Pub Date : 2025-01-01Epub Date: 2024-12-23DOI: 10.20524/aog.2025.0941
Theodoros Voulgaris, Theodoros Alexopoulos, Jiannis Vlachogiannakos, Dimitrios Kamberoglou, George Papatheodoridis, George Karamanolis
Background: Dysphagia and retrosternal chest pain are considered typical manifestations of major esophageal motility disorders (mEMD). High-resolution manometry (HRM) is the gold standard for mEMD diagnosis, while endoscopy and barium swallow are ancillary tools. We aimed to investigate the frequency of mEMD among patients referred for HRM with typical compared to non-typical symptoms. We also evaluated endoscopic and barium swallow data from patients with mEMD who underwent HRM.
Methods: We retrospectively collected epidemiological, endoscopic, barium swallow, and HRM data from 302 patients. Atypical symptoms were considered to be heartburn, regurgitation, globus, oropharyngeal dysphagia, and epigastric pain.
Results: The main referral symptoms were: esophageal dysphagia, 58.3%; chest pain, 13.7%; heartburn, 8.9%; regurgitation, 8.3%; and globus/oropharyngeal dysphagia/epigastric pain, 10.8%. A diagnosis of mEMD was more common when typical symptoms existed (69.9% vs. 15.4%, P<0.001). The majority of patients with mEMD in HRM, independently of their symptoms, had an abnormal barium study (typical: 94.8% vs. non-typical: 100%, P=0.633), while compatible endoscopic data tended to be observed more frequently among patients with typical symptoms (69.1% vs. 40%, P=0.057). An HRM diagnosis of mEMD among patients with compatible findings from either barium swallow or endoscopic examination was statistically more frequent among patients with typical symptoms (92.4% vs. 52.6%, P<0.001).
Conclusions: More than half of patients referred for HRM will be diagnosed with mEMD, at a higher rate when typical symptoms are reported. A lack of compatible endoscopic and barium swallow findings, in the absence of typical symptoms, makes the diagnosis of mEMD almost impossible.
背景:吞咽困难和胸骨后胸痛被认为是严重食管运动障碍(mEMD)的典型表现。高分辨率测压(HRM)是mEMD诊断的金标准,而内窥镜检查和钡餐是辅助工具。我们的目的是调查典型和非典型症状的人力资源管理患者中发生mEMD的频率。我们还评估了接受HRM的mEMD患者的内窥镜和钡餐吞咽数据。方法:回顾性收集302例患者的流行病学、内镜、钡餐和HRM资料。不典型症状被认为是胃灼热、反流、球、口咽吞咽困难和胃脘痛。结果:主要转诊症状为:食管吞咽困难,占58.3%;胸痛,13.7%;胃灼热,8.9%;返流,8.3%;球/口咽吞咽困难/胃脘痛,10.8%。当出现典型症状时,mEMD的诊断更为常见(69.9% vs. 15.4%)。结论:超过一半的HRM患者将被诊断为mEMD,当报告典型症状时,诊断率更高。在没有典型症状的情况下,缺乏相容的内镜和钡餐检查结果,使得mEMD的诊断几乎是不可能的。
{"title":"Diagnostic approach to patients with suspected motility disorders: one size does not fit all.","authors":"Theodoros Voulgaris, Theodoros Alexopoulos, Jiannis Vlachogiannakos, Dimitrios Kamberoglou, George Papatheodoridis, George Karamanolis","doi":"10.20524/aog.2025.0941","DOIUrl":"10.20524/aog.2025.0941","url":null,"abstract":"<p><strong>Background: </strong>Dysphagia and retrosternal chest pain are considered typical manifestations of major esophageal motility disorders (mEMD). High-resolution manometry (HRM) is the gold standard for mEMD diagnosis, while endoscopy and barium swallow are ancillary tools. We aimed to investigate the frequency of mEMD among patients referred for HRM with typical compared to non-typical symptoms. We also evaluated endoscopic and barium swallow data from patients with mEMD who underwent HRM.</p><p><strong>Methods: </strong>We retrospectively collected epidemiological, endoscopic, barium swallow, and HRM data from 302 patients. Atypical symptoms were considered to be heartburn, regurgitation, globus, oropharyngeal dysphagia, and epigastric pain.</p><p><strong>Results: </strong>The main referral symptoms were: esophageal dysphagia, 58.3%; chest pain, 13.7%; heartburn, 8.9%; regurgitation, 8.3%; and globus/oropharyngeal dysphagia/epigastric pain, 10.8%. A diagnosis of mEMD was more common when typical symptoms existed (69.9% vs. 15.4%, P<0.001). The majority of patients with mEMD in HRM, independently of their symptoms, had an abnormal barium study (typical: 94.8% vs. non-typical: 100%, P=0.633), while compatible endoscopic data tended to be observed more frequently among patients with typical symptoms (69.1% vs. 40%, P=0.057). An HRM diagnosis of mEMD among patients with compatible findings from either barium swallow or endoscopic examination was statistically more frequent among patients with typical symptoms (92.4% vs. 52.6%, P<0.001).