Vedolizumab (antibiotic refractory chronic pouchitis) ' Benefit assessment according to '35a Social Code Book V 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Vedolizumab (Antibiotika-refraktäre, chronische Pouchitis) – Nutzenbewertung gemäß § 35a SGB V ( Version 1.0; Status: 25 May 2022). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. Extract IQWiG Reports – Commission No. A22-33_ Vedolizumab (antibiotic-refractory chronic pouchitis) – Benefit assessment according to §35a Social Code Book V1 Extract of dossier assessment A22-33 Version 1.0 Vedolizumab (antibiotic-refractory chronic
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Vedolizumab (Entyvio) - active chronic pouchitis Published 11 July 2022 Statement of advice SMC2506 vedolizumab 300mg powder for concentrate for solution for infusion (Entyvio®) Takeda UK Ltd 10 June 2022 ADVICE: in the absence of a submission from the holder of the marketing authorisation vedolizumab (Entyvio®) is not recommended for use within NHSScotland. Indication under review: treatment of adult patients with moderately to severely active chronic pouchitis, who have undergone proctocolectomy and ileal pouch anal anastomosis for ulcerative colitis, and have had an inadequate response with or lost response to antibiotic therapy. The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result we cannot
Treatment and prevention of pouchitis after ileal pouch-anal anastomosis for chronic ulcerative colitis. Pouchitis occurs in approximately 50% of patients following ileal pouch-anal anastomosis (IPAA) for chronic ulcerative colitis (UC). The primary objective was to determine the efficacy and safety of medical therapies for prevention or treatment of acute or chronic pouchitis. We searched MEDLINE, Embase and CENTRAL from inception to 25 July 2018. We also searched references, trials registers, and conference proceedings. Randomized controlled trials of prevention or treatment of acute or chronic pouchitis in adults who underwent IPAA for UC were considered for inclusion. Two authors independently screened studies for eligibility, extracted data and assessed the risk of bias
AGA Clinical Practice Guideline on the Management of Pouchitis and Inflammatory Pouch Disorders Pouchitis is the most common complication after restorative proctocolectomy with ileal pouch-anal anastomosis for ulcerative colitis. This American Gastroenterological Association (AGA) guideline is intended to support practitioners in the management of pouchitis and inflammatory pouch disorders . A multidisciplinary panel of content experts and guideline methodologists used the Grading of Recommendations Assessment, Development and Evaluation framework to prioritize clinical questions, identify patient-centered outcomes, conduct an evidence synthesis, and develop recommendations for the prevention and treatment of pouchitis, Crohn's-like disease of the pouch, and cuffitis. The AGA guideline panel made 9
Altered Bile Acids and Pouch Microbiota Composition in Patients With Chronic Pouchitis. This article looks at how changes in bile acids and gut bacteria might contribute to chronic pouchitis, a condition that can develop after surgical removal of the colon and creation of a J-pouch for people with inflammatory bowel disease. The goal is to better understand pouchitis and find treatments
Cellular and molecular mechanisms in the pathogenesis of pouchitis: more than just the microbiota. Pouchitis, defined as inflammation of the ileal pouch, is the most common complication following restorative proctocolectomy for refractory ulcerative colitis. Antibiotics remain the first line of therapy for pouchitis, but the majority of patients develop subsequent episodes and some are refractory to antibiotic therapy. This highlights the need for more effective treatment options and points to a more complex pathophysiology beyond the role of th pouch microbiome, similar to what is seen in inflammatory bowel disease. In this review, we outline the putative mechanisms of pouchitis, including genetic predisposition, microbiome alterations, dysfunction of the intestinal barrier and the immune system
