Guang'anmen Hospital, China Academy of Chinese Medical Sciences - No.5, Beixian Pavilion, Xicheng District, Beijing, 100053, China.
School of Pharmacy, Hebei University of Chinese Medicine, 326 New Shinan Road, Qiaoxi District, Shijiazhuang, Hebei, 050091, China.
BMC Gastroenterol. 2023 Oct 6;23(1):346. doi: 10.1186/s12876-023-02938-6.
Therapeutic options for ulcerative colitis (UC) have increased since the introduction of biologics a few decades ago. Due to the wide range of biologics available, physicians have difficulty in selecting biologics and do not know how to balance the best drug between clinical efficacy and safety. This study aimed to compare the efficacy and safety of biologics in treating ulcerative colitis.
In this study, eight electronic databases (PubMed, Web of Science, Cochrane, Embase, Sinomed, China National Knowledge Infrastructure, Chongqing VIP Information, and WanFang Data) were searched to collect eligible studies without language restrictions. Retrieved 1 June 2023, from inception. All articles included in the mesh analysis are randomised controlled trials (RCTs). The inclusion of drugs for each outcome was ranked using a curved surface under cumulative ranking (SUCRA). Higher SUCRA scores were associated with better outcomes, whereas lower SUCRA scores were associated with better safety. This study has registered with PROSPERO, CRD42023389483.
Induction Therapy: Among the biologic therapies evaluated for induction therapy, vedolizumab demonstrated the highest efficacy in achieving clinical remission (OR vs daclizumab, 9.09; 95% CI, 1.01-81.61; SUCRA 94.1) and clinical response. Guselkumab showed the lowest risk of recurrence of UC (SUCRA 94.9%), adverse events resulting in treatment discontinuation (SUCRA 94.8%), and serious infections (SUCRA 78.0%). Maintenance Therapy: For maintenance therapy, vedolizumab ranked highest in maintaining clinical remission (OR vs mesalazine 4.36; 95% CI, 1.65-11.49; SUCRA 89.7) and endoscopic improvement (SUCRA 92.6). Infliximab demonstrated the highest efficacy in endoscopic improvement (SUCRA 92.6%). Ustekinumab had the lowest risk of infections (SUCRA 92.9%), serious adverse events (SUCRA 91.3%), and serious infections (SUCRA 67.6%).
Our network meta-analysis suggests that vedolizumab is the most effective biologic therapy for inducing and maintaining clinical remission in UC patients. Guselkumab shows promise in reducing the risk of recurrence and adverse events during induction therapy. Infliximab is effective in improving endoscopic outcomes during maintenance therapy. Ustekinumab appears to have a favorable safety profile. These findings provide valuable insights for clinicians in selecting the most appropriate biologic therapy for UC patients.
自几十年前生物制剂问世以来，溃疡性结肠炎（UC）的治疗选择有所增加。由于可用的生物制剂种类繁多，医生在选择生物制剂时存在困难，并且不知道如何在临床疗效和安全性之间平衡最佳药物。本研究旨在比较生物制剂治疗溃疡性结肠炎的疗效和安全性。
本研究在没有语言限制的情况下，检索了 8 个电子数据库（PubMed、Web of Science、Cochrane、Embase、Sinomed、中国国家知识基础设施、重庆 VIP 信息和万方数据），以收集符合条件的研究。检索日期为 2023 年 6 月 1 日，从成立开始。纳入的所有文章均为随机对照试验（RCT）。使用累积排序曲面下面积（SUCRA）对每种结局的药物纳入进行排名。较高的 SUCRA 评分与更好的结局相关，而较低的 SUCRA 评分与更好的安全性相关。本研究已在 PROSPERO 上注册，CRD42023389483。
诱导治疗：在评估诱导治疗的生物疗法中，vedolizumab 在达到临床缓解（OR 与 daclizumab，9.09；95%CI，1.01-81.61；SUCRA 94.1）和临床反应方面显示出最高的疗效。 Guselkumab 显示出最低的 UC 复发风险（SUCRA 94.9%）、导致治疗中断的不良事件（SUCRA 94.8%）和严重感染（SUCRA 78.0%）。维持治疗：对于维持治疗，vedolizumab 在维持临床缓解（OR 与 mesalazine，4.36；95%CI，1.65-11.49；SUCRA 89.7）和内镜改善（SUCRA 92.6）方面排名最高。英夫利昔单抗在内镜改善方面显示出最高的疗效（SUCRA 92.6%）。乌司奴单抗的感染风险（SUCRA 92.9%）、严重不良事件（SUCRA 91.3%）和严重感染（SUCRA 67.6%）最低。
我们的网络荟萃分析表明，vedolizumab 是 UC 患者诱导和维持临床缓解最有效的生物治疗方法。 Guselkumab 有望降低诱导治疗期间复发和不良事件的风险。英夫利昔单抗在维持治疗期间可有效改善内镜结局。乌司奴单抗的安全性似乎较好。这些发现为临床医生选择最适合 UC 患者的生物治疗方法提供了有价值的见解。
