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In a phase 4, double-blind, randomized trial, vedolizumab therapy was more effective than placebo in inducing remission in patients with chronic pouchitis after ileal pouch–anal anastomosis for ulcerative colitis.

Although a rising trend in the incidence of inflammatory bowel disease (IBD) in Asia has been recognized, national-level, population-based studies are lacking. In this study, we investigate the epidemiological features and natural course of IBD in Korea, including incidence, bowel resection rates, survival, and cause of death.MethodsWe analyzed the Rare Intractable Disease registration and Health Insurance Review and Assessment Services claims database, which include information on every patients with IBD diagnosed through uniform criteria from 2006 to 2012. Twenty-seven thousand four hundred nineteen patients with IBD newly diagnosed from 2006 to 2012 were traced to bowel resection, survival, and cause of death.ResultsDuring study period, mean annual incidence for ulcerative colitis was 4.6 per 105 and for Crohn's disease (CD) was 3.2 per 105. Bowel resection rates at 1 and 5 years for patients with ulcerative colitis were 0.8% and 2.1%, respectively, and for patients with CD were 5.0% and 9.1%, respectively. Survival of patients with CD was lower than that of the general population, whereas patients with ulcerative colitis had similar survival. In patients with CD, mortality for colon cancer, lung cancer, and gastrointestinal disease was significantly increased compared with general population.ConclusionsIncidence of IBD found in our study is the highest in East Asia. Lower bowel resection rates and higher survival compared to those of Western nations suggest that the natural course of IBD may be different between East Asia and the West.

BackgroundThe aim was to evaluate long-term efficacy, quality of life, and safety in ulcerative colitis patients who received infliximab during the ACT-1 and -2 extension studies.MethodsAdults with moderate-to-severely active ulcerative colitis in the 54-week ACT-1 and 30-week ACT-2 studies who achieved benefit from infliximab were eligible to participate in extension studies and receive up to 3 additional years of therapy. Patients received randomized study medication until all sites were unblinded; placebo-treated patients were discontinued. Patients receiving 5 or 10 mg/kg infliximab continued to receive open-label infliximab every 8 weeks. Patients receiving infliximab 10 mg/kg could decrease to 5 mg/kg; patients receiving infliximab 5 mg/kg could increase to 10 mg/kg if response was lost.ResultsA total of 229 of 484 infliximab-treated patients from the ACT-1 and ACT-2 main studies entered the long-term extensions. Overall, 70 (30.6%) patients discontinued infliximab infusions for adverse events (24 [10.5%]), lack of efficacy (11 [4.8%]), required a colectomy (1 [0.4%]), or for other reasons (34 [14.8%]). Proportions of patients whose Physician's Global Assessment scores were indicative of no or mild disease (score = 0 or 1) were maintained during the extension studies; 76.5% at Extension week 0 and ranged between 90.0% and 94.3% through Extension week 152. Improvement in Inflammatory Bowel Disease Questionnaire scores observed in the main studies was maintained. During the long-term extension, the infliximab safety profile was consistent with that of the main studies; no new or unexpected safety signals were observed.ConclusionsLong-term treatment with infliximab for up to 3 additional years was effective and well tolerated.

Therapy options for mesalamine-refractory ulcerative colitis (UC) include immunosuppressive medications or surgery. Chronic immunosuppressive therapy increases risks of infection and cancer, whereas surgery produces a permanent change in bowel function. We sought to quantify the willingness of patients with UC to accept the risks of chronic immunosuppression to avoid colectomy.MethodsWe conducted a state-of-the-art discrete-choice experiment among 293 patients with UC who were offered a choice of medication or surgical treatments with different features. Random parameters logit was used to estimate patients' willingness to accept trade-offs among treatment features in selecting surgery versus medical treatment.ResultsA desire to avoid surgery and the surgery type (ostomy versus J-pouch) influenced patients' choices more than a specified range of 10-year mortality risks from lymphoma or infection, or disease activity (mild versus remission). To avoid an ostomy, patients were willing to accept a >5% 10-year risk of dying from lymphoma or infection from medical therapy, regardless of medication efficacy. However, data on patients' stated choice indicated perceived equivalence between J-pouch surgery and incompletely effective medical therapy. Patient characteristics and disease history influenced patients' preferences regarding surgery versus medical therapy.ConclusionsPatients with UC are willing to accept relatively high risks of fatal complications from medical therapy to avoid a permanent ostomy and to achieve durable clinical remission. However, patients view J-pouch surgery, but not permanent ileostomy, as an acceptable therapy for refractory UC in which medical therapy is unable to induce a durable remission.

