Pub Date : 2024-07-30eCollection Date: 2024-01-01DOI: 10.1177/17562848241258372
Beatriz Gros, Hannah Ross, Maureen Nwabueze, Nathan Constantine-Cooke, Lauranne A A P Derikx, Mathew Lyons, Claire O'Hare, Colin Noble, Ian D Arnott, Gareth-Rhys Jones, Charlie W Lees, Nikolas Plevris
Background: Long-term vedolizumab (VDZ) outcomes in real-world cohorts have been largely limited to 1-year follow-up, with few bio-naïve patients or objective markers of inflammation assessed.
Objectives: We aimed to assess factors affecting VDZ persistence including clinical, biochemical and faecal biomarker remission at 1, 3 and 5 years.
Design: We performed a retrospective, observational, cohort study.
Methods: All adult inflammatory bowel disease (IBD) patients who had received VDZ induction for ulcerative colitis (UC)/IBD-unclassified (IBDU) were included. Baseline phenotype and follow-up data were collected via a review of electronic medical records.
Results: We included 290 patients [UC n = 271 (93.4%), IBDU n = 19 (6.6%)] with a median time on VDZ of 27.6 months (interquartile range: 14.4-43.2). At the end of follow-up, a total of 157/290 (54.1%) patients remained on VDZ. The median time to discontinuation was 14.1 months (7.0-23.3). Previous exposure to ⩾1 advanced therapy, steroid use at baseline and disease extension (E3 and E2 versus E1) were independent predictors for worse VDZ persistence. Clinical remission (partial Mayo < 2) was 75.7% (171/226), 72.4% (157/217) and 70.2% (127/181) at years 1, 3 and 5, respectively. Steroid use during maintenance VDZ therapy occurred in 31.7% (92/290), hospitalization in 15.5% (45/290) and surgery in 3.4% (10/291). The rate of serious adverse events was 1.2 per 100 patient-years of follow-up.
Conclusion: VDZ effectiveness appears enduring with favourable long-term safety profile. VDZ persistence was influenced by previous exposure to biologics/small molecules, disease distribution and steroid use at baseline in our study.
{"title":"Long-term outcomes and predictors of vedolizumab persistence in ulcerative colitis.","authors":"Beatriz Gros, Hannah Ross, Maureen Nwabueze, Nathan Constantine-Cooke, Lauranne A A P Derikx, Mathew Lyons, Claire O'Hare, Colin Noble, Ian D Arnott, Gareth-Rhys Jones, Charlie W Lees, Nikolas Plevris","doi":"10.1177/17562848241258372","DOIUrl":"10.1177/17562848241258372","url":null,"abstract":"<p><strong>Background: </strong>Long-term vedolizumab (VDZ) outcomes in real-world cohorts have been largely limited to 1-year follow-up, with few bio-naïve patients or objective markers of inflammation assessed.</p><p><strong>Objectives: </strong>We aimed to assess factors affecting VDZ persistence including clinical, biochemical and faecal biomarker remission at 1, 3 and 5 years.</p><p><strong>Design: </strong>We performed a retrospective, observational, cohort study.</p><p><strong>Methods: </strong>All adult inflammatory bowel disease (IBD) patients who had received VDZ induction for ulcerative colitis (UC)/IBD-unclassified (IBDU) were included. Baseline phenotype and follow-up data were collected <i>via</i> a review of electronic medical records.</p><p><strong>Results: </strong>We included 290 patients [UC <i>n</i> = 271 (93.4%), IBDU <i>n</i> = 19 (6.6%)] with a median time on VDZ of 27.6 months (interquartile range: 14.4-43.2). At the end of follow-up, a total of 157/290 (54.1%) patients remained on VDZ. The median time to discontinuation was 14.1 months (7.0-23.3). Previous exposure to ⩾1 advanced therapy, steroid use at baseline and disease extension (E3 and E2 <i>versus</i> E1) were independent predictors for worse VDZ persistence. Clinical remission (partial Mayo < 2) was 75.7% (171/226), 72.4% (157/217) and 70.2% (127/181) at years 1, 3 and 5, respectively. Steroid use during maintenance VDZ therapy occurred in 31.7% (92/290), hospitalization in 15.5% (45/290) and surgery in 3.4% (10/291). The rate of serious adverse events was 1.2 per 100 patient-years of follow-up.</p><p><strong>Conclusion: </strong>VDZ effectiveness appears enduring with favourable long-term safety profile. VDZ persistence was influenced by previous exposure to biologics/small molecules, disease distribution and steroid use at baseline in our study.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":null,"pages":null},"PeriodicalIF":3.9,"publicationDate":"2024-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11289824/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141861345","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}
Pub Date : 2024-07-30eCollection Date: 2024-01-01DOI: 10.1177/17562848241255296
Claudia Di Rosa, Karen Van den Houte, Annamaria Altomare, Michele Pier Luca Guarino, Linde Besard, Joris Arts, Philip Caenepeel, Hubert Piessevaux, Alain Vandenberghe, Cristophe Matthys, Jessica R Biesiekierski, Luc Capiau, Steven Ceulemans, Olivier Gernay, Lydia Jones, Sophie Maes, Christian Peetermans, Willem Raat, Jeroen Stubbe, Rudy Van Boxstael, Olivia Vandeput, Sophie Van Steenbergen, Lukas Van Oudenhove, Tim Vanuytsel, Mike Jones, Jan Tack, Florencia Carbone
Background: Irritable bowel syndrome (IBS) is a disorder of gut-brain interaction characterized by recurrent abdominal pain related to defecation and/or associated to a change in bowel habits. According to the stool type, four different IBS subtypes can be recognized, constipation predominant (IBS-C), diarrhea predominant (IBS-D), mixed (IBS-M), and undefined (IBS-U). Patients report that their IBS symptoms are exacerbated by food. Thus, it is important to find a nutritional approach that could be effective in reducing IBS symptoms.
