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Living Beyond IBD: A Patient's Experience With EIMs and the Case for Multidisciplinary Care. 生活在IBD之外:EIMs患者的经历和多学科治疗的案例。
IF 1.8 Q3 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2025-01-20 eCollection Date: 2025-01-01 DOI: 10.1093/crocol/otaf006
Rocio Castrillon

This editorial explores the complex relationship between inflammatory bowel disease (IBD) and extra-intestinal manifestations (EIMs) and underscores the clinician's critical need for comprehensive EIM care, as well as the physical and emotional burden imposed on the patient. The editorial concludes with actionable steps for clinicians and a call to advance IBD care with a comprehensive multidisciplinary approach that acknowledges the various challenges faced by patients. Together, we can transform the IBD journey into a partnership built on understanding, support, and shared hope.

这篇社论探讨了炎症性肠病(IBD)和肠外表现(EIMs)之间的复杂关系,并强调临床医生对全面的EIM护理的迫切需要,以及对患者施加的身体和情感负担。该社论最后提出了临床医生可采取的步骤,并呼吁通过承认患者面临的各种挑战的综合多学科方法推进IBD护理。我们可以携起手来,将IBD之旅转变为建立在理解、支持和共同希望基础上的伙伴关系。
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引用次数: 0
Patient Advisory Groups in Inflammatory Bowel Disease: A Collaborative Relationship Between Patients and Researchers. 炎症性肠病患者咨询小组:患者和研究人员之间的合作关系。
IF 1.8 Q3 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2025-01-16 eCollection Date: 2025-01-01 DOI: 10.1093/crocol/otaf004
Linda Yoo, Mara Shapiro, Ihsan Kahveci, Isabela Hernandez, Rachael Whittemore, Tanvi Kale, Samantha Winders, Kendra Kamp

Background: Patient advisory groups are key to guiding research studies through meaningful engagement with the population of interest. Although patient advisory groups are greatly valuable to research studies, they are underutilized in inflammatory bowel disease research. Thus, this study aims to describe the development and implementation of a patient advisory group and evaluate the perspectives of researchers and members.

Methods: The Comprehensive Self-Management for inflammatory bowel disease study patient advisory group was created in 2022. The patient advisory group members and researchers completed the Public and Patient Engagement Evaluation Tool via an online survey. Thematic analysis of responses was used to identify common themes, and descriptive statistics were reported.

Results: The patient advisory group comprised of patients with inflammatory bowel disease met quarterly. Eight members and three researchers evaluated the patient advisory group. The five emerging themes were (1) lived experience of patient advisory group members; (2) diversity and representation; (3) purposeful engagement; (4) positives of patient advisory group; and (5) improvements to patient advisory group. All members agreed or strongly agreed that the meetings were a good use of their time, and all researchers strongly agreed that the group added value to the research study.

Conclusion: Patient advisory groups can create unique and positive experiences for both members and researchers when feedback is meaningfully sought, intentional, and incorporated into the study. There is a need to continue creating and using patient advisory groups with the intention of identifying problems and finding solutions alongside the inflammatory bowel disease community.

背景:患者咨询小组是通过与感兴趣的人群进行有意义的接触来指导研究的关键。虽然患者咨询小组对研究非常有价值,但在炎症性肠病研究中未得到充分利用。因此,本研究旨在描述患者咨询小组的发展和实施,并评估研究人员和成员的观点。方法:炎症性肠病综合自我管理研究患者咨询组于2022年创建。患者咨询小组成员和研究人员通过在线调查完成了公众和患者参与评估工具。对答复进行专题分析以确定共同主题,并报告描述性统计数据。结果:由炎症性肠病患者组成的患者咨询组每季度召开一次会议。八名成员和三名研究人员对患者咨询小组进行了评估。五个新兴主题是(1)患者咨询小组成员的生活经验;(2)多样性和代表性;(3)有目的的参与;(4)患者咨询组阳性;(5)患者咨询组的改进。所有的成员都同意或强烈同意,这些会议很好地利用了他们的时间,所有的研究人员都强烈同意,这个小组为研究增加了价值。结论:患者咨询小组可以为成员和研究人员创造独特和积极的体验,当反馈是有意义的,有意的,并纳入研究。有必要继续创建和使用患者咨询小组,以便与炎症性肠病社区一起发现问题并找到解决方案。
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引用次数: 0
Reactions, Reality, and Resilience in Adults with Crohn's Disease: A Qualitative Study. 成人克罗恩病的反应、现实和恢复力:一项定性研究。
IF 1.8 Q3 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2025-01-16 eCollection Date: 2025-01-01 DOI: 10.1093/crocol/otaf003
Katherine Jones, Katherine Baker, Garry A Tew, Jenni Naisby

Background: Crohn's disease (CD) is a lifelong condition that poses unique challenges. This study reports findings from a person's perspective of living with CD to help enhance the understanding of an individual's specific care and support needs.

Methods: Semi-structured telephone interviews were conducted with a convenience sample of adults with Crohn's disease recruited from Newcastle Hospitals NHS Foundation Trust. Data were analyzed after data collection using thematic analysis.

Results: Forty-one (68% female) participants aged 49.1 ± 12 years with a disease duration between 1 and 55 years were interviewed. Three overarching themes emerged, along with 12 subthemes: (1) reactions to presenting symptoms, emotions, and challenges at diagnosis; (2) reality of living with the condition, seeking information, decision making, psychological challenges, experiencing symptoms/complications during remission and the impact on social life, education, employment, and relationships; (3) Resilience involving emotional adaptations, strategies on self-management, social comparisons as a means of coping and barriers to resilience.

