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Ustekinumab use in lactation: drug pharmacokinetics and normal development in exposed infants. Ustekinumab在哺乳中的应用:暴露婴儿的药物药代动力学和正常发育。
IF 4.3 3区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2026-01-24 DOI: 10.1093/ibd/izaf336
Christina Balmer, Philip O Anderson, Julie Korgaard, Jens Kjeldsen, Signe Wildt, Mette Julsgaard
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引用次数: 0
Endoscopic and pathologic findings of esophagogastroduodenal involvement in Crohn disease in Korea: a prospective single-center cohort study. 韩国克罗恩病食管胃十二指肠受累的内镜和病理结果:一项前瞻性单中心队列研究。
IF 4.3 3区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2026-01-20 DOI: 10.1093/ibd/izaf320
Ga Hee Kim, Jihun Kim, Ji Yong Ahn, Sang Hyoung Park, Sung Wook Hwang, Byong Duk Ye, Hwoon-Yong Jung, Suk-Kyun Yang

Background and aims: The characteristics and incidence of esophagogastroduodenal involvement in Crohn disease remain unclear in Korea. In this study we aimed to investigate the prevalence and clinicopathological characteristics of Crohn disease with esophagogastroduodenal involvement.

Methods: A total of 115 patients with Crohn disease who underwent esophagogastroduodenoscopy (EGD) with esophageal, gastric, and duodenal biopsies were prospectively enrolled in 2020-2021 at a tertiary care center. Five specimens were obtained-1 each from the esophagus, gastric body, gastric antrum, duodenal bulb, and second duodenal portion-and histologically reviewed.

Results: The median patient age was 30.0 years, and 74.8% of patients were male. Based on histological features, 56 patients (48.7%) had esophagogastroduodenal involvement (15 esophageal, 44 gastric, 36 duodenal). Notable histopathological findings included non-caseating granulomas in 8 cases (7.0%), focally enhanced gastritis in 38 cases (33.0%), and lymphocytic esophagitis in 13 cases (10.7%). Endoscopic findings suggestive of esophagogastroduodenal involvement were detected in 94 of 115 patients (81.7%). Typical findings included longitudinal or aphthous erosions (esophagus, 3/115 [2.6%]; stomach, 45/115 [39.1%]; duodenum, 19/115 [16.5%]), longitudinal or aphthous ulcers [duodenum: 4/115 (3.5%)], bamboo-joint-like appearance [stomach: 81/115 (70.4%); duodenum: 3/115 (2.6%)], and scar changes [stomach: 2/115 (1.6%); duodenum: 3/115 (2.6%)]. In multivariable analysis, elevated fecal calprotectin (≥100 μg/g) was associated with esophagogastroduodenal involvement in Crohn disease (odds ratio, 6.57; 95% CI, 1.99-21.66; P <.001).

Conclusions: The proportion of esophagogastroduodenal involvement was relatively high among Korean patients with Crohn disease who underwent EGD. In patients with elevated fecal calprotectin, EGD with histopathological examination is recommended to identify esophagogastroduodenal involvement.

背景和目的:在韩国,克罗恩病累及食管胃十二指肠的特点和发生率尚不清楚。本研究旨在探讨克罗恩病累及食管胃十二指肠的患病率及临床病理特征。方法:2020-2021年,在一家三级保健中心前瞻性纳入115名接受食管胃十二指肠镜检查(EGD)并进行食管、胃和十二指肠活检的克罗恩病患者。取食管、胃体、胃窦、十二指肠球部和第二十二指肠各1个标本,进行组织学检查。结果:患者中位年龄为30.0岁,男性占74.8%。根据组织学特征,56例(48.7%)患者有食管胃十二指肠受累(食管15例,胃44例,十二指肠36例)。组织学上的主要表现为非干酪化肉芽肿8例(7.0%),局灶性胃炎38例(33.0%),淋巴细胞性食管炎13例(10.7%)。115例患者中有94例(81.7%)的内镜检查结果提示食管胃十二指肠受累。典型表现为纵向或阿弗氏溃疡(食管,3/115[2.6%];胃,45/115[39.1%];十二指肠,19/115[16.5%]),纵向或阿弗氏溃疡[十二指肠:4/115(3.5%)],竹关节样外观[胃:81/115 (70.4%);十二指肠:3/115(2.6%),瘢痕改变[胃:2/115 (1.6%)];十二指肠:3/115(2.6%)]。在多变量分析中,粪钙保护蛋白升高(≥100 μg/g)与克罗恩病食管胃十二指肠受累相关(优势比为6.57;95% CI为1.99 ~ 21.66;P)结论:韩国克罗恩病行EGD的患者中食管胃十二指肠受累的比例相对较高。在粪钙保护蛋白升高的患者中,建议进行EGD和组织病理学检查,以确定食管胃十二指肠是否受累。
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引用次数: 0
The Prevalence of Chronic Opioid Use in Patients With Inflammatory Bowel Disease: A Nationwide Danish Register-Based Study Over a 25-Year Period of Time. 炎症性肠病患者慢性阿片类药物使用的患病率:一项为期25年的丹麦全国登记研究
IF 4.3 3区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2026-01-20 DOI: 10.1093/ibd/izaf308
Jennifer Youn, Jan Nielsen, Erantis Sørensen, Mette Wod, Sonia Friedman, Bente Mertz Nørgård

