Pub Date : 2025-02-01Epub Date: 2024-09-24DOI: 10.14309/ajg.0000000000003096
Ryan Leung, Michelle Leong Ching Yeung, Yunhao Li, Mayssan Muftah, Walter W Chan, Wai K Leung
Introduction: There are limited epidemiological studies on eosinophilic esophagitis (EoE) in Asia. We studied the temporal trend of EoE in Asia, the presenting symptoms, and association with atopic diseases.
Methods: Literature search on PubMed, Embase, MEDLINE, Scopus, and Web of Science was performed to retrieve studies published between 1980 and 2023 that reported the prevalence or incidence of EoE in Asia. We used a random-effects model to estimate the pooled incidence and prevalence. I2 index and Cochran Q test were used to assess heterogeneity. Subgroup analyses were conducted for study types, different regions, years of examination, and age groups. The proportion of atopic diseases among patients with EoE was presented.
Results: Twenty-five studies from Asia were included. The pooled prevalence of EoE was 33.5 cases per 100,000 inhabitants in population-based studies and 11.0 cases per 1,000 patients/visitors in hospital-based studies. The incidence rate among children was 12.3 cases per 1,000 patients/visitors, whereas for adults, it was only 0.2 cases per 1,000 patients/visitors. Among population-based studies, there was an increase in prevalence from 19.8 per 100,000 individuals in 2005-2009 to 73.0 per 100,000 individuals in 2015-2019. A similar upward trend was observed in hospital-based studies conducted during the same period. Patients with EoE commonly presented with dysphagia (36.3%) and nausea and vomiting (34.6%). History of atopy was reported in 57.2% of patients with EoE in Asia.
Discussion: The prevalence and incidence of EoE in Asia have been rising over the past decades. Because of the limited number of Asian studies and variations in patient sources, caution should be exercised when interpreting these results.
{"title":"Temporal Trend of Incidence and Prevalence of Eosinophilic Esophagitis in Asia: A Systematic Review and Meta-Analysis.","authors":"Ryan Leung, Michelle Leong Ching Yeung, Yunhao Li, Mayssan Muftah, Walter W Chan, Wai K Leung","doi":"10.14309/ajg.0000000000003096","DOIUrl":"10.14309/ajg.0000000000003096","url":null,"abstract":"<p><strong>Introduction: </strong>There are limited epidemiological studies on eosinophilic esophagitis (EoE) in Asia. We studied the temporal trend of EoE in Asia, the presenting symptoms, and association with atopic diseases.</p><p><strong>Methods: </strong>Literature search on PubMed, Embase, MEDLINE, Scopus, and Web of Science was performed to retrieve studies published between 1980 and 2023 that reported the prevalence or incidence of EoE in Asia. We used a random-effects model to estimate the pooled incidence and prevalence. I2 index and Cochran Q test were used to assess heterogeneity. Subgroup analyses were conducted for study types, different regions, years of examination, and age groups. The proportion of atopic diseases among patients with EoE was presented.</p><p><strong>Results: </strong>Twenty-five studies from Asia were included. The pooled prevalence of EoE was 33.5 cases per 100,000 inhabitants in population-based studies and 11.0 cases per 1,000 patients/visitors in hospital-based studies. The incidence rate among children was 12.3 cases per 1,000 patients/visitors, whereas for adults, it was only 0.2 cases per 1,000 patients/visitors. Among population-based studies, there was an increase in prevalence from 19.8 per 100,000 individuals in 2005-2009 to 73.0 per 100,000 individuals in 2015-2019. A similar upward trend was observed in hospital-based studies conducted during the same period. Patients with EoE commonly presented with dysphagia (36.3%) and nausea and vomiting (34.6%). History of atopy was reported in 57.2% of patients with EoE in Asia.</p><p><strong>Discussion: </strong>The prevalence and incidence of EoE in Asia have been rising over the past decades. Because of the limited number of Asian studies and variations in patient sources, caution should be exercised when interpreting these results.</p>","PeriodicalId":7608,"journal":{"name":"American Journal of Gastroenterology","volume":" ","pages":"320-331"},"PeriodicalIF":8.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142306954","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01Epub Date: 2024-10-02DOI: 10.14309/ajg.0000000000003061