Conclusions: The results highlight the complex health journey and challenges faced by people living with Crohn's disease and provide health care professionals with a greater insight into the psychological challenges and emotional complexities of the condition to facilitate a more holistic approach to planning care.

背景:克罗恩病(CD)是一种具有独特挑战的终身疾病。本研究从一个乳糜泻患者的角度报告了研究结果,以帮助提高对个人具体护理和支持需求的理解。方法:对从纽卡斯尔医院NHS基金会信托基金招募的克罗恩病成人进行半结构化电话访谈。数据收集后采用专题分析对数据进行分析。结果:41人(68%为女性),年龄49.1±12岁,病程1 ~ 55年。出现了三个总体主题,以及12个子主题:(1)对呈现症状,情绪和诊断挑战的反应;(2)患者的现实生活、寻求信息、决策、心理挑战、缓解期间的症状/并发症以及对社会生活、教育、就业和人际关系的影响;(3)心理弹性包括情绪适应、自我管理策略、作为应对手段的社会比较和心理弹性的障碍。结论:研究结果突出了克罗恩病患者复杂的健康历程和面临的挑战,并为卫生保健专业人员提供了更深入地了解这种疾病的心理挑战和情感复杂性,以促进更全面的方法来规划护理。
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引用次数: 0
Dysplasia and Colorectal Cancer Surveillance in Ulcerative Colitis Patients in Latin America: Real-World Data. 拉丁美洲溃疡性结肠炎患者的发育不良和结直肠癌监测:真实世界数据。
IF 1.8 Q3 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2025-01-14 eCollection Date: 2025-01-01 DOI: 10.1093/crocol/otae081
Viviana Parra-Izquierdo, William Otero-Regino, Fabian Juliao-Baños, Juan Sebastián Frías-Ordoñez, Edgar Ibañez-Pinilla, Fabio Leonel Gil-Parada, Hernando Marulanda-Fernández, Lina Otero-Parra, Elder Otero-Ramos, Fabian Eduardo Puentes-Manosalva, Gerardo Andrés Guzmán Rojas, Kenneth Ernest-Suárez, Keyla Villa-Ovalles, Juan Eloy Paredes-Mendez, María Luisa Jara-Alba, David Andrade-Zamora, Manuel Alonso Ardila-Báez, Cristian Flórez-Sarmiento, Guillermo Veitia, Abel Sánchez, Lazaro Antonio Arango-Molano, Fernando Fluxa, Natália Sousa Freitas Queiroz, Mariastella Serrano

Background: The prevalence of colorectal cancer (CRC) in patients with ulcerative colitis (UC) is higher than in the general population, in Latin America there is a progressive increase of UC, and information about CRC screening in inflammatory bowel disease (IBD) is scarce. The aim of this study was to analyze the findings of endoscopic surveillance of CRC in patients with IBD according to available technology.

Methods: Multicenter, cross-sectional, analytical study conducted in Latin American countries, in patients with UC, predominantly with more than 8 years of diagnosis and different degrees of disease activity. Surveillance colonoscopies were performed according to available technology. Risk factors for dysplasia detection were analyzed.

Results: One hundred and forty-four patients, 55.5% women, mean age 47.3 (range 17.1 to 90; SD 15.64) years and mean duration of disease 12.71 (range 0.64 to 57.13; SD 8.08) years. Forty-nine lesions were identified, 18 corresponded to dysplasia. The detection rate of dysplasia per lesion and per procedure was 36.7% and 12.5%, respectively. By logistic regression analysis, the duration of disease (OR 1.12;95%CI:1.047 to 1.215, P = .002) and the presence of post-inflammatory polyps (OR 3.4;95%CI:1.11 to 10.36, P = .031) were risk factors for higher detection of dysplasia. Digital chromoendoscopy was associated with greater detection of dysplasia (OR 4.99, 95%CI: 1.092 to 22.864, P = .038).

Conclusions: In our region, the duration of disease and the presence of post-inflammatory polyps were the factors with the highest association for dysplasia detection, and digital chromoendoscopy with directed biopsies was the technique of choice. The implementation of a specific surveillance program in colonoscopy in IBD is an effective strategy to achieve high detection rates.

背景:溃疡性结肠炎(UC)患者中结直肠癌(CRC)的患病率高于一般人群,在拉丁美洲,UC的发病率呈进行性增加,关于炎症性肠病(IBD)中CRC筛查的信息很少。本研究的目的是根据现有技术分析IBD患者CRC的内镜监测结果。方法:在拉丁美洲国家进行多中心、横断面、分析性研究,研究对象为UC患者,主要是诊断超过8年且不同程度的疾病活动。根据现有技术进行监测结肠镜检查。分析异常增生检测的危险因素。结果:144例患者,女性55.5%,平均年龄47.3岁(范围17.1 ~ 90岁;SD 15.64)年,平均病程12.71(范围0.64 ~ 57.13;SD 8.08)年。发现49个病变,18个对应于发育不良。每个病变和每个手术的异常增生检出率分别为36.7%和12.5%。通过logistic回归分析,病程(OR 1.12;95%CI:1.047 ~ 1.215, P = 0.002)和炎症后息肉的存在(OR 3.4;95%CI:1.11 ~ 10.36, P = 0.031)是异常增生检出率较高的危险因素。数字彩色内镜检查与更高的异常增生检出率相关(OR 4.99, 95%CI: 1.092 ~ 22.864, P = 0.038)。结论:在我们的地区,疾病的持续时间和炎症后息肉的存在是异常增生检测的最高相关性因素,数字彩色内镜与定向活检是首选技术。在IBD结肠镜检查中实施特定的监测计划是实现高检出率的有效策略。
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引用次数: 0
Temporal Trends in Surgery and Hospitalization Rates for Crohn's Disease in Brazil: A Population-Based Study. 巴西克罗恩病手术和住院率的时间趋势:一项基于人群的研究
IF 1.8 Q3 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2025-01-09 eCollection Date: 2025-01-01 DOI: 10.1093/crocol/otae082
João Augusto Dos Reis Guerra, Daniela Oliveira Magro, Claudio Saddy Rodrigues Coy, Douglas A Valverde, Emilia Sousa de Oliveira, Abel Botelho Quaresma, Paulo Gustavo Kotze

