Assessment and reporting of extraintestinal manifestations and fatigue in phase 3 inflammatory bowel disease clinical trials.

Journal of Crohn's & colitis Pub Date : 2025-01-11 DOI:10.1093/ecco-jcc/jjaf009

Tarun Chhibba, Karan Sachdeva, Ashwin N Ananthakrishnan

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Abstract

Background: Extraintestinal manifestations (EIMs) of inflammatory bowel disease (IBD) are frequently experienced by patients and may lead to severe symptoms and fatigue. However, the reporting patterns of these outcomes in IBD randomized controlled trials (RCTs) are not clear.

Methods: We searched placebo-controlled phase 3 RCTs of advanced therapies in IBD and assessed the frequency and means of reporting EIM and fatigue data in these studies.

Results: Thirty-three phase 3 RCTs for Crohn's disease (CD) (n = 16) or ulcerative colitis (UC) (n = 16) were identified between 2002 and 2023. While all trials (16/16) in CD collected some EIM data, we could only ascertain 6/16 (38%) collected EIM data in UC trials. Fewer than one-third (9/32, 28%) reported EIM prevalence at baseline; fewer reported the improvement with active treatment (9%). Fatigue was measured in 20/32 trials (63%).

Conclusions: EIM and fatigue data are inconsistently collected in RCTs of IBD. Standardizing collection methods across RCTs would provide greater insight on these agents and their efficacy in treating these manifestations of disease.

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炎症性肠病3期临床试验中肠外表现和疲劳的评估和报告。

背景：炎症性肠病（IBD）的肠外表现（EIMs）是患者经常经历的，可能导致严重的症状和疲劳。然而，这些结果在IBD随机对照试验（rct）中的报告模式尚不清楚。方法：我们检索了IBD先进疗法的安慰剂对照3期随机对照试验，并评估了这些研究中报告EIM和疲劳数据的频率和方法。结果：在2002-2023年间，共发现33例针对克罗恩病（CD）（n=16）或溃疡性结肠炎（UC）（n=16）的3期随机对照试验。虽然所有CD试验（16/16）都收集了一些EIM数据，但我们只能确定6/16（38%）的UC试验收集了EIM数据。不到三分之一（9/32,28%）报告了基线时的EIM患病率；较少报告积极治疗后的改善（9%）。32个试验中有20个（63%）测量了疲劳。结论：在IBD的随机对照试验中，EIM和疲劳数据收集不一致。标准化随机对照试验的收集方法将使人们更深入地了解这些药物及其在治疗这些疾病表现方面的功效。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Journal of Crohn's & colitis

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