Background: Despite the common use of opioids in patients with inflammatory bowel disease (IBD), there are limited studies on the prevalence of chronic opioid use in this population.

Methods: We conducted a nationwide Danish register-based study to examine the prevalence proportion of chronic opioid use in patients with IBD from 1996 to 2021. Analysis was performed for patients with Crohn's disease (CD) and ulcerative colitis (UC) and stratified by sex and age groups of young adults (18-39 years), adults (40-59 years), and elderly (+60 years).

Results: A total of 51 837 patients with IBD were identified. The prevalence proportion of chronic opioid use increased from 1996 and reached the highest point at 14.26% (95% confidence interval [CI], 13.67%-14.84%) for patients with CD in 2011 and 8.21% (95% CI, 7.88%-8.54%) in patients with UC in 2012. Subsequently, the prevalence proportion of chronic opioid use decreased to 8.88% (95% CI, 8.41%-9.35%) in patients with CD and 4.96% (95% CI, 4.70%-5.21%) in patients with UC by 2021. Throughout the 25-year period, female patients had higher prevalence proportion of chronic opioid use compared with that of male patients. Elderly patients had higher prevalence proportion of chronic opioid use compared with that of adult and young adult patients.

Discussions: Many patients with IBD rely on chronic opioid use as part of their pain management. Further investigations are needed to study the complications and sequelae of chronic opioid use in patients with IBD.

背景:尽管炎症性肠病(IBD)患者普遍使用阿片类药物,但关于这一人群中慢性阿片类药物使用的患病率的研究有限。方法:我们进行了一项全国性的丹麦登记研究,以检查1996年至2021年IBD患者慢性阿片类药物使用的流行比例。对克罗恩病(CD)和溃疡性结肠炎(UC)患者进行分析,并按性别和年龄组分层,分别为年轻人(18-39岁)、成年人(40-59岁)和老年人(60岁以上)。结果:共发现51 837例IBD患者。慢性阿片类药物使用的患病率比例从1996年开始上升,2011年CD患者达到最高点14.26%(95%可信区间[CI], 13.67%-14.84%), 2012年UC患者达到最高点8.21% (95% CI, 7.88%-8.54%)。随后,到2021年,慢性阿片类药物使用的患病率在CD患者中降至8.88% (95% CI, 8.41%-9.35%),在UC患者中降至4.96% (95% CI, 4.70%-5.21%)。在25年期间,女性患者慢性阿片类药物使用的患病率高于男性患者。老年患者慢性阿片类药物使用的患病率高于成年和青年患者。讨论:许多IBD患者依赖慢性阿片类药物使用作为疼痛管理的一部分。需要进一步研究IBD患者慢性阿片类药物使用的并发症和后遗症。
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引用次数: 0
Plasma Proteomics for Risk Prediction and Therapeutic Target Discovery in Crohn's Disease and Ulcerative Colitis. 血浆蛋白质组学用于克罗恩病和溃疡性结肠炎的风险预测和治疗靶点发现。
IF 4.3 3区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2026-01-16 DOI: 10.1093/ibd/izaf325
Xiaoqin Gan, Yanjun Zhang, Yuanyuan Zhang, Ziliang Ye, Sisi Yang, Hao Xiang, Yu Huang, Yiting Wu, Yiwei Zhang, Xianhui Qin

Objectives: We aimed to identify plasma proteins associated with incident Crohn's disease (CD) and ulcerative colitis (UC), develop and validate predictive models for CD and UC risk, and uncover novel protein-based drug targets.

Methods: The study included 46 523 participants from England in the UK. Biobank as the development set and 47 105 participants for internal replication. An external validation set comprised 5807 participants from Scotland and Wales. Plasma proteomic profiling was performed on 2911 proteins.

Results: In the development set, 49 and 34 proteins were significantly associated with incident CD and UC risk, respectively (Bonferroni P < .05). These findings were replicated in the internal replication set. Two-sample Mendelian randomization (MR) analysis identified three proteins (TIMP1, TNFRSF10A, and LTBR) with causal associations for CD and four proteins (CCL20, OSM, NOS2, and CD300E) for UC. Among these, TIMP1 and CD300E represent novel, undrugged targets, while the remaining five are currently druggable. The proteomic-based model, incorporating age, sex, and candidate proteins, demonstrated strong predictive performance in the external validation set, with a C-index of 0.94 (95% CI, 0.88-1.00) for CD and 0.82 (95% CI, 0.73-0.92) for UC. Integrating candidate proteins or the top 10 proteins into clinically based models significantly enhanced risk prediction for both CD and UC.

