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Last update 08 May 2025

Pouchitis

Last update 08 May 2025

Basic Info

Synonyms

Ileitis, Pouch, Pouch Ileitis, Pouchitis

+ [7]

Introduction

Acute INFLAMMATION in the INTESTINAL MUCOSA of the continent ileal reservoir (or pouch) in patients who have undergone ILEOSTOMY and restorative proctocolectomy (PROCTOCOLECTOMY, RESTORATIVE).

Drugs associated with Pouchitis

Vedolizumab

Target

α4β7

Mechanism

α4β7 antagonists

Active Org.

Takeda Pharmaceutical Co., Ltd. [+11]

Originator Org.

Millennium Pharmaceuticals, Inc.

Active Indication

Ileal Diseases [+17]

Inactive Indication

Acute Graft Versus Host Disease [+8]

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

United States

First Approval Date20 May 2014

Liraglutide

Target

GLP-1R

Mechanism

GLP-1R agonists

Active Org.

Novo Nordisk A/S [+3]

Originator Org.

Novo Nordisk A/S

Active Indication

Obesity [+3]

Inactive Indication

Arthritis, Psoriatic [+20]

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

European Union [+3]

First Approval Date30 Jun 2009

Ustekinumab

Target

IL-12 x IL-23

Mechanism

IL-12 inhibitors [+1]

Active Org.

Janssen Research & Development LLC [+9]

Originator Org.

Janssen Biotech, Inc.

Active Indication

Colitis, Ulcerative [+13]

Inactive Indication

Dermatomyositis [+17]

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

European Union [+3]

First Approval Date15 Jan 2009

Clinical Trials associated with Pouchitis

NCT06916390

/ Not yet recruitingPhase 4IIT

Guselkumab Intervention and Diet Evaluation for Pouchitis

Restorative proctocolectomy (RPC) with ileal pouch-anal anastomosis (IPAA) is considered the procedure of choice in patients with ulcerative colitis (UC) refractory to medical therapy or with neoplasia. The most common complication after IPAA is the development of pouchitis. Pouchitis is clinically characterized by variable symptoms including increased stool frequency, altered consistency, bloody stools, abdominal cramping, urgency, and incontinence. Symptomatic pouchitis longer than four weeks is considered chronic pouchitis.
The conventional treatment for acute and chronic pouchitis is antibiotics, such as metronidazole and ciprofloxacin. The disease course of antibiotic responsive pouchitis may evolve into antibiotic dependent (requiring antibiotic maintenance therapy) pouchitis and then antibiotic refractory (no response to antibiotic treatment) pouchitis. Although many patients respond to antibiotic therapy, there is also evidence that suggest that aberrant regulation of the mucosal immune system might play a part in the pathogenesis of pouchitis arising from an abnormal mucosal immune response to a dysbiosis of the pouch microbiota. If individuals fail to respond to antibiotics, anti-tumor necrosis factor (anti-TNF) agents and vedolizumab have been proposed for the treatment of chronic pouchitis.
Guselkumab, an interleukin-23 (IL-23) p19 subunit antagonist monoclonal antibody, is proven to be efficacious in patients with moderately-to-severely active UC. Efficacy of guselkumab in treating UC has been shown in multiple large clinical trials. However, patients with pouchitis were never the targeted population and were even often excluded from the trials.
Pouchitis becomes a chronic problem with a huge impact in the quality of life of these patients. The incidence of pouchitis has been rising in the last decades. This increase might be explained by a change in dietary habits of this population.
This open label single center trial at UZ Leuven aims to evaluate the efficacy and safety of guselkumab in the treatment of chronic antibiotic refractory pouchitis during a 48-week treatment period, with or without a dietary intervention. Twenty subjects with a proctocolectomy and IPAA for UC who have developed chronic or relapsing pouchitis will be enrolled.