Vedolizumab for the Treatment of Chronic Pouchitis. Approximately half the patients with ulcerative colitis who undergo restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) will subsequently have pouchitis, and among those patients, one fifth will have chronic pouchitis. We conducted a phase 4, double-blind, randomized trial to evaluate vedolizumab in adult patients in whom chronic pouchitis had developed after undergoing IPAA for ulcerative colitis. Patients were assigned (in a 1:1 ratio) to receive vedolizumab intravenously at a dose of 300 mg or placebo on day 1 and at weeks 2, 6, 14, 22, and 30. All the patients received concomitant ciprofloxacin from weeks 1 to 4. The primary end point was modified Pouchitis Disease Activity Index (mPDAI)-defined remission (an mPDAI
Pouchitis: pathophysiology and management. Pouchitis is an acute or chronic inflammatory disease of the ileal reservoir. It is common after restorative proctocolectomy with ileal pouch-anal anastomosis, and treatment of chronic antibiotic-refractory pouchitis has proven challenging. Most cases of acute pouchitis evolve into chronic pouchitis. The aetiology of acute pouchitis is likely to be partly related to the gut microbiota, whereas the pathophysiology of chronic pouchitis involves abnormal interactions between genetic disposition, faecal stasis, the gut microbiota, dysregulated host immunity, surgical techniques, ischaemia and mesentery-related factors. Pouchoscopy with biopsy is the most valuable modality for diagnosis, disease monitoring, assessment of treatment response, dysplasia
Antibiotic Use in the 12 months Prior to Ileal Pouch-Anal Anastomosis Increases the Risk for Pouchitis. Pouchitis is the most common complication after ileal pouch-anal anastomosis (IPAA) for ulcerative colitis (UC), however clinical and environmental risk factors for pouchitis remain poorly understood. We explored the relationship between specific clinical factors and the incidence of pouchitis . We established a population-based cohort of all adult persons in Denmark undergoing proctocolectomy with IPAA for UC from 1996-2020. We used Cox Proportional Hazard modeling to assess the impact of antibiotic, non-steroidal anti-inflammatory drug (NSAID) exposure, and appendectomy on diagnosis of acute pouchitis in the first 2 years after IPAA surgery. Among 1,616 eligible patients, 46% developed
Evidence-Based Approach to Chronic Antibiotic Refractory Pouchitis: A Review. Chronic antibiotic refractory pouchitis after restorative proctocolectomy with ileal pouch-anal anastomosis, characterized by at least 4 weeks of pouchitis symptoms that have not responded to standard antibiotic therapy, presents a therapeutic challenge for patients and healthcare providers. The aim of this narrative review was to summarize the current evidence regarding management of chronic antibiotic refractory pouchitis. Studies were identified through search of PubMed database from the National Library of Medicine. We included case series, cohort studies, randomized-controlled trials, and systematic reviews with meta-analyses that addressed chronic antibiotic refractory pouchitis management
The effect of non-pooled multi-donor faecal microbiota transplantation for inducing clinical remission in patients with chronic pouchitis: Results from a multicentre randomised double-blinded placebo-controlled trial (MicroPouch). To investigate if treatment with non-pooled multi-donor faecal microbiota transplantation (FMT) for four weeks was superior to placebo to induce clinical remission in patients with chronic pouchitis. The study was a randomised double-blinded placebo-controlled study with a 4-week intervention period and 12-month follow-up. Eligible patients with chronic pouchitis were recruited from five Danish hospitals. Participants were randomised to non-pooled multi-donor FMT derived from four faecal donors, or placebo. Treatment was delivered daily by enema for two weeks followed
Endoscopic Response Reduces the Risk of Subsequent Pouchitis in Patients with Crohn's Disease Like Pouch Inflammation. The aim of this study was to report the frequency and impact of endoscopic response and remission on the risk of subsequent pouchitis in patients with Crohn's disease like pouch inflammation (CDLPI) on therapy. This was a single center, retrospective study of patients >18 years with CDLPI on therapy. Among 110 included patients with CDLPI in clinical remission, endoscopic remission was not significantly associated with a reduced risk of subsequent pouchitis when compared to endoscopic response. Endoscopic response, not remission, is sufficient to reduce the risk of subsequent pouchitis in patients with CDLPI.
