Adalimumab for induction of clinical remission in moderately to severely active ulcerative colitis: results of a randomised controlled trial The Effects of Infliximab Therapy on Health-Related Quality of Life in Ulcerative Colitis Patients The impact of biologics on health-related quality of life in patients with inflammatory bowel disease Long-term Clinical Experience with Vedolizumab in Patients with Inflammatory Bowel Disease Infliximab for induction and maintenance therapy for ulcerative colitis. An open-labeled, randomized study comparing systemic interferon-α-2A and prednisolone enemas in the treatment of left-sided ulcerative colitis Efficacy and safety of adalimumab in Japanese patients with moderately to severely active ulcerative colitis Adalimumab induces and maintains clinical remission in patients with moderate-to-severe ulcerative colitis. A new measure of health status for clinical trials in inflammatory bowel disease. Infliximab in moderately severe glucocorticoid resistant ulcerative colitis: a randomised controlled trial The Short Inflammatory Bowel Disease Questionnaire: a quality of life instrument for community physicians managing inflammatory bowel disease. CCRPT Investigators. Canadian Crohn's Relapse Prevention Trial. Does self-administration of a quality of life index for inflammatory bowel disease change the results? Long-term functional outcome and quality of life after stapled restorative proctocolectomy. Response and remission are associated with improved quality of life, employment and disability status, hours worked, and productivity of patients with ulcerative colitis Clinical trial: a multicentre, randomized, double‐blind, placebo‐controlled, dose‐finding, phase II study of subcutaneous interferon‐β‐1a in moderately active ulcerative colitis Vedolizumab as induction and maintenance therapy for ulcerative colitis. Quality of life: a valid and reliable measure of therapeutic efficacy in the treatment of inflammatory bowel disease. Canadian Crohn's Relapse Prevention Trial Study Group. Subcutaneous golimumab induces clinical response and remission in patients with moderate-to-severe ulcerative colitis.
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 = 0.02 ) . In the enema group , significant improvements were found in the Powell-Tuck Index ( p = 0.0009 ) , whereas no significant improvements were detected in the IBDQ scores ( p = 0.055 ) or rectal histological scores ( p = 0.052 ) . There were no differences between scores of the two groups either before or after treatment . Only moderate side effects  from the IFN-α-2A treatment were seen during the first 2–4 wk of treatment . CONCLUSION : IFN-α-2A treatment result ed in significant depression of the disease activity as reflected by the Powell-Tuck Index , IBDQ score , and histological disease activity scoring . The preliminary trial thus suggests that IFN-α-2A may be effective in the treatment of active left-sided ulcerative colitis . Larger , r and omized trials are , however , warranted to confirm this finding , owing to possible type II errors in group comparisons Background Adalimumab is a fully human , monoclonal antibody against tumor necrosis factor that is approved in Western countries for the treatment of moderately to severely active ulcerative colitis ( UC ) . Methods This 52-week , phase 2/3 , r and omized , double-blind study evaluated adalimumab for induction and maintenance treatment in 273 anti-TNF – naive Japanese patients with UC who were refractory to corticosteroids , immunomodulators , or both . Patients received placebo , adalimumab 80/40 ( 80 mg at week 0 , then 40 mg every other week ) , or adalimumab 160/80 ( 160/80 mg at weeks 0/2 , then 40 mg every other week ) in addition to background UC therapy . Results At week 8 , remission rates were similar among treatment arms , but more patients treated with adalimumab 160/80 achieved response ( placebo , 35 % ; 80/40 , 43 % ; 160/80 , 50 % ; P = 0.044 for 160/80 vs placebo ) and mucosal healing ( placebo , 30 % ; 80/40 , 39 % ; 160/80 , 44 % ; P = 0.045 for 160/80 vs placebo ) compared with placebo . At week 52 , more patients receiving adalimumab 40 mg every other week achieved response ( 18 vs 31 % ; P = 0.021 ) , remission ( 7 vs 23 % ; P = 0.001 ) , and mucosal healing ( 16 vs 29 % ; P = 0.015 ) compared with placebo . Week 8 response to adalimumab was associated with greater rates of response ( 61 % ) , remission ( 46 % ) , and mucosal healing ( 57 % ) at week 52 relative to the overall population . Rates of serious adverse