Pub Date : 2025-11-03DOI: 10.1097/MCG.0000000000002275
Shabari Shenoy, Jake Debroff, Joshua Lacoste, Elisabeth Giselbrecht, Nicole O Gbenebitse, Rachita Llona, Hunter R Moran, Felix Rozenberg, Laurie Keefer, Serre-Yu Wong
Introduction: Perianal fistulizing Crohn's disease (PFCD) is known to impact patients' quality of life (QoL). However, the interactions between PFCD activity itself with patients' psychosocial well-being and social determinants of health (SDOH) are not fully understood.
Methods: We conducted a survey study of adult patients with clinically active and inactive PFCD defined by the presence or absence of perianal pain and/or drainage between July 2023 and April 2024. The survey included the Crohn's anal fistula quality of life (CAF-QoL) scale, PROMIS scale, IBD Internalized Stigma Scale (modified), Everyday discrimination scale, Health Leads screening tool for SDOH, and Cantril ladder for life satisfaction.
Results: The study included 97 patients with active and 31 with inactive PFCD. Patients with active PFCD reported lower QoL (P<0.001), higher rates of anxiety and depression (P<0.001), decreased life satisfaction (P<0.001), and higher internalized stigma (P<0.001) than patients with inactive PFCD. Lower QoL was associated with lower annual household income (P<0.004) and elevated internalized stigma (P=0.001). Nonwhite patients with active PFCD reported higher internalized stigma related to discrimination experiences (P=0.006). Patients with active PFCD were more likely to report social isolation compared with inactive patients (23.7% vs. 0.0%, P=0.001).
Conclusion: Internalized stigma, nonwhite race, financial resource strain, and social isolation negatively impact patients with PFCD, with those having symptomatic PFCD more affected than those with inactive perianal disease. Providers should screen for these factors to identify vulnerable patients who would benefit from psychosocial care and patient navigation.
{"title":"Invisible Burdens: The Influence of Stigma and Social Determinants on Quality of Life in Perianal Fistulizing Crohn's Disease.","authors":"Shabari Shenoy, Jake Debroff, Joshua Lacoste, Elisabeth Giselbrecht, Nicole O Gbenebitse, Rachita Llona, Hunter R Moran, Felix Rozenberg, Laurie Keefer, Serre-Yu Wong","doi":"10.1097/MCG.0000000000002275","DOIUrl":"https://doi.org/10.1097/MCG.0000000000002275","url":null,"abstract":"<p><strong>Introduction: </strong>Perianal fistulizing Crohn's disease (PFCD) is known to impact patients' quality of life (QoL). However, the interactions between PFCD activity itself with patients' psychosocial well-being and social determinants of health (SDOH) are not fully understood.</p><p><strong>Methods: </strong>We conducted a survey study of adult patients with clinically active and inactive PFCD defined by the presence or absence of perianal pain and/or drainage between July 2023 and April 2024. The survey included the Crohn's anal fistula quality of life (CAF-QoL) scale, PROMIS scale, IBD Internalized Stigma Scale (modified), Everyday discrimination scale, Health Leads screening tool for SDOH, and Cantril ladder for life satisfaction.</p><p><strong>Results: </strong>The study included 97 patients with active and 31 with inactive PFCD. Patients with active PFCD reported lower QoL (P<0.001), higher rates of anxiety and depression (P<0.001), decreased life satisfaction (P<0.001), and higher internalized stigma (P<0.001) than patients with inactive PFCD. Lower QoL was associated with lower annual household income (P<0.004) and elevated internalized stigma (P=0.001). Nonwhite patients with active PFCD reported higher internalized stigma related to discrimination experiences (P=0.006). Patients with active PFCD were more likely to report social isolation compared with inactive patients (23.7% vs. 0.0%, P=0.001).</p><p><strong>Conclusion: </strong>Internalized stigma, nonwhite race, financial resource strain, and social isolation negatively impact patients with PFCD, with those having symptomatic PFCD more affected than those with inactive perianal disease. Providers should screen for these factors to identify vulnerable patients who would benefit from psychosocial care and patient navigation.</p>","PeriodicalId":15457,"journal":{"name":"Journal of clinical gastroenterology","volume":" ","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-11-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145438160","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-10-29DOI: 10.1097/MCG.0000000000002265
Neil R Sharma, Harishankar Gopakumar, Talia F Malik, Aqsa Khan, Dushyant S Dahiya, Ishaan Vohra, Christina M Zelt, Ashley Rumple, Mindy Flanagan, Antonio Mendoza-Ladd, Abdul A Adam, Ahmed B Saeed, Mohamed Othman, Saowanee Ngamruengphong, Suchapa Arayakarnkul, Amit Bhatt, Dennis Yang, Mohammad Bilal, Mariajose Rojas De Leon, Alexander Schlachterman, Pranita Madaka, Faisal Kamal, Anand Kumar, Blake Thompson, Prashant Kedia, David Diehl, Sagar Shah, Alireza Sedarat, Andrew Y Wang, Amaninder Dhaliwal, Davinderbir S Pannu, Meir Mizrahi, Michel Kahaleh, Sherif Andrawes, Peter V Draganov
Introduction: The ideal resection strategy for rectal neoplasms extending to the dentate line (RNDLs) remains unclear. Transanal surgical approaches and endoscopic mucosal resection (EMR) have their limitations related to inadequate visualization, device maneuverability, and securing an adequate margin on the anal side. Endoscopic submucosal dissection (ESD) appears to overcome some of the limitations of transanal surgical and snare-based endoscopic techniques. Therefore, we evaluated the safety and efficacy of ESD for resection of distal rectal lesions within 2 cm of the dentate line.
