Therapeutic Advances in Gastroenterology最新文献

{"title":"Jaundice marks immunoglobulin G4-related cholangitis in type 1 autoimmune pancreatitis patients.","authors":"Chi-Huan Wu, Kai-Feng Sung, Chung-Guei Huang, Shih-Chiang Huang, Yung-Lin Chang, Sheng-Fu Wang, Wei-Pin Lin, Tsung-Hsing Chen, Cheng-Jen Chen, Chung-Wei Su, Cheng-Yu Lin, Chia-Jung Kuo, Yi-Chung Hsieh, Jennifer Tai, Ming-Ling Chang","doi":"10.1177/17562848261447198","DOIUrl":"10.1177/17562848261447198","url":null,"abstract":"<p><strong>Background: </strong>The phenotype of immunoglobulin G4 (IgG4)-related cholangitis (IRC) patients among type 1 autoimmune pancreatitis (AIP-1) patients in Taiwan, where secondary biliary cholangitis is prevalent, is unknown.</p><p><strong>Objectives: </strong>To evaluate the phenotype of IRC in AIP-1 patients.</p><p><strong>Design: </strong>Retrospective cohort study.</p><p><strong>Methods: </strong>A 15-year cohort study of 237 AIP-1 patients was conducted. AIP-1 was diagnosed according to the HISORt criteria.</p><p><strong>Results: </strong>Of 237 AIP-1 patients, 90 (37.9%) had IRC (males: <i>n</i> = 80 (88.9%); type 1 IRC: <i>n</i> = 80 (88.8%); mean age: 65.63 years). Among AIP-1 patients, those with IRC had higher alanine aminotransferase (ALT) (179.4 ± 202.6 vs 118.0 ± 167.8 U/L, <i>p</i> = 0.014), alkaline phosphatase (ALP) (322.5 ± 239.1 vs 201.4 ± 193.7 U/L, <i>p</i> < 0.001), total bilirubin (bili-T) (5.69 ± 5.28 vs 2.95 ± 4.19 mg/dL, <i>p</i> < 0.001), and IgG4 (1271.9 ± 1256.3 vs 904.0 ± 811.4 mg/dL, <i>p</i> = 0.015) levels and a borderline higher cumulative incidence of mortality (14.4 vs 7.5%, <i>p</i> = 0.068) than those without IRC did. Moreover, baseline bili-T levels (odds ratio (OR): 1.194, <i>p</i> = 0.031) (cutoff: >2.2 mg/dL) were independently associated with IRC. Among AIP-1 patients, baseline ALP (OR: 1.004, <i>p</i> = 0.001), fibrosis-4 index (OR: 1.156, <i>p</i> = 0.025), cirrhosis (OR: 23.157, <i>p</i> < 0.001), and neutrophil-to-lymphocyte ratio (NLR) (OR: 1.103, <i>p</i> = 0.008) were associated with mortality. Among the IRC-AIP-1 patients, baseline ALP levels (OR: 1.002, <i>p</i> = 0.028) and NLR (OR: 1.091, <i>p</i> = 0.012) were associated with mortality.</p><p><strong>Conclusion: </strong>In total, 37.9% of AIP-1 patients had IRC. Higher levels of hepatocellular injury, cholestatic features, and IgG4 were noted in patients with IRC than in patients without IRC. Baseline bili-T level (cutoff > 2.2 mg/dL) is an indicator of IRC among AIP-1 patients. Biliary injury and systemic inflammation are associated with mortality in all AIP-1 and IRC-AIP-1 patients. Liver fibrosis subsequent to IRC might further increase mortality in AIP-1 patients.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"19 ","pages":"17562848261447198"},"PeriodicalIF":3.8,"publicationDate":"2026-05-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13172725/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147964894","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical characteristics and treatment pathways of ulcerative colitis patients with isolated proctitis in Europe and the United States.","authors":"Alessandro Armuzzi, Silvio Danese, Manuel Barreiro-de Acosta, Peter Hur, Lauren Bartolome, Karolina Wosik, Hannah Knight, Vanda Palace, Laurent Peyrin-Biroulet","doi":"10.1177/17562848261448080","DOIUrl":"10.1177/17562848261448080","url":null,"abstract":"<p><strong>Background: </strong>Treatment guidance and real-world data assessing the management and burden of isolated proctitis (IP) are limited.</p><p><strong>Objective: </strong>We aimed to understand disease burden in ulcerative colitis (UC) patients with different degrees of disease extension, focusing on IP.</p><p><strong>Design: </strong>A cross-sectional survey, with retrospective data collection, of physicians and their consulting patients was conducted in France, Germany, Italy, Spain, the United Kingdom, and the United States between January 2020 and March 2021.</p><p><strong>Methods: </strong>Data were drawn from the Adelphi Real World UC Disease Specific Programme™. Physicians reported clinical presentation and treatment history for patients with UC. Patients were stratified according to their disease extension into IP (non-refractory (never received an immunomodulator (IM)/advanced therapy (AT)) or refractory (received an IM/AT)) and more extensive UC (MEUC) groups. Analyses were descriptive.