John Moore Vierling, Paul J Pockros
{"title":"Lessons From COBALT: Will the Bell Also Toll for Thee?","authors":"John Moore Vierling, Paul J Pockros","doi":"10.14309/ajg.0000000000003061","DOIUrl":"10.14309/ajg.0000000000003061","url":null,"abstract":"","PeriodicalId":7608,"journal":{"name":"American Journal of Gastroenterology","volume":" ","pages":"342-343"},"PeriodicalIF":8.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142360942","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01Epub Date: 2024-09-27DOI: 10.14309/ajg.0000000000003079
Brent Hiramoto, Thomas R McCarty, Mayssan Muftah, Walter W Chan
{"title":"Response to Hobai.","authors":"Brent Hiramoto, Thomas R McCarty, Mayssan Muftah, Walter W Chan","doi":"10.14309/ajg.0000000000003079","DOIUrl":"10.14309/ajg.0000000000003079","url":null,"abstract":"","PeriodicalId":7608,"journal":{"name":"American Journal of Gastroenterology","volume":" ","pages":"483"},"PeriodicalIF":8.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11785492/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142339346","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01Epub Date: 2024-07-15DOI: 10.14309/ajg.0000000000002965
Margalida Calafat, Carles Suria, Francisco Mesonero, Ruth de Francisco, Carmen Yagüe Caballero, Luisa de la Peña, Alejandro Hernández-Camba, Ainhoa Marcé, Beatriz Gallego, Noelia Martín-Vicente, Montserrat Rivero, Marisa Iborra, Iván Guerra, Marta Carrillo-Palau, Lucía Madero, Beatriz Burgueño, David Monfort, Gisela Torres, Marta Teller, Juan Ángel Ferrer Rosique, Pablo Vega Villaamil, Cristina Roig, Angel Ponferrada-Diaz, Elena Betoré Glaría, Yamile Zabana, Javier P Gisbert, David Busquets, Noelia Alcaide, Blau Camps, Jesús Legido, Maria González-Vivo, Marta Maia Bosca-Watts, Isabel Pérez-Martínez, Diego Casas Deza, Jordi Guardiola, Laura Arranz Hernández, Mercè Navarro, Carla J Gargallo-Puyuelo, Fiorella Cañete, Míriam Mañosa, Eugeni Domènech
Introduction: The coexistence of HIV infection and inflammatory bowel disease (IBD) is uncommon. Data on the impact of HIV on IBD course and its management are scarce. The aim of this study was to describe the IBD phenotype, therapeutic requirements, and prevalence of opportunistic infections (OIs) in IBD patients with a coexistent HIV infection.
Methods: Case-control, retrospective study includes all HIV-positive patients diagnosed with IBD in the Nationwide study on genetic and environmental determinants of inflammatory bowel disease registry. Patients with positive HIV serology (HIV-IBD) were compared with controls (HIV seronegative), matched 1:3 by year of IBD diagnosis, age, sex, and type of IBD.
Results: A total of 364 patients (91 HIV-IBD and 273 IBD controls) were included. In the whole cohort, 58% had ulcerative colitis, 35% had Crohn's disease (CD), and 7% were IBD unclassified. The HIV-IBD group presented a significantly higher proportion of proctitis in ulcerative colitis and colonic location in CD but fewer extraintestinal manifestations than controls. Regarding treatments, nonbiological therapies (37.4% vs 57.9%; P = 0.001) and biologicals (26.4% vs 42.1%; P = 0.007), were used less frequently among patients in the HIV-IBD group. Conversely, patients with HIV-IBD developed more OI than controls, regardless of nonbiological therapy use. In the multivariate analysis, HIV infection (odds ratio 4.765, 95% confidence interval (CI) 2.48-9.14; P < 0.001) and having ≥1 comorbidity (OR 2.445, 95% CI 1.23-4.85; P = 0.010) were risk factors for developing OI, while CD was protective (OR 0.372, 95% CI 0.18-0.78; P = 0.009).
Discussion: HIV infection seems to be associated with a less aggressive phenotype of IBD and a lesser use of nonbiological therapies and biologicals but entails a greater risk of developing OI.