Introduction: Biological therapy has transformed the natural course of inflammatory bowel disease, but there are still controversies regarding its potential to reduce surgical rates for Crohn's disease (CD). This study, conducted with the support of the Brazilian National Healthcare System, aimed to analyze temporal trends in surgery and hospitalization rates among patients with CD and to correlate these data with the dispensing of azathioprine (AZA), infliximab (IFX), and adalimumab (ADA).

Methodology: This retrospective observational study used data from the National Public Healthcare Department of Informatics through the TT Disease Explorer® platform from 2012 to 2022. Demographic data, medications used, and the prevalence of surgical procedures and hospitalizations associated with the International Classification of Diseases codes for CD were analyzed. Annual average percent changes (AAPCs) were calculated to assess temporal trends.

Results: Between 2012 and 2022, there was a significant increase of 288.07% in the diagnoses of CD, rising from 27 551 to 106 917 cases. Concurrently, there was an increase in the absolute number of patients treated with AZA, IFX, and ADA, with increasing rates of 65.79%, 251.09%, and 242.48%, respectively. However, the proportion of patients receiving AZA per CD patients decreased by 57.28%, from 44.79% to 19.13% (AAPC = -7.94%, 95% CI, -8.05 to -7.83; P < .001). The use of IFX remained relatively stable, with a slight change from 13.82% to 12.50% (AAPC = 0.01%, 95% CI, -0.20 to 0.22; P = .935), while the use of ADA decreased by 11.75%, from 11.65% to 10.28% (AAPC = -1.74%, 95% CI, -2.48 to -1.82; P < .001). The absolute number of hospitalizations related to CD increased by 57.71%. Despite the rise in the number of cases and the greater availability of biological treatments, the proportion of hospitalized patients decreased by 59.29%, from 6.19% to 2.52% (AAPC = -7.04%, 95% CI, -7.42 to -6.66; P < .001). Similarly, the proportion of surgical procedures relative to the total number of cases decreased by 55.08%, from 1.09% to 0.49% (AAPC = -5.73%, 95% CI, -6.68 to -4.77; P < .001).

Conclusions: Despite the cumulative increase in the prevalence of CD cases in the country and the absolute increase in the dispensing of biologics, the proportion of hospitalizations and surgical procedures among CD patients treated in the public health system in Brazil decreased.

