Therapeutic Advances in Gastroenterology最新文献

{"title":"CD8+ cell dominance in immune checkpoint inhibitor-induced colitis and its heterogeneity across endoscopic features.","authors":"Min Kyu Kim, Hye-Nam Son, Seung Wook Hong, Sang Hyoung Park, Dong-Hoon Yang, Byong Duk Ye, Jeong-Sik Byeon, Seung-Jae Myung, Suk-Kyun Yang, Shinkyo Yoon, Sung Wook Hwang","doi":"10.1177/17562848241309445","DOIUrl":"10.1177/17562848241309445","url":null,"abstract":"<p><strong>Background: </strong>Immune checkpoint inhibitor (ICI)-induced colitis is a significant adverse event associated with ICI therapy, known to be linked to increased cytotoxic T-cell activity.</p><p><strong>Objectives: </strong>To compare T-cell subsets based on the endoscopic features of ICI-induced colitis and to compare these findings with those of inflammatory bowel disease (IBD).</p><p><strong>Design: </strong>Prospective cohort study.</p><p><strong>Methods: </strong>We analyzed patients with ICI-induced colitis, confirmed through both endoscopic and histological evaluation. Biopsy specimens were examined using multiplex immunohistochemistry to assess their immune cell profile. Clinical outcomes were analyzed. Immune cell profiles were compared based on their endoscopic features and contrasted with those of patients with IBD.</p><p><strong>Results: </strong>Seventeen patients with ICI-induced colitis were included in the study. All patients showed clinical improvement after treatment, and steroids were administered to 11 patients (64.7%). Based on endoscopic features, the patients were classified as Crohn's disease (CD)-like (<i>n</i> = 3, 17.6%), ulcerative colitis (UC)-like (<i>n</i> = 9, 52.9%), or microscopic colitis (MC)-like (<i>n</i> = 5, 29.4%). In ICI-induced colitis, cytotoxic T cells (Tc cells) were more predominant than helper T cells (Th cells) (<i>p</i> = 0.053), and this trend was most pronounced in the MC-like subtype (<i>p</i> = 0.020). When comparing the number of CD8+ cells infiltrating the crypts, both the UC-like and MC-like subtypes had significantly more infiltrating cells than the CD-like subtype (<i>p</i> = 0.008 and <i>p</i> = 0.016, respectively). In comparison to IBD, IBD exhibited a Th-dominant profile, whereas CD-like ICI-induced colitis had a lower Th cell density than CD (<i>p</i> = 0.032) and UC-like ICI-induced colitis had a higher Tc density than UC (<i>p</i> = 0.045).</p><p><strong>Conclusion: </strong>Analysis of T-cell subsets of ICI-induced colitis revealed a Tc-dominant profile, contrasting with the Th dominance observed in patients with IBD. The Tc-dominant profile was evident in UC-like and MC-like subtypes, with significant crypt infiltration by CD8+ cells. Tc may play an important role in the pathophysiology of ICI-induced colitis.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"17 ","pages":"17562848241309445"},"PeriodicalIF":3.9,"publicationDate":"2024-12-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11672375/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142904071","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 randomized treatment withdrawal of budesonide oral suspension on clinically relevant efficacy outcomes in patients with eosinophilic esophagitis: a post hoc analysis.","authors":"Evan S Dellon, Margaret H Collins, David A Katzka, Vincent A Mukkada, Gary W Falk, Wenwen Zhang, Bridgett Goodwin, Brian Terreri, Mena Boules, Nirav K Desai, Ikuo Hirano","doi":"10.1177/17562848241307602","DOIUrl":"10.1177/17562848241307602","url":null,"abstract":"<p><strong>Background: </strong>Relapse after corticosteroid withdrawal in eosinophilic esophagitis is not well understood.</p><p><strong>Objectives: </strong>Budesonide oral suspension (BOS) 2.0 mg twice daily (b.i.d.) was evaluated in two consecutive phase III studies (12 and 36 weeks, respectively). For clinicopathologic responders after 12 weeks of BOS treatment, we assessed randomized treatment withdrawal for up to 36 weeks of therapy.</p><p><strong>Design: </strong>Post hoc analysis of a phase III, double-blind, randomized withdrawal study.