Methods: This is a large-scale multicenter retrospective study of patients who underwent ESD for RNDLs between 2015 and 2023. The primary outcomes were the rates of R0 and en bloc resection. Secondary outcomes were immediate and delayed adverse events.
Results: A total of 255 patients across 20 institutions were included (mean age 63.60, women 52.20%). The median lesion size was 40 mm (IQR: 30 to 55), and the median resection time was 110 minutes (IQR: 81 to 169). The en bloc resection rate was 93.70% (n=236), and the rate of R0 resection was 85.40% (n=216). The rate of overall adverse events was 8.70% (n=22, 95% CI: 5.22% to 12.17%), with 13 cases of bleeding (5.10%), 4 cases of full-thickness perforation, and 1 case of postprocedural pain requiring intervention. All AEs were managed conservatively without the need for subsequent surgical or endoscopic interventions.
Conclusions: ESD is safe and effective for resecting RNDLs with high en bloc and R0 resection rates, offering the potential for complete resection with minimal morbidity. It offers advantages over TEN, TAMIS, and other forms of transanal surgery due to the anatomy being less conducive to the equipment required for these techniques, lower cost, and lower rates of complications. However, careful patient selection, meticulous procedural planning, and close follow-up are essential to ensure optimal outcomes and minimize the risk of complications. Long-term follow-up studies and additional prospective controlled trials are warranted.
{"title":"Large North American Multicenter Experience on Endoscopic Submucosal Dissection of Rectal Neoplasms Extending to the Dentate Line.","authors":"Neil R Sharma, Harishankar Gopakumar, Talia F Malik, Aqsa Khan, Dushyant S Dahiya, Ishaan Vohra, Christina M Zelt, Ashley Rumple, Mindy Flanagan, Antonio Mendoza-Ladd, Abdul A Adam, Ahmed B Saeed, Mohamed Othman, Saowanee Ngamruengphong, Suchapa Arayakarnkul, Amit Bhatt, Dennis Yang, Mohammad Bilal, Mariajose Rojas De Leon, Alexander Schlachterman, Pranita Madaka, Faisal Kamal, Anand Kumar, Blake Thompson, Prashant Kedia, David Diehl, Sagar Shah, Alireza Sedarat, Andrew Y Wang, Amaninder Dhaliwal, Davinderbir S Pannu, Meir Mizrahi, Michel Kahaleh, Sherif Andrawes, Peter V Draganov","doi":"10.1097/MCG.0000000000002265","DOIUrl":"https://doi.org/10.1097/MCG.0000000000002265","url":null,"abstract":"<p><strong>Introduction: </strong>The ideal resection strategy for rectal neoplasms extending to the dentate line (RNDLs) remains unclear. Transanal surgical approaches and endoscopic mucosal resection (EMR) have their limitations related to inadequate visualization, device maneuverability, and securing an adequate margin on the anal side. Endoscopic submucosal dissection (ESD) appears to overcome some of the limitations of transanal surgical and snare-based endoscopic techniques. Therefore, we evaluated the safety and efficacy of ESD for resection of distal rectal lesions within 2 cm of the dentate line.</p><p><strong>Methods: </strong>This is a large-scale multicenter retrospective study of patients who underwent ESD for RNDLs between 2015 and 2023. The primary outcomes were the rates of R0 and en bloc resection. Secondary outcomes were immediate and delayed adverse events.</p><p><strong>Results: </strong>A total of 255 patients across 20 institutions were included (mean age 63.60, women 52.20%). The median lesion size was 40 mm (IQR: 30 to 55), and the median resection time was 110 minutes (IQR: 81 to 169). The en bloc resection rate was 93.70% (n=236), and the rate of R0 resection was 85.40% (n=216). The rate of overall adverse events was 8.70% (n=22, 95% CI: 5.22% to 12.17%), with 13 cases of bleeding (5.10%), 4 cases of full-thickness perforation, and 1 case of postprocedural pain requiring intervention. All AEs were managed conservatively without the need for subsequent surgical or endoscopic interventions.</p><p><strong>Conclusions: </strong>ESD is safe and effective for resecting RNDLs with high en bloc and R0 resection rates, offering the potential for complete resection with minimal morbidity. It offers advantages over TEN, TAMIS, and other forms of transanal surgery due to the anatomy being less conducive to the equipment required for these techniques, lower cost, and lower rates of complications. However, careful patient selection, meticulous procedural planning, and close follow-up are essential to ensure optimal outcomes and minimize the risk of complications. Long-term follow-up studies and additional prospective controlled trials are warranted.</p>","PeriodicalId":15457,"journal":{"name":"Journal of clinical gastroenterology","volume":" ","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145401017","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-10-24DOI: 10.1097/MCG.0000000000002269
Karen Xiao, Fatima Khan, Richard Link, Armando Dominguez-Diaz, Prince Ameyaw, Jamil Alexis, Cheng-Hung Tai, Valerie Assalone, Mimoza Nasufi, Michelle L Hughes, Caroline Loeser, Kenneth Hung, Darrick K Li
Goals: To evaluate whether low-volume bowel preparation achieved similar rates of bowel cleansing as standard volume bowel preparations among hospitalized patients and assess the tolerability and safety of their use in this population.