Start Date30 Sep 2025

Sponsor / Collaborator-

NCT06861140

/ Not yet recruitingNot ApplicableIIT

Untersuchung Des Einflusses Einer Tryptophanreichen Diät Auf Das Therapeutische Potential Von Probiotika Nach Antibiotischer Therapie Bei Chronischer Pouchitis (Try Pro Pouch). Eine Prospektive Randomisierte Kontrollierte Doppelblinde Interventionsstudie

Patients with a pouch frequently suffer from chronic inflammation of the intestinal tract, called pouchitis. Pouchitis is routienly treated with repeated courses of antibiotics and probiotics, which does not stop the inflammation from recurring and exposes the patients to the risk of developing antibiotic -resistant pouchitis. Experimental data suggest that the effectiveness of the antibiotic and probiotic treatment can be prolonged by high consumption of trypotophan, an aminoacid present in everyday food. The Try Pro Pouch study aims to compare the consumption of high amounts of tryptophan against placebo in patients with pouchitis.

Start Date01 Apr 2025

Sponsor / Collaborator

Universitätsklinikum Hamburg-Eppendorf

NCT06864403

/ Not yet recruitingPhase 4IIT

Mirikizumab in the Treatment of Chronic Inflammatory Conditions of the Pouch

The goal of this clinical trial is to learn if mirikizumab works to treat pouch disorders in adults. The main questions it aims to answer are:
Does mirikizumab reduce symptoms of pouch disorders
Participants will:
Take mirikizumab every 4 weeks for one year Visit the clinic once every month for two months and at the end of the study Keep a diary of their symptoms

Start Date01 Apr 2025

Sponsor / Collaborator

The University of North Carolina at Chapel Hill

[+1]

100 Clinical Results associated with Pouchitis

100 Translational Medicine associated with Pouchitis

0 Patents (Medical) associated with Pouchitis

2,047

Literatures (Medical) associated with Pouchitis

01 May 2025·Digestive and Liver Disease

Impact of histologic disease activity on long-term outcomes in patients with ileal pouch-anal anastomosis for ulcerative colitis

Article

Author: Piovani, Daniele ; Bezzio, Cristina ; Bonovas, Stefanos ; Spinelli, Antonino ; Repici, Alessandro ; Armuzzi, Alessandro ; Figlioli, Gisella ; Spaggiari, Paola ; Iuzzolino, Martina ; Dal Buono, Arianna ; Gabbiadini, Roberto

BACKGROUNDIleal pouch-anal anastomosis (IPAA) for ulcerative colitis (UC) can incur in complications. The impact of histological activity on the development of pouch-related complications is poorly studied.AIMTo assess the association between histology and long-term outcomes in UC-IPAA.METHODSSingle-center, ambidirectional cohort study including UC-IPAA patients undergoing pouchscopy after ileostomy closure. Histological activity was defined as a Pouchitis Disease Activity Index histology subscore ≥2. The primary outcomes were: (i) development of chronic pouchitis, (ii) need of therapy escalation (azathioprine/biologics), and (iii) a composite outcome of treatment with biologics/azathioprine, pouch-related hospitalization or pouch failure.RESULTSA total of 104 patients were included. After pouchoscopy, the median patient follow-up was 2.3 years (IQR, 1.3-4.0). Eighteen patients (17.3 %) developed chronic pouchitis, 20 (19.2 %) initiated biologics/azathioprine, and 25 (24 %) experienced the composite outcome. After adjusting for confounders, histological activity was significantly associated with development of chronic pouchitis (aHR=4.44; 95 % CI, 1.43-13.80; p=0.010), the treatment with biologics/azathioprine (aHR=4.74; 95 % CI, 1.53-14.71; p=0.007), and the composite outcome (aHR=3.94; 95 % CI, 1.53-10.13; p=0.004).CONCLUSIONHistological activity is associated with the development of chronic pouchitis and the need for azathioprine/biologics in UC-IPAA patients, highlighting its potential role in guiding long-term management.

25 Apr 2025·Zhonghua wei chang wai ke za zhi = Chinese journal of gastrointestinal surgery

[Surgical treatment of ulcerative colitis: a 10-year retrospective analysis at a surgical referral center].