</p><p><strong>Methods: </strong>Clinicopathologic responders (⩽6 eosinophils per high-power field (eos/hpf) and ⩾30% reduction in Dysphagia Symptom Questionnaire (DSQ) score from baseline) after 12 weeks of BOS were randomized to continue BOS 2.0 mg b.i.d. (BOS-BOS) or withdraw to placebo (PBO; BOS-PBO) for up to 36 weeks. Relapsers (⩾15 eos/hpf (⩾2 esophageal regions) and ⩾4 days of dysphagia (DSQ)) could reinitiate BOS 2.0 mg b.i.d. This post hoc analysis assessed a more clinically relevant relapse definition (⩾15 eos/hpf (⩾1 esophageal region) and ⩾4 days of dysphagia (DSQ)) for BOS-BOS versus BOS-PBO patients over 36 weeks. To account for BOS-PBO patients who reinitiated BOS before week 36, patients' last observations before reinitiating BOS were carried forward (last observation carried forward (LOCF)) for histologic, symptom, and endoscopic efficacy endpoints (at weeks 12 and 36).</p><p><strong>Results: </strong>Of 48 patients included (BOS-BOS, <i>n</i> = 25; BOS-PBO, <i>n</i> = 23), significantly more BOS-PBO than BOS-BOS patients relapsed over 36 weeks using this post hoc relapse definition (60.9% vs 28.0%; <i>p</i> = 0.022). More BOS-BOS than BOS-PBO patients maintained histologic responses (all thresholds) and showed improvements in symptom and endoscopic efficacy endpoints.</p><p><strong>Conclusion: </strong>More BOS-PBO than BOS-BOS patients relapsed, determined by a more clinically relevant post hoc relapse definition. Using LOCF, more BOS-BOS than BOS-PBO patients also maintained or had improvements in efficacy endpoints.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifiers (https://clinicaltrials.gov/): NCT02605837, NCT02736409.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"17 ","pages":"17562848241307602"},"PeriodicalIF":3.9,"publicationDate":"2024-12-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11672502/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142902867","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":"Mediation role of body mass index in the relationship between food-specific serum immunoglobulin G reactivity and colorectal adenomas in a Chinese population: a cross-sectional study.","authors":"Guanchao Sun, Xiaona Ma, Shiping Xu, Binbin Su, Qianqian Chen, Xiaoyu Dong, Lihui Wang, Jun Wan, Hui Shi","doi":"10.1177/17562848241307601","DOIUrl":"10.1177/17562848241307601","url":null,"abstract":"<p><strong>Background: </strong>Colorectal adenomas (CAs) represent a significant global health issue, particularly in China, where lifestyle modifications have contributed to their increased prevalence. These adenomas are precursors to colorectal cancer. While high-fiber diets have been shown to decrease risk, the implications of food-specific serum immunoglobulin G reactivity (FSsIgGR) on CAs remain uncertain and warrant further investigation.</p><p><strong>Objectives: </strong>To investigate the association between FSsIgGR and the occurrence of CAs in the Chinese population, assess the mediating influence of body mass index (BMI), and offer insights into potential prevention strategies.</p><p><strong>Design: </strong>A retrospective cross-sectional study.</p><p><strong>Methods: </strong>This study is based on 8796 individuals who underwent colonoscopy at the Second Medical Center of Chinese PLA General Hospital from 2017 to 2021. We examined the relationship between FSsIgGR and CAs using logistic regression, controlling for various confounders. Interaction effects were explored through subgroup analysis. We addressed missing data using multiple imputation and confirmed the robustness of our findings through sensitivity analysis. The role of BMI as a mediator was quantified using structural equation modeling.</p><p><strong>Results: </strong>The cohort comprised 2703 patients diagnosed with CAs and 6093 polyp-free controls, with an average age of 50.1 years, of whom 70.1% were male. The analysis revealed a significant inverse association between FSsIgGR and the incidence of CAs (adjusted odds ratio = 0.97; 95% confidence interval: 0.95-0.99; <i>p</i> < 0.001). Dose-response analysis indicated a linear reduction in CAs risk correlating with an increased number of IgG-positive food items. Structural equation modeling showed that BMI mediated 6.02% of the effect on CAs risk (<i>p</i> = 0.038).</p><p><strong>Conclusion: </strong>Our findings suggest that FSsIgGR correlates with a reduced risk of developing CAs, with BMI partially mediating this effect. These results add a novel dimension to CAs risk assessment and prevention, highlighting potential dietary interventions.