Wang Shuhan, Sun Hui, Wang Qian, Xiao Han
Lanzhou University Second Hospital, Lanzhou University, Lanzhou, China.
Front Pharmacol. 2025 Apr 28;16:1490667. doi: 10.3389/fphar.2025.1490667. eCollection 2025.
The treatment outcomes of inflammatory bowel disease (IBD) have been significantly improved by the advent of new biologics, including ulcerative colitis (UC) and Crohn's disease (CD), particularly for refractory cases. However, the growing number of therapeutic options has also complicated clinical decision-making regarding drug selection and switching. The overall performance of IL-23 p19 inhibitors for the treatment of IBD was evaluated by the systematic review and meta-analysis in this study.
The objective of this study was to combine the multiple indicators to accurately evaluate the efficacy and safety of IL-23 p19 inhibitors, aimed to offer an insight into the development of clinical physicians' medication.
A comprehensive literature review on PubMed, Embase, Web of Science, and Cochrane Library until June 2024 was conducted in this study, which mainly focused on the randomized controlled trials (RCTs) to evaluate the IL-23 p19 inhibitors within adult patients with UC or CD. Additionally, the clinical outcomes, endoscopic findings, histological assessments, and safety profiles were aggregated and subjected to analysis by a random-effects model.
Twenty-five RCTs [15 CD, 10 UC] were involved in this study, and it was revealed that IL-23 p19 inhibitors showed significant effects on clinical remission (CR) in IBD, regardless of induction or maintenance treatment (CD, induction: risk ratio [RR] 1.95, 95% confidence interval [CI] 1.71-2.23; I = 0%, p = 0.68; UC, induction: RR 2.69, 95% CI 1.80-4.03; I = 50%, p = 0.09; CD, maintenance: RR 1.24, 95% CI 1.04-1.48; I = 0%, p = 0.57; UC, maintenance: RR 2.62, 95% CI 0.92-7.49; I = 42%, p = 0.19), and the risk of adverse events (AEs) was similar to that of placebo (CD, induction: RR 0.88, 95% CI 0.82-0.94; I = 2%, p = 0.41; UC, induction: RR 0.92, 95% CI 0.82-1.03; I = 0%, p = 0.54; CD, maintenance: RR 1.00, 95% CI 0.89-1.13; I = 29%, p = 0.25; UC, maintenance: RR 0.96, 95% CI 0.87-1.06; I = 0%, p = 0.44).
In IBD treatment, IL-23 p19 inhibitor therapy exhibited effective functions in the inducement and maintenance of clinical and endoscopic remissions, as well as in some histological cases.
https://www.crd.york.ac.uk/PROSPERO/view/CRD42024569807, identifier CRD42024569807.
包括溃疡性结肠炎（UC）和克罗恩病（CD）在内的炎症性肠病（IBD）的治疗结果因新型生物制剂的出现而得到显著改善，尤其是对于难治性病例。然而，治疗选择的增加也使药物选择和换药方面的临床决策变得复杂。本研究通过系统评价和荟萃分析评估了IL-23 p19抑制剂治疗IBD的总体疗效。
本研究的目的是综合多个指标准确评估IL-23 p19抑制剂的疗效和安全性，旨在为临床医生用药提供参考。
本研究对截至2024年6月的PubMed、Embase、Web of Science和Cochrane图书馆进行了全面的文献检索，主要关注评估成年UC或CD患者中IL-23 p19抑制剂的随机对照试验（RCT）。此外，汇总临床结局、内镜检查结果、组织学评估和安全性概况，并采用随机效应模型进行分析。
本研究纳入了25项RCT[15项CD，10项UC]，结果显示IL-23 p19抑制剂对IBD的临床缓解（CR）有显著效果，无论诱导治疗还是维持治疗（CD，诱导：风险比[RR]1.95，95%置信区间[CI]1.71-2.23；I=0%，p=0.68；UC，诱导：RR 2.69，95%CI 1.80-4.03；I=50%，p=0.09；CD，维持：RR 1.24，95%CI 1.04-1.48；I=0%，p=0.57；UC，维持：RR 2.62，95%CI 0.92-7.49；I=42%，p=0.19），且不良事件（AE）风险与安慰剂相似（CD，诱导：RR 0.88，95%CI 0.82-0.94；I=2%，p=0.41；UC，诱导：RR 0.92，95%CI 0.82-1.03；I=0%，p=0.54；CD，维持：RR 1.00，95%CI 0.89-1.13；I=29%，p=0.25；UC，维持：RR 0.96，95%CI 0.87-1.06；I=0%，p=0.44）。
在IBD治疗中，IL-23 p19抑制剂治疗在诱导和维持临床及内镜缓解以及部分组织学病例中显示出有效作用。
https://www.crd.york.ac.uk/PROSPERO/view/CRD42024569807，标识符CRD42024569807。