</p><p><strong>Results: </strong>Among patients with IP (<i>n</i> = 221) and MEUC (<i>n</i> = 1607), respectively, the most common symptoms were abdominal pain (33.8% and 26.0%), bowel urgency (22.7% and 23.6%), and fatigue (22.7% and 23.8%). Physicians also commonly reported passing mucus (19.0%), tenesmus (15.7%), and rectal bleeding (15.3%) among patients with IP. Following diagnosis, 21.3% of IP and 42.8% of MEUC patients had received an IM, and 33.5% of IP and 68.9% of MEUC patients had received an AT. According to derived total Mayo scores, at consultation, 40.3% (95% confidence interval: 33.7, 47.1) of IP and 50.4% (47.9, 52.9) of MEUC patients were in remission; the lowest proportion of patients in remission was among refractory IP patients (35.0% (25.8, 45.0)).</p><p><strong>Conclusion: </strong>Patients with IP experienced a range of symptoms, with many requiring treatment beyond the guideline-recommended first-line conventional therapies. In addition, the majority of IP patients with IM and/or AT experience were not in remission.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"19 ","pages":"17562848261448080"},"PeriodicalIF":3.8,"publicationDate":"2026-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13167275/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147943348","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Exclusive enteral nutrition and infliximab combination therapy are superior to monotherapy in inducing endoscopic response in active adult Crohn's disease.","authors":"Xinglan Li, Xudong Wu, Dengfeng Kang, Leilei Fang, Changqin Liu, Yanhong Shi, Li Yang, Zhanju Liu, Liang Chen","doi":"10.1177/17562848261445516","DOIUrl":"10.1177/17562848261445516","url":null,"abstract":"<p><strong>Background: </strong>Anti-tumor necrosis factor alpha (anti-TNFα) agents assume a significant role in the management of Crohn's disease (CD). Exclusive enteral nutrition (EEN) is as effective as corticosteroids for inducing remission in children with active CD, but less effective in adults. Few studies have compared the relative effectiveness of these strategies in achieving endoscopic improvement and symptom relief.</p><p><strong>Objectives: </strong>We aimed to compare the efficacy of EEN, infliximab (IFX), and combination therapy in adult patients with CD.</p><p><strong>Design: </strong>Retrospective cohort study.</p><p><strong>Methods: </strong>Between March 2021 and June 2024, 270 adult patients with active CD were recruited and received EEN, IFX, or combination treatment for 14 weeks. Propensity-score (PS) matching was conducted to balance the baseline characteristics across the three groups. The fecal 16S rRNA sequencing and metabolomics analyses were applied to further analyze the underlying mechanism involved in combination and monotherapy.</p><p><strong>Results: </strong>Of the 270 reviewed patients, a total of 146 PS-matched adult CD patients who received EEN (<i>n</i> = 29), IFX (<i>n</i> = 56), and combination therapy (<i>n</i> = 61), respectively, were analyzed. The combination therapy of EEN plus IFX demonstrated greater improvement in endoscopic response at week 14 compared to both the EEN group (<i>p</i> = 0.021) and the IFX group (<i>p</i> = 0.032), but not in endoscopic remission. Combination therapy also exhibited a significantly higher clinical response rate compared with EEN (<i>p</i> = 0.027) and IFX (<i>p</i> = 0.038) monotherapy, but no significant difference in clinical remission. Furthermore, compared with IFX monotherapy, combination therapy increased the IFX trough level at week 14 (<i>p</i> < 0.001). Fecal 16S rRNA sequencing revealed that combination therapy successfully restored the abundance of <i>Bacteroidetes</i> and related genera. Targeted metabolomics further confirmed a significant increase in short-chain fatty acids (SCFA) and key metabolites (e.g., indolelactic acid) in fecal samples 14 weeks after combination therapy.