events were similar between treatment arms . Conclusions Induction with adalimumab 160/80 mg led to early response and mucosal healing . Maintenance adalimumab had greater rates of long-term response , remission , and mucosal healing compared with placebo . No new safety signals were identified BACKGROUND & AIMS Adalimumab is a fully human monoclonal antibody that binds tumor necrosis factor (TNF)-α . Its efficacy as maintenance therapy for patients with ulcerative colitis has not been studied in a controlled , double-blind trial . METHODS Ulcerative colitis long-term remission and maintenance with adalimumab 2 ( ULTRA 2 ) was a r and omized , double-blind , placebo-controlled trial to evaluate the efficacy of adalimumab in induction and maintenance of clinical remission in 494 patients with moderate-to-severe ulcerative colitis who received concurrent treatment with oral corticosteroids or immunosuppressants . Patients were stratified based on prior exposure to TNF-α antagonists ( either had or had not been previously treated with anti-TNF-α ) and r and omly assigned to groups given adalimumab 160 mg at week 0 , 80 mg at week 2 , and then 40 mg every other week or placebo . Primary end points were remission at weeks 8 and 52 . RESULTS Overall rates of clinical remission at week 8 were 16.5 % on adalimumab and 9.3 % on placebo ( P = .019 ) ; corresponding values for week 52 were 17.3 % and 8.5 % ( P = .004 ) . Among anti-TNF-α naïve patients , rates of remission at week 8 were 21.3 % on adalimumab and 11 % on placebo ( P = .017 ) ; corresponding values for week 52 were 22 % and 12.4 % ( P = .029 ) . Among patients who had previously received anti-TNF agents , rates of remission at week 8 were 9.2 % on adalimumab and 6.9 % on placebo ( P = .559 ) ; corresponding values for week 52 were 10.2 % and 3 % ( P = .039 ) . Serious adverse events occurred in 12 % of patients given adalimumab or placebo . Serious infections developed in 1.6 % of patients given adalimumab and 1.9 % given placebo . In the group given adalimumab , 1 patient developed squamous cell carcinoma and 1 developed gastric cancer . CONCLUSIONS Adalimumab was safe and more effective than placebo in inducing and maintaining clinical remission in patients with moderate-to-severe ulcerative colitis who did not have an adequate response to conventional therapy with steroids or immunosuppressants We have developed a measure of subjective health status ( quality of life ) for patients with inflammatory bowel disease ( IBD ) . Ninety-seven patients with IBD described problems they had experienced as a result of the disease ; the 32 most frequent and important items were included in the Inflammatory Bowel Disease Question naire ( IBDQ ) . Sixty-one IBD patients were evaluated twice . One month separated the evaluations , at which disease activity indices , the IBDQ , and a number of other question naires were administered . Reproducibility studies in 19 stable patients showed improvement in scores , but also a small within-person st and ard deviation . Responsiveness studies revealed large changes in scores in patients who had improved or deteriorated and suggested that the IBDQ was more responsive than a general health status measure . Responsiveness appeared greater in patients with ulcerative colitis than in those with Crohn 's disease . Predicted and observed correlations between changes in IBDQ score and changes in other measures were similar . We conclude that although further testing is required , particularly in examining the relation between changes in the IBDQ and changes in the activity of Crohn 's disease , the IBDQ shows promise as a measure of health status for clinical trials in IBD Background : Tumour necrosis factor production is increased in the mucosa of patients with active ulcerative colitis . The benefits of infliximab in Crohn ’s disease are established . We investigated its efficacy in ulcerative colitis . Methods : We conducted a r and omised placebo controlled trial of infliximab ( 5 mg/kg ) in the treatment of glucocorticoid resistant ulcerative colitis . Infusions were given at weeks 0 and 2 . Disease activity and quality of life were recorded over eight weeks of follow up . Remission was defined as an ulcerative colitis symptom score ( UCSS ) of ⩽2 and /or Baron score of 0 at week 6 . Patients not in remission were offered open label infliximab 10 mg/kg and review ed two weeks later . Results : After two weeks , there was no statistically significant difference between the infliximab and placebo groups in