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Dysplasia in Pseudopolyps: Selection Bias, Reactive Atypia, and the Ulcer Paradox. 假性息肉的发育不良:选择偏倚、反应性异型性和溃疡悖论。
IF 8.7 Pub Date : 2026-01-10 DOI: 10.1093/ecco-jcc/jjag001
Yusuf Bünyamin Ketencİ, Hakan Demiroz, Muge Ustaoğlu Dede
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引用次数: 0
ECCO consensus on management of inflammatory bowel disease in low- and middle-income countries. ECCO关于中低收入国家炎症性肠病管理的共识。
IF 8.7 Pub Date : 2026-01-09 DOI: 10.1093/ecco-jcc/jjaf125
Alaa El-Hussuna, Almuthe Christina Hauer, Tarkan Karakan, Valerie Pittet, Henit Yanai, Jalpa Devi, Jesus K Yamamoto-Furusho, Ali Reza Sima, Hailemichael Desalegn, Mutaz Idrees Sultan, Vishal Sharma, Hany Shehab, Lamya Mrabti, Natalia Queiroz, Anuraag Jena, Andy Darma, Karin Davidson, Nicolas Avellaneda, Muhammed Elhadi, April Roslani, Dakshitha Wickramasinghe, Carlo Angelo Cajucom, Shaji Sebastian

Background: The incidence and prevalence of inflammatory bowel disease [IBD] have increased significantly in low- and middle-income countries [LMICs] in recent decades. Managing IBD in these settings presents substantial challenges. This consensus aims to describe the epidemiology of IBD in LMICs and to highlight the key challenges in its diagnosis and treatment.

Method: The consensus-defining strategy followed the previous European Crohn's and Colitis Organisation [ECCO] consensus guidelines [available at www.ecco-ibd.eu]. The authors reviewed the available evidence and formulated statements accordingly. Provisional ECCO statements and supporting text were drafted based on a comprehensive literature review and further refined through two voting rounds, which included external reviewers and national representatives from ECCO's 36 member countries. The final ECCO statements, representing a consensus of at least 80% agreement among participants, were approved during an online meeting. Consensus statements should be interpreted in context with their accompanying commentary rather than in isolation and should not be used solely to guide patient management. The supporting text was finalized under the guidance of each working group leader [VP, HY, TK, AH] and subsequently integrated by the consensus leader [AE].

Results: Data on IBD epidemiology in LMICs remain limited. Public and healthcare professional awareness and timely access to early diagnostic modalities, advanced medical and surgical therapies, and specialist multidisciplinary care are key gaps in IBD care in LMICs. The complexity and chronic nature of IBD, along with the necessity for a multidisciplinary approach, pose significant challenges to adopting a holistic management strategy in LMICs.

Conclusion: There is a critical need for further studies to assess the specific needs of LMICs. Such research will help guide resource allocation and improve IBD management in these settings.

背景:近几十年来,炎症性肠病(IBD)在低收入和中等收入国家(LMICs)的发病率和患病率显著增加。在这些环境中管理IBD存在重大挑战。这一共识旨在描述中低收入国家IBD的流行病学,并强调其诊断和治疗方面的主要挑战。方法:共识定义策略遵循先前的欧洲克罗恩病和结肠炎组织[ECCO]共识指南[可在www.ecco-ibd.eu获得]。作者审查了现有的证据,并相应地制定了声明。ECCO的临时声明和支持文本是在全面文献审查的基础上起草的,并通过两轮投票进一步完善,投票包括外部审稿人和ECCO 36个成员国的国家代表。ECCO的最终声明在一次在线会议上获得批准,代表了参与者之间至少80%的共识。共识声明应与其附带的评论结合起来解释,而不是孤立地解释,不应仅用于指导患者管理。支持文本在各工作组负责人[VP, HY, TK, AH]的指导下定稿,随后由共识负责人[AE]进行整合。结果:关于中低收入国家IBD流行病学的数据仍然有限。公众和卫生保健专业人员的认识以及及时获得早期诊断方式、先进的医疗和手术疗法以及多学科专业护理是中低收入国家IBD护理方面的主要差距。IBD的复杂性和慢性性质,以及多学科方法的必要性,对在中低收入国家采用整体管理策略提出了重大挑战。结论:迫切需要进一步的研究来评估中低收入国家的具体需求。这样的研究将有助于在这些环境中指导资源分配和改善IBD管理。
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引用次数: 0
The Global Leadership Initiative on Malnutrition criteria for the diagnosis of malnutrition in patients with inflammatory bowel disease: a systematic review and meta-analysis. 诊断炎症性肠病患者营养不良的营养不良标准全球领导倡议:系统回顾和荟萃分析
IF 8.7 Pub Date : 2026-01-09 DOI: 10.1093/ecco-jcc/jjaf209
Niki Papageorgiou, Anna-Bettina Haidich, Eirini Pagkalidou, Androniki Papaemmanouil, Olga Giouleme, Areti Triantafyllou, Michail Chourdakis, Xenophon Theodoridis