Article

Author: Zhou, Y ; Gong, J F ; Waresi, Abudourexiti ; Zhu, F ; Li, S ; Yang, Z R ; Wang, Z Y ; Chen, M F ; Guo, Y Z

Objective: To investigate the clinical characteristics, postoperative complications, and risk factors for pouchitis in surgical patients with ulcerative colitis (UC). Methods: This was a retrospective observational study. The clinical data of 336 UC patients who had undergone surgical treatment at the Inflammatory Bowel Disease Center of the Department of General Surgery, Jinling Hospital Affiliated to Nanjing University Medical School from February 2014 to February 2024 were enrolled. The study patients were stratified into 2014-2019 (n = 158) and 2020-2024 groups (n = 178), these being the periods before and after biologics were covered for treatment of UC by national insurance in China in 2020. Clinical characteristics and surgical complications were analyzed and compared between the 2014-2019 and 2020-2024 groups. Multivariable logistic regression was performed to identify the risk factors associated with pouchitis in UC patients undergoing total proctocolectomy with ileal pouch-anal anastomosis (TPC-IPAA). Results: The study cohort comprised 336 UC patients, 193 (57.4%) of whom were men. The median preoperative disease course was 48.0 months and the mean age at colectomy was 46.4±15.4 years. TPC-IPAA had been performed on 275 patients (81.8%), 129 in the 2014-2019 group and 146 in the 2020-2024 group. Sixty-one patients had undergone total or subtotal colectomy, 29 in the 2014-2019 group and 32 in the 2020-2024 group. 262 (78.0%) UC patients underwent surgery due to medical refractory. Ninety-nine (29.5%) had used biopharmaceuticals within 2 months prior to surgery, 63 (18.8%) of them having received infliximab. A smaller proportion of patients had undergone surgery for UC that was refractory to medications in the 2020-2024 group than in the 2014-2019 group (73.0% [130/178] vs. 83.5% [132/158], χ²=5.384, P=0.020), the patients were older at colectomy (48.0±15.4 years vs. 44.6±15.2 years, t=-2.008, P=0.045), the body mass index was higher (20.2±3.1 kg/m² vs. 19.4±3.2 kg/m², t=-2.201, P=0.028), the Mayo score prior to surgery was lower (M[Q₁, Q₃]: 11.0 [9.2, 12.0 points] vs. 12.0 [11.0, 12.0) points, Z=-4.242, P=0.001), the rate of Charlson Comorbidity Index ≥ 3 scores was higher (27.0% [48/178] vs. 17.1% [27/158], χ²=5.384, P=0.020), a greater percentage of patients had received biologics prior to surgery (41.0% [73/178) vs. 16.5% [26/158], χ²=24.285, P<0.001), and intraoperative blood loss was greater (M[Q₁, Q₃]: 100.0 [100.0, 150.0] ml vs. 50.0 [30.0, 100.0] ml, Z=-7.054, P<0.001) despite the operation time being shorter (253.8±74.6 minutes vs. 315.2±96.8 minutes, t=6.265, P<0.001). Among the 275 patients undergoing TPC-IPAA, 95 (34.6%) had early complications (within 30 days after surgery), 20 (7.3%) of which were Clavien-Dindo Grade III-IV complications. Among these patients, 50 (18.2%) had ileus or small bowel obstruction, 11 in the 2014-2019 group and 39 in the 2020-2024 group; this difference is statistically significant (χ²=15.225, P<0.001). Ninety-one patients (33.1%) had late complications (more than 30 days after surgery), 75 (27.3%) being pouchitis (36 in the 2014-2019 group and 39 in the 2020-2024 group); this difference is not statistically significant (χ²=0.049, P=0.824). Five patients (1.8%) had undergone pouch excision with permanent ileostomy. Among the 61 patients who had undergone total or subtotal colectomy, 26 (42.6%) developed early postoperative complications, including 10 (16.4%) Clavien-Dindo Grade III-IV complications and one death (1.6%), the last being attributable to multiorgan dysfunction. Three patients (4.9%) had late complications; the difference in incidence of postoperative complications between the 2014-2019 and 2020-2024 groups is not statistically significant (both P>0.05). Multivariable analysis identified intraoperative blood transfusion (OR: 2.12, 95% CI: 1.19-3.75, P=0.010) and interval to stoma closure > 120 days (OR: 2.05, 95%CI: 1.16-3.62, P = 0.013) as independent risk factors for development of pouchitis in UC patients undergoing TPC-IPAA. Conclusion: Surgical treatment of UC remains safe in the biologics era. Proactive strategies to reduce intraoperative blood transfusion and achieve timely stoma closure may reduce the risk of pouchitis in UC patients undergoing TPC-IPAA.