Background This systematic review explored different medications and methods for prevention and treatment of pouchitis after restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA). Methods PubMed, Scopus, and Web of Science were searched for randomized clinical trials that assessed prevention or treatment of pouchitis. The systematic review was reported in line with updated 2020 PRISMA guidelines. Risk of bias in the trials included was assessed using the ROB-2 tool and certainty of evidence was assessed using GRADE. The main outcomes were the incidence of new pouchitis episodes in the preventative studies and resolution or improvement of active pouchitis in the treatment studies. Results Fifteen randomized trials were included. A meta-analysis of 7 trials on probiotics revealed significantly lower odds of pouchitis with the use of probiotics (RR: 0.26, 95% CI: 0.16–0.42, I 2  = 20%, p  < 0.001) and similar odds of adverse effects to placebo (RR: 2.43, 95% CI: 0.11–55.9, I 2  = 0, p  = 0.579). One trial investigated the prophylactic role of allopurinol in preventing pouchitis and found a comparable incidence of pouchitis in the two groups (31% vs 28%; p  = 0.73). Seven trials assessed different treatments for active pouchitis. One recorded the resolution of pouchitis in all patients treated with ciprofloxacin versus 67% treated with metronidazole. Both budesonide enema and oral metronidazole were associated with similar significant improvement in pouchitis (58.3% vs 50%, p  = 0.67). Rifaximin, adalimumab, fecal microbiota transplantation, and bismuth carbomer foam enema were not effective in treating pouchitis. Conclusions Probiotics are effective in preventing pouchitis after IPAA. Antibiotics, including ciprofloxacin and metronidazole, are likely effective in treating active pouchitis.

Cytomegalovirus (CMV) is frequently detected in patients with ulcerative colitis (UC). The impact of CMV infection on the outcome of UC exacerbation remains unclear. The benefit of combining antiviral with anti-inflammatory treatment has not been evaluated yet. The aim of this study was to compare the outcome of CMV-positive hospitalized patients with UC treated with antiviral therapy either alone or combined with salvage anti-inflammatory therapy (infliximab [IFX] or cyclosporine A [CsA]).MethodsThis was a multicenter retrospective study of hospitalized CMV-positive patients with UC. The patients were classified into 2 groups: antiviral—if treated with antivirals alone; combined—if treated with both antiviral and anti-inflammatory therapy. The outcomes included the rate of colectomy in both arms during the course of hospitalization and after 3/12 months.ResultsA total of 110 patients were included; 47 (42.7%) patients did not receive IFX nor CsA; 36 (32.7%) received IFX during hospitalization or within 1 month before hospitalization; 20 (18.1%) patients received CsA during hospitalization; 7 (6.4%) were exposed to both IFX and CsA. The rate of colectomy was 14.5% at 30 days, 20.0% at 3 months, and 34.8% at 12 months. Colectomy rates were similar across treatment groups. No clinical and demographic variables were independently associated with the risk of colectomy.ConclusionsIFX or cyclosporine therapy is not associated with additional risk for colectomy over antiviral therapy alone in hospitalized CMV-positive patients with UC.

Background A nested qualitative interview study within the CONSTRUCT trial was conducted to explore experiences and perceptions of patients with acute severe ulcerative colitis following treatment with infliximab or ciclosporin, surgery, or other medication. Methods Two hundred seventy patients with steroid-resistant ulcerative colitis were randomised to either infliximab or ciclosporin. Interviews were conducted with 20 trial participants. Thirty-five data capture events took place in total, 20 interviews conducted 3 months after treatment and a further 15 interviews with the same cohort as second interviews at 12 months. Results Disease duration varied but similar stories emerged about how people adjusted to living with ulcerative colitis. Issues raised by patients included; the debilitating effect of the disease on quality of life, living with the unpredictability of symptoms and treatment, dealing with embarrassment and stigma and the desire to share knowledge of the disease with others to combat the private nature of this debilitating illness and bring greater visibility to patient experience of symptoms and outcomes. Conclusion Patients were more positive about treatment with infliximab than ciclosporin, mainly due to the cumbersome intravenous regimen required for ciclosporin. Prompt diagnosis is required and early reporting of changes in symptoms is encouraged to ensure appropriate treatment. Trial registration This trial is registered with the ISRCTN registry; number ISRCTN22663589 . The date of registration was 16/05/2008.