Conclusions: This study identifies novel plasma protein associations with CD and UC, supported by genetic evidence, and highlights their potential as therapeutic targets. Plasma proteomics significantly improves risk prediction for incident CD and UC compared to traditional clinical models, offering new avenues for drug discovery and personalized risk assessment.

目的:我们旨在确定与克罗恩病(CD)和溃疡性结肠炎(UC)事件相关的血浆蛋白,开发和验证CD和UC风险的预测模型,并发现新的基于蛋白质的药物靶点。方法:该研究包括来自英国的46 523名参与者。生物库作为开发集和47105个参与者进行内部复制。外部验证集包括来自苏格兰和威尔士的5807名参与者。对2911个蛋白进行血浆蛋白质组学分析。结果:在发育组中,49种和34种蛋白分别与CD和UC的发生风险显著相关(Bonferroni P < 0.05)。这些发现在内部复制集中得到了重复。双样本孟德尔随机化(MR)分析发现,3种蛋白(TIMP1、TNFRSF10A和LTBR)与CD有因果关系,4种蛋白(CCL20、OSM、NOS2和CD300E)与UC有因果关系。其中,TIMP1和CD300E是新的、未被破坏的靶点,而其余5个目前是可药物化的。基于蛋白质组学的模型,包括年龄、性别和候选蛋白质,在外部验证集中显示出很强的预测性能,CD的c指数为0.94 (95% CI, 0.88-1.00), UC的c指数为0.82 (95% CI, 0.73-0.92)。将候选蛋白或前10种蛋白整合到临床模型中,可显著提高CD和UC的风险预测。结论:这项研究发现了新的血浆蛋白与CD和UC的关联,并有遗传证据支持,并强调了它们作为治疗靶点的潜力。与传统的临床模型相比,血浆蛋白质组学显著提高了发生CD和UC的风险预测,为药物发现和个性化风险评估提供了新的途径。
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引用次数: 0
A Real-World Longitudinal Case-Study Implementing Digital Screening and Treatment for Distress in Inflammatory Bowel Disease: The COMPASS-IBD Patient Journey. 在炎性肠病中实施数字筛查和治疗的真实世界纵向病例研究:COMPASS-IBD患者之旅。
IF 4.3 3区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2026-01-13 DOI: 10.1093/ibd/izaf259
Annie S K Jones, Natasha Seaton, Sophie Harding, Alexa Duff, Joanna Hudson, Abigail Wroe, Sam Norton, Harinder Singh, Jemima Onih, Rona Moss-Morris

Background: Comorbid psychological distress (anxiety and depression) in inflammatory bowel disease (IBD) is common and associated with poorer outcomes and increased healthcare burden. Scalable and accessible integrated care is needed. This study examined the feasibility of implementing routine digital mental health screening and digital cognitive-behavioral therapy (COMPASS-IBD) for psychological distress in a large IBD service.

Methods: During implementation, distress was identified by screening or IBD clinician referral. Further triage determined eligibility to receive COMPASS-IBD with trainee therapist support (12 weeks). Pre- and post-intervention outcomes examined reach, acceptability, implementation, and potential effectiveness of the new pathway.

Results: Screening was completed by 827 patients (from November 2022 to September 2023), with 196 patients meeting clinical cutoffs and referred for IBD psychology triage. An additional 82 patients were directly referred via IBD clinicians. Of 91 eligible patients, 65 (71.4%) were enrolled into COMPASS-IBD. Distress significantly reduced post-intervention (Patient Health Questionnaire Anxiety and Depression Scale = -6.203; 95% confidence interval, -8.76 to -3.64; P < .001; Cohen's d = -0.553). Symptoms of anxiety, depression, and IBD-related quality of life significantly improved, but IBD symptomatology did not. Full adherence (≥5 online and ≥3 therapist sessions) to COMPASS-IBD was completed by 32.3% of patients. After initially increasing, the IBD psychology waitlist decreased in wait time (30.8%) and number (63.4%) by the end of study implementation. Patients were accepting of the new treatment pathway.

Conclusions: Routine mental health screening and COMPASS-IBD were successfully implemented in an outpatient IBD service, but support from trainee psychologists and the research team was required. This new integrated pathway can identify and treat psychological distress in IBD with minimal service resource.