</p><p><strong>Conclusion: </strong>Combination therapy is more effective than EEN or IFX monotherapy for short-term endoscopic and clinical response. Mechanistically, combination therapy reshapes the gut microbiota, restores levels of SCFAs, and increases key protective fecal metabolites, offering a promising strategy for the management of CD.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"19 ","pages":"17562848261445516"},"PeriodicalIF":3.8,"publicationDate":"2026-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13167384/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147943338","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clostridioides difficile infection in inflammatory bowel disease: an observational study in flares of ulcerative colitis and a South Asian region-specific systematic review and meta-analysis.","authors":"Deepak Bansal, Sapna Pahil, Abhirup Chatterjee, Simran Kaur, Harshal S Mandavdhare, Jimil Shah, Vaneet Jearth, Aravind Sekar, Sandeep Raut, Harjeet Singh, Sahil Khanna, Saroj Kant Sinha, Neelam Taneja, Usha Dutta, Vishal Sharma","doi":"10.1177/17562848261446520","DOIUrl":"10.1177/17562848261446520","url":null,"abstract":"<p><strong>Background: </strong><i>Clostridioides difficile</i> infection (CDI) is well-recognised as a cause of flare in inflammatory bowel disease (IBD).</p><p><strong>Objectives: </strong>To prospectively evaluate CDI as a cause of flare in moderate-to-severe ulcerative colitis (UC) and perform a region-specific systematic review to evaluate the role of CDI in IBD patients in South Asia.</p><p><strong>Design: </strong>A single-centre prospective observational study followed by a region-specific systematic review.</p><p><strong>Data sources and methods: </strong>The observational study was conducted between December 2024 and December 2025 and included patients with moderate-to-severe UC flares. Triple testing using Stool glutamate dehydrogenase (GDH), an enzyme immunoassay (EIA) for toxin A/B, and polymerase chain reaction (PCR) testing was performed. A literature search in PubMed, Embase, and Scopus was conducted on 5th December 2025 to identify relevant studies from South Asia. Information on the study population (IBD type, age, gender, disease activity), the testing method, and the outcomes of CDI testing were extracted. The pooled prevalence of CDI was estimated using a random-effects model. The risk of Bias was assessed using Joanna Briggs' tool.</p><p><strong>Results: </strong>Of the 101 patients with active UC, 59 had acute severe UC. Six patients tested positive for GDH, whereas only one tested positive for EIA and PCR. A total of 13 studies reporting on 1267 patients were included in the systematic review. Pooled prevalence of CDI was 0.06 (0.03-0.11, <i>I</i> ² = 80.8%). Subgroup analyses were performed by testing method, study type, and region. However, there was persistent statistical heterogeneity. Funnel plot and Egger's test suggested the presence of publication bias.</p><p><strong>Conclusion: </strong>Our observational study shows a low prevalence of CDI as a cause of UC flares. The findings of the systematic review suggest high variability in the CDI positivity across South Asia. These differences were not fully explained by the method of testing, the type of study, or the geographic location of the study.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"19 ","pages":"17562848261446520"},"PeriodicalIF":3.8,"publicationDate":"2026-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13167341/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147943402","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A novel clustering of down syndrome and coeliac disease complicated by enteritis and small intestinal strictures: a case series.","authors":"Cynthia Kanagasundaram, Joanna Efklides, Elaine Koh, Sarah Ryan, Tim Elliott, Lani Prideaux, Xiao-Fei Kong, Sern Wei Yeoh, Jaycen Cruickshank, Jason A Tye-Din","doi":"10.1177/17562848261446854","DOIUrl":"10.1177/17562848261446854","url":null,"abstract":"<p><p>Down syndrome (DS) increases risk for autoimmune conditions, including coeliac disease (CeD). Here, we report five adults with DS and biopsy-proven CeD who developed enteritis and symptomatic small bowel stricturing, a clustering not previously described in this population. All five patients had