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克罗恩病临床试验中可通过和不可通过狭窄的结局:一项事后分析。

Outcomes of Passable and Non-passable Strictures in Clinical Trials of Crohn's Disease: A Post-hoc Analysis.

机构信息

Department of Medicine [Division of Gastroenterology] and Farncombe Family Digestive Health Research Institute, M cmaster University, Hamilton, ON, Canada.

Division of Gastroenterology, University of California San Diego, La Jolla, CA, USA.

出版信息

J Crohns Colitis. 2021 Oct 7;15(10):1649-1657. doi: 10.1093/ecco-jcc/jjab045.

DOI:10.1093/ecco-jcc/jjab045
PMID:33693522
Abstract

BACKGROUND AND AIMS

There is paucity of evidence on the reversibility of Crohn's disease [CD]-related strictures treated with therapies. We aimed to describe the clinical and endoscopic outcomes of CD patients with non-passable strictures.

METHODS

This was a post-hoc analysis of three large CD clinical trial programmes examining outcomes with infliximab, ustekinumab, and azathioprine, which included data on 576 patients including 105 with non-passable strictures and 45 with passable strictures, as measured using the Simple Endoscopic Score for Crohn's Disease [SES-CD]. The impact of non-passable strictures on achieving clinical remission [CR] and endoscopic remission [ER] was assessed using multivariate logistic regression models. CR was defined as a Crohn's Disease Activity Index [CDAI] <150, clinical response as a CDAI reduction of ≥100 points, and ER as SES-CD score <3.

RESULTS

After 1 year of treatment, patients with non-passable strictures demonstrated the ability to achieve passable or no strictures in 62.5% of cases, with 52.4% and 37.5% attaining CR and ER, respectively. However, patients with non-passable strictures at baseline were less likely to demonstrate symptom improvement compared with those with passable or no strictures, with reduced odds of 1-year CR (adjusted odds ratio [aOR] 0.17, 95% CI 0.03-0.99, p = 0.048). No significant differences were observed between patients with non-passable strictures at baseline and those with passable or no strictures in rates of ER [aOR 0.82, 95% CI 0.23-2.85, p = 0.751] at 1 year.

CONCLUSIONS

Patients with non-passable strictures can achieve symptomatic and endoscopic remission when receiving therapies used to treat CD, although they are less likely to obtain CR compared with patients without non-passable strictures. These findings support the importance of balancing the presence of non-passable strictures in trial arms.

摘要

背景与目的

关于接受治疗的克罗恩病(CD)相关狭窄的可逆转性,目前相关证据较少。本研究旨在描述不可通过狭窄的 CD 患者的临床和内镜结局。

方法

这是对三项大型 CD 临床试验计划的事后分析,这些试验计划检查了英夫利昔单抗、乌司奴单抗和硫唑嘌呤的治疗结果,其中包括 576 名患者的数据,包括 105 名不可通过狭窄的患者和 45 名可通过狭窄的患者,使用克罗恩病简单内镜评分(SES-CD)进行测量。使用多变量逻辑回归模型评估不可通过狭窄对实现临床缓解(CR)和内镜缓解(ER)的影响。CR 定义为克罗恩病活动指数(CDAI)<150,临床反应定义为 CDAI 降低≥100 分,ER 定义为 SES-CD 评分<3。

结果

在 1 年的治疗后,不可通过狭窄的患者中有 62.5%的患者能够达到可通过或无狭窄,其中 52.4%和 37.5%分别达到 CR 和 ER。然而,与可通过或无狭窄的患者相比,基线时存在不可通过狭窄的患者症状改善的可能性较低,1 年 CR 的可能性降低(调整优势比 [aOR] 0.17,95%CI 0.03-0.99,p = 0.048)。基线时存在不可通过狭窄的患者与可通过或无狭窄的患者在 1 年时 ER 发生率(aOR 0.82,95%CI 0.23-2.85,p = 0.751)方面无显著差异。

结论

接受用于治疗 CD 的治疗的不可通过狭窄的患者可以实现症状和内镜缓解,但与没有不可通过狭窄的患者相比,他们获得 CR 的可能性较低。这些发现支持在试验臂中平衡不可通过狭窄的存在的重要性。

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