Objective: The present work is a post hoc analysis of the previously published DOMINO trial. It aimed to evaluate the effects of a self-instructed FODMAP-lowering diet smartphone application on symptoms and psychosocial aspects in primary care IBS stratifying the results for each IBS subtypes.
Design: Post hoc analysis.
Methods: Two hundred twenty-two primary care IBS patients followed a FODMAP-lowering diet for 8 weeks with the support of a smartphone application. Two follow-up visits were scheduled after 16 and 24 weeks. IBS-Symptoms Severity Score (IBS-SSS), quality of life (QoL), and adherence and dietary satisfaction were evaluated.
Results: After 8 weeks, IBS-SSS improved in all IBS subtypes (p < 0.0001). Physician Health Questiionnaire (PHQ-15) improved only in IBS-D (p = 0.0006), whereas QoL improved both in IBS-D (p = 0.01) and IBS-M (p = 0.005).
Conclusion: This post hoc analysis showed that the app is useful in all IBS subtypes; thus, it could be used as an effective tool by both general practitioners and patients to manage symptoms in primary care.
Trial registration: Ethical Commission University Hospital of Leuven reference number: S59482. Clinicaltrial.gov reference number: NCT04270487.
{"title":"DOMINO trial <i>post hoc</i> analysis: evaluation of the diet effects on symptoms in IBS subtypes.","authors":"Claudia Di Rosa, Karen Van den Houte, Annamaria Altomare, Michele Pier Luca Guarino, Linde Besard, Joris Arts, Philip Caenepeel, Hubert Piessevaux, Alain Vandenberghe, Cristophe Matthys, Jessica R Biesiekierski, Luc Capiau, Steven Ceulemans, Olivier Gernay, Lydia Jones, Sophie Maes, Christian Peetermans, Willem Raat, Jeroen Stubbe, Rudy Van Boxstael, Olivia Vandeput, Sophie Van Steenbergen, Lukas Van Oudenhove, Tim Vanuytsel, Mike Jones, Jan Tack, Florencia Carbone","doi":"10.1177/17562848241255296","DOIUrl":"10.1177/17562848241255296","url":null,"abstract":"<p><strong>Background: </strong>Irritable bowel syndrome (IBS) is a disorder of gut-brain interaction characterized by recurrent abdominal pain related to defecation and/or associated to a change in bowel habits. According to the stool type, four different IBS subtypes can be recognized, constipation predominant (IBS-C), diarrhea predominant (IBS-D), mixed (IBS-M), and undefined (IBS-U). Patients report that their IBS symptoms are exacerbated by food. Thus, it is important to find a nutritional approach that could be effective in reducing IBS symptoms.</p><p><strong>Objective: </strong>The present work is a <i>post hoc</i> analysis of the previously published DOMINO trial. It aimed to evaluate the effects of a self-instructed FODMAP-lowering diet smartphone application on symptoms and psychosocial aspects in primary care IBS stratifying the results for each IBS subtypes.</p><p><strong>Design: </strong><i>Post hoc</i> analysis.</p><p><strong>Methods: </strong>Two hundred twenty-two primary care IBS patients followed a FODMAP-lowering diet for 8 weeks with the support of a smartphone application. Two follow-up visits were scheduled after 16 and 24 weeks. IBS-Symptoms Severity Score (IBS-SSS), quality of life (QoL), and adherence and dietary satisfaction were evaluated.</p><p><strong>Results: </strong>After 8 weeks, IBS-SSS improved in all IBS subtypes (<i>p</i> < 0.0001). Physician Health Questiionnaire (PHQ-15) improved only in IBS-D (<i>p</i> = 0.0006), whereas QoL improved both in IBS-D (<i>p</i> = 0.01) and IBS-M (<i>p</i> = 0.005).</p><p><strong>Conclusion: </strong>This <i>post hoc</i> analysis showed that the app is useful in all IBS subtypes; thus, it could be used as an effective tool by both general practitioners and patients to manage symptoms in primary care.</p><p><strong>Trial registration: </strong>Ethical Commission University Hospital of Leuven reference number: S59482. Clinicaltrial.gov reference number: NCT04270487.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":null,"pages":null},"PeriodicalIF":3.9,"publicationDate":"2024-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11289810/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141861344","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}
Primary biliary cholangitis (PBC) is a chronic autoimmune cholestatic disease characterized by the destruction of the small intrahepatic bile ducts, which can progress to liver cirrhosis. The gold standard in the treatment of PBC is ursodeoxycholic acid (UDCA), which is indicated in all patients with PBC because it improves not only biochemical parameters but also patients' survival. An important milestone in the identification of patients at risk is the assessment of biochemical response to UDCA. Patients who respond to treatment have a lower incidence of hepatic events and better prognosis than patients who do not. Several scoring systems can be used to assess the response and identify non-responders who will benefit from second-line treatment. Obeticholic acid (OCA) is currently the only approved second-line treatment for PBC, which is effective for non-responders to UDCA therapy or patients, who have not tolerated UDCA therapy. However, OCA is contraindicated in advanced liver cirrhosis and portal hypertension. Moreover, pruritus may be a limiting factor for the administration of OCA. Fibrates have shown promising data supporting their use in non-responders to UDCA because they improve the biochemical parameters and elastographic findings and have possible antipruritic effects. Therefore, the idea of a triple treatment seems interesting. Clinical research is focusing on several other groups of drugs: peroxisome proliferator-activated receptor (PPAR) δ- and α/δ agonists, non-steroidal farnesoid X receptor agonists, fibroblast growth factor 19 modulators, and inhibitors of nicotinamide adenine dinucleotide phosphate oxidase 1 and 4.