confirmed DS and CeD, and despite apparent adherence to a gluten-free diet, all developed small bowel strictures requiring endoscopic intervention, most commonly at the duodenal D1/D2 junction. Stricture histology demonstrated active CeD with varying degrees of inflammation and fibrosis. Three patients had elevated faecal calprotectin without consistent colonic pathology, suggesting enteritis as an important inflammatory driver. Two patients responded well to open capsule budesonide with symptom resolution and histological improvement. One patient showed no sustained benefit from multiple immunosuppressive agents, including corticosteroids, azathioprine, and infliximab, requiring repeated endoscopic dilatations. Differential diagnoses, including Crohn's disease, tuberculosis, nonsteroidal anti-inflammatory drug (NSAID) enteropathy, refractory CeD, and cryptogenic multifocal ulcerating stenosing enteritis were excluded based on clinical history, imaging, and histological findings. No granulomas or aberrant T-cell populations were identified. We propose this clustering may reflect a shared pathogenic mechanism linked to the interferonopathy of DS. Trisomy 21 causes overexpression of interferon receptors, creating heightened interferon signalling. Combined with CeD-triggered interferon production from gluten exposure, this may drive amplified immune activation, chronic enteritis, and fibrotic stricture formation. This hypothesis warrants further investigation through transcriptomic and immunohistochemical studies. Clinicians should consider this clustering in DS patients with CeD who present with persistent gastrointestinal symptoms. Given the underlying biology, JAK inhibitors may represent a promising therapeutic option for this phenotype and merit future study.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"19 ","pages":"17562848261446854"},"PeriodicalIF":3.8,"publicationDate":"2026-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13161639/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147934860","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Long-term risk of irritable bowel syndrome associated with social isolation and loneliness: a large-scale prospective cohort study with mediation analysis.","authors":"Yesheng Zhou, Si Liu, Qian Zhang, Shutian Zhang, Shanshan Wu","doi":"10.1177/17562848261446458","DOIUrl":"10.1177/17562848261446458","url":null,"abstract":"<p><strong>Background: </strong>Social isolation and loneliness are common among older adults and have been linked to metabolic disorders, psychological conditions, and unhealthy lifestyle behaviors. However, their associations with incident irritable bowel syndrome (IBS) remain unclear.</p><p><strong>Objective: </strong>To investigate the associations of social isolation and loneliness with incident IBS risk, and the mediating roles of anxiety or depression.</p><p><strong>Design: </strong>Population-based prospective cohort study.</p><p><strong>Methods: </strong>Participants without IBS and with available social isolation and loneliness data at recruitment were included (<i>N</i> = 394,458). Social isolation was assessed using household size, social contact frequency, and weekly social activities, while loneliness was measured by self-reported feelings of loneliness and willingness to confide. The primary outcome was incident IBS. Cox regression with sequential mediation analysis was conducted to estimate the effect.</p><p><strong>Results: </strong>During a median follow-up of 14.5 years, 8307 (2.1%) incident IBS cases were identified. Overall, 209,081 (53.0%), 149,729 (38.0%), and 35,648 (9.0%) participants were classified as least, moderately, and most isolated, respectively. The 14-year cumulative incidence of IBS increased from 2.0% (95% confidence interval (CI): 2.0-2.1) in the least isolated group to 2.2% (95% CI: 2.2-2.3) and 2.6% (95% CI: 2.4-2.8) in the moderately and most isolated groups (population-attributable fraction (PAF) = 3.6%). Compared with the least isolated group, most isolated individuals had a 20.0% higher IBS risk (hazard ratio (HR) = 1.20, 95% CI: 1.11-1.29), with 24.7% of the effect mediated by depression or anxiety. The 14-year cumulative incidence of IBS was 3.1% (95% CI: 