通过随机对照试验的系统评价和荟萃分析,IL-23抑制的临床见解:risankizumab治疗克罗恩病

IF 3.9 3区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY
Therapeutic Advances in Gastroenterology Pub Date : 2025-05-19 eCollection Date: 2025-01-01 DOI:10.1177/17562848251338743
Po-Feng Huang, Tien-Yu Huang, Yi-Chiao Cheng, Peng-Jen Chen, Wei-Kuo Chang, Chao-Feng Chang
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引用次数: 0

摘要

背景和目的:克罗恩病是一种慢性炎症性疾病,全球患病率不断上升,以腹痛、腹泻和疲劳为特征。白细胞介素(IL)-23在克罗恩病的发病机制中起关键作用,使其成为治疗靶点。Risankizumab是一种靶向il - 23p19亚基的单克隆抗体,已在临床试验中显示出潜力。目的:本荟萃分析评估了Risankizumab在中重度克罗恩病患者实现临床缓解、临床反应和内镜缓解方面的有效性和安全性。设计:按照PRISMA 2020指南进行系统评价和荟萃分析。数据来源和方法:综合检索PubMed、Embase、Cochrane CENTRAL、Web of Science和ClinicalTrials.gov,以确定评估Risankizumab治疗克罗恩病的随机对照试验(rct)。主要结局是临床缓解、临床反应和内镜下缓解,次要结局是治疗相关的不良事件。随机效应模型以95%的置信区间估计优势比(or)。meta回归分析了剂量依赖性和持续时间依赖性效应。结果:涉及1774名受试者的4项随机对照试验显示,Risankizumab显著改善了临床缓解(OR = 2.223)、临床缓解(OR = 2.483)和内镜下缓解(OR = 4.112)。观察到剂量依赖性改善,治疗时间影响临床缓解(p = 0.0158),但不影响临床缓解或内镜缓解。利桑单抗组和安慰剂组的不良事件发生率相当(OR = 0.872, p = 0.592)。结论:Risankizumab在中度至重度克罗恩病的临床和内镜治疗中是有效的,显示出剂量依赖性的益处和良好的安全性,支持其作为治疗选择。然而,研究数量有限可能会影响这些发现的稳健性。需要进一步的大规模随机对照试验来验证其长期疗效、老年人群的安全性以及biologic-naïve患者的有效性。试验注册:本系统评价和荟萃分析已在INPLASY数据库注册,注册号为INPLASY202530014。完整的协议可在DOI: 10.37766/inplasy2025.3.0014访问。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Clinical insights into IL-23 inhibition: risankizumab for Crohn's disease through a systematic review and meta-analysis of randomized controlled trials.

Background and aims: Crohn's disease is a chronic inflammatory disorder with rising global prevalence, marked by abdominal pain, diarrhea, and fatigue. Interleukin (IL)-23 plays a pivotal role in Crohn's disease pathogenesis, making it a therapeutic target. Risankizumab, a monoclonal antibody targeting the IL-23 p19 subunit, has shown potential in clinical trials.

Objectives: This meta-analysis evaluates the efficacy and safety of Risankizumab in achieving clinical remission, clinical response, and endoscopic remission in patients with moderate-to-severe Crohn's disease.

Design: A systematic review and meta-analysis were conducted following PRISMA 2020 guidelines.

Data sources and methods: A comprehensive search of PubMed, Embase, Cochrane CENTRAL, Web of Science, and ClinicalTrials.gov was performed to identify randomized controlled trials (RCTs) assessing Risankizumab in Crohn's disease. Primary outcomes were clinical remission, clinical response, and endoscopic remission, with secondary outcomes focusing on treatment-related adverse events. A random-effects model estimated odds ratios (ORs) with 95% confidence intervals. Meta-regression analyzed dose- and duration-dependent effects.

Results: Four RCTs involving 1774 participants showed that Risankizumab significantly improved clinical remission (OR = 2.223), clinical response (OR = 2.483), and endoscopic remission (OR = 4.112). Dose-dependent improvements were observed, with treatment duration affecting clinical remission (p = 0.0158) but not clinical response or endoscopic remission. Adverse event rates were comparable between Risankizumab and placebo groups (OR = 0.872, p = 0.592).

Conclusion: Risankizumab is effective in achieving clinical and endoscopic outcomes in moderate-to-severe Crohn's disease, demonstrating dose-dependent benefits and a favorable safety profile, supporting its use as a therapeutic option. However, the limited number of studies may affect the robustness of these findings. Further large-scale RCTs are needed to validate its long-term efficacy, safety in elderly populations, and effectiveness in biologic-naïve patients.

Trial registration: This systematic review and meta-analysis were registered with the INPLASY database under registration number INPLASY202530014. The full protocol is accessible at DOI: 10.37766/inplasy2025.3.0014.

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来源期刊
Therapeutic Advances in Gastroenterology
Therapeutic Advances in Gastroenterology GASTROENTEROLOGY & HEPATOLOGY-
CiteScore
6.70
自引率
2.40%
发文量
103
审稿时长
15 weeks
期刊介绍: Therapeutic Advances in Gastroenterology is an open access journal which delivers the highest quality peer-reviewed original research articles, reviews, and scholarly comment on pioneering efforts and innovative studies in the medical treatment of gastrointestinal and hepatic disorders. The journal has a strong clinical and pharmacological focus and is aimed at an international audience of clinicians and researchers in gastroenterology and related disciplines, providing an online forum for rapid dissemination of recent research and perspectives in this area. The editors welcome original research articles across all areas of gastroenterology and hepatology. The journal publishes original research articles and review articles primarily. Original research manuscripts may include laboratory, animal or human/clinical studies – all phases. Letters to the Editor and Case Reports will also be considered.
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