{"title":"The treatment of primary biliary cholangitis: from shadow to light.","authors":"Drazilova Sylvia, Koky Tomas, Macej Marian, Janicko Martin, Simkova Dagmar, Jarcuska Peter","doi":"10.1177/17562848241265782","DOIUrl":"10.1177/17562848241265782","url":null,"abstract":"<p><p>Primary biliary cholangitis (PBC) is a chronic autoimmune cholestatic disease characterized by the destruction of the small intrahepatic bile ducts, which can progress to liver cirrhosis. The gold standard in the treatment of PBC is ursodeoxycholic acid (UDCA), which is indicated in all patients with PBC because it improves not only biochemical parameters but also patients' survival. An important milestone in the identification of patients at risk is the assessment of biochemical response to UDCA. Patients who respond to treatment have a lower incidence of hepatic events and better prognosis than patients who do not. Several scoring systems can be used to assess the response and identify non-responders who will benefit from second-line treatment. Obeticholic acid (OCA) is currently the only approved second-line treatment for PBC, which is effective for non-responders to UDCA therapy or patients, who have not tolerated UDCA therapy. However, OCA is contraindicated in advanced liver cirrhosis and portal hypertension. Moreover, pruritus may be a limiting factor for the administration of OCA. Fibrates have shown promising data supporting their use in non-responders to UDCA because they improve the biochemical parameters and elastographic findings and have possible antipruritic effects. Therefore, the idea of a triple treatment seems interesting. Clinical research is focusing on several other groups of drugs: peroxisome proliferator-activated receptor (PPAR) δ- and α/δ agonists, non-steroidal farnesoid X receptor agonists, fibroblast growth factor 19 modulators, and inhibitors of nicotinamide adenine dinucleotide phosphate oxidase 1 and 4.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":null,"pages":null},"PeriodicalIF":3.9,"publicationDate":"2024-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11287753/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141856848","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}
Pub Date : 2024-07-23eCollection Date: 2024-01-01DOI: 10.1177/17562848241265761
Shahed Kamal, Jonathan P Segal
{"title":"Comment on: [10 years of biologic use patterns in patients with inflammatory bowel disease: treatment persistence, switching and dose intensification - a nationwide population-based study].","authors":"Shahed Kamal, Jonathan P Segal","doi":"10.1177/17562848241265761","DOIUrl":"10.1177/17562848241265761","url":null,"abstract":"","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":null,"pages":null},"PeriodicalIF":3.9,"publicationDate":"2024-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11271143/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141761910","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}
Pub Date : 2024-07-23eCollection Date: 2024-01-01DOI: 10.1177/17562848241255298
Gohar Jalayeri Nia, Ola Selnes, Pablo Cortegoso Valdivia, Anastasios Koulaouzidis
Wireless capsule endoscopy (CE) has revolutionized gastrointestinal diagnostics, offering a non-invasive means to visualize and monitor the GI tract. This review traces the evolution of CE technology. Addressing the limitations of traditional white light (WL) CE, the paper explores non-WL technologies, integrating diverse sensing modalities and novel biomarkers to enhance diagnostic capabilities. Concluding with an assessment of Technology Readiness Levels, the paper emphasizes the transformative impact of non-WL colon CE devices on GI diagnostics, promising more precise, patient-centric, and accessible healthcare for GI disorders.
无线胶囊内窥镜(CE)为胃肠道诊断带来了革命性的变化,提供了一种非侵入性的胃肠道可视化和监测手段。本综述回顾了无线胶囊内镜技术的发展历程。针对传统白光(WL)CE 的局限性,本文探讨了非白光技术,整合了多种传感模式和新型生物标记物,以提高诊断能力。最后,本文对技术就绪水平进行了评估,强调了非白光结肠 CE 设备对消化道诊断的变革性影响,有望为消化道疾病提供更精确、以患者为中心、更便捷的医疗服务。
{"title":"An overview of emerging smart capsules using other-than-light technologies for colonic disease detection.","authors":"Gohar Jalayeri Nia, Ola Selnes, Pablo Cortegoso Valdivia, Anastasios Koulaouzidis","doi":"10.1177/17562848241255298","DOIUrl":"https://doi.org/10.1177/17562848241255298","url":null,"abstract":"<p><p>Wireless capsule endoscopy (CE) has revolutionized gastrointestinal diagnostics, offering a non-invasive means to visualize and monitor the GI tract. This review traces the evolution of CE technology. Addressing the limitations of traditional white light (WL) CE, the paper explores non-WL technologies, integrating diverse sensing modalities and novel biomarkers to enhance diagnostic capabilities. Concluding with an assessment of Technology Readiness Levels, the paper emphasizes the transformative impact of non-WL colon CE devices on GI diagnostics, promising more precise, patient-centric, and accessible healthcare for GI disorders.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":null,"pages":null},"PeriodicalIF":3.9,"publicationDate":"2024-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11268015/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141761909","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}
Pub Date : 2024-06-22eCollection Date: 2024-01-01DOI: 10.1177/17562848241259289
Maria Elena Ainora, Antonio Liguori, Irene Mignini, Marco Cintoni, Linda Galasso, Lucrezia Laterza, Loris Riccardo Lopetuso, Matteo Garcovich, Laura Riccardi, Antonio Gasbarrini, Franco Scaldaferri, Maria Assunta Zocco
Background: The approval of ustekinumab (UST) has opened new options for the treatment of Crohn's disease (CD), but potential markers predicting the efficacy of this interleukin-12/23 inhibitor are lacking. Contrast-enhanced ultrasound (CEUS) is non-invasive alternative to endoscopy, demonstrating early transmural changes after treatment induction.