Many patients with ulcerative colitis (UC) fear the potential side effects of immunosuppressive therapies. However, those with medically refractory disease often require total proctocolectomy (TPC) with a permanent ostomy or pouch, which may reduce quality of life. Prior studies have identified TPC predictors; however, no clinically useful prognostic tools exist to guide shared therapeutic decision-making. We therefore sought to develop a prediction tool of future TPC risk in UC patients. In this retrospective study, clinic charts of UC patients were reviewed from January 1, 2017, to December 31, 2017. Cases had TPC performed for refractory UC after January 1, 2008. Controls had no prior UC surgery. Clinical data were assessed 1-12 months preceding TPC or clinic visit for cases and controls, respectively. We randomly selected two-thirds of patients to develop a TPC prediction model using multivariable logistic regression. One-third was reserved for model validation. We identified 115 cases and 325 controls. TPC predictors included albumin, 9-point Mayo score >5, Mayo endoscopic subscore >1, and corticosteroid use within 6 months. The areas under the receiver operating characteristic curve for the multivariable model were 0.94 (95% confidence interval [CI], 0.92-0.95) and 0.92 (95% CI, 0.89-0.95) for the test and validation cohorts, respectively. The validation cohort demonstrated a significant difference in calculated probability distributions between patients who did and did not have TPC (P < 0.01). We incorporated our model into a web-based application to allow convenient calculation of a patient's TPC risk. We created a user-friendly tool to assess TPC risk in UC. Prospective assessment will determine its utility for shared therapeutic decision-making.

Background Although colonoscopy preparation may cause symptom flares in patients with ulcerative colitis (UC), little is known about the standard preparation regimen in this population. Aim We aimed to compare 4L polyethylene glycol (4L-PEG) with 2L polyethylene glycol plus ascorbic acid (2L-PEG-Asc) in quiescent UC patients. Methods Patients with inactive UC undergoing colonoscopy for surveillance or checkup of mucosal healing were prospectively enrolled at 5 tertiary hospitals. They were randomly assigned to 4L-PEG and 2L-PEG-Asc groups. The Boston Bowel Preparation Scale (BBPS) was used for the preparation quality. Symptoms were assessed using the Simple Clinical Colitis Activity Index (SCCAI) before colonoscopy, at 1 and 4 weeks after the procedure. Results Overall, 109 patients were included in the study (4L-PEG group 53, 2L-PEG-Asc group 56, the mean age at diagnosis 42.25 years, male 77). The quality of preparation was comparable between the groups (BBPS ≥ 6, 96.2 vs. 92.9%, p  = 0.679). Although 26 patients (23.8%) had increased SCCAI scores within 4 weeks after colonoscopy, resulting in a medication dose-up or add-on in 3 patients (2.7%), the rise in scores was not different between the groups. No serious adverse events during preparation were observed in either group. However, the 2L-PEG-Asc group was more likely to be willing to repeat the preparation with the same agent than the 4L-PEG group (82.1 vs. 64.2%, respectively, p  = 0.034). Conclusion PEG-based regimens with different volumes are equally effective and safe in inactive UC patients. 2L-PEG-Asc is more acceptable in this population as indicated by the willingness for further usage.

BackgroundProbiotics have anti-inflammatory effects in patients with inflammatory bowel disease and appear to regulate mucosal immune response through reductions in proinflammatory cytokines. The probiotic VSL#3 prevents pouchitis if started within a week of ileostomy closure and maintains remission following antibacterial treatment in patients with refractory or recurrent pouchitis. However, the efficacy of probiotics and their effects on regulatory cells if started at a greater time after surgery in patients undergoing ileal pouch anal anastomosis (IPAA) for ulcerative colitis are unknown.MethodsWe conducted an open-label study in which 31 patients at different periods from surgery without signs and symptoms of pouchitis were randomized to 2 sachets of VSL#3 once daily or no treatment for 12 months. Pouchitis disease activity index (PDAI) was evaluated at baseline and after 3, 6, and 12 months. The percentage of CD4+ T lymphocytes expressing CD25 and the inactive form of transforming growth factor-β [latency-associated peptide (LAP)] were evaluated at baseline and after 3 and 6 months in peripheral-blood mononuclear cells and mucosal biopsies. Variation in tissue interleukin-1β and Foxp3 mRNA expression was also evaluated.ResultsDuring the study period, VSL#3-treated patients showed a significant reduction in PDAI score and a significant increase in the percentage of mucosal CD4+CD25high and CD4+ LAP-positive cells compared with baseline values. Tissue samples at different points showed a significant reduction in IL-1β mRNA expression, and a significant increase in Foxp3 mRNA expression.ConclusionsWe conclude that VSL#3 administration in patients with IPAA modulates the PDAI and expands the number of mucosal regulatory T cells.