An International Consensus on Appropriate Management of Corticosteroids in Clinical Trials in Inflammatory Bowel Disease

IF 25.7 1区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Gastroenterology Pub Date : 2025-05-28 DOI:10.1053/j.gastro.2025.05.015

Jurij Hanžel, Virginia Solitano, Sudheer Kumar Vuyyuru, Remo Panaccione, Bruce E. Sands, Laurent Peyrin-Biroulet, Silvio Danese, Geert R. D'Haens, Raja Atreya, Matthieu Allez, Charles N. Bernstein, Peter Bossuyt, Brian Bressler, Robert V. Bryant, Benjamin L. Cohen, Jean-Frederic Colombel, Ferdinando D’Amico, Axel Dignass, Marla Dubinsky, Phillip Fleshner, Christopher Ma

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引用次数: 0

Abstract

Background & Aims

Approval of new therapies for inflammatory bowel disease (IBD) requires rigorously designed and well-executed randomized controlled trials (RCTs). Corticosteroids remain a cornerstone of IBD induction therapy and many patients in trials are enrolled while taking corticosteroids. Despite this, approaches to corticosteroid management in RCTs have been highly heterogeneous, often differing from clinical practice. This negatively impacts patients’ willingness to participate due to prolonged corticosteroid exposure and may potentially bias outcomes in the clinical trial. Our aim is to provide comprehensive standardized recommendations on key aspects of corticosteroid use in IBD clinical trials through a multi-phase, international expert consensus, with a goal to help inform and standardize practice in future RCTs.

Methods

The consensus was informed by a systematic review of MEDLINE, EMBASE, and the Cochrane CENTRAL Register of Controlled Trials, which determined the corticosteroid management rules used in placebo-controlled trials of advanced therapies in IBD. International expert consensus recommendations for all aspects of corticosteroid management in RCTs were then developed using a modified Delphi process with two rounds of survey questions and a ratification meeting.

Results

These recommendations propose management of corticosteroids during screening, induction, and maintenance phases of pharmacologic trials in IBD, and define corticosteroid-related endpoints. We emphasize the need for minimizing corticosteroid exposure through expedited tapering and shorter fixed-dosing periods that more closely reflect clinical care, and provide recommendations for standardized definitions of corticosteroid-free remission.

Conclusions

These recommendations will serve to optimize trial design and facilitate appropriate, acceptable, and standardized RCT corticosteroid handling practices.

Abstract Image

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炎症性肠病临床试验中皮质类固醇适当管理的国际共识

背景,炎症性肠病（IBD）新疗法的批准需要严格设计和执行良好的随机对照试验（rct）。皮质类固醇仍然是IBD诱导治疗的基石，许多试验患者在服用皮质类固醇的同时入组。尽管如此，随机对照试验中皮质类固醇治疗的方法是高度异质性的，往往与临床实践不同。由于长期暴露于皮质类固醇，这对患者参与的意愿产生了负面影响，并可能使临床试验的结果产生偏倚。我们的目标是通过多阶段的国际专家共识，为IBD临床试验中皮质类固醇使用的关键方面提供全面的标准化建议，目标是帮助在未来的随机对照试验中提供信息和标准化的实践。方法通过对MEDLINE、EMBASE和Cochrane中央对照试验注册库的系统综述，确定了IBD高级治疗的安慰剂对照试验中使用的皮质类固醇管理规则，得出了这一共识。国际专家对随机对照试验中皮质类固醇管理各方面的共识建议，然后使用改进的德尔菲过程，包括两轮调查问题和一次批准会议。结果这些建议建议在IBD药物试验的筛选、诱导和维持阶段对皮质类固醇进行管理，并确定皮质类固醇相关终点。我们强调通过加速减量和缩短固定给药时间来减少皮质类固醇暴露的必要性，这更能反映临床护理，并为无皮质类固醇缓解的标准化定义提供建议。这些建议将有助于优化试验设计，促进适当、可接受和标准化的皮质类固醇处理方法。

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来源期刊

Gastroenterology 医学-胃肠肝病学

CiteScore

45.60

自引率

2.40%

发文量

4366

审稿时长

26 days

期刊介绍： Gastroenterology is the most prominent journal in the field of gastrointestinal disease. It is the flagship journal of the American Gastroenterological Association and delivers authoritative coverage of clinical, translational, and basic studies of all aspects of the digestive system, including the liver and pancreas, as well as nutrition. Some regular features of Gastroenterology include original research studies by leading authorities, comprehensive reviews and perspectives on important topics in adult and pediatric gastroenterology and hepatology. The journal also includes features such as editorials, correspondence, and commentaries, as well as special sections like "Mentoring, Education and Training Corner," "Diversity, Equity and Inclusion in GI," "Gastro Digest," "Gastro Curbside Consult," and "Gastro Grand Rounds." Gastroenterology also provides digital media materials such as videos and "GI Rapid Reel" animations. It is abstracted and indexed in various databases including Scopus, Biological Abstracts, Current Contents, Embase, Nutrition Abstracts, Chemical Abstracts, Current Awareness in Biological Sciences, PubMed/Medline, and the Science Citation Index.