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"17 ","pages":"17562848241307601"},"PeriodicalIF":3.9,"publicationDate":"2024-12-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11664519/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142883264","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":"Look above the IRP: predicting abnormal confirmatory testing in patients with esophagogastric junction outflow obstruction.","authors":"Alexandra Strauss Starling, Shivani U Thanawala, Claire A Beveridge, Gary W Falk, Kristle L Lynch","doi":"10.1177/17562848241306128","DOIUrl":"10.1177/17562848241306128","url":null,"abstract":"<p><strong>Background: </strong>Esophagogastric junction outflow obstruction (EGJOO) is a manometric diagnosis based on Chicago Classification version 4.0 (CC4.0) that requires confirmatory testing for clinical relevancy. However, it is still unclear which patients will respond to therapy.</p><p><strong>Objectives: </strong>To evaluate manometric and clinical predictors of abnormal confirmatory testing for patients with EGJOO.</p><p><strong>Design: </strong>This was a prospective observational study of patients with manometric EGJOO and chest pain or dysphagia who underwent confirmatory testing.</p><p><strong>Methods: </strong>Patients with EGJOO on manometry were enrolled and underwent timed barium esophagram or endoFLIP. A subset of patients was given validated surveys, including Eckardt scores (ES) and PROMIS-10.</p><p><strong>Results: </strong>For patients with a CC4.0 EGJOO diagnosis, abnormal peristalsis (OR = 7.0, 95% CI = 1.01-44.6, <i>p</i> = 0.04) and increases in ES (OR = 2.34 95% CI = 1.13-4.86, <i>p</i> = 0.02) were associated with positive confirmatory testing.</p><p><strong>Conclusion: </strong>Patients with potentially actionable EGJOO were more likely to have an abnormal peristaltic subtype of EGJOO or higher ES.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"17 ","pages":"17562848241306128"},"PeriodicalIF":3.9,"publicationDate":"2024-12-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11672487/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142903068","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":"Advancing therapeutic frontiers: a pipeline of novel drugs for luminal and perianal Crohn's disease management.","authors":"Luisa Bertin, Martina Crepaldi, Miriana Zanconato, Greta Lorenzon, Daria Maniero, Caterina de Barba, Erica Bonazzi, Sonia Facchin, Marco Scarpa, Cesare Ruffolo, Imerio Angriman, Andrea Buda, Fabiana Zingone, Brigida Barberio, Edoardo Vincenzo Savarino","doi":"10.1177/17562848241303651","DOIUrl":"10.1177/17562848241303651","url":null,"abstract":"<p><p>Crohn's disease (CD) is a chronic, complex inflammatory disorder of the gastrointestinal tract that presents significant therapeutic challenges. Despite the availability of a wide range of treatments, many patients experience primary non-response, secondary loss of response, or adverse events, limiting the overall effectiveness of current therapies. Clinical trials often report response rates below 60%, partly due to stringent inclusion criteria. Emerging therapies that target novel pathways offer promise in overcoming these limitations. This review explores the latest investigational drugs in phases I, II, and III clinical trials for treating both luminal and perianal CD. We highlight promising therapies that target known mechanisms, including selective Janus kinase inhibitors, anti-adhesion molecules, tumor necrosis factor inhibitors, and IL-23 selective inhibitors. In addition, we delve into novel therapeutic strategies such as sphingosine-1-phosphate receptor modulators, miR-124 upregulators, anti-fractalkine (CX3CL1), anti-TL1A, peroxisome proliferator-activated receptor gamma agonists, TGFBRI/ALK5 inhibitors, anti-CCR9 agents, and other innovative small molecules, as well as combination therapies. These emerging approaches, by addressing new pathways and mechanisms of action, have the potential to surpass the limitations of existing treatments and significantly improve CD management. However, the path to developing new therapies for inflammatory bowel disease (IBD) is fraught with challenges, including complex trial designs, ethical concerns regarding placebo use, recruitment difficulties, and escalating costs. The landscape of IBD clinical trials is shifting toward greater inclusivity, improved patient diversity, and innovative trial designs, such as adaptive and Bayesian approaches, to address these challenges. By overcoming these obstacles, the drug development pipeline can advance more effective, accessible, and timely treatments for CD.