2.9-3.4) in the lonely group versus 2.1% (95% CI: 2.1-2.1) in the non-lonely group (PAF = 2.1%). Compared with non-lonely individuals (95.2%), lonely individuals (4.8%) showed a 46.0% increased IBS risk (HR = 1.46, 95% CI: 1.34-1.59), with 26.5% of the effect mediated by depression or anxiety. In addition, one increment in social isolation score (HR = 1.08, 95% CI: 1.04-1.11) and loneliness score (HR = 1.27, 95% CI: 1.23-1.32) were associated with 8.0% and 27.0% higher IBS risk, respectively. Particularly, most isolated and lonely individuals exhibited a 60.0% greater IBS risk versus their non-lonely and least isolated counterparts (HR = 1.60, 95% CI: 1.35-1.89).</p><p><strong>Conclusion: </strong>Both social isolation and loneliness are associated with increased IBS risk, partially mediated by depression or anxiety. Multi-level psychosocial and environmental interventions may help reduce IBS burden.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"19 ","pages":"17562848261446458"},"PeriodicalIF":3.8,"publicationDate":"2026-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13158496/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147934775","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Phenotype-driven management in ileocecal Crohn's disease: a narrative review with a proposed research framework.","authors":"Chuong Dinh Nguyen, Luan Minh Dang, Thong Duy Vo, Hoang Huu Bui, Partha Pal, Taku Kobayashi, Byong Duk Ye","doi":"10.1177/17562848261446459","DOIUrl":"10.1177/17562848261446459","url":null,"abstract":"<p><p>The management of localized ileocecal Crohn's disease (CD) requires balancing escalation of medical therapy against early surgical resection. While clinical phenotyping guides initial management, standard assessments often fail to distinguish reversible inflammation from irreversible fibrosis. This limitation remains a major barrier to personalized care. This narrative review aims to review current evidence on clinical features, imaging modalities, and biomarkers relevant to intestinal fibrosis and to propose a phenotype-driven framework for treatment selection in localized ileocecal CD. To address this, we synthesized current literature on intestinal fibrogenesis, cross-sectional imaging (magnetization transfer MRI (MT-MRI), shear wave elastography (SWE)), and therapeutic outcomes. Evidence was integrated to develop a conceptual algorithm incorporating disease phenotype, quantitative imaging markers, and multidisciplinary decision-making. The proposed two-tiered framework begins with the Montreal classification (Tier 1). B1 phenotypes are directed toward early intensive treat-to-target medical strategies, while B3 phenotypes may require individualized surgical management, sometimes preceded by short-term medical optimization depending on complication severity. For the challenging B2 phenotype, we propose a precision medicine pathway (Tier 2) utilizing quantitative imaging, such as MT-MRI or SWE. This pathway is intended to help stratify B2 strictures into fibrosis-dominant, inflammation-dominant, or indeterminate phenotypes within a multidisciplinary decision-making process. A phenotype-driven approach incorporating clinical and imaging information may help inform therapeutic decision-making across the spectrum of ileocecal CD, particularly in the management of stricturing disease. The proposed framework provides a roadmap for prospective validation and future clinical trials aimed at optimizing treatment selection in stricturing disease.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"19 ","pages":"17562848261446459"},"PeriodicalIF":3.8,"publicationDate":"2026-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13158495/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147934795","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Vedolizumab clinical decision support tool predicts clinically relevant targets in patients with Crohn's disease.","authors":"Parambir S Dulai, Giorgos Bamias, Vipul Jairath, Anthony Buisson, Marlies Meyer, Dirk Lindner, Christian Agboton, Laurent Peyrin-Biroulet","doi":"10.1177/17562848261436120","DOIUrl":"10.1177/17562848261436120","url":null,"abstract":"<p><strong>Background: </strong>The vedolizumab-specific clinical decision support tool (VDZ-CDST) was developed to predict the probability of a response to vedolizumab treatment in patients with Crohn's disease (CD).