 weeks in ACT 2 . RESULTS In ACT 1 , 69 percent of patients who received 5 mg of infliximab and 61 percent of those who received 10 mg had a clinical response at week 8 , as compared with 37 percent of those who received placebo ( P<0.001 for both comparisons with placebo ) . A response was defined as a decrease in the Mayo score of at least 3 points and at least 30 percent , with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute rectal-bleeding subscore of 0 or 1 . In ACT 2 , 64 percent of patients who received 5 mg of infliximab and 69 percent of those who received 10 mg had a clinical response at week 8 , as compared with 29 percent of those who received placebo ( P<0.001 for both comparisons with placebo ) . In both studies , patients who received infliximab were more likely to have a clinical response at week 30 ( P < or = 0.002 for all comparisons ) . In ACT 1 , more patients who received 5 mg or 10 mg of infliximab had a clinical response at week 54 ( 45 percent and 44 percent , respectively ) than did those who received placebo ( 20 percent , P<0.001 for both comparisons ) . CONCLUSIONS Patients with moderate-to-severe active ulcerative colitis treated with infliximab at weeks 0 , 2 , and 6 and every eight weeks thereafter were more likely to have a clinical response at weeks 8 , 30 , and 54 than were those receiving placebo . ( Clinical Trials.gov numbers , NCT00036439 and NCT00096655 . OBJECTIVE : The aim of this study was to compare the treatment efficacies of subcutaneous interferon-α-2A ( IFN-α-2A ) injections versus prednisolone enemas in active left-sided ulcerative colitis in an open-labeled , r and omized study . METHODS : Sixteen ulcerative colitis patients received IFN-α-2A subcutaneously  ( dosage : first wk , 9 MIU three times weekly [ t.i.w . ] ; second wk , 6 MIU t.i.w . ; wk 3–12 , 3 MIU t.i.w . ) , and 16 received prednisolone enemas for 30 days ( 100 ml once daily , 0.25 mg of prednisolone/ml ) . The Powell-Tuck Index , Inflammatory Bowel Disease Question naire ( IBDQ ) score , and rectal histological activities were assessed before and after treatment . Thirteen patients in the IFN-α-2A group and all 16 in the prednisolone enema group completed the treatment . RESULTS : IFN-α-2A treatment showed significant improvements in the Powell-Tuck Index ( p = 0.0002 ) , IBDQ score ( p = 0.002 ) , and rectal histological activity scores ( p = 0.0 
    Output:
    