Dai Youran, Yang Wenhui, Xu Li, Pan Pingting, Liu Shan, Sun Yingzhe, Hu Suying, Li Qiushuang, Hu Fang
The First Clinical College, Zhejiang Chinese Medical University, Hangzhou, Zhejiang, China.
Department of Anorectal Surgery, The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Traditional Chinese Medicine), Hangzhou, Zhejiang, China.
Pharmacol Res Perspect. 2025 Jun;13(3):e70108. doi: 10.1002/prp2.70108.
Ongoing evaluations of targeted therapies for moderate-to-severe ulcerative colitis (UC) continue to unfold, with the emergence of novel drugs. However, head-to-head trials comparing these therapies are still lacking. The aim of this study is to investigate the therapeutic effects of targeted therapies in moderate-to-severe UC. The Cochrane Library, Web of Science, PubMed, and Embase were searched from the inception to November 12, 2024. Statistical analyses included multivariate random effects models and Bayesian modeling. Stratified and sensitivity analyses were also performed. Publication bias was assessed using funnel plots. Outcomes such as clinical response/remission, endoscopic remission, mucosal healing, quality of life, adverse events (AEs), and serious adverse events (SAEs) were used to quantify the relative therapeutic effects. Thirty-three studies (33 reported on the induction phase; 13 reported on the maintenance phase) were identified. In the induction phase, Upadacitinib 45 mg demonstrated the highest efficacy in achieving clinical remission (OR 10.03; 95% CI, 4.83-20.80), clinical response (OR 7.96; 95% CI, 3.89-16.28), and mucosal healing rate (OR 8.91; 95% CI, 3.36-23.62). Cobitolimod 250 mg was the first-ranked treatment (SUCRA, 92.67%) in Endoscopic remission. Vedolizumab 108 mg was the best dosage in reducing Adverse Events (AEs). The optimal dosage for reducing Serious Adverse Events (SAEs) was found to be Tulisokibart 1000/500 mg. During the maintenance phase, Etrasimod 2 mg/kg ranked first in clinical remission (OR 9.58; 95% CI, 2.82-32.59), and Upadacitinib 45 mg was superior in endoscopic remission. Additionally, the most effective medication for raising quality of life was Guselkumab 200 mg (OR 3.04; 95% CI, 1.70-5.40). Consequently, there is a need for further high-quality research to conclusively determine the best therapeutic option.
随着新型药物的出现，针对中重度溃疡性结肠炎（UC）的靶向治疗的持续评估仍在不断展开。然而，比较这些疗法的头对头试验仍然缺乏。本研究的目的是调查靶向治疗在中重度UC中的治疗效果。检索了Cochrane图书馆、科学网、PubMed和Embase，检索时间从创刊至2024年11月12日。统计分析包括多变量随机效应模型和贝叶斯建模。还进行了分层分析和敏感性分析。使用漏斗图评估发表偏倚。使用临床反应/缓解、内镜缓解、黏膜愈合、生活质量、不良事件（AE）和严重不良事件（SAE）等结果来量化相对治疗效果。共纳入33项研究（33项报告了诱导期；13项报告了维持期）。在诱导期，乌帕替尼45mg在实现临床缓解（OR 10.03；95%CI，4.83 - 20.80）、临床反应（OR 7.96；95%CI，3.89 - 16.28）和黏膜愈合率（OR 8.91；95%CI，3.36 - 23.62）方面显示出最高疗效。可比特250mg在内镜缓解方面排名第一（累积排序曲线下面积，92.67%）。维多珠单抗108mg在减少不良事件（AE）方面是最佳剂量。发现减少严重不良事件（SAE）的最佳剂量是托法替布1000/500mg。在维持期，依曲莫德2mg/kg在临床缓解方面排名第一（OR 9.58；95%CI，2.82 - 32.59），乌帕替尼45mg在内镜缓解方面更具优势。此外，改善生活质量最有效的药物是古塞库单抗200mg（OR 3.04；95%CI，1.70 - 5.40）。因此，需要进一步开展高质量研究以最终确定最佳治疗方案。