the proportion of patients with a Baron score of 0 ( 13 % ( 3/23 ) v 5 % ( 1/19 ) ( 95 % confidence interval ( CI ) −9 % to 24 % ) ; p=0.74 ) . After six weeks , remission ( UCSS ⩽2 ) rates were 39 % ( 9/23 ) versus 30 % ( 6/20 ) ( 95 % CI −19 to 34 % ; p=0.76 ) . The median improvement in UCSS was 3 for the infliximab group and 2.5 for the placebo group ( p=0.82 , Mann-Whitney U test ) . A Baron score of 0 was likely in either group ( 26 % ( 6/23 ) v 30 % ( 6/20 ) ( 95 % CI −30 % to 23 % ) ; p=0.96 ) . Improvement in the IBDQ and EuroQol was not significantly different between the groups ( p=0.22 and 0.3 , respectively , Mann-Whitney U test ) . Twenty eligible patients were given open labelled infusions . Remission was achieved in 3/11 ( 27 % ) patients initially treated with infliximab and in 1/9 ( 11 % ) patients treated with placebo . Conclusion : These data do not support the use of infliximab in the management of moderately active glucocorticoid resistant ulcerative colitis OBJECTIVE Health-related quality of life ( HRQOL ) affects outcome in chronic diseases such as inflammatory bowel disease ( IBD ) . The inflammatory bowel disease question naire ( IBDQ ) , a disease-specific HRQOL question naire , can define changes in health status in IBD , but simple instruments are needed for daily application . The present study proposed to develop a short version of the IBDQ , the SIBDQ , for community physicians . METHODS Using data from a clinical trial in 149 patients with Crohn 's disease , 10 items were selected ( by forward stepwise regression ) that best explained the variance of the IBDQ or dimensional scores ( bowel , systemic , social , emotional ) . The validity , reliability , and responsiveness of the SIBDQ were then assessed in 150 different patients with Crohn 's disease and 45 with ulcerative colitis . All scores were reported with a 7-point scale ( 1 = poor HRQOL , 7 = optimum HRQOL ) . RESULTS Mean SIBDQ scores were similar ( p = 0.22 ) in Crohn 's patients among 14 participating centers at study entry . Mean scores were lower in active Crohn 's disease ( range 4.00 - 4.92 ) than inactive disease ( range 4.67 - 5.83 ; p = 0.0015 ) . In active ulcerative colitis , the mean SIBDQ was 4.79 + /- 1.17 compared to 5.90 + /- 0.80 ( p = 0.0006 ) in inactive disease . The SIBDQ explained 92 % and 90 % of the IBDQ variance in Crohn 's disease and ulcerative colitis , respectively . In patients with stable Crohn 's disease , the test-retest reliability coefficient was 0.65 and Crohnbach 's alpha was 0.78 , indicating good reliability . In patients with Crohn 's disease who relapsed during follow-up , the mean SIBDQ decreased by -0.93 + 0.55 ( p = 0.001 ) . CONCLUSION The SIBDQ is valid , reliable , and able to detect meaningful clinical changes in HRQOL that might occur in the office setting We assessed the effect of self-administration of a disease-specific health-related quality of life instrument , the Inflammatory Bowel Disease Question naire ( IBDQ ) , on score results . Patients were assessed at two visits in two tertiary centers . " Experienced " patients ( N = 31 ) with Crohn 's disease had previously completed the IBDQ several times while " novices " ( N = 37 ) with Crohn 's disease or ulcerative colitis had no prior exposure to the IBDQ  . At each visit a self-administered IBDQ followed by a nurse-administered IBDQ  ( score range , 1 - 7 ; absolute score range , 32 - 224 ) and disease activity were assessed . At visit 1 , the mean rates of discrepant responses between nurse and self-administered scores were 24 + /- 15 % in experienced patients and 34 + /- 17 % in novice patients ( p = 0.018 ) , which fell to 21 + /- 16 and 23 + /- 10 % , respectively , by visit 2 ( p = NS ) . However , discrepancy rates were not significantly different between novice and experienced patients when adjusted by center . Discrepancies occurred r and omly in all 32 IBDQ items . Eighty percent of all discrepant responses differed by only one grade of a seven-point Likert scale . Baseline self-administered scores for all patients were 4.80 + /- 1.24 ( absolute score , 153.0 + /- 39.9 ) . Mean score differences at each visit ( nurse minus self ) were very small , ranging from 0.029 to 0.136 , and would not be considered clinical ly important . Intraclass correlation coefficients between the nurse and self-administered IBDQ and the four dimensional scores were > or = 0.97 by visit 2 , indicating excellent concordance and minimal observer error . Mean changes in score over time were of comparable magnitude