导言:艾滋病病毒感染与炎症性肠病(IBD)并存的情况并不常见。有关 HIV 对 IBD 病程及其治疗的影响的数据很少。本研究旨在描述同时感染 HIV 的 IBD 患者的 IBD 表型、治疗要求和机会性感染(OIs)的发生率:病例对照、回顾性研究包括全国炎症性肠病遗传与环境决定因素研究登记中所有被诊断为 IBD 的 HIV 阳性患者。将艾滋病毒血清学呈阳性的患者(HIV-IBD)与对照组(艾滋病毒血清阴性)进行比较,按照 IBD 诊断年份、年龄、性别和 IBD 类型进行 1:3 匹配:共纳入了 364 名患者(91 名 HIV-IBD 患者和 273 名 IBD 对照组患者)。在整个队列中,58%患有溃疡性结肠炎,35%患有克罗恩病(CD),7%属于未分类的IBD。与对照组相比,HIV-IBD 组的溃疡性结肠炎患者直肠炎的比例和 CD 患者结肠部位的比例明显较高,但肠道外表现较少。在治疗方面,HIV-IBD 组患者较少使用非生物制剂疗法(37.4% vs 57.9%;P = 0.001)和生物制剂疗法(26.4% vs 42.1%;P = 0.007)。相反,与对照组相比,HIV-IBD 患者无论使用哪种非生物制剂治疗,都会出现更多的 OI。在多变量分析中,HIV 感染(几率比 4.765,95% 置信区间 (CI)2.48-9.14;P < 0.001)和合并症≥1(OR 2.445,95% CI 1.23-4.85;P = 0.010)是发生 OI 的风险因素,而 CD 具有保护作用(OR 0.372,95% CI 0.18-0.78;P = 0.009):讨论:HIV 感染似乎与侵袭性较低的 IBD 表型以及较少使用非生物制剂疗法和生物制剂有关,但却会增加罹患 OI 的风险。
{"title":"HIV Infection Is Associated With a Less Aggressive Phenotype of Inflammatory Bowel Disease: A Multicenter Study of the ENEIDA Registry.","authors":"Margalida Calafat, Carles Suria, Francisco Mesonero, Ruth de Francisco, Carmen Yagüe Caballero, Luisa de la Peña, Alejandro Hernández-Camba, Ainhoa Marcé, Beatriz Gallego, Noelia Martín-Vicente, Montserrat Rivero, Marisa Iborra, Iván Guerra, Marta Carrillo-Palau, Lucía Madero, Beatriz Burgueño, David Monfort, Gisela Torres, Marta Teller, Juan Ángel Ferrer Rosique, Pablo Vega Villaamil, Cristina Roig, Angel Ponferrada-Diaz, Elena Betoré Glaría, Yamile Zabana, Javier P Gisbert, David Busquets, Noelia Alcaide, Blau Camps, Jesús Legido, Maria González-Vivo, Marta Maia Bosca-Watts, Isabel Pérez-Martínez, Diego Casas Deza, Jordi Guardiola, Laura Arranz Hernández, Mercè Navarro, Carla J Gargallo-Puyuelo, Fiorella Cañete, Míriam Mañosa, Eugeni Domènech","doi":"10.14309/ajg.0000000000002965","DOIUrl":"https://doi.org/10.14309/ajg.0000000000002965","url":null,"abstract":"<p><strong>Introduction: </strong>The coexistence of HIV infection and inflammatory bowel disease (IBD) is uncommon. Data on the impact of HIV on IBD course and its management are scarce. The aim of this study was to describe the IBD phenotype, therapeutic requirements, and prevalence of opportunistic infections (OIs) in IBD patients with a coexistent HIV infection.</p><p><strong>Methods: </strong>Case-control, retrospective study includes all HIV-positive patients diagnosed with IBD in the Nationwide study on genetic and environmental determinants of inflammatory bowel disease registry. Patients with positive HIV serology (HIV-IBD) were compared with controls (HIV seronegative), matched 1:3 by year of IBD diagnosis, age, sex, and type of IBD.</p><p><strong>Results: </strong>A total of 364 patients (91 HIV-IBD and 273 IBD controls) were included. In the whole cohort, 58% had ulcerative colitis, 35% had Crohn's disease (CD), and 7% were IBD unclassified. The HIV-IBD group presented a significantly higher proportion of proctitis in ulcerative colitis and colonic location in CD but fewer extraintestinal manifestations than controls. Regarding treatments, nonbiological therapies (37.4% vs 57.9%; P = 0.001) and biologicals (26.4% vs 42.1%; P = 0.007), were used less frequently among patients in the HIV-IBD group. Conversely, patients with HIV-IBD developed more OI than controls, regardless of nonbiological therapy use. In the multivariate analysis, HIV infection (odds ratio 4.765, 95% confidence interval (CI) 2.48-9.14; P < 0.001) and having ≥1 comorbidity (OR 2.445, 95% CI 1.23-4.85; P = 0.010) were risk factors for developing OI, while CD was protective (OR 0.372, 95% CI 0.18-0.78; P = 0.009).</p><p><strong>Discussion: </strong>HIV infection seems to be associated with a less aggressive phenotype of IBD and a lesser use of nonbiological therapies and biologicals but entails a greater risk of developing OI.</p>","PeriodicalId":7608,"journal":{"name":"American Journal of Gastroenterology","volume":"120 2","pages":"431-439"},"PeriodicalIF":8.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143070870","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Introduction: Postendoscopic submucosal dissection (ESD) coagulation syndrome (PECS) prevention is one of the common postoperative complications of colorectal ESD. Considering the increasing incidence of PECS, it is critical to investigate various prevention methods. The objective of this study was to evaluate the efficacy of transrectal drainage tubes (TDTs) in PECS prevention in patients following colorectal ESD.
Methods: From July 2022 to July 2023, a multicenter, randomized controlled clinical trial was conducted in 3 hospitals in China. Patients with superficial colorectal lesions ≥20 mm who had undergone ESD for a single lesion were enrolled. Initially, 229 patients were included in the study and 5 were excluded. Two hundred twenty-four were randomly assigned to the TDT and non-TDT group in the end. This open-label study utilized a parallel design with a 1:1 allocation ratio, and endoscopists and patients were not blind to the randomization, and a 24 Fr drainage tube was inserted approximately 10-15 cm above the anus after the ESD under the endoscopy and tightly attached to a drainage bag. The TDTs were removed in 1-3 days following the ESD.