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"17 ","pages":"17562848241303651"},"PeriodicalIF":3.9,"publicationDate":"2024-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11660281/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142878374","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":"Inflammatory bowel disease and cardiac function: a systematic review of literature with meta-analysis.","authors":"Caroline Almeida Soares, João Gouveia Fiuza, Cláudio André Melo Rodrigues, Nuno Craveiro, Júlio Gil Pereira, Paula Cristina Ribeiro Fernandes Sousa, Diana Catarina Pinto Martins, Eugénia Maria Cancela, Maria Paula Ministro Dos Santos","doi":"10.1177/17562848241299534","DOIUrl":"10.1177/17562848241299534","url":null,"abstract":"<p><strong>Background: </strong>Morphological and functional cardiac involvement is rarely described in patients with inflammatory bowel disease (IBD) but there is evidence that they have an increased risk of cardiovascular (CV) events despite the lower prevalence of traditional CV risk factors.</p><p><strong>Objectives: </strong>Our systematic review and meta-analysis examined the relationship between IBD and cardiac function, namely the incidence of heart failure (HF) and subclinical echocardiographic changes.</p><p><strong>Data sources and methods: </strong>Two medical databases, PubMed and Scopus, were systematically searched up to September 2022 to identify all studies reporting HF and/or echocardiographic changes in IBD patients.</p><p><strong>Results: </strong>The qualitative analysis comprised a total of 18 studies (14 retrospective and 4 prospective studies) involving 59,838 patients. IBD was associated with subtle systolic and diastolic alterations, vascular dysfunction, increased risk for HF hospitalizations, and globally worse CV outcomes. Nine studies were included in the meta-analysis. In the IBD population, we found statistically significant reduced early to late diastolic transmitral flow (E/A), higher E to early diastolic mitral annular tissue velocity (E/e'), and decreased global longitudinal strain. Increased left atrial diameter and area were also present in IBD patients but no statistical significance was reached. Inter-atrial and right intra-atrial conduction delays were observed.</p><p><strong>Conclusion: </strong>The IBD population has an increased risk for left ventricular and atrial dysfunction, vascular changes, arrhythmias, and HF hospitalization. Screening with sensitive imaging like speckle tracking echocardiography could identify early subclinical changes. IBD is in fact a CV risk factor and tight inflammation control may reduce CV risk.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"17 ","pages":"17562848241299534"},"PeriodicalIF":3.9,"publicationDate":"2024-12-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11650564/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142848176","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":"Endoscopic innovations in diagnosis and management of pancreatic cancer: a narrative review and future directions.","authors":"Prateek Suresh Harne, Vaishali Harne, Curtis Wray, Nirav Thosani","doi":"10.1177/17562848241297434","DOIUrl":"10.1177/17562848241297434","url":null,"abstract":"<p><p>Pancreatic cancer serves as the third leading cause of cancer-associated morbidity and mortality in the United States, with a 5-year survival rate of only 12% with an expected increase in incidence and mortality in the coming years. Pancreatic ductal adenocarcinomas constitute most pancreatic malignancies. Certain genetic syndromes, including Lynch syndrome, hereditary breast and ovarian cancer syndrome, hereditary pancreatitis, familial adenomatous polyposis, Peutz-Jeghers syndrome, familial pancreatic cancer mutation, and ataxia telangiectasia, confer a significantly higher risk. Screening for pancreatic malignancies currently targets patients with germline mutations or those with significant family history. Screening the general population is not currently viable owing to overall low incidence and lack of specific tests. Endoscopic ultrasound (EUS) and its applied advances are increasingly being used for surveillance, diagnosis, and management of pancreatic malignancies and have now become an indispensable tool in their management. For patients with risk factors, EUS in combination with magnetic resonance imaging/magnetic resonance cholangiopancreatography is used for screening. The role of endoscopic modalities has been expanding with the increased utilization of endoscopic retrograde