A Systematic Review on Long-Term Efficacy Outcome Measures in Crohn's Disease Patients.

IF 8.3 2区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Journal of Crohns & Colitis Pub Date : 2023-10-20 DOI:10.1093/ecco-jcc/jjad037
Laura M Janssen, Rob H Creemers, Adriaan A van Bodegraven, Marie J Pierik
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Abstract

Background: The traditional long-term treatment goal of Crohn's disease [CD] is maintenance of corticosteroid-free clinical remission. Additional treatment targets, such as biochemical, endoscopic and patient-reported remission, are advocated. The relapsing-remitting nature of CD provides a challenge to the timing of target assessment. Cross-sectional assessment at predetermined moments disregards the health state in between measurements. In this systematic review, we provide an overview of outcomes used to assess long-term efficacy in clinical trials in CD.

Methods: A systematic search of the PubMed and EMBASE databases was performed to identify clinical trials in luminal CD reporting on maintenance treatment [strategies] since 1995. Two independent reviewers selected eligible articles for full text retrieval, and assessed if long-term corticosteroid-free clinical, biochemical, endoscopic or patient-reported efficacy outcomes were used.

Results: The search resulted in 2452 hits and 82 articles were included. Clinical activity was used in 80 studies [98%] as the long-term efficacy outcome, and in 21 [26%] of these concomitant corticosteroid use was taken into account. C-reactive protein was used in 32 studies [41%], faecal calprotectin in 15 studies [18%], endoscopic activity in 34 studies [41%] and patient-reported outcome in 32 studies [39%]. In seven studies, clinical, biochemical, endoscopic activity and the patient's perspective were measured. In most studies cross-sectional measures or multiple measurements over time were used.

Conclusion: In none of the published clinical trials in CD was sustained remission on all treatment targets reported. Cross-sectional outcomes at predetermined times were widely applied, leading to lack of information regarding sustained corticosteroid-free remission for this relapsing-remitting chronic disease.

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克罗恩病患者长期疗效指标的系统评价。
背景:克罗恩病的传统长期治疗目标是维持无皮质类固醇的临床缓解。提倡其他治疗目标,如生化、内镜和患者报告的缓解。CD的复发-缓解性质对目标评估的时机提出了挑战。在预定时刻的横截面评估忽略了测量之间的健康状态。在这篇系统综述中,我们概述了用于评估CD临床试验长期疗效的结果。方法:对PubMed和EMBASE数据库进行系统搜索,以确定自1995年以来关于维持治疗[策略]的管腔CD临床试验报告。两名独立评审员选择符合条件的文章进行全文检索,并评估是否使用了长期无皮质类固醇的临床、生化、内镜或患者报告的疗效结果。结果:搜索结果为2452次点击,共收录82篇文章。临床活动在80项研究中被用作长期疗效结果[98%],在21项研究中[26%]考虑了皮质类固醇的伴随使用。32项研究使用C反应蛋白[41%],15项研究使用粪便钙卫蛋白[18%],34项研究使用内镜活动[41%]和32项研究中患者报告的结果[39%]。在七项研究中,测量了临床、生化、内镜活动和患者的视角。在大多数研究中,使用了横截面测量或随时间的多次测量。结论:在已发表的CD临床试验中,没有一项在所有治疗靶点上得到持续缓解。在预定时间的横断面结果被广泛应用,导致缺乏关于这种复发缓解型慢性病持续无皮质类固醇缓解的信息。
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来源期刊
Journal of Crohns & Colitis
Journal of Crohns & Colitis 医学-胃肠肝病学
CiteScore
15.50
自引率
7.50%
发文量
1048
审稿时长
1 months
期刊介绍: Journal of Crohns and Colitis is concerned with the dissemination of knowledge on clinical, basic science and innovative methods related to inflammatory bowel diseases. The journal publishes original articles, review papers, editorials, leading articles, viewpoints, case reports, innovative methods and letters to the editor.
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