Results: A total of 229 eligible patients were enrolled in this study, and 5 patients were excluded. Ultimately, 224 patients were assigned to the TDT group (n = 112) and non-TDT group (n = 112). The median age for the patients was 63.45 years (IQR 57-71; 59 men [52.68%]) in the TDT group and 60.95 years (IQR 54-68; 60 men [53.57%]) in the non-TDT group. Intention-to-treat analysis showed patients in the TDT group had a lower incidence of PECS than patients in the non-TDT group (7 [6.25%] vs 20 [17.86%]; relative risk, 0.350; 95% confidence interval [CI], 0.154-0.795; P = 0.008). In the subgroup analysis, TDTs were found to prevent PECS in patients of the female gender (odd ratio, 0.097; 95% CI, 0.021-0.449; P = 0.001), tumor size <4 cm (odd ratio, 0.203; 95% CI, 0.056-0.728; P = 0.011), tumor located in the left-sided colorectum (odd ratio, 0. 339 95% CI, 0.120-0.957; P = 0.035), and shorter procedure time (<45 minutes) (odd ratio, 0.316; 95% CI, 0.113-0.879; P = 0.023). The tube fell off in 1 case (0.89%) accidentally ahead of time. No TDT-related complication was observed.
Discussion: The results from this randomized clinical study indicate that the application of TDTs effectively reduced the incidence of PECS in patients after colorectal ESD ( chictr.org.cn Identifier: ChiCTR2200062164).
{"title":"Transrectal Drainage Tube Use for Preventing Postendoscopic Submucosal Dissection Coagulation Syndrome in Patients With Colorectal Lesions: A Multicenter Randomized Controlled Clinical Trial.","authors":"Jingyi Liu, Zhipeng Qi, Dongli He, Jianhong Shen, Mingyan Cai, Shilun Cai, Qiang Shi, Zhong Ren, Hui Pan, Bing Li, Yunshi Zhong","doi":"10.14309/ajg.0000000000002959","DOIUrl":"10.14309/ajg.0000000000002959","url":null,"abstract":"<p><strong>Introduction: </strong>Postendoscopic submucosal dissection (ESD) coagulation syndrome (PECS) prevention is one of the common postoperative complications of colorectal ESD. Considering the increasing incidence of PECS, it is critical to investigate various prevention methods. The objective of this study was to evaluate the efficacy of transrectal drainage tubes (TDTs) in PECS prevention in patients following colorectal ESD.</p><p><strong>Methods: </strong>From July 2022 to July 2023, a multicenter, randomized controlled clinical trial was conducted in 3 hospitals in China. Patients with superficial colorectal lesions ≥20 mm who had undergone ESD for a single lesion were enrolled. Initially, 229 patients were included in the study and 5 were excluded. Two hundred twenty-four were randomly assigned to the TDT and non-TDT group in the end. This open-label study utilized a parallel design with a 1:1 allocation ratio, and endoscopists and patients were not blind to the randomization, and a 24 Fr drainage tube was inserted approximately 10-15 cm above the anus after the ESD under the endoscopy and tightly attached to a drainage bag. The TDTs were removed in 1-3 days following the ESD.</p><p><strong>Results: </strong>A total of 229 eligible patients were enrolled in this study, and 5 patients were excluded. Ultimately, 224 patients were assigned to the TDT group (n = 112) and non-TDT group (n = 112). The median age for the patients was 63.45 years (IQR 57-71; 59 men [52.68%]) in the TDT group and 60.95 years (IQR 54-68; 60 men [53.57%]) in the non-TDT group. Intention-to-treat analysis showed patients in the TDT group had a lower incidence of PECS than patients in the non-TDT group (7 [6.25%] vs 20 [17.86%]; relative risk, 0.350; 95% confidence interval [CI], 0.154-0.795; P = 0.008). In the subgroup analysis, TDTs were found to prevent PECS in patients of the female gender (odd ratio, 0.097; 95% CI, 0.021-0.449; P = 0.001), tumor size <4 cm (odd ratio, 0.203; 95% CI, 0.056-0.728; P = 0.011), tumor located in the left-sided colorectum (odd ratio, 0. 339 95% CI, 0.120-0.957; P = 0.035), and shorter procedure time (<45 minutes) (odd ratio, 0.316; 95% CI, 0.113-0.879; P = 0.023). The tube fell off in 1 case (0.89%) accidentally ahead of time. No TDT-related complication was observed.</p><p><strong>Discussion: </strong>The results from this randomized clinical study indicate that the application of TDTs effectively reduced the incidence of PECS in patients after colorectal ESD ( chictr.org.cn Identifier: ChiCTR2200062164).</p>","PeriodicalId":7608,"journal":{"name":"American Journal of Gastroenterology","volume":" ","pages":"379-389"},"PeriodicalIF":8.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141578741","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01Epub Date: 2024-08-14DOI: 10.14309/ajg.0000000000003029
Kris V Kowdley, Gideon M Hirschfield, Charles Coombs, Elizabeth S Malecha, Leona Bessonova, Jing Li, Nuvan Rathnayaka, George Mells, David E Jones, Palak J Trivedi, Bettina E Hansen, Rachel Smith, James Wason, Shaun Hiu, Dorcas N Kareithi, Andrew L Mason, Christopher L Bowlus, Kate Muller, Marco Carbone, Marina Berenguer, Piotr Milkiewicz, Femi Adekunle, Alejandra Villamil
Introduction: Obeticholic acid (OCA) treatment for primary biliary cholangitis (PBC) was conditionally approved in the phase 3 POISE trial. The COBALT confirmatory trial assessed whether clinical outcomes in patients with PBC improve with OCA therapy.