生物疗法已经改变了炎症性肠病的自然病程,但关于其降低克罗恩病(CD)手术率的潜力仍存在争议。这项研究是在巴西国家医疗保健系统的支持下进行的,旨在分析CD患者手术和住院率的时间趋势,并将这些数据与硫唑嘌呤(AZA)、英夫利昔单抗(IFX)和阿达木单抗(ADA)的配药相关联。方法:这项回顾性观察性研究通过TT疾病探索者®平台使用了2012年至2022年国家公共卫生信息部的数据。分析了与国际疾病分类编码相关的人口统计数据、使用的药物、外科手术和住院率。计算年平均百分比变化(AAPCs)来评估时间趋势。结果:2012年至2022年,CD诊断率显著增加288.07%,从27 551例增加到106 917例。同时,接受AZA、IFX和ADA治疗的患者绝对人数也有所增加,增幅分别为65.79%、251.09%和242.48%。然而,每名CD患者中接受AZA治疗的患者比例下降了57.28%,从44.79%降至19.13% (AAPC = -7.94%, 95% CI, -8.05 ~ -7.83;P P = 0.935),而ADA的使用率下降了11.75%,从11.65%降至10.28% (AAPC = -1.74%, 95% CI, -2.48 ~ -1.82;结论:尽管该国CD病例的患病率累积增加,生物制剂的分配也绝对增加,但巴西公共卫生系统治疗的CD患者住院和手术的比例下降。
{"title":"Temporal Trends in Surgery and Hospitalization Rates for Crohn's Disease in Brazil: A Population-Based Study.","authors":"João Augusto Dos Reis Guerra, Daniela Oliveira Magro, Claudio Saddy Rodrigues Coy, Douglas A Valverde, Emilia Sousa de Oliveira, Abel Botelho Quaresma, Paulo Gustavo Kotze","doi":"10.1093/crocol/otae082","DOIUrl":"https://doi.org/10.1093/crocol/otae082","url":null,"abstract":"<p><strong>Introduction: </strong>Biological therapy has transformed the natural course of inflammatory bowel disease, but there are still controversies regarding its potential to reduce surgical rates for Crohn's disease (CD). This study, conducted with the support of the Brazilian National Healthcare System, aimed to analyze temporal trends in surgery and hospitalization rates among patients with CD and to correlate these data with the dispensing of azathioprine (AZA), infliximab (IFX), and adalimumab (ADA).</p><p><strong>Methodology: </strong>This retrospective observational study used data from the National Public Healthcare Department of Informatics through the TT Disease Explorer<sup>®</sup> platform from 2012 to 2022. Demographic data, medications used, and the prevalence of surgical procedures and hospitalizations associated with the International Classification of Diseases codes for CD were analyzed. Annual average percent changes (AAPCs) were calculated to assess temporal trends.</p><p><strong>Results: </strong>Between 2012 and 2022, there was a significant increase of 288.07% in the diagnoses of CD, rising from 27 551 to 106 917 cases. Concurrently, there was an increase in the absolute number of patients treated with AZA, IFX, and ADA, with increasing rates of 65.79%, 251.09%, and 242.48%, respectively. However, the proportion of patients receiving AZA per CD patients decreased by 57.28%, from 44.79% to 19.13% (AAPC = -7.94%, 95% CI, -8.05 to -7.83; <i>P</i> < .001). The use of IFX remained relatively stable, with a slight change from 13.82% to 12.50% (AAPC = 0.01%, 95% CI, -0.20 to 0.22; <i>P</i> = .935), while the use of ADA decreased by 11.75%, from 11.65% to 10.28% (AAPC = -1.74%, 95% CI, -2.48 to -1.82; <i>P</i> < .001). The absolute number of hospitalizations related to CD increased by 57.71%. Despite the rise in the number of cases and the greater availability of biological treatments, the proportion of hospitalized patients decreased by 59.29%, from 6.19% to 2.52% (AAPC = -7.04%, 95% CI, -7.42 to -6.66; <i>P</i> < .001). Similarly, the proportion of surgical procedures relative to the total number of cases decreased by 55.08%, from 1.09% to 0.49% (AAPC = -5.73%, 95% CI, -6.68 to -4.77; <i>P</i> < .001).</p><p><strong>Conclusions: </strong>Despite the cumulative increase in the prevalence of CD cases in the country and the absolute increase in the dispensing of biologics, the proportion of hospitalizations and surgical procedures among CD patients treated in the public health system in Brazil decreased.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":"7 1","pages":"otae082"},"PeriodicalIF":1.8,"publicationDate":"2025-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11979744/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143978342","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}
引用次数: 0
Efficacy and Safety of Mirikizumab in the Treatment of Moderately to Severely Active Ulcerative Colitis Regardless of Baseline Modified Mayo Score: Results From the Phase 3 LUCENT Trials. Mirikizumab治疗中度至重度活动性溃疡性结肠炎的有效性和安全性,无论基线修改的Mayo评分如何:来自3期LUCENT试验的结果
IF 1.8 Q3 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2025-01-08 eCollection Date: 2025-04-01 DOI: 10.1093/crocol/otaf002
Bincy Abraham, Jianmin Wu, Séverine Vermeire, Gil Melmed, Ryan Ungaro, Aline Charabaty, Richard Moses, Faye Chan-Diehl, Jerome Paulissen, Baojin Zhu, Edward L Barnes, Adam C Ehrlich, David T Rubin

Background: The modified Mayo score (mMS) is a measure for ulcerative colitis (UC) disease activity. Recent US Food and Drug Administration guidance for moderately to severely active UC trials suggests that patients should have baseline mMS of 5-9 including an endoscopy score of at least 2, as opposed to the previous range of 4-9. This disclosure reports results from patients with UC with baseline mMS of 5-9 who received mirikizumab, a monoclonal antibody directed against the interleukin-23 p19 subunit, or placebo in the phase 3 LUCENT trials.

Methods: Mirikizumab was evaluated in the randomized, double-blind, placebo-controlled LUCENT-1 (NCT03518086) and LUCENT-2 (NCT03524092) trials, and the ongoing long-term LUCENT-3 (NCT03519945) trial, which use mMS 4-9. Analyses for patients with baseline mMS of 5-9 (excluding patients with mMS of 4) were conducted according to LUCENT trial statistical analysis plans. Categorical efficacy endpoints were summarized using proportions and confidence intervals. Continuous efficacy endpoints are presented as least-squares mean (standard error) changes from baseline.

Results: Mirikizumab demonstrated efficacy for the primary endpoint of clinical remission and major secondary endpoints including clinical response, endoscopic improvement, histologic-endoscopic mucosal improvement/remission, bowel urgency remission, and corticosteroid-free remission. Importantly, mirikizumab exhibited greater improvements versus placebo in the Inflammatory Bowel Disease Questionnaire, fatigue, symptomatic remission, and work productivity. Finally, mirikizumab demonstrated long-term (104-week) sustained, durable efficacy across all studied endpoints. No new safety signals were identified during the 2-year follow-up.

Conclusions: Mirikizumab delivered significant clinical benefit for patients with baseline mMS of 5-9 and demonstrated a favorable safety profile.