</p><p><strong>Conclusions: </strong>More than half of patients referred for HRM will be diagnosed with mEMD, at a higher rate when typical symptoms are reported. A lack of compatible endoscopic and barium swallow findings, in the absence of typical symptoms, makes the diagnosis of mEMD almost impossible.</p>","PeriodicalId":7978,"journal":{"name":"Annals of Gastroenterology","volume":"38 1","pages":"12-19"},"PeriodicalIF":2.1,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11724384/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142969316","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: Inflammatory bowel disease (IBD), which affects over 2.3 million people in the USA, involves chronic gut inflammation and can lead to cardiovascular complications, including pericarditis. Whether pericarditis in IBD patients is caused by medication, or by the disease itself, remains unclear. Our study aimed to determine the prevalence of pericarditis in IBD and its impact on cardiac complications, outcomes and resource utilization.
Methods: NIS data were obtained for IBD patients from 2016-2020. Outcomes were assessed using multivariate logistic regression, adjusting for demographics, hospital characteristics, comorbidities, and IBD etiology.
Results: In our study of 1.52 million IBD patients, 0.6% had pericarditis, of whom a majority were women (54.1%) and white (76.3%), over 65 years old (43.1%), enrolled in Medicare (51.7%), and living in urban areas (96.3%). Adjusting for confounding factors, IBD patients with pericarditis had higher odds of cardiac arrest (adjusted odds ratio [aOR] 2.73, 95% confidence interval [CI] 1.90-3.91), cardiogenic shock (aOR 6.42, 95%CI 4.77-8.64), and ventricular arrhythmia (aOR 2.13, 95%CI 1.63-2.78 (P<0.001 for all).
Conclusions: Our study found that pericarditis, though rare at 0.6%, significantly impacts cardiovascular health and healthcare utilization in IBD patients, with higher prevalence of pericarditis in older individuals, females, and those with comorbidities such as diabetes, hypertension or chronic kidney disease highlighting the need for further research to enhance therapeutic approaches and patient care.
{"title":"Impact of pericarditis on cardiovascular complications and healthcare utilization in patients with inflammatory bowel disease: a National Inpatient Sample study.","authors":"Ayushi Garg, Rohan Menon, Ajit Brar, Hunza Chaudhary, Aalam Sohal, Avneet Kaur, Vijaywant Singh Brar","doi":"10.20524/aog.2024.0931","DOIUrl":"10.20524/aog.2024.0931","url":null,"abstract":"<p><strong>Background: </strong>Inflammatory bowel disease (IBD), which affects over 2.3 million people in the USA, involves chronic gut inflammation and can lead to cardiovascular complications, including pericarditis. Whether pericarditis in IBD patients is caused by medication, or by the disease itself, remains unclear. Our study aimed to determine the prevalence of pericarditis in IBD and its impact on cardiac complications, outcomes and resource utilization.</p><p><strong>Methods: </strong>NIS data were obtained for IBD patients from 2016-2020. Outcomes were assessed using multivariate logistic regression, adjusting for demographics, hospital characteristics, comorbidities, and IBD etiology.</p><p><strong>Results: </strong>In our study of 1.52 million IBD patients, 0.6% had pericarditis, of whom a majority were women (54.1%) and white (76.3%), over 65 years old (43.1%), enrolled in Medicare (51.7%), and living in urban areas (96.3%). Adjusting for confounding factors, IBD patients with pericarditis had higher odds of cardiac arrest (adjusted odds ratio [aOR] 2.73, 95% confidence interval [CI] 1.90-3.91), cardiogenic shock (aOR 6.42, 95%CI 4.77-8.64), and ventricular arrhythmia (aOR 2.13, 95%CI 1.63-2.78 (P<0.001 for all).</p><p><strong>Conclusions: </strong>Our study found that pericarditis, though rare at 0.6%, significantly impacts cardiovascular health and healthcare utilization in IBD patients, with higher prevalence of pericarditis in older individuals, females, and those with comorbidities such as diabetes, hypertension or chronic kidney disease highlighting the need for further research to enhance therapeutic approaches and patient care.</p>","PeriodicalId":7978,"journal":{"name":"Annals of Gastroenterology","volume":"38 1","pages":"51-59"},"PeriodicalIF":2.1,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11724386/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142969349","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-01Epub Date: 2024-12-12DOI: 10.20524/aog.2024.0936