Methods: Patients randomized to OCA (5-10 mg) were compared with placebo (randomized controlled trial [RCT]) or external control (EC). The primary composite endpoint was time to death, liver transplant, model for end-stage liver disease score ≥15, uncontrolled ascites, or hospitalization for hepatic decompensation. A prespecified propensity score-weighted EC group was derived from a US healthcare claims database.
Results: In the RCT, the primary endpoint occurred in 28.6% of OCA (n = 168) and 28.9% of placebo patients (n = 166; intent-to-treat analysis hazard ratio [HR] = 1.01, 95% confidence interval = 0.68-1.51), but functional unblinding and crossover to commercial therapy occurred, especially in the placebo arm. Correcting for these using inverse probability of censoring weighting and as-treated analyses shifted the HR to favor OCA. In the EC (n = 1,051), the weighted primary endpoint occurred in 10.1% of OCA and 21.5% of non-OCA patients (HR = 0.39; 95% confidence interval = 0.22-0.69; P = 0.001). No new safety signals were identified in the RCT.
Discussion: Functional unblinding and treatment crossover, particularly in the placebo arm, confounded the intent-to-treat estimate of outcomes associated with OCA in the RCT. Comparison with the real-world EC showed that OCA treatment significantly reduced the risk of negative clinical outcomes. These analyses demonstrate the value of EC data in confirmatory trials and suggest that treatment with OCA improves clinical outcomes in patients with PBC.
{"title":"COBALT: A Confirmatory Trial of Obeticholic Acid in Primary Biliary Cholangitis With Placebo and External Controls.","authors":"Kris V Kowdley, Gideon M Hirschfield, Charles Coombs, Elizabeth S Malecha, Leona Bessonova, Jing Li, Nuvan Rathnayaka, George Mells, David E Jones, Palak J Trivedi, Bettina E Hansen, Rachel Smith, James Wason, Shaun Hiu, Dorcas N Kareithi, Andrew L Mason, Christopher L Bowlus, Kate Muller, Marco Carbone, Marina Berenguer, Piotr Milkiewicz, Femi Adekunle, Alejandra Villamil","doi":"10.14309/ajg.0000000000003029","DOIUrl":"10.14309/ajg.0000000000003029","url":null,"abstract":"<p><strong>Introduction: </strong>Obeticholic acid (OCA) treatment for primary biliary cholangitis (PBC) was conditionally approved in the phase 3 POISE trial. The COBALT confirmatory trial assessed whether clinical outcomes in patients with PBC improve with OCA therapy.</p><p><strong>Methods: </strong>Patients randomized to OCA (5-10 mg) were compared with placebo (randomized controlled trial [RCT]) or external control (EC). The primary composite endpoint was time to death, liver transplant, model for end-stage liver disease score ≥15, uncontrolled ascites, or hospitalization for hepatic decompensation. A prespecified propensity score-weighted EC group was derived from a US healthcare claims database.</p><p><strong>Results: </strong>In the RCT, the primary endpoint occurred in 28.6% of OCA (n = 168) and 28.9% of placebo patients (n = 166; intent-to-treat analysis hazard ratio [HR] = 1.01, 95% confidence interval = 0.68-1.51), but functional unblinding and crossover to commercial therapy occurred, especially in the placebo arm. Correcting for these using inverse probability of censoring weighting and as-treated analyses shifted the HR to favor OCA. In the EC (n = 1,051), the weighted primary endpoint occurred in 10.1% of OCA and 21.5% of non-OCA patients (HR = 0.39; 95% confidence interval = 0.22-0.69; P = 0.001). No new safety signals were identified in the RCT.</p><p><strong>Discussion: </strong>Functional unblinding and treatment crossover, particularly in the placebo arm, confounded the intent-to-treat estimate of outcomes associated with OCA in the RCT. Comparison with the real-world EC showed that OCA treatment significantly reduced the risk of negative clinical outcomes. These analyses demonstrate the value of EC data in confirmatory trials and suggest that treatment with OCA improves clinical outcomes in patients with PBC.</p>","PeriodicalId":7608,"journal":{"name":"American Journal of Gastroenterology","volume":" ","pages":"390-400"},"PeriodicalIF":8.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11774195/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141974853","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01Epub Date: 2024-09-04DOI: 10.14309/ajg.0000000000003076
Byron P Vaughn, Alexander Khoruts, Monika Fischer