Objectives: We conducted a prospective monocentric study aiming to explore the value of multimodal intestinal ultrasound (IUS) in predicting the response to UST in patients with active CD who have been previously exposed to anti-tumour necrosis factor α (TNFα).
Design and methods: Consecutive patients with moderate-to-severe CD involving the terminal ileum who were scheduled to begin UST therapy were enrolled between January 2020 and October 2021 in the inflammatory bowel diseases outpatient centre. A complete IUS evaluation, including B-mode, Doppler, dynamic CEUS and elastography, was performed at the time of induction (T0) and after 8 (T1), 16 (T2), 24 (T3) and 48 (T4) weeks of therapy. Each IUS parameter and their variations from baseline were correlated with endoscopic response and mucosal healing after 1 year.
Results: A total of 52 patients were included, 29 (55.8%) of which reached endoscopic response at T4. The univariate analysis revealed that, between T3 and T0, the percentage changes of bowel wall thickness, Limberg score, mean signal intensity, rise time, wash-in rate, C reactive protein and Harvey-Bradshaw Index were associated with long-term therapeutic outcome. Based on the above parameters, we developed an IUS score that showed a good performance in predicting 1 year-endoscopic response (area under the curve: 0.91).
Conclusion: Multimodal ultrasound could be helpful to predict long-term therapeutic outcome in patients with CD treated with UST.
Registration: NCT05987501.
背景:乌司他单抗(UST)的批准为克罗恩病(CD)的治疗提供了新的选择,但目前还缺乏预测这种白细胞介素-12/23抑制剂疗效的潜在标志物。对比增强超声(CEUS)是内窥镜检查的无创替代方法,可显示治疗诱导后的早期跨膜变化:我们开展了一项前瞻性单中心研究,旨在探索多模式肠道超声(IUS)在预测曾接受过抗肿瘤坏死因子α(TNFα)治疗的活动性 CD 患者对 UST 反应中的价值:2020年1月至2021年10月期间,炎症性肠病门诊中心连续招募了回肠末端受累的中重度CD患者,这些患者计划开始UST治疗。在诱导治疗时(T0)和治疗 8 周(T1)、16 周(T2)、24 周(T3)和 48 周(T4)后进行了全面的 IUS 评估,包括 B 型、多普勒、动态 CEUS 和弹性成像。每个 IUS 参数及其与基线的变化与内镜反应和 1 年后粘膜愈合相关:结果:共纳入 52 例患者,其中 29 例(55.8%)在 T4 达到内镜反应。单变量分析显示,在 T3 和 T0 之间,肠壁厚度、Limberg 评分、平均信号强度、上升时间、冲洗率、C 反应蛋白和 Harvey-Bradshaw 指数的百分比变化与长期疗效相关。根据上述参数,我们制定了一个 IUS 评分,该评分在预测 1 年的内镜反应方面表现良好(曲线下面积:0.91):结论:多模态超声有助于预测接受 UST 治疗的 CD 患者的长期疗效:NCT05987501。
{"title":"Multimodal dynamic ultrasound approach as predictor of response in patients with Crohn's disease treated with ustekinumab.","authors":"Maria Elena Ainora, Antonio Liguori, Irene Mignini, Marco Cintoni, Linda Galasso, Lucrezia Laterza, Loris Riccardo Lopetuso, Matteo Garcovich, Laura Riccardi, Antonio Gasbarrini, Franco Scaldaferri, Maria Assunta Zocco","doi":"10.1177/17562848241259289","DOIUrl":"10.1177/17562848241259289","url":null,"abstract":"<p><strong>Background: </strong>The approval of ustekinumab (UST) has opened new options for the treatment of Crohn's disease (CD), but potential markers predicting the efficacy of this interleukin-12/23 inhibitor are lacking. Contrast-enhanced ultrasound (CEUS) is non-invasive alternative to endoscopy, demonstrating early transmural changes after treatment induction.</p><p><strong>Objectives: </strong>We conducted a prospective monocentric study aiming to explore the value of multimodal intestinal ultrasound (IUS) in predicting the response to UST in patients with active CD who have been previously exposed to anti-tumour necrosis factor α (TNFα).</p><p><strong>Design and methods: </strong>Consecutive patients with moderate-to-severe CD involving the terminal ileum who were scheduled to begin UST therapy were enrolled between January 2020 and October 2021 in the inflammatory bowel diseases outpatient centre. A complete IUS evaluation, including B-mode, Doppler, dynamic CEUS and elastography, was performed at the time of induction (T0) and after 8 (T1), 16 (T2), 24 (T3) and 48 (T4) weeks of therapy. Each IUS parameter and their variations from baseline were correlated with endoscopic response and mucosal healing after 1 year.</p><p><strong>Results: </strong>A total of 52 patients were included, 29 (55.8%) of which reached endoscopic response at T4. The univariate analysis revealed that, between T3 and T0, the percentage changes of bowel wall thickness, Limberg score, mean signal intensity, rise time, wash-in rate, C reactive protein and Harvey-Bradshaw Index were associated with long-term therapeutic outcome. Based on the above parameters, we developed an IUS score that showed a good performance in predicting 1 year-endoscopic response (area under the curve: 0.91).</p><p><strong>Conclusion: </strong>Multimodal ultrasound could be helpful to predict long-term therapeutic outcome in patients with CD treated with UST.</p><p><strong>Registration: </strong>NCT05987501.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":null,"pages":null},"PeriodicalIF":3.9,"publicationDate":"2024-06-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11193931/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141443593","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}