</p><p><strong>Objective: </strong>This post hoc analysis aimed to characterize the VDZ-CDST's ability to predict clinical outcomes and quality of life (QoL) among vedolizumab-treated patients.</p><p><strong>Design: </strong>Post hoc analysis of pooled clinical trial data.</p><p><strong>Methods: </strong>Pooled data from GEMINI 2, VERSIFY, and VISIBLE 2 clinical trials were utilized, and patients with CD were classified using the VDZ-CDST as having a low, intermediate, or high probability of response to vedolizumab. Mean patient-reported outcome 2 score, symptomatic response, symptomatic remission, and QoL (Inflammatory Bowel Disease Questionnaire) were assessed. Data up to 1 year were analyzed.</p><p><strong>Results: </strong>Overall, 1189 patients with CD were included. The VDZ-CDST classified 240, 548, and 401 patients as having a low, intermediate, and high probability of response to vedolizumab, respectively. Mean patient-reported outcome 2 scores decreased from baseline to week 52 in all groups, with fastest and greatest reductions in the high probability group. Symptomatic response at week 6 was achieved by 40.4%, 23.9%, and 9.6% in the high, intermediate, and low probability groups, respectively, and rates in the high probability group were greatest through week 52. Rates of symptomatic remission were highest in the high probability group, followed by intermediate and low at week 6 through week 52. The greatest improvements in QoL were observed in the high probability group.</p><p><strong>Conclusion: </strong>These findings provide confirmatory evidence of the utility of the VDZ-CDST in identifying patients with CD who are most likely to achieve optimal clinical and QoL outcomes with vedolizumab treatment.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"19 ","pages":"17562848261436120"},"PeriodicalIF":3.8,"publicationDate":"2026-05-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13157563/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147876273","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effect of <i>Helicobacter pylori</i> infection on the risk of inflammatory bowel disease: an umbrella review and second-order meta-analysis.","authors":"Xiaomin Wang, Haonan Zhao, Honglu Yu, Juan Liu, Yongguo Zhang, Jiang Chen, Xingshun Qi","doi":"10.1177/17562848261444293","DOIUrl":"10.1177/17562848261444293","url":null,"abstract":"<p><strong>Background: </strong>Multiple meta-analyses have evaluated the effect of <i>Helicobacter pylori</i> (<i>H. pylori</i>) infection on the risk of inflammatory bowel disease (IBD), but their findings remain inconsistent.</p><p><strong>Objectives: </strong>To critically assess the existing meta-analyses regarding the effect of <i>H. pylori</i> infection on the risk of IBD.</p><p><strong>Data sources and methods: </strong>We systematically searched four electronic databases and manually screened the reference lists of relevant articles. A Measurement Tool to Assess systematic Reviews 2 (AMSTAR-2), Grade of Recommendation, Assessment, Development, and Evaluation (GRADE), and Graphical Representation of Overlap for OVErviews (GROOVE) tools were used to assess the methodological quality, evidence quality, and the overall overlap of primary studies among the included meta-analyses, respectively. A second-order meta-analysis was performed on primary studies derived from the included meta-analyses with very high overlap to explore the association of <i>H. pylori</i> infection with IBD risk and identify the potential influencing factors. Risk ratios (RRs) were pooled.