Patients with inflammatory bowel disease (IBD) have an increased risk of Clostridioides difficile infection (CDI), which can lead to worse IBD outcomes. The diagnosis of CDI in patients with IBD is complicated by higher C. difficile colonization rates and shared clinical symptoms of intestinal inflammation. Traditional risk factors for CDI, such as antibiotic exposure, may be lacking in patients with IBD because of underlying intestinal microbiota dysbiosis. Although CDI disproportionately affects people with IBD, patients with IBD are typically excluded from CDI clinical trials creating a knowledge gap in the diagnosis and management of these 2 diseases. This narrative review aims to provide a comprehensive overview of the diagnosis, treatment, and prevention of CDI in patients with IBD. Distinguishing CDI from C. difficile colonization in the setting of an IBD exacerbation is important to avoid treatment delays. When CDI is diagnosed, extended courses of anti- C. difficile antibiotics may lead to better CDI outcomes. Regardless of a diagnosis of CDI, the presence of C. difficile in a patient with IBD should prompt a disease assessment of the underlying IBD. Microbiota-based therapies and bezlotoxumab seem to be effective in preventing CDI recurrence in patients with IBD. Patients with IBD should be considered at high risk of CDI recurrence and evaluated for a preventative strategy when diagnosed with CDI. Ultimately, the comanagement of CDI in a patient with IBD requires a nuanced, patient-specific approach to distinguish CDI from C. difficile colonization, prevent CDI recurrence, and manage the underlying IBD.
{"title":"Diagnosis and Management of Clostridioides difficile in Inflammatory Bowel Disease.","authors":"Byron P Vaughn, Alexander Khoruts, Monika Fischer","doi":"10.14309/ajg.0000000000003076","DOIUrl":"10.14309/ajg.0000000000003076","url":null,"abstract":"<p><p>Patients with inflammatory bowel disease (IBD) have an increased risk of Clostridioides difficile infection (CDI), which can lead to worse IBD outcomes. The diagnosis of CDI in patients with IBD is complicated by higher C. difficile colonization rates and shared clinical symptoms of intestinal inflammation. Traditional risk factors for CDI, such as antibiotic exposure, may be lacking in patients with IBD because of underlying intestinal microbiota dysbiosis. Although CDI disproportionately affects people with IBD, patients with IBD are typically excluded from CDI clinical trials creating a knowledge gap in the diagnosis and management of these 2 diseases. This narrative review aims to provide a comprehensive overview of the diagnosis, treatment, and prevention of CDI in patients with IBD. Distinguishing CDI from C. difficile colonization in the setting of an IBD exacerbation is important to avoid treatment delays. When CDI is diagnosed, extended courses of anti- C. difficile antibiotics may lead to better CDI outcomes. Regardless of a diagnosis of CDI, the presence of C. difficile in a patient with IBD should prompt a disease assessment of the underlying IBD. Microbiota-based therapies and bezlotoxumab seem to be effective in preventing CDI recurrence in patients with IBD. Patients with IBD should be considered at high risk of CDI recurrence and evaluated for a preventative strategy when diagnosed with CDI. Ultimately, the comanagement of CDI in a patient with IBD requires a nuanced, patient-specific approach to distinguish CDI from C. difficile colonization, prevent CDI recurrence, and manage the underlying IBD.</p>","PeriodicalId":7608,"journal":{"name":"American Journal of Gastroenterology","volume":" ","pages":"313-319"},"PeriodicalIF":8.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142124563","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01Epub Date: 2024-07-03DOI: 10.14309/ajg.0000000000002933
Atul Lodh, Goo Lee, Frederick H Weber
{"title":"What Is the Skinny on This Unusual Esophageal Finding: A Rare Case of Esophageal Epidermoid Metaplasia.","authors":"Atul Lodh, Goo Lee, Frederick H Weber","doi":"10.14309/ajg.0000000000002933","DOIUrl":"10.14309/ajg.0000000000002933","url":null,"abstract":"","PeriodicalId":7608,"journal":{"name":"American Journal of Gastroenterology","volume":" ","pages":"277"},"PeriodicalIF":8.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141632367","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01Epub Date: 2024-06-27DOI: 10.14309/ajg.0000000000002920
Byungyoon Yun, Heejoo Park, Sang Hoon Ahn, Juyeon Oh, Beom Kyung Kim, Jin-Ha Yoon
Introduction: New terminologies of metabolic dysfunction-associated steatotic liver disease (MASLD) have been developed. We assessed hepatocellular carcinoma (HCC) risk across MASLD and/or alcohol intake.