cholangiopancreatography, EUS-directed therapies include EUS-guided fine-needle aspiration and EUS-fine-needle biopsy (FNB). EUS combined with FNB has the highest specificity and sensitivity for detecting pancreatic cancer amongst available modalities. Studies also recognize that artificial intelligence assisted EUS in the early detection of pancreatic cancer. At the same time, surgical resection has been historically considered the only curative treatment for pancreatic cancer, over 80% of patients present with unresectable disease. We also discuss EUS-guided therapies of physicochemicals (radiofrequency ablation, brachytherapy, and intratumor chemotherapy), biological agents (gene therapies and oncolytic viruses), and immunotherapy. We aim to perform a detailed review of the current burden, risk factors, role of screening, diagnosis, and endoscopic advances in the treatment modalities available for pancreatic cancer.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"17 ","pages":"17562848241297434"},"PeriodicalIF":3.9,"publicationDate":"2024-12-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11632891/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142814616","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":"Efficacy and safety of prucalopride in patients with chronic idiopathic constipation stratified by age, body mass index, and renal function: a post hoc analysis of phase III and IV, randomized, placebo-controlled clinical studies.","authors":"Anthony Lembo, Kyle Staller, Mena Boules, Paul Feuerstadt, William Spalding, André Gabriel, Ashraf Youssef, Yunlong Xie, Brian Terreri, Brooks D Cash","doi":"10.1177/17562848241299731","DOIUrl":"10.1177/17562848241299731","url":null,"abstract":"<p><strong>Background: </strong>Prucalopride (1 or 2 mg once daily) is approved for treating adults with chronic idiopathic constipation (CIC).</p><p><strong>Objectives: </strong>We determined the effect of age, body mass index (BMI), and renal function on the efficacy and safety of prucalopride in adults with CIC.</p><p><strong>Design: </strong>Data were pooled from six 12-week, phase III-IV clinical studies in adults who received prucalopride (1 or 2 mg once daily) or placebo for CIC.</p><p><strong>Methods: </strong>Adults were stratified by age (<50; 50-64; ⩾65 years), BMI (underweight/healthy weight, <25 kg/m²; overweight, 25 to <30 kg/m²; obese, ⩾30 kg/m²), and renal function (normal renal function, estimated glomerular filtration rate (eGFR) ⩾90 mL/min/1.73 m²; mild renal impairment, eGFR 60 to <90 mL/min/1.73 m²; moderate renal impairment, eGFR 30 to <60 mL/min/1.73 m²). The primary efficacy endpoint was the proportion of patients with a mean of ⩾3 complete spontaneous bowel movements/week over 12 weeks. Safety data were evaluated descriptively.</p><p><strong>Results: </strong>Of 2484 patients stratified by age (prucalopride, <i>n</i> = 1237; placebo, <i>n</i> = 1247), 1402, 708, and 374 were aged <50, 50-64, and ⩾65 years, respectively. Of 2482 patients stratified by BMI (prucalopride, <i>n</i> = 1237; placebo, <i>n</i> = 1245), 1425, 713, and 344 were underweight/healthy weight, overweight, and obese, respectively. Of 2474 patients stratified by renal function (prucalopride, <i>n</i> = 1233; placebo, <i>n</i> = 1241), 1444, 869, and 161 had normal renal function, mild renal impairment, and moderate renal impairment, respectively. More prucalopride-treated than placebo-treated patients achieved the primary efficacy endpoint. The difference was significant for all subgroups, except for the obese and moderate renal impairment subgroups. More prucalopride-treated than placebo-treated patients reported treatment-related adverse events in most subgroups.</p><p><strong>Conclusion: </strong>Prucalopride demonstrated efficacy in adults with CIC, irrespective of age, BMI, and renal function. No unexpected safety concerns were identified.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifiers (https://clinicaltrials.gov/): NCT01147926, NCT01424228, NCT01116206, NCT00483886, NCT00485940, NCT00488137.