How comparative studies can inform treatment decisions for Crohn's disease.

IF 3.6 3区 医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Expert Opinion on Biological Therapy Pub Date : 2024-09-01 Epub Date: 2024-08-12 DOI:10.1080/14712598.2024.2389985
Giuseppe Privitera, Cristina Bezzio, Arianna Dal Buono, Roberto Gabbiadini, Laura Loy, Luca Brandaleone, Giacomo Marcozzi, Giulia Migliorisi, Alessandro Armuzzi
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Abstract

Introduction: As new therapies for the treatment of Crohn's disease (CD) are approved, there is an increasing need for evidence that clarifies their positioning and sequencing.

Areas covered: Comparative effectiveness research (CER) aims to inform physicians' decisions when they choose which intervention (drug or treatment strategy) to administer to their patients. Pragmatic head-to-head trials represent the best tools for CER, but only a few have been published in the IBD field. Network meta-analyses can point toward the superiority of one drug over another, but they do not reflect everyday clinical practice. Finally, real-world evidence complements that coming from head-to-head trials and network meta-analyses, assessing the real-life effectiveness of therapeutic interventions.

Expert opinion: There is insufficient evidence to create a definitive therapeutic algorithm for CD, but some general considerations can be made. Anti-TNF-α agents seemingly represent the most 'sustainable' first-line choice, considering benefit-harm ratio and costs; vedolizumab, ustekinumab, and risankizumab may be considered as first-line choice when safety issues become prominent. In the event of pharmacodynamic failure, out-of-class swap is to be preferred - possibly with anti-IL23p19 as the best option, with unclear data regarding upadacitinib positioning; a second anti-TNF-α could be considered, as a second choice, after pharmacokinetic failure.

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比较研究如何为克罗恩病的治疗决策提供依据。
简介:随着治疗克罗恩病(Crohn's disease,CD)的新疗法获得批准,人们越来越需要证据来明确这些疗法的定位和排序:比较有效性研究(CER)旨在为医生选择对患者采取何种干预措施(药物或治疗策略)提供依据。务实的头对头试验是 CER 的最佳工具,但在 IBD 领域发表的试验却寥寥无几。网络荟萃分析可以指出一种药物优于另一种药物,但它们并不能反映日常临床实践。最后,真实世界的证据是对正面试验和网络荟萃分析证据的补充,可评估治疗干预措施的真实有效性:专家意见:目前还没有足够的证据为 CD 制定明确的治疗算法,但可以做出一些一般性的考虑。考虑到效益-危害比和成本,抗肿瘤坏死因子-α药物似乎是最 "可持续 "的一线选择;当安全性问题变得突出时,可考虑将韦多珠单抗、乌斯特库单抗和利桑珠单抗作为一线选择。在药效学失效的情况下,应优先考虑类外换药--可能以抗IL23p19为最佳选择,但有关乌达替尼定位的数据尚不明确;在药效学失效后,可考虑将第二种抗肿瘤坏死因子-α作为第二选择。
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来源期刊
Expert Opinion on Biological Therapy
Expert Opinion on Biological Therapy 医学-生物工程与应用微生物
CiteScore
8.60
自引率
0.00%
发文量
96
审稿时长
3-8 weeks
期刊介绍: Expert Opinion on Biological Therapy (1471-2598; 1744-7682) is a MEDLINE-indexed, international journal publishing peer-reviewed research across all aspects of biological therapy. Each article is structured to incorporate the author’s own expert opinion on the impact of the topic on research and clinical practice and the scope for future development. The audience consists of scientists and managers in the healthcare and biopharmaceutical industries and others closely involved in the development and application of biological therapies for the treatment of human disease. The journal welcomes: Reviews covering therapeutic antibodies and vaccines, peptides and proteins, gene therapies and gene transfer technologies, cell-based therapies and regenerative medicine Drug evaluations reviewing the clinical data on a particular biological agent Original research papers reporting the results of clinical investigations on biological agents and biotherapeutic-based studies with a strong link to clinical practice Comprehensive coverage in each review is complemented by the unique Expert Collection format and includes the following sections: Expert Opinion – a personal view of the data presented in the article, a discussion on the developments that are likely to be important in the future, and the avenues of research likely to become exciting as further studies yield more detailed results; Article Highlights – an executive summary of the author’s most critical points.
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