Methods: We included participants aged 40-79 years receiving a national health checkup from 2009 to 2010 in the Republic of Korea, classified as follows: non-MASLD, MASLD, MASLD with increased alcohol intake (MetALD; weekly alcohol 210-420 g for male and 140-350 g for female individuals), and alcohol-associated liver disease (ALD; excessive alcohol intake with weekly alcohol ≥420 g for male or ≥350 g for female individuals). The primary outcome was HCC incidence. HCC risk was estimated using multivariable Cox proportional hazard models.
Results: Among 6,412,209 participants, proportions of non-MASLD, MASLD, MetALD, and ALD cases were 59.5%, 32.4%, 4.8%, and 3.4%, respectively. During follow-up (median 13.3 years), 27,118 had newly developed HCC. Compared with non-MASLD, the HCC risk increased from MASLD (adjusted hazard ratio [aHR] 1.66, 95% confidence interval [CI] 1.62-1.71) and MetALD (aHR 2.17, 95% CI 2.08-2.27) to ALD (aHR 2.34, 95% CI 2.24-2.45) in a stepwise manner. Furthermore, the older and non-cirrhosis subgroups were more vulnerable to detrimental effects of MASLD and/or alcohol intake, concerning HCC risk. Among the older, female, and cirrhosis subgroups, MetALD poses similar HCC risks as ALD.
Discussion: HCC risk increased from MASLD and MetALD to ALD in a stepwise manner, compared with non-MASLD. For an effective primary prevention of HCC, a comprehensive approach should be required to modify both metabolic dysfunction and alcohol intake habit.
{"title":"Liver Cancer Risk Across Metabolic Dysfunction-Associated Steatotic Liver Disease and/or Alcohol: A Nationwide Study.","authors":"Byungyoon Yun, Heejoo Park, Sang Hoon Ahn, Juyeon Oh, Beom Kyung Kim, Jin-Ha Yoon","doi":"10.14309/ajg.0000000000002920","DOIUrl":"10.14309/ajg.0000000000002920","url":null,"abstract":"<p><strong>Introduction: </strong>New terminologies of metabolic dysfunction-associated steatotic liver disease (MASLD) have been developed. We assessed hepatocellular carcinoma (HCC) risk across MASLD and/or alcohol intake.</p><p><strong>Methods: </strong>We included participants aged 40-79 years receiving a national health checkup from 2009 to 2010 in the Republic of Korea, classified as follows: non-MASLD, MASLD, MASLD with increased alcohol intake (MetALD; weekly alcohol 210-420 g for male and 140-350 g for female individuals), and alcohol-associated liver disease (ALD; excessive alcohol intake with weekly alcohol ≥420 g for male or ≥350 g for female individuals). The primary outcome was HCC incidence. HCC risk was estimated using multivariable Cox proportional hazard models.</p><p><strong>Results: </strong>Among 6,412,209 participants, proportions of non-MASLD, MASLD, MetALD, and ALD cases were 59.5%, 32.4%, 4.8%, and 3.4%, respectively. During follow-up (median 13.3 years), 27,118 had newly developed HCC. Compared with non-MASLD, the HCC risk increased from MASLD (adjusted hazard ratio [aHR] 1.66, 95% confidence interval [CI] 1.62-1.71) and MetALD (aHR 2.17, 95% CI 2.08-2.27) to ALD (aHR 2.34, 95% CI 2.24-2.45) in a stepwise manner. Furthermore, the older and non-cirrhosis subgroups were more vulnerable to detrimental effects of MASLD and/or alcohol intake, concerning HCC risk. Among the older, female, and cirrhosis subgroups, MetALD poses similar HCC risks as ALD.</p><p><strong>Discussion: </strong>HCC risk increased from MASLD and MetALD to ALD in a stepwise manner, compared with non-MASLD. For an effective primary prevention of HCC, a comprehensive approach should be required to modify both metabolic dysfunction and alcohol intake habit.</p>","PeriodicalId":7608,"journal":{"name":"American Journal of Gastroenterology","volume":" ","pages":"410-419"},"PeriodicalIF":8.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141454646","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01Epub Date: 2024-08-20DOI: 10.14309/ajg.0000000000003033
Livia Guadagnoli, Sophie Abber, Annelies Geeraerts, Hannelore Geysen, Ans Pauwels, Jan Tack, Lukas Van Oudenhove, Tim Vanuytsel
Introduction: Real-time symptom reporting during ambulatory reflux monitoring plays a key role in the evaluation of esophageal symptoms, although the underlying processes are poorly understood. We aim to identify the psychological and physiological factors associated with real-time reflux symptom reporting and symptom-reflux association parameters.