Konstantina Dimopoulou, Dina Tiniakos, Nikolaos Arkadopoulos, Periklis G Foukas
Digestive tract carcinomas are the most commonly occurring cancers worldwide, but their prognosis with traditional treatments remains poor. T lymphocytes are well-recognized as crucial components of effective anti-tumor immunity, and current immunotherapeutic strategies concentrate mainly on T-cell-mediated immunity reinforcement, whereas the role of B lymphocytes and plasma cells (PCs) has been neglected in the past, and it is only recently that these cells have been considered as key players in the tumor microenvironment (TME). In this review, we describe the complex dual role of B lymphocytes and PCs in promoting and inhibiting tumor progression in the TME of digestive tract carcinomas, and we demonstrate their prognostic value. Furthermore, we highlight their controversial function in cancer and nominate them as additional therapeutic targets for the development of new treatment interventions that might alter the dismal prognosis of digestive tract tumors.
{"title":"Landscape of B lymphocytes and plasma cells in digestive tract carcinomas.","authors":"Konstantina Dimopoulou, Dina Tiniakos, Nikolaos Arkadopoulos, Periklis G Foukas","doi":"10.20524/aog.2024.0936","DOIUrl":"10.20524/aog.2024.0936","url":null,"abstract":"<p><p>Digestive tract carcinomas are the most commonly occurring cancers worldwide, but their prognosis with traditional treatments remains poor. T lymphocytes are well-recognized as crucial components of effective anti-tumor immunity, and current immunotherapeutic strategies concentrate mainly on T-cell-mediated immunity reinforcement, whereas the role of B lymphocytes and plasma cells (PCs) has been neglected in the past, and it is only recently that these cells have been considered as key players in the tumor microenvironment (TME). In this review, we describe the complex dual role of B lymphocytes and PCs in promoting and inhibiting tumor progression in the TME of digestive tract carcinomas, and we demonstrate their prognostic value. Furthermore, we highlight their controversial function in cancer and nominate them as additional therapeutic targets for the development of new treatment interventions that might alter the dismal prognosis of digestive tract tumors.</p>","PeriodicalId":7978,"journal":{"name":"Annals of Gastroenterology","volume":"38 1","pages":"1-11"},"PeriodicalIF":2.1,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11724378/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142969266","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-01Epub Date: 2025-09-26DOI: 10.20524/aog.2025.1005
Adonis A Protopapas, Nefeli Protopapa, Vaia Kyritsi, Athanasios Filippidis, Christos Savopoulos, Andreas N Protopapas
Background: The global medical community has set a goal of reducing the prevalence of viral hepatitis by 2030, focusing on screening large segments of the population who are unaware of being infected. This study aimed to investigate the efficacy of screening hospitalized patients for viral hepatitis.
Method: All patients hospitalized in an internal medicine department between January 2021 and September 2023 underwent screening for hepatitis B and C (HBV/C).
Results: A total of 3914 patients were screened (mean age 69.8±16.9 years). A total of 112 (2.9%) patients had positive surface antigen, and 1281 (32.8%) patients had evidence of prior HBV infection (anti-HBc+), of whom the majority (952, 74.4%) also had concurrent positive anti-HBs antibodies. HBV DNA testing was performed in 65 patients (58%), with 60 patients (92.3%) showing detectable HBV DNA levels. Of these, 13 had chronic HBV infection, and 47 had chronic HBV hepatitis. Finally, 28 patients (71.8% of eligible patients) received treatment. During screening for HCV, 102 patients (2.7%) were anti-HCV(+), and 53 patients (52%) underwent HCV RNA testing. Twenty-nine patients showed detectable HCV RNA levels (54.7%), with 13 patients eventually receiving treatment (52% of eligible patients).