Background and aims: This study aims to evaluate the diagnostic accuracy of tools commonly employed in clinical practice for the assessment of malnutrition in patients with inflammatory bowel disease (IBD), including Global Leadership Initiative on Malnutrition (GLIM) criteria, Subjective Global Assessment (SGA), European Society of Parenteral and Enteral Nutrition (ESPEN) criteria, and World Health Organization (WHO)-related body mass index (BMI).

Methods: Eligible observational studies and randomized controlled trials (RCTs) were identified through searches of databases, including PubMed, Scopus, Web of Science Core Collection, Cochrane Central Register of Controlled Trials (CENTRAL), and Epistemonikos, until August 2024. Clinical trial registries, grey literature, and reference lists of included studies were also screened. Study selection, data extraction, and quality assessment were conducted independently by two reviewers. A bivariate mixed-effects model was utilized to evaluate the diagnostic test accuracy, producing pooled estimates for sensitivity and specificity with the corresponding confidence intervals (CIs), using SGA as a reference method for malnutrition diagnosis.

Results: Nine primary studies (1420 participants) and data from one unpublished work were included in the present systematic review. Based on data derived from three studies, GLIM criteria demonstrated high sensitivity (0.80, 95% CI: 0.68-0.88) and moderate specificity (0.71, 95% CI: 0.53-0.84) using SGA as a reference standard. The certainty of the evidence supporting these findings was rated as very low.

Conclusions: The GLIM criteria demonstrate potential as an effective tool for diagnosing malnutrition in patients with IBD. However, further validation is necessary, requiring additional diagnostic accuracy studies to enhance their reliability and establish their clinical applicability.

背景与目的:本研究旨在评估临床实践中常用的评估炎症性肠病(IBD)患者营养不良的工具的诊断准确性,包括全球营养不良领导倡议(GLIM)标准、主观全球评估(SGA)、欧洲肠外和肠内营养学会(ESPEN)标准和世界卫生组织(WHO)相关的体重指数(BMI)。方法:通过检索PubMed、Scopus、Web of Science Core Collection、Cochrane Central Register of controlled trials (Central)和Epistemonikos等数据库,筛选符合条件的观察性研究和随机对照试验(rct),检索截止至2024年8月。临床试验注册、灰色文献和纳入研究的参考文献列表也被筛选。研究选择、数据提取和质量评估由两位审稿人独立进行。采用双变量混合效应模型评估诊断试验的准确性,并以相应的置信区间(CI)对敏感性和特异性进行汇总估计,以SGA作为营养不良诊断的参考方法。结果:本综述纳入了9项主要研究(1420名受试者)和1项未发表的研究数据。基于三个研究的数据,以SGA为参考标准,GLIM标准具有高灵敏度(0.80,95% CI: 0.68-0.88)和中等特异性(0.71,95% CI: 0.53-0.84)。支持这些发现的证据的确定性被评为非常低。结论:GLIM标准显示出作为诊断IBD患者营养不良的有效工具的潜力。然而,进一步的验证是必要的,需要额外的诊断准确性研究,以提高其可靠性和建立其临床适用性。
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引用次数: 0
Implementation of values-based healthcare in inflammatory bowel disease-a review. 基于价值观的医疗保健在炎症性肠病中的实施-综述文章。
IF 8.7 Pub Date : 2026-01-09 DOI: 10.1093/ecco-jcc/jjaf173
Patrick Hilley, Simone Chin, Darren Wong, Peter De Cruz