for both self ( 0.320 + /- 0.819 ) and nurse ( 0.260 + /- 0.831 ) assessment s. We conclude that the IBDQ may be reliably used as a self-administered instrument in clinical trials OBJECTIVE To evaluate prospect ively long-term quality of life and functional outcome after  restorative proctocolectomy ( RPC ) with ileal pouch-anal anastomosis , and to evaluate and vali date a novel quality -of-life indicator in this group of patients . SUMMARY BACKGROUND DATA Restorative proctocolectomy with ileal pouch-anal anastomosis is now the preferred option when total proctocolectomy is required for ulcerative colitis or familial adenomatous polyposis , but long-term data on functional outcome and quality of life after the procedure are lacking . METHODS Patients ( n = 977 ) who underwent RPC with stapled anastomosis for colitis or polyposis coli and who were followed for > or = 12 months were included .  Quality of life , fecal incontinence , and satisfaction with surgery were prospect ively evaluated by structured interview or question naire for 1 to 12 years after surgery ( median 5.0 ) . Quality of life was scored using the Clevel and Global Quality of Life ( CGQL ) instrument ( Fazio Score ) . This is a novel score developed over the past 15 years by the senior author . Quality of life was also evaluated in a subgroup of patients with the Short Form 36 ( SF-36 ) . The CGQL was vali date d by determining its reliability , responsiveness , and validity as well as its correlation with the SF-36 score . RESULTS Postoperative quality of life as measured by SF-36 was excellent and compared well with published norms for the general U.S. population . The CGQL was found to be reliable , responsive , and valid , and there was a high correlation with the SF-36 scores . Using the CGQL , quality of life was shown to increase after the first 2 years after surgery , and there was no deterioration thereafter . The prevalence of perfect continence increased from 75.5 % before surgery to 82.4 % after surgery , and although this deteriorated somewhat > 2 years after surgery , it was no worse than preoperative values . Ninety-eight percent of patients would recommend the surgery to others . CONCLUSIONS Long-term quality of life after ileal pouch surgery is excellent and the level of continence is satisfactory . This surgery is an excellent long-term option in patients requiring total proctocolectomy . The CGQL is a simple , valid , and reliable measure of quality of life after pelvic pouch surgery and may well be applicable in many other clinical conditions Background : Impairment of health‐related quality of life , employment , and productivity has been documented in patients with moderate to severe ulcerative colitis . Methods : Using prospect ively collected data from the Active Ulcerative Colitis Trials 1 and 2 , we examined the impact of clinical response or remission , as defined using the Mayo score , on health‐related quality of life , employment , disability , productivity , and hours worked per week . These analyses were based on observed data and included all 728 patients , regardless of their r and omized treatment group ( i.e. ,  placebo and infliximab patients were grouped for analysis ) . Changes in Inflammatory Bowel Disease Question naire ( IBDQ ) and Medical Outcomes Study 36‐Item Short Form ( SF‐36 ) scores among nonresponders , responders , and patients in remission were compared . In addition , changes in employment , disability status , productivity , and hours worked per week of patients in clinical remission and patients not in clinical remission were compared . Results : Ulcerative colitis patients in clinical response or remission had significantly improved IBDQ and SF‐36 scores at week 30 compared with those of nonresponders ( P < 0.001 ) . Among those not employed at baseline , including those receiving disability compensation , greater percentages of patients in remission at week 30 were employed ( 20.6 % ) and not receiving disability compensation ( 58.8 % ) than were those not in remission ( 8.3 % and 20.0 % , respectively ; P < 0.05 for both comparisons ) . At week 30 , improvements from baseline in productivity and both actual and fully productive hours worked per week were greater for patients in remission compared with those not in remission ( P < 0.05 for all three comparisons ) . Conclusions : These results confirm the validity of response and remission as defined using the Mayo score Background Ulcerative colitis ( UC ) pathophysiology is characterized by an imbalance