Conclusions: Screening for viral hepatitis can be easily and effectively performed in hospitalized patients. However, significant care should be taken to ensure that all patients undergo the entire screening process and receive treatment when eligible. Additionally, a substantial proportion of patients with previous HBV infection was recorded, which is of considerable importance in the era of immunosuppressive therapies.
{"title":"Universal screening for viral hepatitis in all inpatients of a university internal medicine department.","authors":"Adonis A Protopapas, Nefeli Protopapa, Vaia Kyritsi, Athanasios Filippidis, Christos Savopoulos, Andreas N Protopapas","doi":"10.20524/aog.2025.1005","DOIUrl":"10.20524/aog.2025.1005","url":null,"abstract":"<p><strong>Background: </strong>The global medical community has set a goal of reducing the prevalence of viral hepatitis by 2030, focusing on screening large segments of the population who are unaware of being infected. This study aimed to investigate the efficacy of screening hospitalized patients for viral hepatitis.</p><p><strong>Method: </strong>All patients hospitalized in an internal medicine department between January 2021 and September 2023 underwent screening for hepatitis B and C (HBV/C).</p><p><strong>Results: </strong>A total of 3914 patients were screened (mean age 69.8±16.9 years). A total of 112 (2.9%) patients had positive surface antigen, and 1281 (32.8%) patients had evidence of prior HBV infection (anti-HBc+), of whom the majority (952, 74.4%) also had concurrent positive anti-HBs antibodies. HBV DNA testing was performed in 65 patients (58%), with 60 patients (92.3%) showing detectable HBV DNA levels. Of these, 13 had chronic HBV infection, and 47 had chronic HBV hepatitis. Finally, 28 patients (71.8% of eligible patients) received treatment. During screening for HCV, 102 patients (2.7%) were anti-HCV(+), and 53 patients (52%) underwent HCV RNA testing. Twenty-nine patients showed detectable HCV RNA levels (54.7%), with 13 patients eventually receiving treatment (52% of eligible patients).</p><p><strong>Conclusions: </strong>Screening for viral hepatitis can be easily and effectively performed in hospitalized patients. However, significant care should be taken to ensure that all patients undergo the entire screening process and receive treatment when eligible. Additionally, a substantial proportion of patients with previous HBV infection was recorded, which is of considerable importance in the era of immunosuppressive therapies.</p>","PeriodicalId":7978,"journal":{"name":"Annals of Gastroenterology","volume":"38 6","pages":"1-5"},"PeriodicalIF":2.2,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12513335/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145278794","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-01Epub Date: 2025-09-26DOI: 10.20524/aog.2025.1004
Aikaterini Mantaka, George Demetriou, Konstantinos Lasithiotakis, Ioanna Papatzelou, Stephanie Panayiotou, Melina Kavousanaki, Dimitrios N Samonakis
Background: Elective umbilical hernia repair (UHR) is recommended for symptomatic patients who have decompensated cirrhosis with ascites. However, the exact timing, the type of surgery, and the factors affecting the outcomes are not clearly defined.
Methods: We prospectively collected data of patients with decompensated cirrhosis and ascites, who underwent UHR between January 2016 and July 2024. Complications and mortality were recorded during the early post-surgery period, at 30 days, at 3 months, and at 12 months after surgery. Our aim was to assess the short-term and long-term outcomes of decompensated cirrhotic patients who underwent either elective or emergency UHR.
Results: We included 19 patients (15 male), median model for end-stage liver disease score 15 (interquartile range [IQR] 11-39), who underwent UHR (16 emergent, 3 elective). Median survival time at 12 months after UHR was 5.5 months (IQR 0.3-86), whereas the mortality rates at 12 months were up to 68.42% (13/19 patients). No association was found between survival and type of surgery, type of anesthesia, preoperative use of diuretics, ascites grade or laboratory findings. Survival rates at 30 days (P=0.086), 3 months (P=0.022), and 12 months (P=0.031) postoperatively were better in patients who underwent emergent UHR.
Conclusions: UHR in decompensated cirrhotics is associated with high mortality. Several risk factors are implicated in the outcomes, with the severity of liver disease having a central role.