The rising global prevalence of inflammatory bowel disease (IBD) and costs of care associated with its management mandates the need to constrain costs whilst improving patient outcomes. Traditional care models such as fee for service do not capture the functional impact of IBD across the whole patient journey. There is a need to develop innovative care models to better address the multifaceted needs of patients with IBD. Values-based healthcare (VBHC) is a model of care that aims to deliver quality care by prioritizing outcomes that matter to patients in a manner that demonstrates cost-effectiveness of health service provision. In this comprehensive scoping review of the literature, we examine the implementation of VBHC-orientated approaches to IBD care delivery and assess how they have demonstrated value in relation to clinical outcomes, patient-reported outcomes, costs (direct and indirect), and healthcare utilization. In addition, we outline key enablers and barriers to implementation of VBHC models in IBD. We then describe the ideal composition of IBD VBHC models and parameters required for implementation and demonstration of their value proposition.

随着全球炎症性肠病(IBD)患病率的上升以及与IBD管理相关的医疗费用的增加,有必要在改善患者预后的同时限制成本。传统的护理模式,如按服务收费,并没有捕捉到IBD在整个患者旅程中的功能影响。有必要开发创新的护理模式,以更好地满足IBD患者的多方面需求。基于价值的医疗保健(VBHC)是一种医疗模式,旨在通过优先考虑对患者重要的结果,以证明卫生服务提供的成本效益的方式提供高质量的医疗服务。在这篇全面的文献综述中,我们研究了以vbhc为导向的IBD护理方法的实施,并评估了它们在临床结果、患者报告结果(PROs)、成本(直接和间接)和医疗保健利用(HCU)方面的价值。此外,我们还概述了在IBD中实施VBHC模型的关键推动因素和障碍。然后,我们描述了IBD VBHC模型的理想组成以及实现和演示其价值主张所需的参数。
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引用次数: 0
Guselkumab-mediated marked improvement in a case of refractory ulcerative colitis resistant to mirikizumab: evidence for switching between IL-23p19 inhibitors. guselkumab介导的对米利珠单抗耐药的难治性溃疡性结肠炎的显著改善:IL-23p19抑制剂切换的证据
IF 8.7 Pub Date : 2026-01-09 DOI: 10.1093/ecco-jcc/jjaf230
Reiko Kunisaki, Hideaki Kimura, Shin Maeda
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引用次数: 0
Quality metrics reflecting patient experience of GI endoscopy in Inflammatory Bowel Disease: results of national endoscopy dataset analysis. 反映炎症性肠病患者胃肠道内镜检查经验的质量指标:国家内镜数据集分析结果。
IF 8.7 Pub Date : 2026-01-09 DOI: 10.1093/ecco-jcc/jjaf211
Fiona Jones, Aonghus Lavelle, Finbar McCarthy, Stephen Patchett, Ashraf Morcos, Manus Moloney, Garret Cullen, Eoin Slattery, Jan Leyden, Colm O' Morain, Laurence Egan, Irene Zammarchi, Marietta Iacucci, Glen A Doherty

Introduction: ESGE have recently defined important performance measures for endoscopy in IBD. The role of patient experience in quality assessment of endoscopy in IBD is yet to be defined. We undertook an observational study based on analysis of a large multi-centre dataset with national coverage in Ireland. The aim was to analyse individual and composite metrics that reflect patients' experience with endoscopic procedures for IBD.