10 Apr 2025·Inflammatory Bowel Diseases

Altered Bile Acids and Pouch Microbiota Composition in Patients With Chronic Pouchitis

Communications

Author: Dunleavy, Katie ; Camilleri, Michael ; Raffals, Laura

Lay SummaryThis 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 to improve patients’ health.

News (Medical) associated with Pouchitis

10 Sep 2024

·www.businesswire.com

MRM Health Appoints Grégoire Franoux as Chief Business Officer and Adds Ron Robison to its Board of Directors

GHENT, Belgium--( BUSINESS WIRE )-- MRM Health NV, a clinical-stage biopharmaceutical company developing innovative therapeutics for inflammatory, CNS and metabolic diseases, today announced the appointment of Grégoire Franoux, M.B.A., to the newly created role of Chief Business Officer. Concurrently, the company has strengthened its Board of Directors with the appointment of industry veteran Ron Robison, M.D. “ We are excited to have Grégoire join our executive team at this pivotal moment for MRM Health, on the cusp of late-stage clinical development for our lead candidate MH002 in ulcerative colitis and pouchitis, from our proprietary CORAL platform designed to harness the full power of the gut microbiome to develop effective and safe therapeutics,” said Sam Possemiers, Ph.D., Chief Executive Officer of MRM Health. “Grégoire’s extensive expertise in corporate development, combined with his strategic acumen, will be crucial as we continue to advance our pipeline and expand our reach. ” Mr. Franoux will lead the company’s business development and corporate strategy, focusing on forging strategic partnerships and driving growth. He brings 20 years of experience in strategic planning, licensing, business development and corporate finance within the biotechnology sector. He joins MRM Health from Belfius Bank, where he was spearheading Corporate Finance and Capital Markets activities in the Life Sciences sector. Prior to joining Belfius, Gregoire held senior business development positions at Oxurion, Gruenenthal GmbH and Flamel Technologies. He holds an M.S. in Biotechnology from ESIEE Paris, an M.S. in International Finance from IAE Aix-Marseille, and an Executive M.B.A. from INSEAD. “ It is an exciting time to join the MRM Health team as the company makes important progress advancing next-generation LBPs for inflammatory, CNS and metabolic diseases. I look forward to optimizing the value of MRM’s potentially life-altering therapies and delivering them to patients in need ,” commented Grégoire Franoux. In addition, MRM Health welcomes Ron Robison, M.D., to its Board of Directors. Ron, who previously served as Vice President at AbbVie, brings over three decades of experience in drug development and commercialization. Ron also served in global senior pharmaceutical R&D leadership roles at several organizations, including Mallinckrodt Medical, Sanofi/Sterling Winthrop, Nycomed, Amersham Health, Abbott and Head of R&D and Chief Medical Officer at Solvay Pharmaceuticals. Ron has overseen the approval of more than 20 new molecular entities worldwide with over ten innovative clinical indications obtained under FDA breakthrough therapy designation. Dr. Robison holds an M.D. from the Oregon Health Sciences University, an M.S. in Medical Informatics/Biomedical Engineering from the University of Utah, and a B.S. from Oregon State University. MRM Health Chairman Werner Cautreels added, “ We are thrilled to have Ron join our Board. His deep industry knowledge and experience progressing assets through clinical and global regulatory development will be invaluable as we continue to grow and develop potentially transformative therapies. ” -Ends- About MRM Health MRM Health is a clinical-stage biotech developing innovative therapeutics for inflammatory, CNS and metabolic diseases. The Company’s most advanced program MH002 is in preparation for pivotal clinical development in Ulcerative Colitis and/or in the orphan disease indication Pouchitis. MRM Health leverages its proprietary disruptive CORAL ® technology platform to design microbiome-based biotherapeutics, based on disease-focused specific combinations of 5 to 10 live gut bacteria, and to optimize them for faster onset-of-action and increased potency and robustness. A significant differentiator is the ability to manufacture these consortia as single drug substance in a single standardized, scalable and highly cost-effective process. In addition to the program in Inflammatory Bowel Diseases, MRM Health has ongoing preclinical programs in Parkinson’s Disease and Spondyloarthritis, and partnered programs with IFF in Type 2 Diabetes and NAFLD. For more information, please visit the website at www.mrmhealth.com .