{"title":"Prospective analysis of outcomes in umbilical hernia repair for patients with decompensated cirrhosis.","authors":"Aikaterini Mantaka, George Demetriou, Konstantinos Lasithiotakis, Ioanna Papatzelou, Stephanie Panayiotou, Melina Kavousanaki, Dimitrios N Samonakis","doi":"10.20524/aog.2025.1004","DOIUrl":"10.20524/aog.2025.1004","url":null,"abstract":"<p><strong>Background: </strong>Elective umbilical hernia repair (UHR) is recommended for symptomatic patients who have decompensated cirrhosis with ascites. However, the exact timing, the type of surgery, and the factors affecting the outcomes are not clearly defined.</p><p><strong>Methods: </strong>We prospectively collected data of patients with decompensated cirrhosis and ascites, who underwent UHR between January 2016 and July 2024. Complications and mortality were recorded during the early post-surgery period, at 30 days, at 3 months, and at 12 months after surgery. Our aim was to assess the short-term and long-term outcomes of decompensated cirrhotic patients who underwent either elective or emergency UHR.</p><p><strong>Results: </strong>We included 19 patients (15 male), median model for end-stage liver disease score 15 (interquartile range [IQR] 11-39), who underwent UHR (16 emergent, 3 elective). Median survival time at 12 months after UHR was 5.5 months (IQR 0.3-86), whereas the mortality rates at 12 months were up to 68.42% (13/19 patients). No association was found between survival and type of surgery, type of anesthesia, preoperative use of diuretics, ascites grade or laboratory findings. Survival rates at 30 days (P=0.086), 3 months (P=0.022), and 12 months (P=0.031) postoperatively were better in patients who underwent emergent UHR.</p><p><strong>Conclusions: </strong>UHR in decompensated cirrhotics is associated with high mortality. Several risk factors are implicated in the outcomes, with the severity of liver disease having a central role.</p>","PeriodicalId":7978,"journal":{"name":"Annals of Gastroenterology","volume":"38 6","pages":"1-10"},"PeriodicalIF":2.2,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12513332/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145278741","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-01Epub Date: 2025-09-26DOI: 10.20524/aog.2025.1007
Cristina Casanova-Martínez, Esther Espino-Paisán, Martina Lema-Oreiro, María José Álvarez-Sánchez, Laura Buján-de-Gonzalo
Background: Complex perianal fistulas in Crohn's disease (CD) represent a therapeutic challenge. Darvadstrocel has demonstrated efficacy in clinical trials, but evidence from real-life clinical practice is limited. This study evaluated the effectiveness and safety of darvadstrocel in real-life clinical practice, and assessed the economic impact associated with the outcome-based payment model (OBPM) linked to its funding within the Spanish National Health System.
Methods: An observational, descriptive, retrospective study was conducted on patients treated with darvadstrocel in the Servizo Galego de Saúde (SERGAS) between December 2019 and December 2024. Data were collected from the Therapeutic Value of Medicines Information System (VALTERMED), including demographic, clinical, safety and effectiveness variables at 6 and 12 months post-treatment. Descriptive statistics and Fisher's exact test were used for subgroup analyses.
Results: A total of 26 patients were included (50.0% female; median age: 38.4 years). Combined remission was achieved in 69.2% (n=18) at 6 months and 57.7% (n=15) at 12 months. No significant differences were observed among subgroups. No treatment-related adverse events were reported. Regarding sustainability, the OBPM resulted in SERGAS covering 81.5% of the total treatment costs, as the second payment installment was not made for non-responders.
Conclusions: Darvadstrocel demonstrated high effectiveness and safety in real-world clinical practice for patients with CD and complex perianal fistulas, with remission rates consistent with previous studies. The implementation of the OBPM linked to health outcomes proved to be a valuable tool for funding innovative therapies.