背景:改良梅奥评分(mMS)是衡量溃疡性结肠炎(UC)疾病活动性的一种方法。最近美国食品和药物管理局对中度至重度活动性UC试验的指导建议,患者的基线mMS应为5-9,包括内窥镜评分至少为2分,而不是之前的4-9分。本披露报告了基线mMS为5-9的UC患者在iii期朗讯试验中接受mirikizumab(一种针对白细胞介素- 23p19亚基的单克隆抗体)或安慰剂治疗的结果。方法:Mirikizumab在随机,双盲,安慰剂对照的LUCENT-1 (NCT03518086)和LUCENT-2 (NCT03524092)试验以及正在进行的长期LUCENT-3 (NCT03519945)试验中进行评估,该试验使用mMS 4-9。基线mMS为5-9的患者(不包括mMS为4的患者)根据朗讯试验统计分析计划进行分析。分类疗效终点用比例和置信区间进行总结。连续疗效终点表示为基线的最小二乘平均值(标准误差)变化。结果:Mirikizumab在临床缓解的主要终点和主要次要终点(包括临床反应、内镜改善、组织学-内镜粘膜改善/缓解、肠急症缓解和无皮质类固醇缓解)均显示出疗效。重要的是,与安慰剂相比,mirikizumab在炎症性肠病问卷、疲劳、症状缓解和工作效率方面表现出更大的改善。最后,mirikizumab在所有研究终点均表现出长期(104周)持续、持久的疗效。在2年的随访中没有发现新的安全信号。结论:Mirikizumab为基线mMS为5-9的患者提供了显着的临床益处,并证明了良好的安全性。
{"title":"Efficacy and Safety of Mirikizumab in the Treatment of Moderately to Severely Active Ulcerative Colitis Regardless of Baseline Modified Mayo Score: Results From the Phase 3 LUCENT Trials.","authors":"Bincy Abraham, Jianmin Wu, Séverine Vermeire, Gil Melmed, Ryan Ungaro, Aline Charabaty, Richard Moses, Faye Chan-Diehl, Jerome Paulissen, Baojin Zhu, Edward L Barnes, Adam C Ehrlich, David T Rubin","doi":"10.1093/crocol/otaf002","DOIUrl":"https://doi.org/10.1093/crocol/otaf002","url":null,"abstract":"<p><strong>Background: </strong>The modified Mayo score (mMS) is a measure for ulcerative colitis (UC) disease activity. Recent US Food and Drug Administration guidance for moderately to severely active UC trials suggests that patients should have baseline mMS of 5-9 including an endoscopy score of at least 2, as opposed to the previous range of 4-9. This disclosure reports results from patients with UC with baseline mMS of 5-9 who received mirikizumab, a monoclonal antibody directed against the interleukin-23 p19 subunit, or placebo in the phase 3 LUCENT trials.</p><p><strong>Methods: </strong>Mirikizumab was evaluated in the randomized, double-blind, placebo-controlled LUCENT-1 (NCT03518086) and LUCENT-2 (NCT03524092) trials, and the ongoing long-term LUCENT-3 (NCT03519945) trial, which use mMS 4-9. Analyses for patients with baseline mMS of 5-9 (excluding patients with mMS of 4) were conducted according to LUCENT trial statistical analysis plans. Categorical efficacy endpoints were summarized using proportions and confidence intervals. Continuous efficacy endpoints are presented as least-squares mean (standard error) changes from baseline.</p><p><strong>Results: </strong>Mirikizumab demonstrated efficacy for the primary endpoint of clinical remission and major secondary endpoints including clinical response, endoscopic improvement, histologic-endoscopic mucosal improvement/remission, bowel urgency remission, and corticosteroid-free remission. Importantly, mirikizumab exhibited greater improvements versus placebo in the Inflammatory Bowel Disease Questionnaire, fatigue, symptomatic remission, and work productivity. Finally, mirikizumab demonstrated long-term (104-week) sustained, durable efficacy across all studied endpoints. No new safety signals were identified during the 2-year follow-up.</p><p><strong>Conclusions: </strong>Mirikizumab delivered significant clinical benefit for patients with baseline mMS of 5-9 and demonstrated a favorable safety profile.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":"7 2","pages":"otaf002"},"PeriodicalIF":1.8,"publicationDate":"2025-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12010086/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143965094","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}
引用次数: 0
Intravenous Steroids Do Not Improve Short-Term Outcomes of Patients With Crohn's Disease Presenting With an Acute Small Bowel Obstruction. 静脉注射类固醇不能改善伴有急性小肠阻塞的克罗恩病患者的短期预后
IF 1.8 Q3 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2025-01-08 eCollection Date: 2025-01-01 DOI: 10.1093/crocol/otae064
Mariely Garcia, Anketse Debebe, Farhan Mahmood, Sharon Nirenberg, Alexa Rendon, Eunyoung Yang, Jiani Xiang, Jean-Frédéric Colombel, Tamara Kahan, Ghoncheh Ghiasian, Adam S Faye, Irving Levine, Michael Farber, Michael Ramada, Tisor Omoakhe, Keith Sultan, David B Sachar

Background: Intravenous (IV) steroids are commonly used to treat acute flares of Crohn's disease (CD). However, it is unclear if they are beneficial in the setting of uncomplicated small bowel obstruction (SBO). We sought to examine if IV steroid administration improved short-term outcomes in patients with CD hospitalized for acute, uncomplicated SBO across three New York City hospital systems.

Methods: This retrospective study included patients ≥ 18 years old admitted between January 1, 2011, and December 31, 2019, with Crohn's disease and an admission diagnosis of uncomplicated acute SBO, defined as cases without adhesions, fistula, phlegmon, and sepsis. Primary endpoints (length of stay and frequency of surgery) were compared between patients who received IV steroids upon admission and those who did not.

Results: Our analysis included 674 unique patients. Ninety-two (14%) received IV steroids, and 582 (86%) did not. IV steroid use did not result in shorter hospital stays (median days [IQR]: 3.0 (2.0-5.5) days vs 3.0 (2.0-6.0) days in the no-steroid group, P = .65) or reduce the need for surgery (4 patients (4.4%) vs 28 patients (4.8%) in the no-steroid group, P = .85). Sex, age, disease duration, concomitant biologic therapy, and NG tube placement did not independently contribute to either outcome.

Conclusions: These findings suggest that IV steroid administration for uncomplicated SBO in CD patients does not decrease hospital length of stay or need for surgery. Further research may help identify specific obstruction patterns or other therapies associated with different outcomes.