背景:炎症性肠病(IBD)的共病心理困扰(焦虑和抑郁)很常见,并与较差的预后和增加的医疗负担相关。需要可扩展和可获得的综合护理。本研究考察了在大型IBD服务中实施常规数字心理健康筛查和数字认知行为疗法(COMPASS-IBD)治疗心理困扰的可行性。方法:在实施过程中,通过筛查或IBD临床医生转诊来识别窘迫。进一步的分类确定了在实习治疗师支持下接受COMPASS-IBD治疗的资格(12周)。干预前和干预后的结果检查了新途径的覆盖范围、可接受性、实施和潜在有效性。结果:827例患者(2022年11月至2023年9月)完成筛查,其中196例患者符合临床临界值,转介IBD心理分诊。另外82名患者通过IBD临床医生直接转诊。在91名符合条件的患者中,65名(71.4%)入组COMPASS-IBD。患者健康问卷焦虑抑郁量表= -6.203;95%可信区间为-8.76 ~ -3.64;P结论:常规心理健康筛查和COMPASS-IBD在IBD门诊服务中成功实施,但需要实习心理学家和研究团队的支持。这种新的综合途径可以用最少的服务资源识别和治疗IBD患者的心理困扰。
{"title":"A Real-World Longitudinal Case-Study Implementing Digital Screening and Treatment for Distress in Inflammatory Bowel Disease: The COMPASS-IBD Patient Journey.","authors":"Annie S K Jones, Natasha Seaton, Sophie Harding, Alexa Duff, Joanna Hudson, Abigail Wroe, Sam Norton, Harinder Singh, Jemima Onih, Rona Moss-Morris","doi":"10.1093/ibd/izaf259","DOIUrl":"https://doi.org/10.1093/ibd/izaf259","url":null,"abstract":"<p><strong>Background: </strong>Comorbid psychological distress (anxiety and depression) in inflammatory bowel disease (IBD) is common and associated with poorer outcomes and increased healthcare burden. Scalable and accessible integrated care is needed. This study examined the feasibility of implementing routine digital mental health screening and digital cognitive-behavioral therapy (COMPASS-IBD) for psychological distress in a large IBD service.</p><p><strong>Methods: </strong>During implementation, distress was identified by screening or IBD clinician referral. Further triage determined eligibility to receive COMPASS-IBD with trainee therapist support (12 weeks). Pre- and post-intervention outcomes examined reach, acceptability, implementation, and potential effectiveness of the new pathway.</p><p><strong>Results: </strong>Screening was completed by 827 patients (from November 2022 to September 2023), with 196 patients meeting clinical cutoffs and referred for IBD psychology triage. An additional 82 patients were directly referred via IBD clinicians. Of 91 eligible patients, 65 (71.4%) were enrolled into COMPASS-IBD. Distress significantly reduced post-intervention (Patient Health Questionnaire Anxiety and Depression Scale = -6.203; 95% confidence interval, -8.76 to -3.64; P < .001; Cohen's d = -0.553). Symptoms of anxiety, depression, and IBD-related quality of life significantly improved, but IBD symptomatology did not. Full adherence (≥5 online and ≥3 therapist sessions) to COMPASS-IBD was completed by 32.3% of patients. After initially increasing, the IBD psychology waitlist decreased in wait time (30.8%) and number (63.4%) by the end of study implementation. Patients were accepting of the new treatment pathway.</p><p><strong>Conclusions: </strong>Routine mental health screening and COMPASS-IBD were successfully implemented in an outpatient IBD service, but support from trainee psychologists and the research team was required. This new integrated pathway can identify and treat psychological distress in IBD with minimal service resource.</p>","PeriodicalId":13623,"journal":{"name":"Inflammatory Bowel Diseases","volume":" ","pages":""},"PeriodicalIF":4.3,"publicationDate":"2026-01-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145959121","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Timing is Everything: Lessons Learned for Building Microbiome-Based Models in Pediatric Crohn's Disease. 时间决定一切:在儿童克罗恩病中建立基于微生物组的模型的经验教训。
IF 4.3 3区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2026-01-11 DOI: 10.1093/ibd/izaf313
Charlotte M Verburgt, Katherine A Dunn, Joseph P Bielawski, Anthony R Otley, Melvin B Heyman, Whitney Sunseri, Dror S Shouval, Rotem S Boneh, Tim de Meij, Jeffrey S Hyams, Lee A Denson, Subra Kugathasan, Marc A Benninga, Wouter J de Jonge, Johan E Van Limbergen
{"title":"Timing is Everything: Lessons Learned for Building Microbiome-Based Models in Pediatric Crohn's Disease.","authors":"Charlotte M Verburgt, Katherine A Dunn, Joseph P Bielawski, Anthony R Otley, Melvin B Heyman, Whitney Sunseri, Dror S Shouval, Rotem S Boneh, Tim de Meij, Jeffrey S Hyams, Lee A Denson, Subra Kugathasan, Marc A Benninga, Wouter J de Jonge, Johan E Van Limbergen","doi":"10.1093/ibd/izaf313","DOIUrl":"https://doi.org/10.1093/ibd/izaf313","url":null,"abstract":"","PeriodicalId":13623,"journal":{"name":"Inflammatory Bowel Diseases","volume":" ","pages":""},"PeriodicalIF":4.3,"publicationDate":"2026-01-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145948733","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Low-Dose Aspirin and the Prevention of Colorectal Cancer in Inflammatory Bowel Disease: A Nationwide Cohort Study. 低剂量阿司匹林和预防炎症性肠病的结直肠癌:一项全国性队列研究。
IF 4.3 3区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2026-01-09 DOI: 10.1093/ibd/izaf304
Yan-Jiun Huang, Jui-An Lin, Wan-Ming Chen, Ben-Chang Shia, Szu-Yuan Wu