背景:克罗恩病(CD)的复杂肛周瘘是一个治疗挑战。darvadstrogel已经在临床试验中证明了疗效,但来自现实临床实践的证据有限。本研究评估了达伐司特沙在现实临床实践中的有效性和安全性,并评估了与西班牙国家卫生系统内的资助相关的基于结果的支付模式(OBPM)的经济影响。方法:对2019年12月至2024年12月期间在Servizo Galego de Saúde (SERGAS)接受达伐司卓治疗的患者进行观察性、描述性、回顾性研究。数据收集自药物治疗价值信息系统(valterminology),包括治疗后6个月和12个月的人口统计学、临床、安全性和有效性变量。亚组分析采用描述性统计和Fisher精确检验。结果:共纳入26例患者,其中女性50.0%,中位年龄38.4岁。6个月时达到联合缓解的69.2% (n=18), 12个月时达到57.7% (n=15)。亚组间无显著差异。未见治疗相关不良事件的报道。在可持续性方面,OBPM导致SERGAS覆盖了总治疗费用的81.5%,因为没有对无反应者进行第二次付款。结论:在现实世界的临床实践中,达伐司特尔对CD和复杂肛周瘘患者表现出高效率和安全性,缓解率与先前的研究一致。实施与健康结果挂钩的目标管理已被证明是资助创新疗法的宝贵工具。
{"title":"Darvadstrocel: real-world clinical outcomes and economic impact in the Spanish national health system.","authors":"Cristina Casanova-Martínez, Esther Espino-Paisán, Martina Lema-Oreiro, María José Álvarez-Sánchez, Laura Buján-de-Gonzalo","doi":"10.20524/aog.2025.1007","DOIUrl":"10.20524/aog.2025.1007","url":null,"abstract":"<p><strong>Background: </strong>Complex perianal fistulas in Crohn's disease (CD) represent a therapeutic challenge. Darvadstrocel has demonstrated efficacy in clinical trials, but evidence from real-life clinical practice is limited. This study evaluated the effectiveness and safety of darvadstrocel in real-life clinical practice, and assessed the economic impact associated with the outcome-based payment model (OBPM) linked to its funding within the Spanish National Health System.</p><p><strong>Methods: </strong>An observational, descriptive, retrospective study was conducted on patients treated with darvadstrocel in the Servizo Galego de Saúde (SERGAS) between December 2019 and December 2024. Data were collected from the Therapeutic Value of Medicines Information System (VALTERMED), including demographic, clinical, safety and effectiveness variables at 6 and 12 months post-treatment. Descriptive statistics and Fisher's exact test were used for subgroup analyses.</p><p><strong>Results: </strong>A total of 26 patients were included (50.0% female; median age: 38.4 years). Combined remission was achieved in 69.2% (n=18) at 6 months and 57.7% (n=15) at 12 months. No significant differences were observed among subgroups. No treatment-related adverse events were reported. Regarding sustainability, the OBPM resulted in SERGAS covering 81.5% of the total treatment costs, as the second payment installment was not made for non-responders.</p><p><strong>Conclusions: </strong>Darvadstrocel demonstrated high effectiveness and safety in real-world clinical practice for patients with CD and complex perianal fistulas, with remission rates consistent with previous studies. The implementation of the OBPM linked to health outcomes proved to be a valuable tool for funding innovative therapies.</p>","PeriodicalId":7978,"journal":{"name":"Annals of Gastroenterology","volume":"38 6","pages":"1-6"},"PeriodicalIF":2.2,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12513338/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145278771","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-01Epub Date: 2025-09-26DOI: 10.20524/aog.2025.1002
Tommaso Antenucci, Rosario Arena
Endoscopic resection is the standard approach for removing colorectal adenomas. Despite technical advances, recurrence remains a concern. This unique review explores current endoscopic strategies for the management of local adenoma recurrence, evaluating efficacy, safety and limitations, based on available evidence.
{"title":"Endoscopic strategies for the management of locally recurrent colorectal adenomas.","authors":"Tommaso Antenucci, Rosario Arena","doi":"10.20524/aog.2025.1002","DOIUrl":"10.20524/aog.2025.1002","url":null,"abstract":"<p><p>Endoscopic resection is the standard approach for removing colorectal adenomas. Despite technical advances, recurrence remains a concern. This unique review explores current endoscopic strategies for the management of local adenoma recurrence, evaluating efficacy, safety and limitations, based on available evidence.</p>","PeriodicalId":7978,"journal":{"name":"Annals of Gastroenterology","volume":"38 6","pages":"1-7"},"PeriodicalIF":2.2,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12513330/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145278802","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-01Epub Date: 2025-09-26DOI: 10.20524/aog.2025.1006
Gursimran S Kochhar, Himsikhar Khataniar, Jana G Hashash, Francis A Farraye, Aakash Desai
Background: Eosinophilic esophagitis (EoE) and inflammatory bowel disease (IBD) are immunemediated disorders whose coexistence is incompletely defined.
Methods: We conducted a cohort study using the TriNetX database, examining a cohort of patients with IBD and EoE over the period 2013-2022. We stratified the cohort by type of IBD, age, sex and race, to assess the incidence and risk factors for the development of EoE in patients with IBD. Additionally, we evaluated the 5-year risk of EoE-specific outcomes in patients with and without IBD.