背景:静脉注射类固醇通常用于治疗克罗恩病(CD)的急性发作。然而,目前尚不清楚它们是否对无并发症的小肠梗阻(SBO)有益。我们试图检查静脉注射类固醇是否改善了三家纽约市医院系统中因急性无并发症SBO住院的乳糜泻患者的短期预后。方法:本回顾性研究纳入2011年1月1日至2019年12月31日住院的≥18岁克罗恩病患者,入院诊断为无并发症的急性SBO,定义为无粘连、瘘管、痰和脓毒症。主要终点(住院时间和手术频率)在入院时接受静脉注射类固醇和未接受静脉注射类固醇的患者之间进行比较。结果:我们的分析包括674例独特的患者。92例(14%)接受静脉注射类固醇,582例(86%)未接受静脉注射类固醇。静脉注射类固醇不会缩短住院时间(中位天数[IQR]: 3.0(2.0-5.5)天,而非类固醇组为3.0(2.0-6.0)天,P = 0.65)或减少手术需求(4例患者(4.4%)对28例患者(4.8%),P = 0.85)。性别、年龄、疾病持续时间、伴随生物治疗和NG管放置对这两种结果都没有独立的影响。结论:这些发现表明,静脉注射类固醇治疗非复杂性SBO并不能缩短住院时间或减少手术需求。进一步的研究可能有助于确定特定的梗阻模式或其他与不同结果相关的治疗方法。
{"title":"Intravenous Steroids Do Not Improve Short-Term Outcomes of Patients With Crohn's Disease Presenting With an Acute Small Bowel Obstruction.","authors":"Mariely Garcia, Anketse Debebe, Farhan Mahmood, Sharon Nirenberg, Alexa Rendon, Eunyoung Yang, Jiani Xiang, Jean-Frédéric Colombel, Tamara Kahan, Ghoncheh Ghiasian, Adam S Faye, Irving Levine, Michael Farber, Michael Ramada, Tisor Omoakhe, Keith Sultan, David B Sachar","doi":"10.1093/crocol/otae064","DOIUrl":"10.1093/crocol/otae064","url":null,"abstract":"<p><strong>Background: </strong>Intravenous (IV) steroids are commonly used to treat acute flares of Crohn's disease (CD). However, it is unclear if they are beneficial in the setting of uncomplicated small bowel obstruction (SBO). We sought to examine if IV steroid administration improved short-term outcomes in patients with CD hospitalized for acute, uncomplicated SBO across three New York City hospital systems.</p><p><strong>Methods: </strong>This retrospective study included patients ≥ 18 years old admitted between January 1, 2011, and December 31, 2019, with Crohn's disease and an admission diagnosis of uncomplicated acute SBO, defined as cases without adhesions, fistula, phlegmon, and sepsis. Primary endpoints (length of stay and frequency of surgery) were compared between patients who received IV steroids upon admission and those who did not.</p><p><strong>Results: </strong>Our analysis included 674 unique patients. Ninety-two (14%) received IV steroids, and 582 (86%) did not. IV steroid use did not result in shorter hospital stays (median days [IQR]: 3.0 (2.0-5.5) days vs 3.0 (2.0-6.0) days in the no-steroid group, <i>P</i> = .65) or reduce the need for surgery (4 patients (4.4%) vs 28 patients (4.8%) in the no-steroid group, <i>P</i> = .85). Sex, age, disease duration, concomitant biologic therapy, and NG tube placement did not independently contribute to either outcome.</p><p><strong>Conclusions: </strong>These findings suggest that IV steroid administration for uncomplicated SBO in CD patients does not decrease hospital length of stay or need for surgery. Further research may help identify specific obstruction patterns or other therapies associated with different outcomes.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":"7 1","pages":"otae064"},"PeriodicalIF":1.8,"publicationDate":"2025-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11744190/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143001646","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}
引用次数: 0
Patient and Healthcare Professional Perspectives on Crohn's Perianal Fistula Treatment: Results From a Discrete Choice Experiment. 克罗恩肛周瘘治疗的患者和医疗保健专业观点:来自离散选择实验的结果。
IF 1.8 Q3 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2025-01-04 eCollection Date: 2025-01-01 DOI: 10.1093/crocol/otae076
Jeanne Jiang, Bridgett Goodwin, Amod Athavale, Susan E Cazzetta, Lily Chen, Josiah Edelblut, Tao Fan, Nandini Hadker, Pradeep P Nazarey

Background: Crohn's perianal fistulas (CPF) are difficult to manage and often require multiple interventions. This study aimed to assess the preferences of patients and healthcare professionals (HCPs) for attributes of CPF-related procedures/surgeries to better inform CPF management.

Methods: This US cross-sectional, observational study was conducted via a web-enabled questionnaire (October 2021-January 2022) among patients aged 21-89 years with a self-reported physician diagnosis of CPF (with or without CPF-related surgery experience) and HCPs (gastroenterologists and colorectal surgeons who managed ≥3 patients with CPF in the past 12 months). Patient and HCP preferences for CPF-related procedure/surgery attributes were assessed using a discrete choice experiment and stated preference methodology.

Results: In total, 100 patients and 137 HCPs were recruited. Benefits of therapy (symptom control and/or fistula closure) were rated as the most important CPF treatment attribute by both patients and HCPs influencing treatment decisions (mean relative importance 23.9 and 36.3, respectively). The mean relative importance of procedure invasiveness and postoperative discomfort was higher for patients (19.3 and 20.2, respectively) than for HCPs (14.3 and 11.0, respectively), whereas the mean relative importance of fecal incontinence was greater for HCPs than patients (25.0 vs. 19.3, respectively).

Conclusions: Patients and HCPs have different perspectives on the importance of specific CPF-related procedure/surgery attributes. The attributes identified as important to patients and HCPs in this study should be considered when managing patients with CPF and making treatment decisions.