Background: The use of low-volume bowel preparations for colonoscopy preparation is understudied in the inpatient setting, where standard volume preparations remain the standard of care.
Methods: We conducted a multicenter, randomized, single-blind, noninferiority trial. Hospitalized adult patients were randomized to receive low volume (2 L polyethylene glycol and ascorbic acid, 2L PEG+ASC) or standard volume bowel preparation (4 L polyethylene glycol and electrolyte lavage solution, 4L PEG-ELS) before colonoscopy. The primary outcome was noninferiority with respect to the achievement of adequate bowel preparation. Secondary outcomes included rates of electrolyte derangements, acute kidney injury, and patient tolerability.
Results: Five hundred twenty patients were randomized to 2L PEG+ASC (n=257) and 4L PEG-ELS (n=263). In per-protocol analysis, 2L PEG+ASC was noninferior to 4L PEG-ELS for achievement of adequate bowel preparation (55.0% vs. 52.9%, P =0.007). No significant difference was detected with regard to hyponatremia (1.6% vs. 3.3%, P =0.50), hypokalemia (5.3% vs. 8.7%, P =0.27), hyperkalemia (1.1% vs. 0.0% P =0.24), or acute kidney injury (4.3% vs. 3.3%, P =0.73). More 2L PEG+ASC patients found the preparation to be "easy" to tolerate compared with 4L PEG-ELS patients (29.0% vs. 13.1%, P <0.001).
Conclusions: Among hospitalized patients, 2L PEG+ASC was noninferior to 4L PEG-ELS for achieving bowel cleanliness with similar rates of electrolyte disturbance and acute kidney injury and with higher tolerability (ClinicalTrials.gov number, NCT05054036).
目的:评估在住院患者中,小容量肠道准备是否达到了与标准容量肠道准备相似的肠道清洁率,并评估其在该人群中的耐受性和安全性。背景:低容量肠制剂用于结肠镜检查准备的研究在住院环境中尚不充分,其中标准体积制剂仍然是标准的护理。方法:我们进行了一项多中心、随机、单盲、非劣效性试验。住院成年患者在结肠镜检查前随机接受低容量(2L聚乙二醇和抗坏血酸,2L PEG+ASC)或标准容量肠道准备(4L聚乙二醇和电解质灌洗液,4L PEG- els)。主要结局是非劣效性的关于实现充分的肠道准备。次要结局包括电解质紊乱率、急性肾损伤和患者耐受性。结果:520例患者随机分为2L PEG+ASC组(257例)和4L PEG- els组(263例)。在每个方案分析中,2L PEG+ASC在实现充分的肠道准备方面不逊于4L PEG- els(55.0%比52.9%,P=0.007)。在低钠血症(1.6% vs. 3.3%, P=0.50)、低钾血症(5.3% vs. 8.7%, P=0.27)、高钾血症(1.1% vs. 0.0% P=0.24)或急性肾损伤(4.3% vs. 3.3%, P=0.73)方面无显著差异。与4L PEG- els患者相比,更多2L PEG+ASC患者发现该制剂“容易”耐受(29.0% vs. 13.1%)。结论:在住院患者中,2L PEG+ASC在实现肠道清洁方面不低于4L PEG- els,电解质紊乱和急性肾损伤的发生率相似,耐受性更高(ClinicalTrials.gov号,NCT05054036)。
{"title":"Efficacy and Safety of Low Volume Bowel Preparation for Colonoscopy in Hospitalized Patients: A Randomized Noninferiority Trial.","authors":"Karen Xiao, Fatima Khan, Richard Link, Armando Dominguez-Diaz, Prince Ameyaw, Jamil Alexis, Cheng-Hung Tai, Valerie Assalone, Mimoza Nasufi, Michelle L Hughes, Caroline Loeser, Kenneth Hung, Darrick K Li","doi":"10.1097/MCG.0000000000002269","DOIUrl":"10.1097/MCG.0000000000002269","url":null,"abstract":"<p><strong>Goals: </strong>To evaluate whether low-volume bowel preparation achieved similar rates of bowel cleansing as standard volume bowel preparations among hospitalized patients and assess the tolerability and safety of their use in this population.</p><p><strong>Background: </strong>The use of low-volume bowel preparations for colonoscopy preparation is understudied in the inpatient setting, where standard volume preparations remain the standard of care.</p><p><strong>Methods: </strong>We conducted a multicenter, randomized, single-blind, noninferiority trial. Hospitalized adult patients were randomized to receive low volume (2 L polyethylene glycol and ascorbic acid, 2L PEG+ASC) or standard volume bowel preparation (4 L polyethylene glycol and electrolyte lavage solution, 4L PEG-ELS) before colonoscopy. The primary outcome was noninferiority with respect to the achievement of adequate bowel preparation. Secondary outcomes included rates of electrolyte derangements, acute kidney injury, and patient tolerability.</p><p><strong>Results: </strong>Five hundred twenty patients were randomized to 2L PEG+ASC (n=257) and 4L PEG-ELS (n=263). In per-protocol analysis, 2L PEG+ASC was noninferior to 4L PEG-ELS for achievement of adequate bowel preparation (55.0% vs. 52.9%, P =0.007). No significant difference was detected with regard to hyponatremia (1.6% vs. 3.3%, P =0.50), hypokalemia (5.3% vs. 8.7%, P =0.27), hyperkalemia (1.1% vs. 0.0% P =0.24), or acute kidney injury (4.3% vs. 3.3%, P =0.73). More 2L PEG+ASC patients found the preparation to be \"easy\" to tolerate compared with 4L PEG-ELS patients (29.0% vs. 13.1%, P <0.001).</p><p><strong>Conclusions: </strong>Among hospitalized patients, 2L PEG+ASC was noninferior to 4L PEG-ELS for achieving bowel cleanliness with similar rates of electrolyte disturbance and acute kidney injury and with higher tolerability (ClinicalTrials.gov number, NCT05054036).</p>","PeriodicalId":15457,"journal":{"name":"Journal of clinical gastroenterology","volume":" ","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145345619","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-10-23DOI: 10.1097/MCG.0000000000002267
