Elainein Mohamed A Abu, ElSherefy Sama S, Yousef Norhan M, ElKady Sama M, Hamam Nada G, Elgarawany Abdullrahman, Aswa Darin W, Hassan Ahmed Nour Eldin, Allam Salma
Faculty of Medicine, Ain Shams University, Cairo, Egypt.
Faculty of Medicine, Cairo University, Cairo, Egypt.
BMC Gastroenterol. 2025 Apr 29;25(1):307. doi: 10.1186/s12876-025-03627-2.
Ulcerative colitis (UC) is a widespread incurable chronic inflammation of the colon mucosa. Currently, oral small-molecule medications targeting Janus kinase or sphingosine-1-phosphate and monoclonal antibodies to TNF-α,α4β7 integrins and Ustekinumab are the lines of treatment for UC. Up to 50% of patients either do not react to initial treatment or lose response over time, emphasizing the need for innovative treatment. Mirikizumab, a humanized IgG4-variant monoclonal antibody, binds to subunit p19 of interleukin-23. This systematic review aims to evaluate Mirikizumab compared to placebo in treating moderate-to-severe active UC. Following the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines and using the Population, Intervention, Comparison, Outcome, Study design (PICOS) model for inclusion and exclusion criteria, we systematically reviewed the literature. Our inclusion criteria encompassed randomized controlled trials assessing Mirikizumab efficacy in treating UC across demographics. We employed the Cochrane Risk of Bias tool (RoB1) to investigate bias within included studies across its seven domains. The statistical analysis was conducted using Review Manager Version 5 software. Four studies were included, comparing patients treated with mirikizumab to placebo groups. All doses of mirikizumab administered intravenously demonstrated clinical remission, specifically, the 200 mg and 300 mg doses showed significant efficacy, with risk ratios of 4.74 (95% CI [1.43, 15.69]) and 1.82 (95% CI [1.33, 2.50]), respectively. During the maintenance phase of extension trials, symptoms subsided with a subcutaneous 200 mg dose (RR = 1.46, 95% CI [0.47, 4.51], P = 0.51). To conclude, mirikizumab demonstrates significant efficacy in treating UC, substaintially improving clinical, endoscopic, and histological outcomes.
溃疡性结肠炎（UC）是一种广泛存在的、无法治愈的结肠黏膜慢性炎症。目前，针对 Janus 激酶或 1-磷酸鞘氨醇的口服小分子药物以及抗 TNF-α、α4β7 整合素的单克隆抗体和优特克单抗是 UC 的治疗药物。高达 50%的患者对初始治疗无反应或随时间推移失去反应，这凸显了创新治疗的必要性。Mirikizumab 是一种人源化 IgG4 变体单克隆抗体，可与白细胞介素-23 的 p19 亚基结合。本系统评价旨在评估 Mirikizumab 与安慰剂相比治疗中度至重度活动性 UC 的效果。按照系统评价和 Meta 分析的首选报告项目（PRISMA）指南，并使用人群、干预措施、对照、结局、研究设计（PICOS）模型制定纳入和排除标准，我们对文献进行了系统评价。我们的纳入标准包括评估 Mirikizumab 在不同人群中治疗 UC 疗效的随机对照试验。我们使用 Cochrane 偏倚风险工具（RoB1）在纳入研究的七个领域内调查偏倚。使用 Review Manager 5 版软件进行统计分析。共纳入四项研究，将接受 Mirikizumab 治疗的患者与安慰剂组进行比较。所有静脉注射剂量的 Mirikizumab 均显示出临床缓解，具体而言，200 mg 和 300 mg 剂量显示出显著疗效，风险比分别为 4.74（95%CI [1.43, 15.69]）和 1.82（95%CI [1.33, 2.50]）。在扩展试验的维持阶段，皮下注射 200 mg 剂量症状缓解（RR = 1.46，95%CI [0.47, 4.51]，P = 0.51）。总之，Mirikizumab 在治疗 UC 方面显示出显著疗效，可显著改善临床、内镜和组织学结局。