Executive ChangeBreakthrough Therapy

25 Jul 2024

·www.pharmaceutical-technology.com

Sandoz launches ustekinumab biosimilar in Europe

An image of a patient with psoriasis. Sandoz’s ustekinumab biosimilar is indication for several autoimmune conditions including psoriasis. Image credit: Shutterstock/Fuss Sergey Sandoz has announced the European launch of Pyzchiva, a ustekinumab biosimilar approved for the treatment of several autoimmune conditions including psoriasis and Crohn’s disease. Free Buyers Guide Leading Guide to Injectables (Commercial Dose) Companies in Contract Manufacturing for the Pharmaceutical Industry The document includes detailed information on the manufacturers and suppliers and their products, along with contact details, to inform your purchasing decision. Thank you. Go deeper with GlobalData Reports LOA and PTSR Model - Ustekinumab Biosimilar in Ulcerative Colitis Reports LOA and PTSR Model - Ustekinumab in Pouchitis Data Insights The gold standard of business intelligence. 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Pyzchiva is a biosimilar of Johnson and Johnson Innovation Medicine’s (J&J) Stelara , which is approved for treating plaque psoriasis, psoriasis arthritis, and paediatric plaque psoriasis for patients six years and older and weighing over 60kg, as well as Crohn’s disease. In 2021, a Phase III trial (2020-006115-19) demonstrated equivalent efficacy and comparable safety between the biosimilar and reference treatments. The launch comes after the European Medicines Agency (EMA) approved the therapy in April. Following a US Food and Drug Administration (FDA) approval in June, Sandoz has stated that it intends to launch the biosimilar for the US market in February 2025. The launch came in the wake of an agreement between the Swiss company and Samsung Bioepis, finalised in September 2023. Sandoz holds the commercial rights to Pyzchiva in the US, the EU, the UK, Switzerland, and Canada. Meanwhile Samsung Bioepis retains intellectual property rights and remains responsible for development and supply of the drug. The biosimilar joins the Sandoz’s portfolio of five other biosimilars for autoimmune disorders on the market. Launching Pyzchiva in Europe holds particular significance. The continent has the highest prevalence of psoriasis worldwide, estimated to affect 6.4 million people, with over 85% of cases presenting as plaque psoriasis. Along with North America, Western Europe is also home to the world’s highest prevalence of Crohn’s disease, creating ample demand for cheaper, more abundantly available therapeutic options. See Also: MHRA approves Pfizer-BioNTech’s Comirnaty JN.1 vaccine Pipeline power: Sionna’s AbbVie deal could redefine CF therapeutics According to GlobalData, the market surrounding psoriasis treatments is estimated to have doubled since 2014, potentially reaching $13.1bn globally and $4.13bn in the EU in 2024. While Stelara earned $10.8bn in 2023, the drug sales are estimated to drop to $2.9bn in 2028, as per GlobalData. Pyzchiva is set to benefit from this growing market, with its global sales projected to rise to $120m in 2025 and then further to $339m by 2028. GlobalData is the parent company of Pharmaceutical Technology . While not the sole ustekinumab biosimilar approved in Europe, Pyzchiva is the first that is available in 90mg or 45mg concentrations for injection and as a 130mg concentration for infusion—the same dose strengths shown to be effective for the reference medicine. Ustekinumab targets IL-12 and IL-23, both interleukins, which are key to the pathogenesis of several inflammatory diseases. This inhibits signalling and further cytokine production, reducing inflammation and modulating the body’s immune response. Free Buyers Guide Leading Guide to Injectables (Commercial Dose) Companies in Contract Manufacturing for the Pharmaceutical Industry The document includes detailed information on the manufacturers and suppliers and their products, along with contact details, to inform your purchasing decision. Thank you. Your download email will arrive shortly.Please check your mail inbox to download buyer's guide You may also be interested in: Leading Guide to Packaging Materials, Containers and Containment Services for the Pharmaceutical Industry Download now Leading Guide to Purification and Filtration for the Pharmaceutical Industry Download now Top Guide for Drug Delivery Systems Download now Leading Guide to Pharmaceutical Solid Dose (Commercial Dose) Manufacturing Companies for the Pharmaceutical Industry Download now By Pharma Buyers Guide Country Code * UK (+44) USA (+1) Algeria (+213) Andorra (+376) Angola (+244) Anguilla (+1264) Antigua & Barbuda (+1268) Argentina (+54) Armenia (+374) Aruba (+297) Australia (+61) Austria (+43) Azerbaijan (+994) Bahamas (+1242) Bahrain (+973) Bangladesh (+880) Barbados (+1246) Belarus (+375) Belgium (+32) Belize (+501) Benin (+229) Bermuda (+1441) Bhutan (+975) Bolivia (+591) Bosnia Herzegovina (+387) Botswana (+267) Brazil (+55) Brunei (+673) Bulgaria (+359) Burkina Faso (+226) Burundi (+257) Cambodia (+855) Cameroon (+237) Canada (+1) Cape Verde Islands (+238) Cayman Islands (+1345) Central African Republic (+236) Chile (+56) China (+86) Colombia (+57) Comoros (+269) Congo (+242) Cook Islands (+682) Costa Rica (+506) Croatia (+385) Cuba (+53) Cyprus North (+90392) Cyprus South (+357) Czech Republic (+42) Denmark (+45) Djibouti (+253) Dominica (+1809) Dominican Republic (+1809) Ecuador (+593) Egypt (+20) El Salvador (+503) Equatorial Guinea (+240) Eritrea (+291) Estonia (+372) Ethiopia (+251) Falkland Islands (+500) Faroe Islands (+298) Fiji (+679) Finland (+358) France (+33) French Guiana (+594) French Polynesia (+689) Gabon (+241) Gambia (+220) Georgia (+7880) Germany (+49) Ghana (+233) Gibraltar (+350) Greece (+30) Greenland (+299) Grenada (+1473) Guadeloupe (+590) Guam (+671) Guatemala (+502) Guinea (+224) Guinea - 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Drug ApprovalPhase 3VaccineClinical Result