Background: Patients with inflammatory bowel disease (IBD) are at increased risk of colorectal cancer (CRC). However, the chemopreventive role of aspirin remains uncertain due to conflicting findings in prior studies.

Methods: The study sought to evaluate the association between long-term aspirin use and the risk of CRC and all-cause mortality in patients with IBD. We conducted a nationwide propensity score-matched cohort study using Taiwan's National Health Insurance Research Database and Cancer Registry from 2008 to 2022. Time-dependent Cox models and Fine and Gray competing risk models were applied.

Results: Among 2743 matched aspirin users and 2743 nonusers, aspirin use was associated with reduced CRC risk (adjusted hazard ratio, 0.42; 95% confidence interval, 0.31-0.57) and lower all-cause mortality (adjusted hazard ratio, 0.66; 95% confidence interval, 0.58-0.74). A dose-response relationship was found for cumulative exposure, while optimal daily intensity was near 80 mg/d.

Conclusions: Long-term use of low-to-moderate-dose aspirin was associated with reduced risks of CRC and mortality in patients with IBD. These findings support aspirin's potential as a chemopreventive agent and justify further randomized trials.

背景:炎症性肠病(IBD)患者发生结直肠癌(CRC)的风险增加。然而,由于先前的研究结果相互矛盾,阿司匹林的化学预防作用仍然不确定。方法:本研究旨在评估IBD患者长期服用阿司匹林与结直肠癌风险和全因死亡率之间的关系。​采用时变Cox模型和Fine and Gray竞争风险模型。结果:在2743名匹配的阿司匹林服用者和2743名非服用者中,阿司匹林的使用与降低结直肠癌风险(校正风险比,0.42;95%可信区间,0.31-0.57)和降低全因死亡率(校正风险比,0.66;95%可信区间,0.58-0.74)相关。累积暴露存在剂量-反应关系,最佳日暴露强度在80 mg/d附近。结论:长期使用低至中剂量阿司匹林可降低IBD患者的结直肠癌风险和死亡率。这些发现支持阿司匹林作为化学预防剂的潜力,并证明进一步的随机试验是合理的。
{"title":"Low-Dose Aspirin and the Prevention of Colorectal Cancer in Inflammatory Bowel Disease: A Nationwide Cohort Study.","authors":"Yan-Jiun Huang, Jui-An Lin, Wan-Ming Chen, Ben-Chang Shia, Szu-Yuan Wu","doi":"10.1093/ibd/izaf304","DOIUrl":"https://doi.org/10.1093/ibd/izaf304","url":null,"abstract":"<p><strong>Background: </strong>Patients with inflammatory bowel disease (IBD) are at increased risk of colorectal cancer (CRC). However, the chemopreventive role of aspirin remains uncertain due to conflicting findings in prior studies.</p><p><strong>Methods: </strong>The study sought to evaluate the association between long-term aspirin use and the risk of CRC and all-cause mortality in patients with IBD. We conducted a nationwide propensity score-matched cohort study using Taiwan's National Health Insurance Research Database and Cancer Registry from 2008 to 2022. Time-dependent Cox models and Fine and Gray competing risk models were applied.</p><p><strong>Results: </strong>Among 2743 matched aspirin users and 2743 nonusers, aspirin use was associated with reduced CRC risk (adjusted hazard ratio, 0.42; 95% confidence interval, 0.31-0.57) and lower all-cause mortality (adjusted hazard ratio, 0.66; 95% confidence interval, 0.58-0.74). A dose-response relationship was found for cumulative exposure, while optimal daily intensity was near 80 mg/d.</p><p><strong>Conclusions: </strong>Long-term use of low-to-moderate-dose aspirin was associated with reduced risks of CRC and mortality in patients with IBD. These findings support aspirin's potential as a chemopreventive agent and justify further randomized trials.</p>","PeriodicalId":13623,"journal":{"name":"Inflammatory Bowel Diseases","volume":" ","pages":""},"PeriodicalIF":4.3,"publicationDate":"2026-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145933118","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Efficacy, Safety, and Pharmacokinetics of Golimumab in Children with Moderately-To-Severely Active Ulcerative Colitis: Results from the PURSUIT 2 Study. Golimumab治疗中度至重度活动性溃疡性结肠炎的疗效、安全性和药代动力学:来自PURSUIT 2研究的结果
IF 4.3 3区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2026-01-08 DOI: 10.1093/ibd/izaf322
Dan Turner, Kathleen G Lomax, Gigi Veereman, Anne M Griffiths, Jaroslaw Kierkuś, Ben Kang, Katherine Berezny, Lakshmi Padgett, Gary Mao, Yevgeny Zitser, Richard S Strauss, Jeroen Verhoeven, Omoniyi J Adedokun, Jeffrey S Hyams