Methods: Adult patients with refractory reflux symptoms completed psychosocial questionnaires and standard 24-hour pH-impedance monitoring. A hurdle-Poisson model evaluated the association between psychological and physiological (proton pump inhibitor [PPI] use, total number of reflux episodes) variables on real-time symptom frequency, assessed through a button press within 2 minutes of experiencing a symptom. Logistic regression assessed the variables associated with symptom association probability (SAP) and symptom index classification (positive/negative). Complementary machine learning analyses with 8-fold cross-validation further identified variables associated with symptom frequency and sought to optimize SAP classification performance.
Results: Both psychological (pain-related anxiety, depressive symptoms, trait anxiety) and physiological (total number of reflux episodes, off PPI during testing) variables were associated with symptom frequency. The total number of reflux episodes and being studied off PPI were significantly associated with a higher likelihood of being classified as SAP or symptom index positive. The best-performing model in the machine learning analysis demonstrated a poor job of correctly classifying patients as SAP positive/negative (misclassification rate = 41.4%).
Discussion: Real-time reflux symptom reporting is a multifactorial process, with both psychological and physiological processes contributing to different aspects of the reflux disease experience. Findings build on questionnaire-based research to underscore the importance of including psychological processes in our understanding of esophageal symptom reporting.
背景:非卧床反流监测期间的实时症状报告在食管症状评估中起着关键作用,但对其基本过程却知之甚少。我们旨在确定与实时反流症状报告和症状-反流关联参数相关的心理和生理因素:方法:患有难治性反流症状的成年患者填写心理社会调查问卷,并进行标准的 24 小时 pH 值阻抗监测。飓风-泊松模型评估了心理和生理(质子泵抑制剂(PPI)使用情况、反流发作总次数)变量与实时症状频率之间的关联,实时症状频率是在出现症状后两分钟内按下按钮进行评估的。逻辑回归评估了与症状关联概率(SAP)和症状指数(SI)分类(阳性/阴性)相关的变量。采用8倍交叉验证的补充机器学习分析进一步确定了与症状频率相关的变量,并试图优化SAP分类性能:心理(疼痛相关焦虑、抑郁症状、特质焦虑)和生理(反流发作总次数、测试期间未使用 PPI)变量均与症状频率相关。反流发作总次数和停用 PPI 进行研究与被归类为 SAP 或 SI 阳性的可能性较高密切相关。机器学习分析中表现最好的模型在将患者正确分类为 SAP 阳性/阴性方面表现不佳(误分类率=41.4%):实时反流症状报告是一个多因素过程,心理和生理过程对反流疾病体验的不同方面都有影响。研究结果以基于问卷的研究为基础,强调了将心理过程纳入我们对食管症状报告的理解中的重要性。
{"title":"Physiological and Psychological Factors Contribute to Real-Time Esophageal Symptom Reporting in Patients With Refractory Reflux.","authors":"Livia Guadagnoli, Sophie Abber, Annelies Geeraerts, Hannelore Geysen, Ans Pauwels, Jan Tack, Lukas Van Oudenhove, Tim Vanuytsel","doi":"10.14309/ajg.0000000000003033","DOIUrl":"10.14309/ajg.0000000000003033","url":null,"abstract":"<p><strong>Introduction: </strong>Real-time symptom reporting during ambulatory reflux monitoring plays a key role in the evaluation of esophageal symptoms, although the underlying processes are poorly understood. We aim to identify the psychological and physiological factors associated with real-time reflux symptom reporting and symptom-reflux association parameters.</p><p><strong>Methods: </strong>Adult patients with refractory reflux symptoms completed psychosocial questionnaires and standard 24-hour pH-impedance monitoring. A hurdle-Poisson model evaluated the association between psychological and physiological (proton pump inhibitor [PPI] use, total number of reflux episodes) variables on real-time symptom frequency, assessed through a button press within 2 minutes of experiencing a symptom. Logistic regression assessed the variables associated with symptom association probability (SAP) and symptom index classification (positive/negative). Complementary machine learning analyses with 8-fold cross-validation further identified variables associated with symptom frequency and sought to optimize SAP classification performance.</p><p><strong>Results: </strong>Both psychological (pain-related anxiety, depressive symptoms, trait anxiety) and physiological (total number of reflux episodes, off PPI during testing) variables were associated with symptom frequency. The total number of reflux episodes and being studied off PPI were significantly associated with a higher likelihood of being classified as SAP or symptom index positive. The best-performing model in the machine learning analysis demonstrated a poor job of correctly classifying patients as SAP positive/negative (misclassification rate = 41.4%).</p><p><strong>Discussion: </strong>Real-time reflux symptom reporting is a multifactorial process, with both psychological and physiological processes contributing to different aspects of the reflux disease experience. Findings build on questionnaire-based research to underscore the importance of including psychological processes in our understanding of esophageal symptom reporting.</p>","PeriodicalId":7608,"journal":{"name":"American Journal of Gastroenterology","volume":" ","pages":"344-352"},"PeriodicalIF":8.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142003405","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}