***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: BACKGROUND & AIMS Interobserver differences in endoscopic assessment s contribute to variations in rates of response to placebo in ulcerative colitis ( UC ) trials . We investigated whether central ized review of images could reduce these variations . METHODS We performed a 10-week , r and omized , double-blind , placebo-controlled study of 281 patients with mildly to moderately active UC , defined by an Ulcerative Colitis Disease Activity Index ( UCDAI ) sigmoidoscopy score ≥2 , that evaluated the efficacy of delayed-release mesalamine ( Asacol 800-mg tablet ) 4.8 g/day . Endoscopic images were review ed by a single expert central reader . The primary outcome was clinical remission ( UCDAI , stool frequency and bleeding scores of 0 , and no fecal urgency ) at week 6 . RESULTS The primary outcome was achieved by 30.0 % of patients treated with mesalamine and 20.6 % of those given placebo , a difference of 9.4 % ( 95 % confidence interval [ CI ] , -0.7 % to 19.4 % ; P = .069 ) . Significant differences in results from secondary analyses indicated the efficacy of mesalamine . Thirty-one percent of participants , all of whom had a UCDAI sigmoidoscopy score ≥2 as read by the site investigator , were considered ineligible by the central reader . After exclusion of these patients , the remission rates were 29.0 % and 13.8 % in the mesalamine and placebo groups , respectively ( difference of 15 % ; 95 % CI , 3.5%-26.0 % ; P = .011 ) . CONCLUSIONS Although mesalamine 4.8 g/day was not statistically different from placebo for induction of remission in patients with mildly to moderately active UC , based on an intent-to-treat analysis , the totality of the data supports a benefit of treatment . Central review of endoscopic images is critical to the conduct of induction studies in UC ; Clinical Trials.gov Number , NCT01059344 Background : Patients with ulcerative colitis ( UC ) who are in clinical remission may still have underlying endoscopic inflammation , which is associated with inferior clinical outcomes . The goal of this study was to determine the prevalence of active endoscopic disease , and factors associated with it , in patients with UC who are in clinical remission . Methods : Prospect i ve observational study in a single center . Patients with UC in clinical remission ( by Simple Clinical Colitis Activity Index ) were enrolled prospect ively at the time of surveillance colonoscopy .  Disease phenotype , endoscopic activity ( Mayo subscore ) , and histologic score ( Geboes ) were recorded , and blood was drawn for peripheral blood biomarkers . Results : Overall , 149 patients in clinical remission were prospect ively enrolled in this cohort ; 81 % had been in clinical remission for > 6 months , and 86 % were currently prescribed maintenance medications . At endoscopy , 45 % of patients in clinical remission had any endoscopic inflammation ( Mayo endoscopy subscore > 0 ) , and 13 % had scores > 1 . In a multivariate model , variables independently associated with a Mayo endoscopic score > 1 were remission for < 6 months ( P = 0.001 ) , white blood count ( P = 0.01 ) , and C-reactive protein level ( P = 0.009 ) . A model combining these 3 variables had a sensitivity of 94 % and a specificity of 73 % for predicting moderate-to-severe endoscopic activity in patients in clinical remission ( area under the curve , 0.86 ) . In an unselected subgroup of patients who had peripheral blood mononuclear cell messenger RNA profiling , GATA3 messenger RNA levels were significantly higher in patients with endoscopic activity . Conclusions : Duration of clinical remission , white blood count , and C-reactive protein level can predict the probability of ongoing endoscopic activity , despite clinical remission in patients with UC . These parameters could be used to identify patients who require intensification of treatment to achieve mucosal healing BACKGROUND AND AIMS The aim was to derive health state utility scores in ulcerative colitis ( UC ) by establishing the relationship between the physician-rated ulcerative colitis disease activity index ( UCDAI ) and a patient reported EQ-5D by statistically mapping the two instruments . METHODS In a r