Background: Golimumab is an anti-TNFα biologic agent that has been approved for adults with moderately-to-severely active ulcerative colitis (UC). We investigated the efficacy, safety, and pharmacokinetics (PK) of golimumab in biologic-naïve children with moderately-to-severely active UC.

Methods: The prospective, multicenter, open-label PURSUIT 2 study enrolled biologic-naïve children (2 to <18 years) with moderately-to-severely active UC (Mayo score 6-12; endoscopic subscore ≥2) despite conventional treatment. During the 6-week induction phase, patients received subcutaneous (SC) golimumab dosed by weight (<45 kg: 120/60 mg/m2; ≥45 kg: 200/100 mg) at weeks 0/2. Week 6 clinical responders (Mayo score decrease from baseline ≥30% and ≥3 points, with either a decrease in the rectal bleeding subscore of ≥1 or a rectal bleeding subscore of 0/1) continued golimumab dose q4w during the 48-week maintenance phase. The primary endpoint was clinical remission (Mayo score ≤2 points with no individual subscore >1) at week 6. Efficacy and PK data are presented alongside a reference adult UC population who received golimumab SC 200/100 mg at weeks 0/2 and 100 mg q4w thereafter.

Results: Of the 69 patients (mean age, 13.4 ± 3.3 years) enrolled, 31.9% (22/69) were in clinical remission at week 6, and of those, 54.5% (12/22) remained in clinical remission at week 54. At week 54, 31.7% (13/41) of week 6 clinical responders achieved clinical remission. Additionally, 33.3% achieved clinical remission by the Pediatric Ulcerative Colitis Activity Index (PUCAI), 56.5% clinical response by Mayo, 40.6% endoscopic improvement, and 7.2% endoscopic remission at week 6. Of those who were clinical responders at week 6, 34.1% achieved clinical remission by PUCAI, 31.7% corticosteroid-free clinical remission by Mayo, 36.6% endoscopic improvement, and 9.8% endoscopic remission at week 54. Serum golimumab concentrations through week 6 were comparable to the reference adult UC population. Through week 54, 40.6% reported serious adverse events and 13.0% serious infections. No new safety concerns were identified.

Conclusions: Overall, the results of the PURSUIT 2 study support golimumab treatment for children with moderately-to-severely active UC. ClinicalTrials.gov ID: NCT03596645.