11 Jul 2024

·www.pharmaceutical-technology.com

PharmassêtX gains FDA orphan drug status for IBD drug

The safety and effectiveness of EGCG for IBD were supported by peer-reviewed studies. Credit: MMD Creative/Shutterstock. PharmassêtX has received US Food and Drug Administration’s (FDA) orphan drug designation (ODD) for epigallocatechin gallate (EGCG), to treat pouchitis, a rare form of inflammatory bowel disease (IBD). PharmassêtX’s EGCG, a component of green tea, is being developed as a high-purity, high-potency drug for IBD treatment. The safety and effectiveness of EGCG for IBD were supported by peer-reviewed studies, including a clinical trial. A double-blinded, randomised, placebo-controlled, investigator-initiated clinical study of an EGCG-enriched green tea extract demonstrated clinical and endoscopic improvement in patients with mild to moderate ulcerative colitis, without serious adverse events. Further evidence from a retrospective study showed that most refractory pouchitis patients achieved complete symptom relief with EGCG with no serious adverse events reported. See Also: Explainer: Labour has been elected in the UK – now what? EGCG’s mechanism of action includes targeting NF-κB, a regulator of mucosal immunity. PharmassêtX is working to bring its ultra-pure EGCG drug, PSX-514, into clinical trials. The company has partnered with Canada-based global contract research organisation Alimentiv to expedite the development of PSX-514 and bring it to clinic in 2025. PharmassêtX co-founder and CEO Terry Minton stated: “We are grateful to be positioned to provide a much-needed innovative drug, for which there is already substantial evidence of safety and effectiveness, to the underserved community of pouchitis patients. “Our mission as an organisation is to improve outcomes and enhance quality of life for IBD patients. The granting of this ODD is an important milestone along the critical path to accomplishing that mission.

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