Methods: Anonymised data was extracted from electronic procedure records of patients who underwent colonoscopy in 24 Irish hospitals. The Performance Indicator of colonic intubation (PICI), a novel composite score reflecting sedation rates and patient comfort, and IBD-specific endoscopic domains were evaluated.

Results: Data from 261,524 colonoscopies were analysed from 2014-2020. CD patients had significantly lower OR of achieving PICI compared to non-IBD patients (0.69, 0-65-0.74 p < 0.001). Severe colitis was also associated with a significantly lower OR of achieving PICI (OR 0.53 (0.38-0.74, p,0.001). 80.2% of CD patients had a comfort score ≤2 compared to 87.8% of those with UC and 84.2% without IBD. 60.7% of patients with CD required Midazolam dose of 3 mg or more compared to 50.4% of those with UC and 76.7% of those without IBD. . 50% of CD patients required Fentanyl doses >50mcg compared to 34% of UC patients and 30.3% of patients without IBD.

Conclusion: This analysis of a large national endoscopy dataset highlights variability in quality metrics for IBD endoscopy and underscores the need for a metric like PICI to more accurately capture and reflect patient endoscopic experience with IBD.

ESGE最近定义了IBD内窥镜检查的重要性能指标。患者经验在IBD内镜检查质量评估中的作用尚未明确。我们进行了一项观察性研究,该研究基于对爱尔兰全国覆盖的大型多中心数据集的分析。目的是分析反映IBD患者内窥镜治疗经验的个体和综合指标。方法:从24家爱尔兰医院接受结肠镜检查的患者的电子手术记录中提取匿名数据。评估结肠插管性能指标(PICI),一种反映镇静率和患者舒适度的新型复合评分,以及ibd特异性内镜域。结果:分析了2014-2020年261524例结肠镜检查的数据。与非IBD患者相比,CD患者实现PICI的OR显着降低(0.69,0-65-0.74 p 50mcg,而UC患者为34%,非IBD患者为30.3%)。结论:对大型国家内窥镜数据集的分析突出了IBD内窥镜质量指标的可变性,并强调需要像PICI这样的指标来更准确地捕捉和反映IBD患者的内窥镜体验。
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引用次数: 0
From resection to preservation: redefining the surgical paradigm in Crohn's disease. 从切除到保留:重新定义克罗恩病的手术模式。
IF 8.7 Pub Date : 2026-01-09 DOI: 10.1093/ecco-jcc/jjaf208
Giulia Migliorisi, Raphaëlle Delaplace, Sailish Honap, Adeline Germain, Thomas Mouillot, Laurent Peyrin-Biroulet, Paulo G Kotze

Surgery is a pivotal component of the management of Crohn's disease (CD), particularly in cases of disease-related complications or failure of medical therapy. However, the risk of short bowel syndrome following multiple large resections makes bowel preservation strategies a major therapeutic priority. This review gathers insights from a diverse group of inflammatory bowel disease specialists, exploring the full spectrum of bowel-preserving strategies, from conservative surgical techniques and peri-operative optimization to emerging innovations in robotic surgery. The therapeutic paradigm of treat-to-target and tight disease monitoring is shifting the focus from reactive interventions to proactive and personalized care. Looking ahead, the evolving implementation of multi-omics profiling and artificial intelligence holds promise to reshape the role of surgery in CD. Surgery should no longer be viewed solely as a response to complications, but rather as an individualized, biology-driven strategy that prioritizes bowel preservation. In this rapidly advancing field, innovation is measured not only by clinical outcomes but also by every centimeter of bowel preserved.