背景:Golimumab是一种抗tnf α生物制剂,已被批准用于治疗中度至重度活动性溃疡性结肠炎(UC)的成人。我们研究了golimumab在biologic-naïve中度至重度活动性UC患儿中的疗效、安全性和药代动力学(PK)。方法:前瞻性、多中心、开放标签的PURSUIT 2研究在第6周招募biologic-naïve儿童(2至1岁)。疗效和PK数据与参考成年UC人群一起公布,这些人群在第0/2周接受格利木单抗SC 200/100 mg,之后每4周接受100 mg。结果:69例患者(平均年龄13.4±3.3岁)中,31.9%(22/69)患者在第6周临床缓解,其中54.5%(12/22)患者在第54周仍保持临床缓解。在第54周,31.7%(13/41)的第6周临床应答者达到临床缓解。此外,33.3%的儿童溃疡性结肠炎活动指数(PUCAI)达到临床缓解,56.5%的梅奥临床缓解,40.6%的内镜改善,7.2%的内镜缓解在第6周。在第6周有临床反应的患者中,34.1%的患者通过PUCAI达到了临床缓解,31.7%的患者通过Mayo获得了无皮质类固醇的临床缓解,36.6%的患者在内镜下改善,9.8%的患者在第54周达到了内镜下缓解。第6周的血清golimumab浓度与参考成年UC人群相当。到第54周,40.6%的患者报告了严重不良事件,13.0%的患者报告了严重感染。没有发现新的安全隐患。结论:总体而言,PURSUIT 2研究的结果支持golimumab治疗中度至重度活动性UC患儿。ClinicalTrials.gov ID: NCT03596645。
{"title":"Efficacy, Safety, and Pharmacokinetics of Golimumab in Children with Moderately-To-Severely Active Ulcerative Colitis: Results from the PURSUIT 2 Study.","authors":"Dan Turner, Kathleen G Lomax, Gigi Veereman, Anne M Griffiths, Jaroslaw Kierkuś, Ben Kang, Katherine Berezny, Lakshmi Padgett, Gary Mao, Yevgeny Zitser, Richard S Strauss, Jeroen Verhoeven, Omoniyi J Adedokun, Jeffrey S Hyams","doi":"10.1093/ibd/izaf322","DOIUrl":"https://doi.org/10.1093/ibd/izaf322","url":null,"abstract":"<p><strong>Background: </strong>Golimumab is an anti-TNFα biologic agent that has been approved for adults with moderately-to-severely active ulcerative colitis (UC). We investigated the efficacy, safety, and pharmacokinetics (PK) of golimumab in biologic-naïve children with moderately-to-severely active UC.</p><p><strong>Methods: </strong>The prospective, multicenter, open-label PURSUIT 2 study enrolled biologic-naïve children (2 to <18 years) with moderately-to-severely active UC (Mayo score 6-12; endoscopic subscore ≥2) despite conventional treatment. During the 6-week induction phase, patients received subcutaneous (SC) golimumab dosed by weight (<45 kg: 120/60 mg/m2; ≥45 kg: 200/100 mg) at weeks 0/2. Week 6 clinical responders (Mayo score decrease from baseline ≥30% and ≥3 points, with either a decrease in the rectal bleeding subscore of ≥1 or a rectal bleeding subscore of 0/1) continued golimumab dose q4w during the 48-week maintenance phase. The primary endpoint was clinical remission (Mayo score ≤2 points with no individual subscore >1) at week 6. Efficacy and PK data are presented alongside a reference adult UC population who received golimumab SC 200/100 mg at weeks 0/2 and 100 mg q4w thereafter.</p><p><strong>Results: </strong>Of the 69 patients (mean age, 13.4 ± 3.3 years) enrolled, 31.9% (22/69) were in clinical remission at week 6, and of those, 54.5% (12/22) remained in clinical remission at week 54. At week 54, 31.7% (13/41) of week 6 clinical responders achieved clinical remission. Additionally, 33.3% achieved clinical remission by the Pediatric Ulcerative Colitis Activity Index (PUCAI), 56.5% clinical response by Mayo, 40.6% endoscopic improvement, and 7.2% endoscopic remission at week 6. Of those who were clinical responders at week 6, 34.1% achieved clinical remission by PUCAI, 31.7% corticosteroid-free clinical remission by Mayo, 36.6% endoscopic improvement, and 9.8% endoscopic remission at week 54. Serum golimumab concentrations through week 6 were comparable to the reference adult UC population. Through week 54, 40.6% reported serious adverse events and 13.0% serious infections. No new safety concerns were identified.</p><p><strong>Conclusions: </strong>Overall, the results of the PURSUIT 2 study support golimumab treatment for children with moderately-to-severely active UC. ClinicalTrials.gov ID: NCT03596645.</p>","PeriodicalId":13623,"journal":{"name":"Inflammatory Bowel Diseases","volume":" ","pages":""},"PeriodicalIF":4.3,"publicationDate":"2026-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145933091","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Real-World Implementation of Treat to Target in Patients With IBD in a Learning Health System: An IBD Qorus Collaborative Study. 在学习健康系统中IBD患者治疗目标的实际实施:IBD Qorus合作研究。
IF 4.3 3区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2026-01-07 DOI: 10.1093/ibd/izaf287
Siddharth Singh, Brant J Oliver, Jason K Hou, Donald Lum, Welmoed Van Deen, Sarah Harvey, James Testaverde, Alice M Kennedy, Ridhima Oberai, S Alandra Weaver, Corey A Siegel, Gil Y Melmed

Background: We examined real-world utilization of treat-to-target (TTT) strategies and conducted a quality improvement (QI) project to improve uptake of TTT strategies in a learning health system, IBD Qorus.

Methods: We implemented a structured QI intervention to increase uptake of TTT in 41 gastroenterology practices in the United States, over a 13-month intervention period (November 2020 to November 2021; modified breakthrough series [BTS] collaborative), and a 10-month post-BTS observation period (December 2021 to October 2022). Through encounter-level surveys, we examined providers' "intention to TTT" based on discussion of TTT with patients, documentation of inflammation, and intention to change therapy to TTT. We examined changes in rates of "intention to TTT," and whether improvement in intention to TTT influenced site-level rates of remission.