Pub Date : 2024-06-19eCollection Date: 2024-01-01DOI: 10.1177/17562848241251567
Yin Liu, Zhifeng Gao, XiaoHua Hou
Background: Proton-pump inhibitors (PPIs) and potassium-competitive acid blockers (P-CABs) are recommended for erosive esophagitis (EE), with good safety and tolerance. However, it is unclear which is the best treatment option for EE.
Objectives: This study aimed to evaluate the comparative efficacy of P-CABs and PPIs for healing EE patients, seeking an appropriate treatment choice in the 4- or 8-week treatment and standard or double dose.
Design: A systematic review and network meta-analysis.
Data sources and methods: Relevant databases were searched to collect randomized controlled trials of PPIs and P-CABs in the treatment of EE up to 31 May 2023. Studies on standard or double-dose PPIs or P-CABs which were published in English and assessed 4- or 8-week healing effects in EE were included. A network meta-analysis was performed to evaluate the efficacy of the treatments under the frequentist framework. Sensitivity and subgroup analyses of patients with different baseline EE were also conducted.
Results: In all, 34 studies involving 25,054 patients and 9 PPIs, 6 P-CABs, or placebo treatment interventions were included. The pooled 4-week healing rate was significantly statistically lower than the pooled 8-week healing rate for most treatments. Besides, the higher healing rate of double-dose treatment than standard-dose treatment was not observed in the initial treatment of most drugs. The main analysis only included studies conducted for both patients with and without severe EE at baseline, and the proportion of severe EE included in the study was >10%, Keverprazan 20 mg qd ranked best with a surface under the cumulative ranking curve (SUCRA) value of 84.7, followed by Ilaprazole 10 mg qd with a SUCRA value of 82.0, for the healing rate at 8 weeks. Sensitivity analysis showed that the results were robust. Subgroup analysis showed that most P-CABs had higher healing rates than PPIs, particularly for patients with severe EE. And the healing rate of Keverprazan 20 mg qd at 8 weeks ranked best in the subgroup without or with severe EE at baseline.
Conclusion: This study showed that an 8-week treatment seemed more effective than the 4-week treatment for healing EE patients. The healing effect of Keverprazan (20 mg qd) ranked best in 8-week treatment, for both severe and non-severe EE patients.
Trial registration: The study protocol was registered with INPLASY (registration number INPLASY2023120053).
背景:质子泵抑制剂(PPIs)和钾竞争性酸阻滞剂(P-CABs)是治疗侵蚀性食管炎(EE)的推荐药物,具有良好的安全性和耐受性。然而,目前尚不清楚哪种药物是治疗侵蚀性食管炎的最佳选择:本研究旨在评估P-CABs和PPIs对治愈EE患者的疗效比较,寻求4周或8周疗程、标准剂量或双剂量的合适治疗方案:设计:系统综述和网络荟萃分析:检索相关数据库,收集截至 2023 年 5 月 31 日的 PPIs 和 P-CABs 治疗 EE 的随机对照试验。纳入了用英语发表的关于标准剂量或双剂量 PPIs 或 P-CABs 的研究,这些研究对 EE 的 4 周或 8 周疗效进行了评估。在频数主义框架下进行了网络荟萃分析,以评估治疗效果。此外,还对基线EE不同的患者进行了敏感性分析和亚组分析:共纳入了 34 项研究,涉及 25054 名患者和 9 种 PPIs、6 种 P-CABs 或安慰剂治疗干预。从统计学角度看,大多数治疗方法的汇总 4 周愈合率明显低于汇总 8 周愈合率。此外,在大多数药物的初始治疗中,并未观察到双剂量治疗的愈合率高于标准剂量治疗的愈合率。主要分析只纳入了对基线时有和没有严重 EE 的患者进行的研究,且纳入研究的严重 EE 比例大于 10%。在 8 周治愈率方面,开瑞普拉赞 20 毫克/天的累积排名曲线下表面值(SUCRA)为 84.7,排名最佳,其次是伊拉普拉唑 10 毫克/天,SUCRA 值为 82.0。敏感性分析表明结果是可靠的。亚组分析表明,大多数 P-CABs 的治愈率高于 PPIs,尤其是对于重度 EE 患者。在基线无或有严重 EE 的亚组中,Keverprazan 20 毫克 qd 8 周疗程的治愈率最高:结论:这项研究表明,8 周治疗似乎比 4 周治疗对 EE 患者的治愈效果更好。对于重度和非重度胃食管返流患者,8周疗法中开瑞坦(20 毫克/天)的疗效最佳:该研究方案已在INPLASY注册(注册号为INPLASY2023120053)。