between pro‐ and anti‐inflammatory cytokines . Interferon (IFN)‐β‐1a has potent immunoregulatory properties , including stimulation of host defence mechanisms and thus represents a potential treatment 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 Quality of life ( QOL ) , a subjective index of health perception and function , embraces physical , social , and emotional performance but has not had a prominent role in clinical trials of inflammatory bowel disease ( IBD ) . To test the robustness of the Inflammatory Bowel Disease Question naire ( IBDQ ) , a disease-specific QOL index , this study assessed its validity , reliability , and responsiveness during a multicenter trial . METHODS Three hundred five patients with stable Crohn 's disease received cyclosporin or placebo for 18 months . IBDQ and dimensional scores ( bowel , social , systemic , and emotional ) were correlated with disease activity ( Crohn 's disease activity index [ CDAI ] and Harvey-Bradshaw index ) . Concordance of IBDQ scores was tested in 280 stable subjects . Linear regression evaluated change in IBDQ scores over time . RESULTS IBDQ scores correlated highly with CDAI ( r = -0.67 ; P < 0.0001 ) . The reliability coefficient for IBDQ score was 0.70 vs. 0.66 for CDAI and 0.55 for Harvey-Bradshaw index . Regression line slopes of IBDQ scores were significantly different in patients who deteriorated from those who remained stable ( [ b ] < 0.15 ; P < 0.0001 ) . QOL scores were lower in patients who required surgery . CONCLUSIONS The IBDQ is a valid reliable assessment tool that reflects important changes in the health status of patients with IBD . The IBDQ is a robust measure of therapeutic efficacy and should be used in future clinical trials in IBD BACKGROUND & AIMS Little is known about the efficacy of golimumab , a fully human monoclonal antibody to tumor necrosis factor ( TNF ) -α , for treatment of ulcerative colitis ( UC ) . We evaluated subcutaneous golimumab induction therapy in TNF-α antagonist-naïve patients with moderate-to-severe UC despite conventional treatment . METHODS We integrated double-blind phase 2 dose-finding and phase 3 dose-confirmation trials in a study of 1064 adults with UC ( Mayo score : 6 - 12 ; endoscopic subscore ≥ 2 ; 774 patients in phase 3 ) . Patients were r and omly assigned to groups given golimumab doses of 100 mg and then 50 mg ( phase 2 only ) , 200 mg and then 100 mg , or 400 mg and then 200 mg , 2 weeks apart . The phase 3 primary end point was week-6 clinical response . Secondary end points included week-6 clinical remission , mucosal healing , and Inflammatory Bowel Disease Question naire ( IBDQ ) score change . RESULTS In phase 2 , median changes from baseline in the Mayo score were -1.0 , -3.0 , -2.0 , and -3.0 , in the groups given placebo , 100 mg/50 mg , 200/100 mg , and 400/200 mg golimumab , respectively . In phase 3 , rates of clinical response at week 6 were 51.0 % and 54.9 % among patients given 200 mg/100 mg and 400 mg/200 mg golimumab , respectively , vs 30.3 % among those given placebo ( both , P ≤ .0001 ) . Rates of clinical remission and mucosal healing and mean changes in IBDQ scores were significantly greater in both golimumab groups vs the placebo group ( P ≤ .0014 , all comparisons ) . Rates of serious adverse events were 6.1 % and 3.0 % , and rates of serious infection were 1.8 % and 0.5 % , in the placebo and golimumab groups , respectively . One patient in the 400 mg/200 mg group died as a result of surgical complications of an ischiorectal abscess . CONCLUSIONS Treatment with subcutaneous golimumab induces clinical response , remission , and mucosal healing , and increases quality of life in larger percentages of patients with active UC than placebo . Clinical Trials.gov Number : NCT00487539
BACKGROUND Ulcerative colitis ( UC ) is a chronic inflammatory disorder of the colon that has a relapsing-remitting course .
Health related quality of life ( HRQL ) is significantly lower in patients with UC than the general population due to the negative effects of the disease on physical , psychological and social well-being .
R and omized controlled trials ( RCTs ) evaluating medical interventions for UC have traditionally used clinical disease activity indices that focus on symptoms to define primary outcomes such as clinical remission or improvement .
However , this approach does not evaluate benefits that are highly relevant to patients such as HRQL OBJECTIVES : The primary objective was to assess the impact of biologic therapy on the HRQL of UC patients .