手术是克罗恩病(CD)治疗的关键组成部分,特别是在疾病相关并发症或药物治疗失败的情况下。然而,多次大切除后短肠综合征的风险使得肠保存策略成为主要的治疗重点。这篇综述收集了来自不同IBD专家的见解,探索了全方位的肠道保护策略,从保守的手术技术和围手术期优化,到机器人手术的新兴创新。从治疗到目标和严密疾病监测的治疗范式正在将重点从被动干预转移到主动和个性化护理。展望未来,多组学分析和人工智能的不断发展有望重塑手术在CD中的作用。手术不应再仅仅被视为对并发症的反应,而是作为一种个性化的、生物学驱动的策略,优先考虑肠道保护。在这个快速发展的领域,创新不仅是通过临床结果来衡量的,而且是通过保留的每一厘米肠道来衡量的。
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引用次数: 0
Identification of Crohn's disease subtypes in single-cell RNA sequencing signatures of treatment-naive samples across the pediatric gastrointestinal tract. 在整个儿科胃肠道治疗naïve样品的单细胞RNA测序特征中鉴定克罗恩病亚型。
IF 8.7 Pub Date : 2026-01-09 DOI: 10.1093/ecco-jcc/jjaf225
Savannah Washburn, Yeonjoo Hwang, Sushma Chowdary Maddipatla, Shanta Murthy, Tarun Koti, Vasantha L Kolachala, Greg Gibson, Subra Kugathasan, Peng Qiu

Background: Crohn's disease (CD) is characterized by chronic intestinal inflammation. Previous single-cell transcriptomic studies have mostly focused on established disease, leaving a knowledge gap in relation to treatment-naive profiles across multiple regions of the gut.

Methods: To study disease onset, a treatment-naive pediatric CD cohort was recruited, and single-cell transcriptomics was performed on ileum, colon, and rectum biopsies collected at initial endoscopy. A clustering stability assessment workflow was developed to ensure clustering and downstream results were robust.

Results: Inflammation did not strongly influence cellular proportion due to heterogeneity across donor and tissue. Tensor decomposition revealed distinct mesenchymal and myeloid cell-mediated sources of disease pathology, corresponding to previously identified fibrotic and pro-inflammatory disease progression. Integrating transcriptomics and genome-wide association summary statistics for CD suggested myeloid and T cells drive disease, highlighting potential cellular therapeutic targets.

Conclusion: Tensor decomposition stratified donors into clinically meaningful groups based on their transcriptomic profile, suggesting these signatures can be utilized for personalized medicine.

背景:克罗恩病(CD)以慢性肠道炎症为特征。以前的单细胞转录组学研究主要集中在已确定的疾病上,在肠道多个区域的治疗初始谱方面留下了知识空白。方法:为了研究疾病的发病,研究人员招募了一个治疗naïve儿童CD队列,并对初始内镜检查时收集的回肠、结肠和直肠活检进行了单细胞转录组学研究。开发了一个聚类稳定性评估工作流,以确保聚类和下游结果的鲁棒性。结果:由于供体和组织的异质性,炎症对细胞比例没有强烈影响。张量分解揭示了不同的间充质和髓细胞介导的疾病病理来源,与先前确定的纤维化和促炎疾病进展相对应。整合CD的转录组学和基因组全关联汇总统计表明,髓细胞和T细胞驱动疾病,突出潜在的细胞治疗靶点。结论:张量分解根据供体的转录组特征将其分层为具有临床意义的组,表明这些特征可用于个性化医疗。
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引用次数: 0
Modified-two-stage versus three-stage approach in ileoanal pouch surgery for ulcerative colitis. 改良的2期与3期入路在治疗溃疡性结肠炎的回肠袋手术中的应用。
IF 8.7 Pub Date : 2026-01-09 DOI: 10.1093/ecco-jcc/jjaf201
Tycho B Moojen, Malaika S Vlug, Eva Visser, Maud A Reijntjes, Johan F M Lange, Gabriele Bislenghi, Michele Carvello, Janindra Warusavitarne, Roel Hompes, Laurents P S Stassen, Omar D Faiz, Antonino Spinelli, André D'Hoore, Willem A Bemelman

Background and aims: The necessity of diverting loop-ileostomy after a staged ileoanal pouch for ulcerative colitis (UC) remains unclear. This study aimed to compare postoperative outcomes between modified-two-stage and three-stage ileoanal pouch procedures for UC.