{"title":"Potassium-competitive acid blockers and proton-pump inhibitors for healing of erosive esophagitis: a systematic review and network meta-analysis.","authors":"Yin Liu, Zhifeng Gao, XiaoHua Hou","doi":"10.1177/17562848241251567","DOIUrl":"10.1177/17562848241251567","url":null,"abstract":"<p><strong>Background: </strong>Proton-pump inhibitors (PPIs) and potassium-competitive acid blockers (P-CABs) are recommended for erosive esophagitis (EE), with good safety and tolerance. However, it is unclear which is the best treatment option for EE.</p><p><strong>Objectives: </strong>This study aimed to evaluate the comparative efficacy of P-CABs and PPIs for healing EE patients, seeking an appropriate treatment choice in the 4- or 8-week treatment and standard or double dose.</p><p><strong>Design: </strong>A systematic review and network meta-analysis.</p><p><strong>Data sources and methods: </strong>Relevant databases were searched to collect randomized controlled trials of PPIs and P-CABs in the treatment of EE up to 31 May 2023. Studies on standard or double-dose PPIs or P-CABs which were published in English and assessed 4- or 8-week healing effects in EE were included. A network meta-analysis was performed to evaluate the efficacy of the treatments under the frequentist framework. Sensitivity and subgroup analyses of patients with different baseline EE were also conducted.</p><p><strong>Results: </strong>In all, 34 studies involving 25,054 patients and 9 PPIs, 6 P-CABs, or placebo treatment interventions were included. The pooled 4-week healing rate was significantly statistically lower than the pooled 8-week healing rate for most treatments. Besides, the higher healing rate of double-dose treatment than standard-dose treatment was not observed in the initial treatment of most drugs. The main analysis only included studies conducted for both patients with and without severe EE at baseline, and the proportion of severe EE included in the study was >10%, Keverprazan 20 mg qd ranked best with a surface under the cumulative ranking curve (SUCRA) value of 84.7, followed by Ilaprazole 10 mg qd with a SUCRA value of 82.0, for the healing rate at 8 weeks. Sensitivity analysis showed that the results were robust. Subgroup analysis showed that most P-CABs had higher healing rates than PPIs, particularly for patients with severe EE. And the healing rate of Keverprazan 20 mg qd at 8 weeks ranked best in the subgroup without or with severe EE at baseline.</p><p><strong>Conclusion: </strong>This study showed that an 8-week treatment seemed more effective than the 4-week treatment for healing EE patients. The healing effect of Keverprazan (20 mg qd) ranked best in 8-week treatment, for both severe and non-severe EE patients.</p><p><strong>Trial registration: </strong>The study protocol was registered with INPLASY (registration number INPLASY2023120053).</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":null,"pages":null},"PeriodicalIF":3.9,"publicationDate":"2024-06-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11189022/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141433166","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}
Pub Date : 2024-06-16eCollection Date: 2024-01-01DOI: 10.1177/17562848241249664
Peter Whorwell, Robert Lange, Carmelo Scarpignato
Stimulant laxatives are well established as first- or second-line treatments for constipation and although they have a reliable therapeutic effect, alleged safety concerns still exist, particularly with long-term use. The potential harmful effects on the gastrointestinal system (including carcinogenicity) of the long-term use of diphenylmethane [bisacodyl, sodium picosulfate (SPS)] and senna stimulant laxatives were assessed in a comprehensive review of the publications identified in literature searches performed in PubMed and Embase up to and including June 2023. We identified and reviewed 43 publications of interest. While stimulant laxatives at supratherapeutic doses have been shown to cause structural alterations to surface absorptive cells in animals and humans, these effects are reversible and not considered clinically relevant. No formal long-term studies have demonstrated morphological changes in enteric neural elements or intestinal smooth muscle with bisacodyl or SPS in humans. Furthermore, there is no convincing evidence that stimulant laxatives are associated with the development of colon cancer, and in fact, chronic constipation itself has been reported to potentially increase the risk of colon cancer, therefore, the use of stimulant laxatives might reduce this risk. Many studies suggesting a possible harmful effect from laxatives were limited by their failure to consider confounding factors such as concomitant neurological disease, metabolic disorders, and age. These findings highlight the lack of evidence for the harmful effects of laxatives on the colon, and thus, the benefits of treatment with stimulant laxatives, even in the long-term, should be reconsidered for the management of patients with constipation.