Yizhong Wu, Alexander Grieme, Kyle S Liu, Vincent Nguyen, Colby Adamson, Manuel Garza, Eric R Smith, Daryl Ramai, Andrew Han, Bryce Bushe, Douglas G Adler
Introduction: Adjunct agents in bowel preparation for colonoscopy have the potential to improve procedure outcomes. We performed a systematic review and meta-analysis to investigate the effects of adjunct single-dose linaclotide with bowel prep on colonoscopy outcomes.
Methods: We conducted a comprehensive search in PubMed, Embase, Cochrane, and Web of Science from inception until April 2025 for randomized controlled trials comparing single-dose linaclotide adjunct bowel prep and standard bowel prep. Our pooled data was analyzed for adenoma detection rates (ADR), polyp detection rates (PDR), bowel prep quality, adverse reactions, and other secondary outcomes. A random effects model was used, and the data was presented using pooled odds ratios (OR) and mean differences (MD) with 95% CI.
Results: Seven manuscripts were included with 2209 patients (1267 in the linaclotide group and 942 in the control group). The linaclotide group had a significantly higher ADR (OR: 1.31, 95% CI: 1.04-1.64, P=0.02, I2 0%) and PDR (OR: 1.43, 95% CI: 1.13-1.80, P=0.003, I2 0%). Adequate prep was higher in the linaclotide group among patients with diagnosed constipation (P=0.002). The linaclotide group had a lower incidence of abdominal pain (P=0.0009), bloating (P=0.0006), and sleep disturbance (P=0.002).
Conclusion: Linaclotide used as a single dose adjunct to bowel prep before colonoscopy increased ADR and PDR. Adequate prep was higher with linaclotide in patients with diagnosed constipation. Linaclotide also decreased the odds of abdominal pain, bloating, and sleep disturbances.
{"title":"The Efficacy of Single Dose Linaclotide in Polyethylene Glycol-Based Bowel Preparation: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.","authors":"Yizhong Wu, Alexander Grieme, Kyle S Liu, Vincent Nguyen, Colby Adamson, Manuel Garza, Eric R Smith, Daryl Ramai, Andrew Han, Bryce Bushe, Douglas G Adler","doi":"10.1097/MCG.0000000000002267","DOIUrl":"https://doi.org/10.1097/MCG.0000000000002267","url":null,"abstract":"<p><strong>Introduction: </strong>Adjunct agents in bowel preparation for colonoscopy have the potential to improve procedure outcomes. We performed a systematic review and meta-analysis to investigate the effects of adjunct single-dose linaclotide with bowel prep on colonoscopy outcomes.</p><p><strong>Methods: </strong>We conducted a comprehensive search in PubMed, Embase, Cochrane, and Web of Science from inception until April 2025 for randomized controlled trials comparing single-dose linaclotide adjunct bowel prep and standard bowel prep. Our pooled data was analyzed for adenoma detection rates (ADR), polyp detection rates (PDR), bowel prep quality, adverse reactions, and other secondary outcomes. A random effects model was used, and the data was presented using pooled odds ratios (OR) and mean differences (MD) with 95% CI.</p><p><strong>Results: </strong>Seven manuscripts were included with 2209 patients (1267 in the linaclotide group and 942 in the control group). The linaclotide group had a significantly higher ADR (OR: 1.31, 95% CI: 1.04-1.64, P=0.02, I2 0%) and PDR (OR: 1.43, 95% CI: 1.13-1.80, P=0.003, I2 0%). Adequate prep was higher in the linaclotide group among patients with diagnosed constipation (P=0.002). The linaclotide group had a lower incidence of abdominal pain (P=0.0009), bloating (P=0.0006), and sleep disturbance (P=0.002).</p><p><strong>Conclusion: </strong>Linaclotide used as a single dose adjunct to bowel prep before colonoscopy increased ADR and PDR. Adequate prep was higher with linaclotide in patients with diagnosed constipation. Linaclotide also decreased the odds of abdominal pain, bloating, and sleep disturbances.</p>","PeriodicalId":15457,"journal":{"name":"Journal of clinical gastroenterology","volume":" ","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145345576","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-10-16DOI: 10.1097/MCG.0000000000002263
Hadas Labrisch-Kaye, Rachel Buchuk, Yiska Weisband, Amir Ben-Tov, Galia Zacay, Eran Metz, Iris Dotan, Dan Turner, Oren Ledder
Goals: Definitively prove noninferiority of biosimilar infliximab to originator.