and omised controlled trial comparing oral plus enema mesalazine treatment with oral mesalazine treatment alone ( PINCE ) , UCDAI and EQ-5D scores were collected in parallel from patients with active UC . From these data , multinomial logistic regression was used to estimate response probabilities to each of the five domains of the EQ-5D index from assessment of UC disease severity using original and abbreviated ( no endoscopy ) versions of the UCDAI . Predicted EQ-5D responses were converted by Monte Carlo simulation to the EQ-5D index for predicting health-related quality of life ( HRQoL ) . The reliability of the algorithm was tested using UCDAI scores from a second mesalazine RCT ( PODIUM ) . RESULTS The abbreviated-UCDAI showed comparable explanatory performance to the full UCDAI . For patients in remission , mean utility was 0.939 , 0.944 , and 0.940U for PINCE(estimated ) , PINCE(observed ) , and PODIUM , respectively . Mild/moderate and relapsing cases showed mean utilities of 0.801 , 0.811 , and 0.775 , respectively ; whilst for those in severe relapse , the mean utilities were 0.630 , 0.700 and 0.660 units , respectively . The mean squared error between actual and predicted utilities from observations in PINCE was 0.019 . CONCLUSION Response mapping of UC activity to EQ-5D domains produced reliable estimates of patient-rated health state utility consistent with UCDAI rated severity . Comparing abbreviated-UCDAI and full UCDAI suggests that inclusion of endoscopy scores has limited predictive value in estimating patient One hundred forty-two patients with active colonic or ileocolonic Crohn 's disease were included in a multicenter prospect i ve study . Data collection included 28 clinical , biological , and endoscopic items ; the latter were recorded according to a st and ardized colonoscopic protocol ; a previously vali date d endoscopic index of severity was calculated . Oral prednisolone ( 1 mg/kg body wt per day ) was started and maintained until clinical remission and for at least 3 and at most 7 wk . A second clinical biological and endoscopic evaluation was then performed . At initial colonoscopy , mucosal lesions were , by decreasing order of frequency , superficial ulcerations , deep ulcerations , mucosal edema , erythema , pseudopolyps , aphthoid ulcers , ulcerated stenosis , and nonulcerated stenosis ( 93 % , 74 % , 48 % , 44 % , 41 % , 35 % , 10 % , 8 % , and 2 % of cases , respectively ) . No correlation was found between the clinical activity index and any of the endoscopical data ( lesion frequency and surface , endoscopic severity index ) . Ninety-two percent of patients underwent clinical remission within 7 wk of treatment . None of the 28 clinical biological and endoscopical items collected just before treatment could predict clinical response to steroids . Only 38 of the 131 patients in clinical remission were also in endoscopic remission . In conclusion , ( a ) the description and severity of colonoscopic lesions in active Crohn 's disease have been quantified ; ( b ) no correlation exists between clinical severity and nature , surface , or severity of endoscopic lesions ; ( c ) Oral prednisolone ( 1 mg/kg body wt per day ) induces a clinical remission in 92 % of patients within 7 wk ; ( d ) resistance to steroids can not be predicted from the data collected before treatment onset ; and ( e ) only 29 % of patients in clinical remission also achieve endoscopic remission A r and omized clinical trial was conducted to determine whether colonoscopy is useful in deciding how long to maintain steroid treatment in attacks of Crohn 's disease involving the colon . One hundred forty-seven patients with acute attacks of colonic or ileocolonic Crohn 's disease were treated by oral prednisolone , 1 mg.kg-1.day-1 ; 136 achieved clinical remission , but 96 of them still had active endoscopic lesions and were r and omized either to immediate start of steroid tapering ( group A ; n = 46 ) or to continued prednisolone treatment at the same dosage for 5 more weeks before steroid tapering was begun ( group B ; n = 50 ) . In the remaining 40 patients ( already in endoscopic remission , group C ) , steroid tapering was begun immediately . After prednisolone discontinuation , patients were followed up for 18 months or until clinical relapse . Prolongation of prednisolone therapy significantly improved the endoscopic scores in group B ( 30 % of endoscopic remission ) . The frequency of successful steroid weaning was almost identical in groups A and B ( 82 % and 80 % , respectively ) , as was the actuarially calculated relapse clinical rate after steroid withdrawal ( P = 0.22 ) . No factor predictive of clinical relapse could be found . The clinical course of patients in group C was similar to that of those in groups A and B. Overall , only 22 % of the 147 patients were still in clinical remission and off steroids 18 months after prednisolone discontinuation , outlining the need for maintenance therapy . In conclusion , for patients who have achieved clinical remission , adjustment of steroid treatment duration on the basis of endoscopy results is of no benefit , and the endoscopic aspect has no prognostic value ; thus , it appears unnecessary to repeat colonoscopy in such patients before steroid tapering is begun BACKGROUND Gut-selective blockade of lymphocyte trafficking by vedolizumab may constitute effective treatment for ulcerative colitis . METHODS We conducted two integrated r and omized , double-blind , placebo-controlled trials of vedolizumab in patients with active disease . In the trial of induction therapy , 374 patients ( cohort 1 ) received  vedolizumab  ( at a dose of 300 mg ) or placebo intravenously at weeks 0 and 2 , and 521 patients ( cohort 2 ) received open-label  vedolizumab at weeks 0 and 2 , with disease evaluation at week 6 . In the trial of maintenance therapy , patients in either cohort who had a response to vedolizumab at week 6 were r and omly assigned to continue receiving vedolizumab every 8 or 4 weeks or to switch to placebo for up to 52 weeks . A response was defined as a reduction in the Mayo Clinic score ( range , 0 to 12 , with higher scores indicating more active disease ) of at least 3 points and a decrease of at least 30 % from baseline , with an accompanying decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of 0 or 1 . RESULTS Response rates at week 6 were 47.1 % and 25.5 % among patients in the vedolizumab group and placebo group , respectively ( difference with adjustment for stratification factors , 21.7 percentage points ; 95 % confidence interval [ CI ] , 11.6 to 31.7 ; P<0.001 ) . At week 52 , 41.8 % of patients who continued to receive vedolizumab every 8 weeks and 44.8 % of patients who continued to receive vedolizumab every 4 weeks were in clinical remission ( Mayo Clinic score ≤2 and no subscore > 1 ) , as compared with 15.9 % of patients who switched to placebo ( adjusted difference , 26.1 percentage points for vedolizumab every 8 weeks vs. placebo [ 95 % CI , 14.9 to 37.2 ; P<0.001 ] and 29.1 percentage points for vedolizumab every 4 weeks vs. placebo [ 95 % CI , 17.9 to 40.4 ; P<0.001 ] ) . The frequency of adverse events was similar in the vedolizumab and placebo groups . CONCLUSIONS Vedolizumab was more effective than placebo as induction and maintenance therapy for ulcerative colitis . ( Funded by Millennium Pharmaceuticals ; GEMINI 1 Clinical Trials.gov number , NCT00783718 . ) BACKGROUND & AIMS Endoscopy limited to the rectosigmoid colon is the st and ard technique used to measure endoscopic healing in ulcerative colitis ( UC ) clinical trials . We evaluated whether rectosigmoidoscopy adequately measures UC activity in the more proximal colon . METHODS We analyzed data from a phase 2 , placebo-controlled study that evaluated the efficacy and safety of etrolizumab in patients with moderate to severely active UC who had not responded to st and ard therapy . Central readers determined Mayo Clinic endoscopic subscores ( MCSe ) and ulcerative colitis endoscopic index of severity ( UCEIS ) scores from the rectosigmoid and proximal colon in videos of 331 examinations performed at baseline , week 6 , and week 10 . Rates of endoscopic healing ( MCSe ≤ 1 , MCSe = 0 ) and scores from 
    Output:
    
Many patients in endoscopic remission from UC have no rectal bleeding .
Normal stool frequency associates with endoscopic remission , but many patients have abnormal stool frequencies despite endoscopic remission .