{"title":"Review article: do stimulant laxatives damage the gut? A critical analysis of current knowledge.","authors":"Peter Whorwell, Robert Lange, Carmelo Scarpignato","doi":"10.1177/17562848241249664","DOIUrl":"10.1177/17562848241249664","url":null,"abstract":"<p><p>Stimulant laxatives are well established as first- or second-line treatments for constipation and although they have a reliable therapeutic effect, alleged safety concerns still exist, particularly with long-term use. The potential harmful effects on the gastrointestinal system (including carcinogenicity) of the long-term use of diphenylmethane [bisacodyl, sodium picosulfate (SPS)] and senna stimulant laxatives were assessed in a comprehensive review of the publications identified in literature searches performed in PubMed and Embase up to and including June 2023. We identified and reviewed 43 publications of interest. While stimulant laxatives at supratherapeutic doses have been shown to cause structural alterations to surface absorptive cells in animals and humans, these effects are reversible and not considered clinically relevant. No formal long-term studies have demonstrated morphological changes in enteric neural elements or intestinal smooth muscle with bisacodyl or SPS in humans. Furthermore, there is no convincing evidence that stimulant laxatives are associated with the development of colon cancer, and in fact, chronic constipation itself has been reported to potentially increase the risk of colon cancer, therefore, the use of stimulant laxatives might reduce this risk. Many studies suggesting a possible harmful effect from laxatives were limited by their failure to consider confounding factors such as concomitant neurological disease, metabolic disorders, and age. These findings highlight the lack of evidence for the harmful effects of laxatives on the colon, and thus, the benefits of treatment with stimulant laxatives, even in the long-term, should be reconsidered for the management of patients with constipation.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":null,"pages":null},"PeriodicalIF":4.2,"publicationDate":"2024-06-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11181897/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141421503","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}
Pub Date : 2024-06-14eCollection Date: 2024-01-01DOI: 10.1177/17562848241255303
Endre-Botond Gagyi, Brigitta Teutsch, Dániel Sándor Veres, Dániel Pálinkás, Nóra Vörhendi, Klementina Ocskay, Katalin Márta, Péter Jenő Hegyi, Péter Hegyi, Bálint Erőss
Background: Acute pancreatitis (AP) has a high incidence, and patients can develop recurrent acute pancreatitis (RAP) and chronic pancreatitis (CP) after AP.
Objectives: We aimed to estimate the pooled incidence rates (IRs), cumulative incidences, and proportions of RAP and CP after AP.
Design: A systematic review and meta-analysis of studies reporting the proportion of RAP and CP after AP.
Data sources and methods: The systematic search was conducted in three (PubMed, EMBASE, and CENTRAL) databases on 19 December 2023. Articles reporting the proportion of RAP or CP in patients after the first and multiple episodes of AP were eligible. The random effects model was used to calculate the pooled IR with 95% confidence intervals (CIs). The I2 value assessed heterogeneity. The risk of bias assessment was conducted with the Joanna Briggs Institute Critical Appraisal Tool.
Results: We included 119 articles in the quantitative synthesis and 29 in the IRs calculations. Our results showed that the IR of RAP in adult patients after AP was 5.26 per 100 person-years (CI: 3.99-6.94; I2 = 93%), while in children, it was 4.64 per 100 person-years (CI: 2.73-7.87; I2 = 88%). We also found that the IR of CP after AP was 1.4 per 100 person-years (CI: 0.9-2; I2 = 75%), while after RAP, it increased to 4.3 per 100 person-years (CI: 3.1-6.0; I2 = 76%). The risk of bias was moderate in the majority of the included studies.
Conclusion: Our results showed that RAP affects many patients with AP. Compared to patients with the first AP episode, RAP leads to a threefold higher IR for developing CP.
Trial registration: Our protocol was registered on PROSPERO (CRD42021283252).
{"title":"Incidence of recurrent and chronic pancreatitis after acute pancreatitis: a systematic review and meta-analysis.","authors":"Endre-Botond Gagyi, Brigitta Teutsch, Dániel Sándor Veres, Dániel Pálinkás, Nóra Vörhendi, Klementina Ocskay, Katalin Márta, Péter Jenő Hegyi, Péter Hegyi, Bálint Erőss","doi":"10.1177/17562848241255303","DOIUrl":"10.1177/17562848241255303","url":null,"abstract":"<p><strong>Background: </strong>Acute pancreatitis (AP) has a high incidence, and patients can develop recurrent acute pancreatitis (RAP) and chronic pancreatitis (CP) after AP.</p><p><strong>Objectives: </strong>We aimed to estimate the pooled incidence rates (IRs), cumulative incidences, and proportions of RAP and CP after AP.</p><p><strong>Design: </strong>A systematic review and meta-analysis of studies reporting the proportion of RAP and CP after AP.</p><p><strong>Data sources and methods: </strong>The systematic search was conducted in three (PubMed, EMBASE, and CENTRAL) databases on 19 December 2023. Articles reporting the proportion of RAP or CP in patients after the first and multiple episodes of AP were eligible. The random effects model was used to calculate the pooled IR with 95% confidence intervals (CIs). The <i>I</i> <sup>2</sup> value assessed heterogeneity. The risk of bias assessment was conducted with the Joanna Briggs Institute Critical Appraisal Tool.</p><p><strong>Results: </strong>We included 119 articles in the quantitative synthesis and 29 in the IRs calculations. Our results showed that the IR of RAP in adult patients after AP was 5.26 per 100 person-years (CI: 3.99-6.94; <i>I</i> <sup>2</sup> = 93%), while in children, it was 4.64 per 100 person-years (CI: 2.73-7.87; <i>I</i> <sup>2</sup> = 88%). We also found that the IR of CP after AP was 1.4 per 100 person-years (CI: 0.9-2; <i>I</i> <sup>2</sup> = 75%), while after RAP, it increased to 4.3 per 100 person-years (CI: 3.1-6.0; <i>I</i> <sup>2</sup> = 76%). The risk of bias was moderate in the majority of the included studies.</p><p><strong>Conclusion: </strong>Our results showed that RAP affects many patients with AP. Compared to patients with the first AP episode, RAP leads to a threefold higher IR for developing CP.</p><p><strong>Trial registration: </strong>Our protocol was registered on PROSPERO (CRD42021283252).</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":null,"pages":null},"PeriodicalIF":4.2,"publicationDate":"2024-06-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11179553/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141332251","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}
Pub Date : 2024-06-12eCollection Date: 2024-01-01DOI: 10.1177/17562848241242681
Ian Io Lei, Anastasios Koulaouzidis, Gunnar Baatrup, Mark Samaan, Ioanna Parisi, Mark McAlindon, Ervin Toth, Aasma Shaukat, Ursula Valentiner, Konstantinos John Dabos, Ignacio Fernandez, Alexander Robertson, Benedicte Schelde-Olesen, Nicholas Parsons, Ramesh P Arasaradnam
Background: Colon capsule endoscopy (CCE) has gained momentum as an alternative modality for the investigation of the lower gastrointestinal tract. Of the few challenges that remain, the comparison and - eventually - matching of polyps at different timestamps leads to the potential for double reporting and can contribute to false-positive findings and inaccuracies. With the impending artificial intelligence integration, the risk of double reporting the same polyp due to the lack of information on spatial orientation underscores the necessity for establishing criteria for polyp matching.