</p><p><strong>Results: </strong>Twelve meta-analyses encompassing 55 primary studies were included. The methodological quality was very low to low. The evidence quality was very low to high. Moderate- to high-quality evidence suggested that <i>H. pylori</i> virulence factors and antibiotic exposure influenced the association of <i>H. pylori</i> infection with IBD. The overall overlap of primary studies among the included meta-analyses was very high. A second-order meta-analysis demonstrated a negative association of <i>H. pylori</i> infection with any type of IBD (RR: 0.60), Crohn's disease (RR: 0.53), ulcerative colitis (RR: 0.67), and IBD-unclassified (RR: 0.73). Subgroup analyses demonstrated that both IBD subtypes (<i>P</i> _interaction < 0.01), regions (<i>P</i> _interaction < 0.01), and study designs (<i>P</i> _interaction = 0.05) significantly influenced this association. Sensitivity analyses indicated that the results were robust across IBD subtypes and regions, but not across the study designs.</p><p><strong>Discussion: </strong><i>H. pylori</i> infection seems to exhibit a protective effect against the risk of IBD. This association may be influenced by IBD subtypes, regions, <i>H. pylori</i> virulence factors, and antibiotic exposure.</p><p><strong>Design: </strong>This is an umbrella review.</p><p><strong>Registration: </strong>The protocol was prospectively registered with the PROSPERO database (CRD42024559958).</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"19 ","pages":"17562848261444293"},"PeriodicalIF":3.8,"publicationDate":"2026-05-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13157542/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147876265","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Baseline characteristics, treatment patterns, and long-term outcomes in patients with eosinophilic esophagitis initiating dupilumab in routine clinical practice: study protocol of a phase IV, prospective, observational, multicenter registry (EDESIA).","authors":"Evan S Dellon, Mirna Chehade, Emily C McGowan, Elizabeth T Jensen, John Leung, Devrim Eren, James T Angello, Amr Radwan, Sandy R Durrani, Sabina deMarchi","doi":"10.1177/17562848261443887","DOIUrl":"10.1177/17562848261443887","url":null,"abstract":"<p><strong>Background: </strong>Dupilumab, a fully human monoclonal antibody that blocks interleukin-4 and -13 signaling, is approved for the treatment of eosinophilic esophagitis (EoE) based on phase III clinical trials. However, real-world data on dupilumab use for EoE are lacking.</p><p><strong>Objectives: </strong>To assess the characteristics, treatment patterns, and outcomes among patients with EoE aged 12 years or older who receive treatment with dupilumab for EoE as prescribed under the US prescribing information.</p><p><strong>Design: </strong>This study protocol describes a phase IV, prospective, observational, multicenter patient registry, EDESIA, which will enroll approximately 300 patients aged 12 years or older who initiate dupilumab treatment as part of routine care across approximately 50 sites in the USA.</p><p><strong>Methods and analysis: </strong>Baseline data collection will include demographics, disease characteristics, medical history, and prior/concomitant therapies. Data will be collected at baseline (day 1 of treatment) and at follow-up visits through 36 months. Key primary outcomes assessed will include details of food elimination diet, history of food impaction and esophageal dilation, histologic and endoscopic findings, and patient-reported outcomes. Adverse events will be monitored throughout the study.</p><p><strong>Ethics: </strong>The EDESIA registry will be conducted in accordance with the Declaration of Helsinki, the International Council for Harmonization guidelines for Good Clinical Practice, and applicable regulatory requirements. The local institutional review board at each study center will approve the study. Written informed consent will be obtained from all patients and/or a parent/legal guardian.</p><p><strong>Discussion: </strong>EDESIA will address the safety and tolerability of long-term weekly dupilumab treatment in patients with EoE, and inform future treatment guidelines.</p><p><strong>Trial registration: </strong>A US registry of EoE adolescent and adult patients treated with DUPIXENT® as standard of care (EDESIA), NCT06693531 (https://www.clinicaltrials.gov/study/NCT06693531).</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"19 ","pages":"17562848261443887"},"PeriodicalIF":3.8,"publicationDate":"2026-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13145017/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147844732","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}