背景:克罗恩肛周瘘管(CPF)很难治疗,通常需要多种干预措施。本研究旨在评估患者和医疗保健专业人员(HCPs)对CPF相关程序/手术属性的偏好,以更好地为CPF管理提供信息。方法:这项美国横断面观察性研究通过网络调查问卷(2021年10月至2022年1月)在年龄21-89岁的患者中进行,这些患者自我报告医师诊断为CPF(有或没有CPF相关手术经验)和HCPs(在过去12个月内治疗过3例以上CPF患者的胃肠病学家和结直肠外科医生)。使用离散选择实验和陈述偏好方法评估患者和HCP对cpf相关程序/手术属性的偏好。结果:共招募了100名患者和137名HCPs。治疗获益(症状控制和/或瘘管闭合)被患者和影响治疗决策的医务人员评为最重要的CPF治疗属性(平均相对重要性分别为23.9和36.3)。患者的手术侵入性和术后不适的平均相对重要性(分别为19.3和20.2)高于hcp(分别为14.3和11.0),而hcp的大便失禁的平均相对重要性高于患者(分别为25.0和19.3)。结论:患者和HCPs对特定cpf相关的程序/手术属性的重要性有不同的看法。在管理CPF患者和制定治疗决策时,应考虑本研究中确定的对患者和HCPs重要的属性。
{"title":"Patient and Healthcare Professional Perspectives on Crohn's Perianal Fistula Treatment: Results From a Discrete Choice Experiment.","authors":"Jeanne Jiang, Bridgett Goodwin, Amod Athavale, Susan E Cazzetta, Lily Chen, Josiah Edelblut, Tao Fan, Nandini Hadker, Pradeep P Nazarey","doi":"10.1093/crocol/otae076","DOIUrl":"10.1093/crocol/otae076","url":null,"abstract":"<p><strong>Background: </strong>Crohn's perianal fistulas (CPF) are difficult to manage and often require multiple interventions. This study aimed to assess the preferences of patients and healthcare professionals (HCPs) for attributes of CPF-related procedures/surgeries to better inform CPF management.</p><p><strong>Methods: </strong>This US cross-sectional, observational study was conducted via a web-enabled questionnaire (October 2021-January 2022) among patients aged 21-89 years with a self-reported physician diagnosis of CPF (with or without CPF-related surgery experience) and HCPs (gastroenterologists and colorectal surgeons who managed ≥3 patients with CPF in the past 12 months). Patient and HCP preferences for CPF-related procedure/surgery attributes were assessed using a discrete choice experiment and stated preference methodology.</p><p><strong>Results: </strong>In total, 100 patients and 137 HCPs were recruited. Benefits of therapy (symptom control and/or fistula closure) were rated as the most important CPF treatment attribute by both patients and HCPs influencing treatment decisions (mean relative importance 23.9 and 36.3, respectively). The mean relative importance of procedure invasiveness and postoperative discomfort was higher for patients (19.3 and 20.2, respectively) than for HCPs (14.3 and 11.0, respectively), whereas the mean relative importance of fecal incontinence was greater for HCPs than patients (25.0 vs. 19.3, respectively).</p><p><strong>Conclusions: </strong>Patients and HCPs have different perspectives on the importance of specific CPF-related procedure/surgery attributes. The attributes identified as important to patients and HCPs in this study should be considered when managing patients with CPF and making treatment decisions.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":"7 1","pages":"otae076"},"PeriodicalIF":1.8,"publicationDate":"2025-01-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11711682/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142946108","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}
引用次数: 0
Development and Validation of a Scoring System to Predict 2-Year Clinical Remission in Ulcerative Colitis Patients on Vedolizumab. Vedolizumab治疗溃疡性结肠炎患者2年临床缓解预测评分系统的开发和验证
IF 1.8 Q3 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-12-28 eCollection Date: 2025-01-01 DOI: 10.1093/crocol/otae068
Thanaboon Chaemsupaphan, Aviv Pudipeddi, Huiyu Lin, Sudarshan Paramsothy, Viraj Kariyawasam, Melissa Kermeen, Rupert W Leong

Background and aims: Vedolizumab is s gut-selective advanced therapy that is safe and efficacious for the treatment of ulcerative colitis (UC). Once patients achieve successful induction, there is a risk of loss of response leading to eventual flare. We aimed to identify these predictive factors and develop a practical scoring system to determine the ongoing efficacy of vedolizumab.

Methods: We performed logistic regression on prospectively recruited UC subjects from the Vedolizumab Immunomodulator Enforced Withdrawal Study (VIEWS). All patients were in corticosteroid-free clinical remission and endoscopic improvement at baseline and continued vedolizumab. Predictive factors of 2-year corticosteroid-free clinical remission were determined and modeled into the VIEWS score, then validated in a real-world UC cohort.

Results: Of 62 patients in the derivation cohort, 48 (77.4%) maintained clinical remission over two years. The predictive factors of remission were female (odds ratio [OR] 6.0, 95% confidence interval [CI], 1.2-29.7), antitumor necrosis factor naive (OR 3.8, 95% CI,1.0-14.0), baseline histological remission (OR 10.8, 95% CI, 2.4-48.4), thiopurine combination (OR 3.6, 95% CI, 0.7-18.0), and fecal calprotectin level ≤250 µg/g (OR 6.3, 95% CI, 0.9-42.2). These factors were incorporated into VIEWS score, yielding an area under the receiver-operating characteristic (AUROC) curve of 0.89 (95% CI, 0.81-0.98) in the prediction of 2-year clinical remission. Of 64 UC patients in the validation cohort, 40 (62.5%) remained in clinical remission at 2 years with AUROC of 0.77 (95% CI, 0.60-0.94). At the cut-off threshold of 4, the VIEWS score identified 2-year clinical remission with a sensitivity of 88.4% and specificity of 63.6%.