Objectives: This RAND/University of California, Los Angeles (modified Delphi) process aims to identify the key factors or components used to match polyps within a CCE video. This involves exploring the attributes of each factor to create comprehensive polyp-matching criteria based on international expert consensus.
Design: A systematic qualitative study using surveys.
Methods: A panel of 11 international CCE experts convened to assess a survey comprised of 60 statements. Participants anonymously rated statement appropriateness on a 1-9 scale (1-3: inappropriate, 4-6: uncertain and 7-9: appropriate). Following a virtual group discussion of the Round 1 results, a Round 2 survey was developed and completed before the final analysis.
Results: The factors that were agreed to be essential for polyp matching include (1) timestamp, (2) polyp localization, (3) polyp vascular pattern, (4) polyp size, (5) time interval of the polyp appearance between the green and yellow camera, (6) surrounding tissue, (7) polyp morphology and (8) polyp surface and contour. When five or more factors are satisfied, it was agreed that the comparing polyps are likely the same polyp.
Conclusion: This study has established the first complete criteria for polyp matching in CCE. While it might not provide a definitive solution for matching difficult, small and common polyps, these criteria serve as a framework to guide and facilitate the process of polyp-matching.
{"title":"Rationalizing polyp matching criteria in colon capsule endoscopy: an international expert consensus through RAND (modified DELPHI) process.","authors":"Ian Io Lei, Anastasios Koulaouzidis, Gunnar Baatrup, Mark Samaan, Ioanna Parisi, Mark McAlindon, Ervin Toth, Aasma Shaukat, Ursula Valentiner, Konstantinos John Dabos, Ignacio Fernandez, Alexander Robertson, Benedicte Schelde-Olesen, Nicholas Parsons, Ramesh P Arasaradnam","doi":"10.1177/17562848241242681","DOIUrl":"10.1177/17562848241242681","url":null,"abstract":"<p><strong>Background: </strong>Colon capsule endoscopy (CCE) has gained momentum as an alternative modality for the investigation of the lower gastrointestinal tract. Of the few challenges that remain, the comparison and - eventually - matching of polyps at different timestamps leads to the potential for double reporting and can contribute to false-positive findings and inaccuracies. With the impending artificial intelligence integration, the risk of double reporting the same polyp due to the lack of information on spatial orientation underscores the necessity for establishing criteria for polyp matching.</p><p><strong>Objectives: </strong>This RAND/University of California, Los Angeles (modified Delphi) process aims to identify the key factors or components used to match polyps within a CCE video. This involves exploring the attributes of each factor to create comprehensive polyp-matching criteria based on international expert consensus.</p><p><strong>Design: </strong>A systematic qualitative study using surveys.</p><p><strong>Methods: </strong>A panel of 11 international CCE experts convened to assess a survey comprised of 60 statements. Participants anonymously rated statement appropriateness on a 1-9 scale (1-3: inappropriate, 4-6: uncertain and 7-9: appropriate). Following a virtual group discussion of the Round 1 results, a Round 2 survey was developed and completed before the final analysis.</p><p><strong>Results: </strong>The factors that were agreed to be essential for polyp matching include (1) timestamp, (2) polyp localization, (3) polyp vascular pattern, (4) polyp size, (5) time interval of the polyp appearance between the green and yellow camera, (6) surrounding tissue, (7) polyp morphology and (8) polyp surface and contour. When five or more factors are satisfied, it was agreed that the comparing polyps are likely the same polyp.</p><p><strong>Conclusion: </strong>This study has established the first complete criteria for polyp matching in CCE. While it might not provide a definitive solution for matching difficult, small and common polyps, these criteria serve as a framework to guide and facilitate the process of polyp-matching.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":null,"pages":null},"PeriodicalIF":4.2,"publicationDate":"2024-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11179528/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141332252","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}