Background: The advent of biosimilar agents has made biological medications for inflammatory bowel diseases (IBD) more affordable and widely available. We conducted a noninferiority assessment of the effectiveness of the infliximab biosimilar agent CT-P13 versus the original for treatment of IBD in a nationwide analysis.
Study: We used the Epidemiology Group of the Israeli Inflammatory Bowel Disease Research Nucleus Cohort (epi-IIRN), including data on patients with IBD from all Health Maintenance Organizations (HMO) and conducted a noninferiority analysis of infliximab originator and biosimilar CT-P13 based on time from induction of treatment until failure. Treatment failure was defined as steroid dependency, need for IBD-related surgery, or treatment change to an alternative biological. The groups were matched using a propensity score of 0.15 caliper based on sex, ethnicity, district, socio-economic status, age at diagnosis, disease activity, time until biological treatment, prior biological treatments, surgeries, and hospitalizations.
Results: We compared 564 patients treated with infliximab originator matched to 564 treated with CT-P13. The results proved noninferiority in all parameters, with a margin of d=10% or smaller over 5 years (P<0.05). In time to failure, noninferiority was demonstrated with a d=1% (P=0.0004). Noninferiority was also demonstrated in time to steroid dependency (d=5%, P=0.005), surgery (d=1%, P=0.0006), and transfer to alternative biological drug (d=1%, P<0.001). Subanalyses for Crohn's disease and ulcerative colitis separately yielded similar results.
Conclusions: This study demonstrated noninferiority of infliximab biosimilar CT-P13 in comparison to the original in long-term management of IBD.
{"title":"Effectiveness of an Infliximab Biosimilar vs. Originator in Inflammatory Bowel Diseases: A Noninferiority Nationwide Study From the epi-IIRN.","authors":"Hadas Labrisch-Kaye, Rachel Buchuk, Yiska Weisband, Amir Ben-Tov, Galia Zacay, Eran Metz, Iris Dotan, Dan Turner, Oren Ledder","doi":"10.1097/MCG.0000000000002263","DOIUrl":"https://doi.org/10.1097/MCG.0000000000002263","url":null,"abstract":"<p><strong>Goals: </strong>Definitively prove noninferiority of biosimilar infliximab to originator.</p><p><strong>Background: </strong>The advent of biosimilar agents has made biological medications for inflammatory bowel diseases (IBD) more affordable and widely available. We conducted a noninferiority assessment of the effectiveness of the infliximab biosimilar agent CT-P13 versus the original for treatment of IBD in a nationwide analysis.</p><p><strong>Study: </strong>We used the Epidemiology Group of the Israeli Inflammatory Bowel Disease Research Nucleus Cohort (epi-IIRN), including data on patients with IBD from all Health Maintenance Organizations (HMO) and conducted a noninferiority analysis of infliximab originator and biosimilar CT-P13 based on time from induction of treatment until failure. Treatment failure was defined as steroid dependency, need for IBD-related surgery, or treatment change to an alternative biological. The groups were matched using a propensity score of 0.15 caliper based on sex, ethnicity, district, socio-economic status, age at diagnosis, disease activity, time until biological treatment, prior biological treatments, surgeries, and hospitalizations.</p><p><strong>Results: </strong>We compared 564 patients treated with infliximab originator matched to 564 treated with CT-P13. The results proved noninferiority in all parameters, with a margin of d=10% or smaller over 5 years (P<0.05). In time to failure, noninferiority was demonstrated with a d=1% (P=0.0004). Noninferiority was also demonstrated in time to steroid dependency (d=5%, P=0.005), surgery (d=1%, P=0.0006), and transfer to alternative biological drug (d=1%, P<0.001). Subanalyses for Crohn's disease and ulcerative colitis separately yielded similar results.</p><p><strong>Conclusions: </strong>This study demonstrated noninferiority of infliximab biosimilar CT-P13 in comparison to the original in long-term management of IBD.</p>","PeriodicalId":15457,"journal":{"name":"Journal of clinical gastroenterology","volume":" ","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145313040","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-10-14DOI: 10.1097/MCG.0000000000002255
Caitlin C Houghton, Ivo Ditah, Cadman L Leggett, Amrit K Kamboj, Luke Putnam, Sarah L Sokol-Borrelli, John C Lipham
Goals: A systematic review and meta-analysis of published clinical validity studies was conducted to evaluate the predictive performance of the TSP-9 test.