Results: Among 234,582 IBD patients (mean age 45.4 years; 52.5% female; 74.8% White; 52.8% Crohn's disease [CD]), EoE incidence was 0.60% in ulcerative colitis (UC) and 0.83% in CD, highest in 30-34yearold White males. IBD increased EoE risk vs. matched nonIBD controls (adjusted odds ratio [aOR] 2.88, 95% confidence interval [CI] 2.59-3.19). Risk factors in UC were age <40 years (aOR 1.82, 95%CI 1.53-2.16) and male sex (aOR 1.83, 95%CI 1.56-2.15). In CD, age <40 years (aOR 2.71, 95%CI 2.35-3.13), male sex (aOR 1.81, 95%CI 1.58-2.06), obesity (aOR 1.41, 95%CI 1.13-1.75), and prior intestinal surgery (aOR 1.22, 95%CI 1.10-1.50) were significant. After PSM, concurrent IBD reduced the 5year composite risk of esophageal dilation and/or dupilumab use (aOR 0.39, 95%CI 0.29-0.52) compared with EoE alone.
Conclusions: IBD confers roughly 3fold higher odds of EoE. Younger age and male sex are universal risk factors; obesity and surgery are risk factors in CD. EoE complicating IBD is associated with fewer fibrostenotic sequelae than isolated EoE.
{"title":"Epidemiology, risk factors and natural history of eosinophilic esophagitis in patients with inflammatory bowel disease: a population-based cohort study from the United States.","authors":"Gursimran S Kochhar, Himsikhar Khataniar, Jana G Hashash, Francis A Farraye, Aakash Desai","doi":"10.20524/aog.2025.1006","DOIUrl":"10.20524/aog.2025.1006","url":null,"abstract":"<p><strong>Background: </strong>Eosinophilic esophagitis (EoE) and inflammatory bowel disease (IBD) are immunemediated disorders whose coexistence is incompletely defined.</p><p><strong>Methods: </strong>We conducted a cohort study using the TriNetX database, examining a cohort of patients with IBD and EoE over the period 2013-2022. We stratified the cohort by type of IBD, age, sex and race, to assess the incidence and risk factors for the development of EoE in patients with IBD. Additionally, we evaluated the 5-year risk of EoE-specific outcomes in patients with and without IBD.</p><p><strong>Results: </strong>Among 234,582 IBD patients (mean age 45.4 years; 52.5% female; 74.8% White; 52.8% Crohn's disease [CD]), EoE incidence was 0.60% in ulcerative colitis (UC) and 0.83% in CD, highest in 30-34yearold White males. IBD increased EoE risk vs. matched nonIBD controls (adjusted odds ratio [aOR] 2.88, 95% confidence interval [CI] 2.59-3.19). Risk factors in UC were age <40 years (aOR 1.82, 95%CI 1.53-2.16) and male sex (aOR 1.83, 95%CI 1.56-2.15). In CD, age <40 years (aOR 2.71, 95%CI 2.35-3.13), male sex (aOR 1.81, 95%CI 1.58-2.06), obesity (aOR 1.41, 95%CI 1.13-1.75), and prior intestinal surgery (aOR 1.22, 95%CI 1.10-1.50) were significant. After PSM, concurrent IBD reduced the 5year composite risk of esophageal dilation and/or dupilumab use (aOR 0.39, 95%CI 0.29-0.52) compared with EoE alone.</p><p><strong>Conclusions: </strong>IBD confers roughly 3fold higher odds of EoE. Younger age and male sex are universal risk factors; obesity and surgery are risk factors in CD. EoE complicating IBD is associated with fewer fibrostenotic sequelae than isolated EoE.</p>","PeriodicalId":7978,"journal":{"name":"Annals of Gastroenterology","volume":"38 6","pages":"1-8"},"PeriodicalIF":2.2,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12513334/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145278733","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-01Epub Date: 2024-12-12DOI: 10.20524/aog.2024.0935
Antonio Pizuorno Machado, Saltenat Moghaddam Adames, Malek Shatila, Parvir Aujla, Ryan Huey, Yinghong Wang, Anusha Thomas
Background: Immune checkpoint inhibitors (ICI) target microsatellite instability-high (MSI-H) tumors with success. The incidence and characteristics of ICI-related colitis (IMC) in patients with MSI-H colorectal cancers (CRC) are unclear.