Methods: This retrospective cohort study included patients ≥18 years with UC or unclassified inflammatory bowel disease who underwent modified-two-stage or three-stage ileoanal pouch surgery from 2016 to 2021 in six European centers, with a follow-up of more than 12 months. The primary outcome was stoma-free rate at the end of follow-up. Secondary outcomes included perioperative practise, length of hospital stay, anastomotic leakage rate, and timing of diagnosis and treatment.

Results: Overall, 370 patients were included, of whom 228 (61.6%) underwent a modified-two-stage approach and 142 (38.4%) a three-stage approach. The median length of follow-up was 3.6 years (range: 1.0-7.7). Stoma-free rate was 93.8% (213/227) in modified-two-stage patients and 91.5% (130/142) in three-stage patients (P = .404). Notably, 78.4% of modified-two-stage patients never required an ileostomy, while the remaining 21.6% did receive a secondary ileostomy. While the median length of hospital stay for pouch surgery was longer in the modified-two-stage group, total median length of hospital stay after 1 year was shorter (median 7.0 days [IQR 6.0-11.0] vs 9.0 days [IQR 7.0-12.5], P = .015). The Clavien-Dindo score was higher than II in 22.6% of modified-two-stage patients and in 8.7% of three-stage patients (P < .001). Anastomotic leakage rate was higher after the modified-two-stage procedure (18% vs 5%, P < .001), but diagnosis and treatment occurred earlier (86% within 21 days vs 43%, P = .009).

Conclusions: Both approaches have comparable high stoma-free rates at the end of follow-up. Modified-two-stage avoids a temporary stoma in more than 75% of patients, but has a significantly higher rate of anastomotic leakages. Active and early surveillance of the anastomosis after three-stage procedures could improve postoperative outcomes in this group.

背景与目的:溃疡性结肠炎分期回肠袋术后转回肠袢造口术的必要性尚不清楚。本研究旨在比较改良的2期和3期回肠袋手术治疗溃疡性结肠炎的术后结果。方法:这项回顾性队列研究纳入了2016-2021年6个欧洲中心接受改良2期或3期回肠袋手术的≥18岁溃疡性结肠炎或未分类炎症性肠病患者,随访时间超过12个月。主要结局为随访结束时无气孔率。次要结局包括围手术期、住院时间、吻合口漏率、诊断和治疗时机。结果:总共纳入370例患者,其中228例(61.6%)采用改良的2期入路,142例(38.4%)采用3期入路。中位随访时间为3.6年(范围:1.0-7.7年)。改良2期患者无造口率为93.8%(213/227),3期患者无造口率为91.5% (130/142)(p = 0.404)。值得注意的是,78.4%的改良2期患者从未需要回肠造口,而其余21.6%的患者接受了二次回肠造口。改良2期组中位住院时间较长,1年后总中位住院时间较短(中位7.0天(IQR 6.0-11.0) vs . 9.0天(IQR 7.0-12.5), p = 0.015)。22.6%改良2期患者Clavien-Dindo评分高于II, 8.7%改良3期患者Clavien-Dindo评分高于II (p < 0.001)。改良2期术后吻合口瘘发生率较高(18%比5%,p < 0.001),但诊断和治疗时间较早(86%比43%,p = 0.009)。结论:两种方法在随访结束时都有相当高的无气孔率。改良二期手术避免了超过75%的患者的临时造口,但其吻合口漏的发生率明显较高。在三期手术后积极和早期监测吻合可以改善该组的术后预后。
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引用次数: 0
Benefit-risk profile of upadacitinib: exploratory post hoc analysis of phase 2b/3 studies in patients with moderately to severely active ulcerative colitis or Crohn's disease. Upadacitinib的获益-风险概况:中度至重度活动性溃疡性结肠炎或克罗恩病患者2b/3期研究的探索性事后分析
IF 8.7 Pub Date : 2026-01-09 DOI: 10.1093/ecco-jcc/jjaf198
Severine Vermeire, Jean-Frederic Colombel, Silvio Danese, Remo Panaccione, Laurent Peyrin-Biroulet, Kendall Beck, María Chaparro, Javier P Gisbert, Elena Dubcenco, Justin Klaff, Grace Naling, Sharanya Ford, Valencia Remple, Namita Joshi, Smitha Suravaram, Benjamin Duncan, Yibo Wang, Bettina Wick-Urban, Edward V Loftus

Background and aims: Upadacitinib (UPA)-an oral, reversible selective Janus kinase inhibitor-has a favorable benefit-risk profile for patients with Crohn's disease (CD) and ulcerative colitis (UC). We evaluated the benefit-risk of UPA in select subgroups with CD or UC.