Background: Identifying patients with Barrett's esophagus (BE) who will progress to high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC) is challenging. The tissue systems pathology (TSP-9) test can predict risk of progression to HGD/EAC in BE patients.
Study: Databases were searched for studies that assessed the clinical validity of TSP-9, and data describing progressors, non-progressors, TSP-9 results, and hazard ratios (HR) with 95% confidence intervals (CIs) were extracted. Odds ratios (OR), sensitivity, specificity, and prevalence-adjusted positive and negative predictive values (PPVadj/NPVadj) were calculated and used for meta-analysis.
Results: Six studies met eligibility criteria, comprising 699 patients. ORs and HRs for TSP-9 had mean common effect size estimates of 6.52 (95% CI: 4.40-9.66, P<0.0001, I2=33%) and 6.66 (95% CI: 4.59-9.66, P<0.0001, I2=0%), respectively, for predicting progression to HGD/EAC. Mean common effect size estimates were 61% (95% CI: 54%-68%) for sensitivity, 81% (95% CI: 78%-84%) for specificity, 28% (95% CI: 17%-42%) for PPVadj (high risk), 14% (95% CI: 9%-21%) for PPVadj (high/int risk), and 97% (95% CI: 96%-98%) for NPVadj with minimal inter-study heterogeneity (I2=79%, 21%, 0%, 0%, and 0%, respectively).
Conclusions: Effect estimates of TSP-9 performance demonstrate that the test provides risk stratification for BE patients. The TSP-9 test can provide clinically impactful results to enable escalation of care for high-risk patients or to identify low-risk patients who can be safely managed with routine surveillance.
{"title":"The Tissue Systems Pathology Test Predicts Risk of Progression in Patients With Barrett's Esophagus: Systematic Review and Meta-Analysis.","authors":"Caitlin C Houghton, Ivo Ditah, Cadman L Leggett, Amrit K Kamboj, Luke Putnam, Sarah L Sokol-Borrelli, John C Lipham","doi":"10.1097/MCG.0000000000002255","DOIUrl":"https://doi.org/10.1097/MCG.0000000000002255","url":null,"abstract":"<p><strong>Goals: </strong>A systematic review and meta-analysis of published clinical validity studies was conducted to evaluate the predictive performance of the TSP-9 test.</p><p><strong>Background: </strong>Identifying patients with Barrett's esophagus (BE) who will progress to high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC) is challenging. The tissue systems pathology (TSP-9) test can predict risk of progression to HGD/EAC in BE patients.</p><p><strong>Study: </strong>Databases were searched for studies that assessed the clinical validity of TSP-9, and data describing progressors, non-progressors, TSP-9 results, and hazard ratios (HR) with 95% confidence intervals (CIs) were extracted. Odds ratios (OR), sensitivity, specificity, and prevalence-adjusted positive and negative predictive values (PPVadj/NPVadj) were calculated and used for meta-analysis.</p><p><strong>Results: </strong>Six studies met eligibility criteria, comprising 699 patients. ORs and HRs for TSP-9 had mean common effect size estimates of 6.52 (95% CI: 4.40-9.66, P<0.0001, I2=33%) and 6.66 (95% CI: 4.59-9.66, P<0.0001, I2=0%), respectively, for predicting progression to HGD/EAC. Mean common effect size estimates were 61% (95% CI: 54%-68%) for sensitivity, 81% (95% CI: 78%-84%) for specificity, 28% (95% CI: 17%-42%) for PPVadj (high risk), 14% (95% CI: 9%-21%) for PPVadj (high/int risk), and 97% (95% CI: 96%-98%) for NPVadj with minimal inter-study heterogeneity (I2=79%, 21%, 0%, 0%, and 0%, respectively).</p><p><strong>Conclusions: </strong>Effect estimates of TSP-9 performance demonstrate that the test provides risk stratification for BE patients. The TSP-9 test can provide clinically impactful results to enable escalation of care for high-risk patients or to identify low-risk patients who can be safely managed with routine surveillance.</p>","PeriodicalId":15457,"journal":{"name":"Journal of clinical gastroenterology","volume":" ","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145280168","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-10-14DOI: 10.1097/MCG.0000000000002258
Jaya Vasudevan, Dagny Larson, John Damianos, Chandershekhar Shori, Clara DiVincenzo, Yetunde Ishola, Zhouwen D Tang, Jill K J Gaidos, Marissa Burgermaster, Linda A Feagins
Goals: To assess if patients were meeting dietary fiber recommendations and compare intake between those with active versus inactive IBD, and between Crohn's (CD) and ulcerative colitis (UC).
Background: Fiber is an important component of the diet to maintain a healthy gut, including in patients with inflammatory bowel disease (IBD).
Study: A prospective, multicenter, cross-sectional study of eating habits was performed in 2 academic gastroenterology practices. Patients completed a food frequency questionnaire to assess fiber intake. Objective evidence of disease activity was assessed through fecal calprotectin, endoscopy or cross-sectional imaging. High fiber diets were those with ≥30 g/day for men or ≥25 g/day for women. Multivariate logistic regression analysis was performed to assess predictors of high fiber intake.