Microbiota and mucosal gene expression of fecal microbiota transplantation or placebo treated patients with chronic pouchitis. Altered microbiota and impaired host immune function have been linked to the pathogenesis of pouchitis. We used 16S rRNA gene sequencing and RNA sequencing data from a previous randomized clinical trial (RCT) on fecal microbiota transplantation (FMT) therapy in 26 chronic pouchitis patients with one-year follow-up. We analyzed changes in both luminal and mucosal microbiota composition, as well as in host mucosal gene expression to gain insights into the host-microbiota interactions possibly underlying clinical outcomes of the patients. Antibiotic type and pattern of use were significant drivers of the luminal microbiota at baseline. Differential gene expression
Treatment of Chronic Pouchitis With JAK Inhibitors: Results from A Large Multicenter Database. This retrospective study assessed the use of Janus kinase inhibitors in treating chronic pouchitis. While showing relative safety, Janus kinase inhibitors demonstrated effectiveness in <50% of cases, cautioning against their use as first-line agents. Larger randomized trials are recommended for further
EFFICACY AND SAFETY OF USTEKINUMAB FOR CHRONIC POUCHITIS: A PROSPECTIVE OPEN-LABEL MULTICENTER STUDY. Seventeen percent of patients with ulcerative colitis that undergo proctocolectomy with pouch surgery will develop chronic pouchitis. We evaluated the efficacy of ustekinumab for these patients. We performed a prospective study of chronic pouchitis patients receiving ustekinumab intravenously at baseline (∼6mg/kg) and 90mg ustekinumab subcutaneously every 8 weeks thereafter. The modified pouchitis disease activity index (mPDAI) was assessed at baseline, week 16 and 48. The primary endpoint was the proportion of patients achieving steroid-free remission (mPDAI <5 and reduction by ≥2 points) at week 16. Secondary endpoints included the proportion of patients achieving remission at week 48
Tryptophan Metabolites Improve Intestinal Mucosal Barrier via the Aryl Hydrocarbon Receptor-Interleukin-22 Pathway in Murine Dextran Sulfate Sodium-Induced Pouchitis. Pouchitis is the commonest complication after ileal pouch-anal anastomosis for ulcerative colitis. The protective effect of tryptophan metabolites on the mucosal barrier may be an effective method for treating pouchitis. The role of tryptophan metabolites on pouchitis remained unclear. We aimed to establish a murine model of dextran sulfate sodium-induced pouchitis to examine the roles of tryptophan metabolites in its pathogenesis. This is a study combined clinical patient data and animal research. A total of 22 patients were enrolled: 5 with familial adenomatous polyposis after ileal pouch-anal anastomosis, eight ulcerative colitis
Anti-integrin αvβ6 Antibodies Predict Pouchitis in Patients With Ulcerative Colitis After Restorative Proctocolectomy With Ileal Pouch-Anal Anastomosis. Pouchitis is the most common complication of restorative proctocolectomy (RPC) with ileal pouch-anal anastomosis (IPAA) in patients with ulcerative colitis (UC). We previously reported the presence of anti-integrin αvβ6 antibodies in the serum of patients with UC. This study investigated the association between anti-integrin αvβ6 antibodies and the development of pouchitis in patients with UC. Serum levels of anti-integrin αvβ6 antibodies were measured by enzyme-linked immunosorbent assay in 16 patients with UC who underwent RPC with IPAA. Integrin αvβ6 expression in the colonic, terminal ileal, and pouch epithelium was examined using
Mucosal Healing With Vedolizumab in Patients with Chronic Pouchitis: EARNEST, a Randomized, Double-Blind, Placebo-Controlled Trial. Vedolizumab is indicated for the treatment of chronic pouchitis in the EU. We assessed whether vedolizumab induced mucosal healing (MH) and if MH was associated with clinical improvements. EARNEST, a randomized, double-blind, placebo-controlled study, evaluated vedolizumab efficacy and safety in adults with chronic pouchitis. Centrally read endoscopic and histological evaluation was performed at baseline, week (W)14, and W34. Ulcer count, adapted Simple Endoscopic Score for Crohn's Disease (SES-CD) in the pouch, and Pouchitis Disease Activity Index (PDAI) histological component were evaluated. PDAI and Inflammatory Bowel Disease Questionnaire (IBDQ) remission