Methods: We performed a retrospective analysis of adult patients with CRC who received ICI between June 1, 2014, and December 31, 2022, including data on IMC observed up to 3 months after the last dose of ICI. Patients' demographics, oncologic profile, endoscopic features, treatment and clinical outcomes were evaluated.
Results: Of 474 patients with CRC receiving ICI during our study period, 18 developed IMC (3.8%). The majority were Caucasian (88.8%), male (61.1%), and their median age was 69.5 years. Of these patients, 50% received combination therapy with anti-PD-1/L1 and CTLA-4; 66.6% had MSI-H colorectal cancer, 11.1% had a second cancer-melanoma, while 61.2% and 66.7% had grade 1-2 colitis and diarrhea respectively. Endoscopic evaluation was used in 5 patients, of whom 2 had ulcerative inflammation necessitating selective immunosuppressive therapy with biologics. Therapy was withheld in 61.1% because of toxicity; 41.4% and 5.8% were noted to have median Common Terminology Criteria for Adverse Events grade 2 liver and pancreas toxicity respectively. The majority of our cohort received steroid therapy.
Conclusions: The lower severity of IMC, compared to toxicity in other ICI-treated cancers, may be influenced by the tumor microenvironment in MSI-H colorectal cancer after ICI exposure. Larger prospective studies are necessary to determine the role of tumor biology and the gut microbiome in the disease profile and severity of IMC.
{"title":"Immune checkpoint inhibitor-associated gastrointestinal adverse events in patients with colorectal cancer.","authors":"Antonio Pizuorno Machado, Saltenat Moghaddam Adames, Malek Shatila, Parvir Aujla, Ryan Huey, Yinghong Wang, Anusha Thomas","doi":"10.20524/aog.2024.0935","DOIUrl":"10.20524/aog.2024.0935","url":null,"abstract":"<p><strong>Background: </strong>Immune checkpoint inhibitors (ICI) target microsatellite instability-high (MSI-H) tumors with success. The incidence and characteristics of ICI-related colitis (IMC) in patients with MSI-H colorectal cancers (CRC) are unclear.</p><p><strong>Methods: </strong>We performed a retrospective analysis of adult patients with CRC who received ICI between June 1, 2014, and December 31, 2022, including data on IMC observed up to 3 months after the last dose of ICI. Patients' demographics, oncologic profile, endoscopic features, treatment and clinical outcomes were evaluated.</p><p><strong>Results: </strong>Of 474 patients with CRC receiving ICI during our study period, 18 developed IMC (3.8%). The majority were Caucasian (88.8%), male (61.1%), and their median age was 69.5 years. Of these patients, 50% received combination therapy with anti-PD-1/L1 and CTLA-4; 66.6% had MSI-H colorectal cancer, 11.1% had a second cancer-melanoma, while 61.2% and 66.7% had grade 1-2 colitis and diarrhea respectively. Endoscopic evaluation was used in 5 patients, of whom 2 had ulcerative inflammation necessitating selective immunosuppressive therapy with biologics. Therapy was withheld in 61.1% because of toxicity; 41.4% and 5.8% were noted to have median Common Terminology Criteria for Adverse Events grade 2 liver and pancreas toxicity respectively. The majority of our cohort received steroid therapy.</p><p><strong>Conclusions: </strong>The lower severity of IMC, compared to toxicity in other ICI-treated cancers, may be influenced by the tumor microenvironment in MSI-H colorectal cancer after ICI exposure. Larger prospective studies are necessary to determine the role of tumor biology and the gut microbiome in the disease profile and severity of IMC.</p>","PeriodicalId":7978,"journal":{"name":"Annals of Gastroenterology","volume":"38 1","pages":"72-79"},"PeriodicalIF":2.1,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11724375/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142969339","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-01Epub Date: 2024-12-13DOI: 10.20524/aog.2024.0937
Christos Zavos
{"title":"Impact of aspirin on pancreatic cancer.","authors":"Christos Zavos","doi":"10.20524/aog.2024.0937","DOIUrl":"10.20524/aog.2024.0937","url":null,"abstract":"","PeriodicalId":7978,"journal":{"name":"Annals of Gastroenterology","volume":"38 1","pages":"105"},"PeriodicalIF":2.1,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11724380/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142969345","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}