Results: Of 117 patients (71 CD, 43 UC, 3 IBDU), only 26% of patients were consuming high fiber diets. Average dietary fiber intake was lower for patients with active disease versus inactive disease (19 g vs. 24 g, P=0.0048) but on subgroup analysis this remained significant in UC (13 g vs. 22 g, P=0.0044) but not CD (21 g vs. 24 g, P=0.38). Increased education on nutrition was the most important predictor of eating a high fiber diet.
Conclusions: While most IBD patients are not eating high fiber diets, dietary fiber intake is likely similar to the average American diet. Fiber consumption is lower for IBD patients with active disease, particularly for patients with UC. Given education is the best predictor for consuming a high fiber diet, increased education efforts on the benefits of fiber should improve dietary fiber intake.
{"title":"Fiber Intake in Inflammatory Bowel Disease: Impact of Disease Activity and Predictors of High Fiber Intake.","authors":"Jaya Vasudevan, Dagny Larson, John Damianos, Chandershekhar Shori, Clara DiVincenzo, Yetunde Ishola, Zhouwen D Tang, Jill K J Gaidos, Marissa Burgermaster, Linda A Feagins","doi":"10.1097/MCG.0000000000002258","DOIUrl":"https://doi.org/10.1097/MCG.0000000000002258","url":null,"abstract":"<p><strong>Goals: </strong>To assess if patients were meeting dietary fiber recommendations and compare intake between those with active versus inactive IBD, and between Crohn's (CD) and ulcerative colitis (UC).</p><p><strong>Background: </strong>Fiber is an important component of the diet to maintain a healthy gut, including in patients with inflammatory bowel disease (IBD).</p><p><strong>Study: </strong>A prospective, multicenter, cross-sectional study of eating habits was performed in 2 academic gastroenterology practices. Patients completed a food frequency questionnaire to assess fiber intake. Objective evidence of disease activity was assessed through fecal calprotectin, endoscopy or cross-sectional imaging. High fiber diets were those with ≥30 g/day for men or ≥25 g/day for women. Multivariate logistic regression analysis was performed to assess predictors of high fiber intake.</p><p><strong>Results: </strong>Of 117 patients (71 CD, 43 UC, 3 IBDU), only 26% of patients were consuming high fiber diets. Average dietary fiber intake was lower for patients with active disease versus inactive disease (19 g vs. 24 g, P=0.0048) but on subgroup analysis this remained significant in UC (13 g vs. 22 g, P=0.0044) but not CD (21 g vs. 24 g, P=0.38). Increased education on nutrition was the most important predictor of eating a high fiber diet.</p><p><strong>Conclusions: </strong>While most IBD patients are not eating high fiber diets, dietary fiber intake is likely similar to the average American diet. Fiber consumption is lower for IBD patients with active disease, particularly for patients with UC. Given education is the best predictor for consuming a high fiber diet, increased education efforts on the benefits of fiber should improve dietary fiber intake.</p>","PeriodicalId":15457,"journal":{"name":"Journal of clinical gastroenterology","volume":" ","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145280203","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-10-14DOI: 10.1097/MCG.0000000000002244
Muhammad Faizan, Arkadeep Dhali, Abdul Rafae Faisal, Rick Maity, Pramod Singh, Asad Zaman, Mamoona Majeed, Ali Shan Hafeez, Abdullah, Laiba Razaq, Mohammad Abdullah Humayun, Henna Qadri
Background: Gastric cancer remains one of the leading causes of death globally and a major health concern. This study aims to analyze gastric cancer-related mortality trends over 2 decades.
Methods: The CDC WONDER database was used to analyze and stratify de-identified death certificates from 1999 to 2022 across the United States. Trends in age-adjusted mortality rates (AAMR) were assessed using the Joinpoint Regression Program to determine annual percentage changes.
Results: Overall, AAMR decreased from 79.26 in 1999 to 44.81 in 2022. Men and older adults had the highest AAMRs. Non-Hispanic (NH) Black or African Americans had the highest AAMR, while NH Whites had the lowest. Geographically, the Northeast had the highest AAMR, and metropolitan areas had higher AAMRs than nonmetropolitan areas.
Conclusion: Gastric carcinoma has a poor prognosis, and although the general trend is decreasing across all sociodemographic areas, further research is required for targeted interventions and health policies for high-risk populations.