Results: Over 13 months, there were 7932 patient visits (55% with Crohn's disease; 47% in clinical remission); patients in 2160 visits (27%) were not in endoscopic remission. Overall, rates of intention to TTT increased from 31% to 54% (P = .06) with considerable site-to-site variability and was maintained at 49% in the post-BTS observation period. The increased rate was attributable to higher rates of testing for inflammation. Despite an increase in the rate of intention to TTT, there was no significant change in site-level achievement of remission over the same time.

Conclusions: Through a QI initiative in a learning health system, rates of intention to TTT increased significantly over 12-months, though overall rates remained low. Assessing patient-, provider- and practice-level barriers and facilitators for successful implementation of a TTT strategy is warranted to improve clinical outcomes.

背景:我们研究了治疗到目标(TTT)策略在现实世界中的使用情况,并开展了一项质量改进(QI)项目,以提高学习卫生系统IBD Qorus对TTT策略的采用。方法:在13个月的干预期(2020年11月至2021年11月;改进的突破系列[BTS]协作)和BTS后10个月的观察期(2021年12月至2022年10月),我们实施了结构化的QI干预,以增加美国41家胃肠病学诊所对TTT的吸收。通过接触水平调查,我们根据与患者讨论TTT、炎症记录和改变治疗的意愿来检查提供者的“TTT意向”。我们检查了“TTT意向”率的变化,以及TTT意向的改善是否影响了现场水平的缓解率。结果:在13个月内,共有7932名患者就诊(55%为克罗恩病,47%为临床缓解);2160例就诊的患者(27%)没有内窥镜缓解。总体而言,TTT的意愿率从31%上升到54% (P = 0.06),具有相当大的地点差异,在bts后的观察期维持在49%。增加的比率是由于更高的炎症测试率。尽管TTT的意向率有所增加,但在同一时间内,现场水平的缓解成就没有显著变化。结论:通过学习型卫生系统的QI倡议,在12个月内TTT意向率显着增加,尽管总体比率仍然很低。评估患者,提供者和实践层面的障碍和促进成功实施TTT战略是必要的,以改善临床结果。
{"title":"Real-World Implementation of Treat to Target in Patients With IBD in a Learning Health System: An IBD Qorus Collaborative Study.","authors":"Siddharth Singh, Brant J Oliver, Jason K Hou, Donald Lum, Welmoed Van Deen, Sarah Harvey, James Testaverde, Alice M Kennedy, Ridhima Oberai, S Alandra Weaver, Corey A Siegel, Gil Y Melmed","doi":"10.1093/ibd/izaf287","DOIUrl":"https://doi.org/10.1093/ibd/izaf287","url":null,"abstract":"<p><strong>Background: </strong>We examined real-world utilization of treat-to-target (TTT) strategies and conducted a quality improvement (QI) project to improve uptake of TTT strategies in a learning health system, IBD Qorus.</p><p><strong>Methods: </strong>We implemented a structured QI intervention to increase uptake of TTT in 41 gastroenterology practices in the United States, over a 13-month intervention period (November 2020 to November 2021; modified breakthrough series [BTS] collaborative), and a 10-month post-BTS observation period (December 2021 to October 2022). Through encounter-level surveys, we examined providers' \"intention to TTT\" based on discussion of TTT with patients, documentation of inflammation, and intention to change therapy to TTT. We examined changes in rates of \"intention to TTT,\" and whether improvement in intention to TTT influenced site-level rates of remission.</p><p><strong>Results: </strong>Over 13 months, there were 7932 patient visits (55% with Crohn's disease; 47% in clinical remission); patients in 2160 visits (27%) were not in endoscopic remission. Overall, rates of intention to TTT increased from 31% to 54% (P = .06) with considerable site-to-site variability and was maintained at 49% in the post-BTS observation period. The increased rate was attributable to higher rates of testing for inflammation. Despite an increase in the rate of intention to TTT, there was no significant change in site-level achievement of remission over the same time.</p><p><strong>Conclusions: </strong>Through a QI initiative in a learning health system, rates of intention to TTT increased significantly over 12-months, though overall rates remained low. Assessing patient-, provider- and practice-level barriers and facilitators for successful implementation of a TTT strategy is warranted to improve clinical outcomes.</p>","PeriodicalId":13623,"journal":{"name":"Inflammatory Bowel Diseases","volume":" ","pages":""},"PeriodicalIF":4.3,"publicationDate":"2026-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145917491","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
B Cell Dysregulation in IBD: From Pathophysiology to Therapeutic Targeting. IBD中的B细胞失调:从病理生理到治疗靶向。
IF 4.3 3区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2026-01-07 DOI: 10.1093/ibd/izaf311
Divya Jha, Saurabh Mehandru
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Inflammatory Bowel Diseases
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