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"17 ","pages":"17562848241299731"},"PeriodicalIF":3.9,"publicationDate":"2024-12-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11632959/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142814611","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 review of endoscopic ultrasound-guided gallbladder drainage and gastroenterostomy: assisted approaches and comparison with alternative techniques.","authors":"Rongmin Xu, Kai Zhang, Jintao Guo, Siyu Sun","doi":"10.1177/17562848241299755","DOIUrl":"10.1177/17562848241299755","url":null,"abstract":"<p><p>Over the last 40 years, the role of endoscopic ultrasound (EUS) has evolved from being diagnostic to therapeutic. EUS-guided gallbladder drainage (EUS-GBD) and EUS-guided gastroenterostomy (EUS-GE) are emerging techniques in recent years; however, there are limited studies and inconsistent results regarding these techniques. In addition, EUS has become a more common alternative to traditional interventions due to its super minimally invasive nature, but the mobility of both the gallbladder and intestine makes it challenging to introduce stents. An increasing number of researchers are dedicating themselves to solving this problem, leading to the development of various assisted technologies. Consequently, this review focused on the comparison of EUS-GBD and EUS-GE with other alternative approaches and explored the various assisted techniques employed for EUS-GBD and EUS-GE.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"17 ","pages":"17562848241299755"},"PeriodicalIF":3.9,"publicationDate":"2024-12-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11615986/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142781621","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":"Reverse switching from the biosimilar SB2 to the originator infliximab in previously switched patients with inflammatory bowel diseases: results of a prospective long-term cohort study.","authors":"Sarah Fischer, Moritz Donhauser, Sarah Cohnen, Konstantin Fietkau, Marcel Vetter, Maria Grübel-Liehr, Peter Dietrich, Timo Rath, Angelika Wilfer, Ludmilla Sologub, Sabine Krebs, Frank Dörje, Daniel Nagore, Sebastian Meyer, Markus F Neurath, Raja Atreya","doi":"10.1177/17562848241301887","DOIUrl":"https://doi.org/10.1177/17562848241301887","url":null,"abstract":"<p><strong>Background: </strong>Data regarding multiple switches including reverse switching between infliximab and its biosimilars are scarce in the field of inflammatory bowel diseases (IBD).</p><p><strong>Objectives: </strong>We investigated the clinical effectiveness as primary outcome measure after repeated switches. Secondary endpoints included C-reactive protein (CRP) levels, immunogenicity (trough levels (TL); anti-drug antibodies (ADA), safety and drug persistence.</p><p><strong>Design: </strong>This study is a prospective, single-centre, observational cohort study. IBD patients receiving originator infliximab were switched to biosimilar SB2 and then reverse switched after 96 weeks and followed up for another 48 weeks.</p><p><strong>Methods: </strong>Clinical disease activity (Harvey-Bradshaw-index (HBI) in Crohn's disease (CD), partial Mayo score (pMS) in ulcerative colitis (UC)), CRP, TL, ADA, therapy-discontinuations and (serious) adverse events ((S)AE)) were monitored throughout the study.</p><p><strong>Results: </strong>Ninety-five patients (60 CD, 38 female) were enrolled. The median HBI was 2 (interquartile range (IQR) 1-4) at baseline and 2 (1-4) at week 48, resulting in a mean intra-individual change of 0.0 (standard deviation (SD) 1.5). The median pMS was 1 (IQR 0-1) at baseline and 0.5 (0-1) at week 48 resulting in a mean intra-individual change of 0.0 (SD 0.8). Clinical remission was achieved in 80% at baseline and 82% at week 48. Median CRP 2.0 mg/l (IQR 1.0-4.1) at baseline and 2.4 mg/l (1.1-5.2) at week 48 resulted in a mean change of 1.7 (SD 5.8) and no significant differences in CD (<i>p</i> = 0.3) and UC (<i>p</i> = 0.9). Median TL were 7.2 µg/ml (IQR 3.8-19.3) at baseline and 5.5 µg/ml (3.5-13.1) at week 48, resulting in a mean change of -1.0 (SD 7.4) with no statistical significance (CD <i>p</i> = 0.26, UC <i>p</i> = 0.41). De-novo-ADA were developed by 3.4%. The discontinuation rate was 14.7%. Safety signals were consistent with previous studies.</p><p><strong>Conclusion: </strong>Reverse switching had no impact on efficacy of infliximab therapy in our cohort of IBD patients. The switch didn't influence immunogenicity or safety of therapy.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"17 ","pages":"17562848241301887"},"PeriodicalIF":3.9,"publicationDate":"2024-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11608450/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142774026","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}