Clinical use of biologics for Crohn's disease in adults: lessons learned from real-world studies.

IF 3.6 3区 医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY
Expert Opinion on Biological Therapy Pub Date : 2024-03-01 Epub Date: 2024-02-23 DOI:10.1080/14712598.2024.2316180
Antonio Tursi, Giammarco Mocci, Angelo Del Gaudio, Alfredo Papa
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引用次数: 0

Abstract

Introduction: The therapeutic armamentarium for managing Crohn's disease (CD) has expanded significantly in recent decades. Several biologics with three different mechanisms of action [anti-tumor necrosis factor (TNF)-α, anti-integrin α4β7, and anti-IL 12/23] are currently available to manage CD.

Area covered: This narrative review aims to summarize the most significant efficacy and safety data on the use of infliximab (IFX), adalimumab (ADA), vedolizumab (VDZ) and ustekinumab (UST) for the treatment of CD obtained from studies conducted in the real world (RW), compared to the results of randomized clinical trials (RCTs).

Expert opinion: RW studies reported that biologic agents included in this analysis have higher remission rates and lower adverse event rates than findings from RCTs for treating patients with CD. All biological agents have proven effective and safe in RW studies, even when using biosimilars or switching to subcutaneous administration of the molecules for which they are available. Finally, anti-TNF-α agents, particularly IFX, have a higher rate of adverse events (AEs) than VDZ and UST. Therefore, patients at higher risk of AEs may benefit from other biologics than anti-TNF-α. However, further long-term RW studies are needed to confirm these findings.

成人克罗恩病生物制剂的临床应用:从真实世界研究中汲取的经验教训。
导言:近几十年来,治疗克罗恩病(CD)的药物种类大幅增加。目前有多种具有三种不同作用机制的生物制剂[抗肿瘤坏死因子(TNF)-α、抗整合素α4β7和抗IL 12/23]可用于治疗克罗恩病:本综述旨在总结英夫利昔单抗(IFX)、阿达木单抗(ADA)、维妥珠单抗(VDZ)和乌斯替库单抗(UST)治疗CD的最重要疗效和安全性数据,这些数据来自真实世界(RW)的研究,并与随机临床试验(RCT)的结果进行了比较:RW研究报告显示,与治疗CD患者的RCT研究结果相比,本分析中的生物制剂具有更高的缓解率和更低的不良事件发生率。所有生物制剂在RW研究中都被证明是有效和安全的,即使使用生物仿制药或改用皮下给药的分子也是如此。最后,与 VDZ 和 UST 相比,抗肿瘤坏死因子-α 药物(尤其是 IFX)的不良事件(AEs)发生率更高。因此,AEs风险较高的患者可能会从抗肿瘤坏死因子-α以外的其他生物制剂中获益。不过,还需要进一步的长期 RW 研究来证实这些发现。
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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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