Conclusions: Our study determined predictive factors and proposed a scoring system of ongoing clinical remission in UC patients on maintenance vedolizumab. In patients at high risk of relapse, combination therapy with thiopurine may be beneficial.

背景和目的:Vedolizumab是一种安全有效的治疗溃疡性结肠炎(UC)的肠道选择性高级疗法。一旦患者成功诱导,就有失去反应导致最终爆发的风险。我们旨在确定这些预测因素,并开发一个实用的评分系统来确定vedolizumab的持续疗效。方法:我们对Vedolizumab免疫调节剂强制停药研究(VIEWS)中前瞻性招募的UC受试者进行了logistic回归。所有患者在基线时均无皮质类固醇临床缓解和内窥镜改善,并继续使用维多单抗。确定2年无皮质类固醇临床缓解的预测因素,并将其建模到VIEWS评分中,然后在真实的UC队列中进行验证。结果:在衍生队列的62例患者中,48例(77.4%)在两年内保持临床缓解。缓解的预测因素为女性(优势比[OR] 6.0, 95%可信区间[CI], 1.2-29.7)、抗肿瘤坏死因子初始化(OR 3.8, 95% CI,1.0-14.0)、基线组织学缓解(OR 10.8, 95% CI, 2.4-48.4)、硫嘌呤联合治疗(OR 3.6, 95% CI, 0.7-18.0)和粪便钙保护蛋白水平≤250µg/g (OR 6.3, 95% CI, 0.9-42.2)。这些因素被纳入VIEWS评分,在预测2年临床缓解方面,接受者-工作特征(AUROC)曲线下面积为0.89 (95% CI, 0.81-0.98)。在验证队列中的64例UC患者中,40例(62.5%)在2年时仍保持临床缓解,AUROC为0.77 (95% CI, 0.60-0.94)。在截断阈值为4时,VIEWS评分确定2年临床缓解的敏感性为88.4%,特异性为63.6%。结论:我们的研究确定了预测因素,并提出了UC患者维持维多单抗持续临床缓解的评分系统。对于复发风险高的患者,联合硫嘌呤治疗可能是有益的。
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引用次数: 0
Greater Fatigue and Reduced Neurocognitive Speed With Symptomatic Crohn's Disease. 有症状的克罗恩病患者更容易疲劳和神经认知速度降低。
IF 1.8 Q3 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-12-23 eCollection Date: 2025-01-01 DOI: 10.1093/crocol/otae069
Brittaney Bonhomme, Neilanjan Nandi, Shivali Berera, Helen Lee, Galen Leung, Chung Sang Tse, Alexandra Weiss, Lisa Nessel, Yue Ren, Hongzhe Li, Faten N Aberra, James D Lewis

Background: While patients with Crohn's disease commonly report fatigue, an association of Crohn's disease with mild neurocognitive impairment has also been suggested. This study investigated the relationship between Crohn's disease activity, fatigue, and neurocognitive functioning.

Methods: In this cross-sectional study, adults with Crohn's disease (n = 25) and healthy controls (n = 26) completed the PROMIS Fatigue 7a form and Multidimensional Fatigue Inventory and neurocognitive testing across 6 domains. Symptomatic and endoscopic remission were assessed with a short Crohn's Disease Activity Index and Simple Endoscopic Score for Crohn's Disease. Linear regression adjusting for age and sex was used to compare fatigue and neurocognition among patients with Crohn's disease versus controls and those with active Crohn's disease versus those in remission.

Results: Compared to controls, adults with Crohn's disease reported greater overall and domain-specific fatigue (general, physical, and mental) (P < .05 for all comparisons). Patients in symptomatic remission had significantly less fatigue (P < .05). No differences were found in neurocognitive accuracy or speed between Crohn's disease and controls. Disease activity was not associated with accuracy on neurocognitive testing; however, patients with symptomatic Crohn's disease had longer correct response times for social cognition and episodic memory compared to asymptomatic patients (P < .05). Endoscopic disease activity was associated with longer correct response times for tasks linked to social cognition, episodic memory, and complex cognition (P < .05). These differences persisted after adjusting for fatigue.

Conclusions: Patients with symptomatic Crohn's disease experience greater fatigue and have slower response times on neurocognitive testing. However, fatigue does not appear to mediate the slower response times.

背景:虽然克罗恩病患者通常报告疲劳,但克罗恩病与轻度神经认知障碍也有关联。本研究调查了克罗恩病活动性、疲劳和神经认知功能之间的关系。方法:在这项横断面研究中,克罗恩病成人(n = 25)和健康对照(n = 26)完成了PROMIS疲劳7a表格、多维疲劳量表和6个领域的神经认知测试。用短克罗恩病活动指数和简单克罗恩病内窥镜评分评估症状缓解和内窥镜缓解。采用调整年龄和性别的线性回归来比较克罗恩病患者与对照组、活动期克罗恩病患者与缓解期克罗恩病患者的疲劳和神经认知。结果:与对照组相比,患有克罗恩病的成人报告了更大的整体和特定领域的疲劳(一般,身体和精神)(P P P P P)结论:有症状的克罗恩病患者经历更大的疲劳,在神经认知测试中反应时间更慢。然而,疲劳似乎并不能调节较慢的反应时间。
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引用次数: 0
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Crohn's & Colitis 360
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