Short term effectiveness of ustekinumab versus vedolizumab in Crohn's disease after failure of anti-TNF agents: An observational comparative study design with a Bayesian analysis.

IF 16.4 1区化学 Q1 CHEMISTRY, MULTIDISCIPLINARY

Accounts of Chemical Research Pub Date : 2024-09-01 Epub Date: 2024-08-19 DOI:10.4103/sjg.sjg_101_24

Ahmad Alamer, Lina H Al Lehaibi, Mukhtar Alomar, Fahad Aldhuwayan, Saleh Alshouish, Anfal Y Al-Ali, Zakia Almudhry, Abdulaziz Almulhim, Abdulhamid Althagafi, Saad Aldosari, Turki AlAmeel

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引用次数: 0

Abstract

Background: Crohn's disease (CD) is a debilitating gastrointestinal disease with complex etiology. Although effective, recipients of anti-tumor necrosis factor (TNF) agents may experience primary or secondary nonresponse, necessitating alternative treatments. This study is intended to compare the short-term effectiveness of ustekinumab and vedolizumab in treating CD after failure of multiple lines of anti-TNF therapy using real-world data.

Methods: A retrospective study was conducted at a tertiary hospital in Dammam, Saudi Arabia, including adults (≥18 years old) with CD who did not respond to anti-TNF therapy. Primary endpoints were clinical improvement per the Harvey-Bradshaw Index (HBI) scores and remission at 12 weeks on an ordinal outcome scale. Secondary endpoints included clinical, biochemical, and endoscopic remission; clinical response; corticosteroid-free days; and cumulative steroid dose. Proportional odds and logistic regression Bayesian models were used to analyze outcomes, and the probability of treatment effectiveness was calculated from the posterior distribution.

Results: The study included 101 patients (ustekinumab, n = 71 and vedolizumab, n = 30) with a median age of 32 years (IQR: 26.0-38.0); 54.4% were male. At 12 weeks, the HBI endpoint showed an adjusted odds ratio (aOR) = 0.60 (95% confidence interval [CI]: 0.25-1.31), favoring ustekinumab, with a 75% probability of treatment effectiveness over vedolizumab. The clinical ordinal scale had an aOR = 0.61 (95% CI: 0.26-1.35) with a 73% probability of effectiveness for ustekinumab. Ustekinumab was also associated with favorable outcomes in secondary endpoints, reaching up to a 90% probability of effectiveness.

Conclusion: In CD patients with anti-TNF failure, ustekinumab was more effective than vedolizumab in the short term. These real-world insights contribute to understanding CD management but require validation in larger prospective studies and randomized controlled trials.

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抗肿瘤坏死因子药物治疗失败后，乌司替尼与维多珠单抗对克罗恩病的短期疗效：贝叶斯分析法的观察比较研究设计。

背景：克罗恩病（CD）是一种令人衰弱的胃肠道疾病，病因复杂。抗肿瘤坏死因子（TNF）药物虽然有效，但接受者可能会出现原发性或继发性无应答，因此需要替代治疗。本研究旨在利用真实世界的数据，比较乌司替尼和维度珠单抗在多线抗肿瘤坏死因子治疗失败后治疗 CD 的短期疗效：在沙特阿拉伯达曼的一家三甲医院开展了一项回顾性研究，研究对象包括抗肿瘤坏死因子治疗无效的成人（≥18岁）CD患者。主要研究终点是根据哈维-布拉德肖指数（HBI）评分得出的临床改善情况，以及12周后根据序数结果量表得出的缓解情况。次要终点包括临床、生化和内镜缓解；临床反应；无皮质类固醇天数；累计类固醇剂量。采用比例几率和逻辑回归贝叶斯模型分析结果，并根据后验分布计算治疗效果的概率：该研究共纳入101名患者（乌斯特库单抗，n = 71；维妥珠单抗，n = 30），中位年龄为32岁（IQR：26.0-38.0）；54.4%为男性。12周时，HBI终点显示调整后的几率比（aOR）=0.60（95%置信区间[CI]：0.25-1.31），乌司替尼优于维多珠单抗，治疗有效的概率为75%。临床顺序量表的 aOR = 0.61（95% 置信区间 [CI]：0.26-1.35），乌司替库单抗有效的概率为 73%。乌司替库单抗还与次要终点的有利结果相关，有效概率高达90%：结论：在抗肿瘤坏死因子治疗失败的CD患者中，乌司替库单抗在短期内比维多珠单抗更有效。这些真实世界的见解有助于了解 CD 的治疗，但需要在更大规模的前瞻性研究和随机对照试验中进行验证。

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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来源期刊

Accounts of Chemical Research 化学-化学综合

CiteScore

31.40

自引率

1.10%

发文量

312

审稿时长

2 months

期刊介绍： Accounts of Chemical Research presents short, concise and critical articles offering easy-to-read overviews of basic research and applications in all areas of chemistry and biochemistry. These short reviews focus on research from the author’s own laboratory and are designed to teach the reader about a research project. In addition, Accounts of Chemical Research publishes commentaries that give an informed opinion on a current research problem. Special Issues online are devoted to a single topic of unusual activity and significance. Accounts of Chemical Research replaces the traditional article abstract with an article "Conspectus." These entries synopsize the research affording the reader a closer look at the content and significance of an article. Through this provision of a more detailed description of the article contents, the Conspectus enhances the article's discoverability by search engines and the exposure for the research.