Methods: Patients were randomized to UPA 45 mg (UPA45) once daily (QD) or placebo (PBO) induction for 12 (CD: U-EXCEED, U-EXCEL) or 8 weeks (UC: U-ACHIEVE, U-ACCOMPLISH). Clinical responders were re-randomized to QD UPA 15 mg (UPA15), UPA 30 mg (UPA30), or PBO for 52-week maintenance (CD: U-ENDURE; UC: U-ACHIEVE). This exploratory post hoc analysis assessed efficacy and safety outcomes (adverse events of special interest [AESIs]: serious infections, major adverse cardiovascular [CV] events, malignancies, and venous thromboembolic events) by CV risk, prior treatment failure, and age.

Results: This analysis included 1021 patients with CD and 1097 with UC during induction, and 673 with CD and 746 with UC during maintenance. Improved efficacy outcomes comparable to the overall study populations were observed with UPA versus PBO across subgroups. Patients receiving UPA30 generally showed numerically higher rates of improvements versus UPA15. AESI rates were generally comparable between UPA and PBO across subgroups except for numerically higher rates of herpes zoster and serious infections in CD with UPA.

Conclusions: UPA resulted in consistent benefit versus placebo across CV risk, prior treatment failure, and age subgroups. No treatment differences were seen in AESIs across subgroups except herpes zoster and serious infections, reinforcing the favorable benefit-risk profile for UPA in CD and UC seen in the overall study populations.

Clinical trial numbers: NCT02819635, NCT03653026, NCT03345836, NCT03345849, NCT03345823.

背景和目的:Upadacitinib (UPA)是一种口服、可逆的选择性Janus激酶抑制剂,对克罗恩病(CD)和溃疡性结肠炎(UC)患者具有良好的获益-风险特征。我们在选择的CD或UC亚组中评估UPA的获益-风险。方法:患者随机接受每日一次(QD)的UPA45 mg (UPA45)或安慰剂(PBO)诱导,为期12周(CD: U-EXCEED, U-EXCEL)或8周(UC: U-ACHIEVE, U-ACCOMPLISH)。临床应答者被重新随机分配到QD UPA15 mg (UPA15)、UPA30 mg (UPA30)或PBO进行52周的维持(CD: U-ENDURE; UC: U-ACHIEVE)。这项探索性事后分析评估了疗效和安全性结果(特别关注的不良事件[AESIs]:严重感染、主要不良心血管事件、恶性肿瘤和静脉血栓栓塞事件),包括CV风险、先前治疗失败和年龄。结果:该分析包括1021例诱导期CD患者和1097例UC患者,以及673例CD患者和746例UC患者。在各个亚组中,UPA和PBO的疗效结果与总体研究人群相比有所改善。与UPA15相比,接受UPA30治疗的患者通常表现出更高的数值改善率。在UPA和PBO的亚组中,AESI的发生率除了在数值上较高的带状疱疹和UPA合并CD的严重感染发生率外,在其他亚组中大体相当。结论:在CV风险、既往治疗失败和年龄亚组中,UPA与安慰剂的获益一致。除带状疱疹和严重感染外,不同亚组间AESIs治疗没有差异,这加强了在整个研究人群中UPA治疗CD和UC的有利获益-风险特征。临床试验编号:NCT02819635、NCT03653026、NCT03345836、NCT03345849、NCT03345823。
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引用次数: 0
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Journal of Crohn's & colitis
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