{"title":"Demographic Trends in Mortality Related to Gastric Cancer in the United States, 1999 to 2022: A CDC WONDER Study.","authors":"Muhammad Faizan, Arkadeep Dhali, Abdul Rafae Faisal, Rick Maity, Pramod Singh, Asad Zaman, Mamoona Majeed, Ali Shan Hafeez, Abdullah, Laiba Razaq, Mohammad Abdullah Humayun, Henna Qadri","doi":"10.1097/MCG.0000000000002244","DOIUrl":"https://doi.org/10.1097/MCG.0000000000002244","url":null,"abstract":"<p><strong>Background: </strong>Gastric cancer remains one of the leading causes of death globally and a major health concern. This study aims to analyze gastric cancer-related mortality trends over 2 decades.</p><p><strong>Methods: </strong>The CDC WONDER database was used to analyze and stratify de-identified death certificates from 1999 to 2022 across the United States. Trends in age-adjusted mortality rates (AAMR) were assessed using the Joinpoint Regression Program to determine annual percentage changes.</p><p><strong>Results: </strong>Overall, AAMR decreased from 79.26 in 1999 to 44.81 in 2022. Men and older adults had the highest AAMRs. Non-Hispanic (NH) Black or African Americans had the highest AAMR, while NH Whites had the lowest. Geographically, the Northeast had the highest AAMR, and metropolitan areas had higher AAMRs than nonmetropolitan areas.</p><p><strong>Conclusion: </strong>Gastric carcinoma has a poor prognosis, and although the general trend is decreasing across all sociodemographic areas, further research is required for targeted interventions and health policies for high-risk populations.</p>","PeriodicalId":15457,"journal":{"name":"Journal of clinical gastroenterology","volume":" ","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145280185","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background and aims: Type 2 diabetes (T2DM) and inflammatory bowel disease (IBD) are 2 distinct diseases that share a similar pathophysiology; however, the association between the 2 diseases remains elusive. We aimed to investigate the bidirectional association between T2DM and IBD in a large prospective population cohort.
Methods: Participants were recruited from the prospective cohort of UK Biobank. We included 4921 patients with IBD and 438,948 non-IBD to assess the incident risk of T2DM, and 11,649 patients with T2DM and 438,948 non-T2DM to assess the incident risk of IBD. Multivariable Cox proportional hazards regression model was used to calculate adjusted hazard ratio (HR).
Results: A total of 27,373 incident T2DM and 2696 incident IBD cases were identified during a median of 12.6- and 12.9-years' follow-up, respectively. After adjustment for potential confounders, participants with IBD, UC, or CD showed an excess risk of incident T2DM (HR=1.44, 95% CI: 1.31-1.59 for IBD, HR=1.41, 95% CI: 1.26-1.58 for UC, and HR=1.62, 95% CI: 1.39-1.89 for CD, respectively), compared with non-IBD. By contrast, compared with non-T2DM, participants with T2DM also showed higher risk of incident IBD (HR=1.40, 95% CI: 1.15-1.69), UC (HR=1.41, 95% CI: 1.13-1.76), or CD (HR=1.48, 95% CI: 1.08-2.04). Furthermore, the increased risk of incident T2DM was more evident when accompanied with the severity of IBD, and vice versa. Sensitivity analyses and subgroup analyses according to age, sex, and body mass index demonstrated similar results.
Conclusion: IBD and T2DM are bidirectionally associated with higher comorbidity risks. Further investigations are needed to elucidate the shared pathogenesis underlying these 2 diseases.
{"title":"Bidirectional Association of Type 2 Diabetes Mellitus and Inflammatory Bowel Diseases: A Large-scale Prospective Cohort Study.","authors":"Junxuan Xu, Qian Zhang, Zuyao Wang, Si Liu, Shengtao Zhu, Shutian Zhang, Shanshan Wu","doi":"10.1097/MCG.0000000000002264","DOIUrl":"https://doi.org/10.1097/MCG.0000000000002264","url":null,"abstract":"<p><strong>Background and aims: </strong>Type 2 diabetes (T2DM) and inflammatory bowel disease (IBD) are 2 distinct diseases that share a similar pathophysiology; however, the association between the 2 diseases remains elusive. We aimed to investigate the bidirectional association between T2DM and IBD in a large prospective population cohort.</p><p><strong>Methods: </strong>Participants were recruited from the prospective cohort of UK Biobank. We included 4921 patients with IBD and 438,948 non-IBD to assess the incident risk of T2DM, and 11,649 patients with T2DM and 438,948 non-T2DM to assess the incident risk of IBD. Multivariable Cox proportional hazards regression model was used to calculate adjusted hazard ratio (HR).</p><p><strong>Results: </strong>A total of 27,373 incident T2DM and 2696 incident IBD cases were identified during a median of 12.6- and 12.9-years' follow-up, respectively. After adjustment for potential confounders, participants with IBD, UC, or CD showed an excess risk of incident T2DM (HR=1.44, 95% CI: 1.31-1.59 for IBD, HR=1.41, 95% CI: 1.26-1.58 for UC, and HR=1.62, 95% CI: 1.39-1.89 for CD, respectively), compared with non-IBD. By contrast, compared with non-T2DM, participants with T2DM also showed higher risk of incident IBD (HR=1.40, 95% CI: 1.15-1.69), UC (HR=1.41, 95% CI: 1.13-1.76), or CD (HR=1.48, 95% CI: 1.08-2.04). Furthermore, the increased risk of incident T2DM was more evident when accompanied with the severity of IBD, and vice versa. Sensitivity analyses and subgroup analyses according to age, sex, and body mass index demonstrated similar results.</p><p><strong>Conclusion: </strong>IBD and T2DM are bidirectionally associated with higher comorbidity risks. Further investigations are needed to elucidate the shared pathogenesis underlying these 2 diseases.</p>","PeriodicalId":15457,"journal":{"name":"Journal of clinical gastroenterology","volume":" ","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-10-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145274800","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}