Merza Nooraldin, Nawras Yusuf, Saab Omar, Dahiya Dushyant Singh, Ahmed Zohaib, Ranabothu Meghana, Boujemaa Safa, Hassan Mona, Kobeissy Abdallah, Lilley Kirthi
Department of Internal Medicine, University of Toledo, Toledo, OH, USA.
University of Toledo College of Medicine and Life Sciences, Toledo, OH, USA.
Gastroenterology Res. 2023 Dec;16(6):289-306. doi: 10.14740/gr1664. Epub 2023 Nov 3.
Numerous patients with inflammatory bowel disease (IBD) do not respond to conventional or biological therapy. Adalimumab (ADA) and vedolizumab (VDZ), according to certain research, may be a useful alternative treatment for these people. The purpose of this study was to assess the effectiveness and safety of using ADA and VDZ to treat moderate to severe IBD: Crohn's disease (CD) and ulcerative colitis (UC).
We searched PubMed, Medline, Web of Science, Scopus, the Cochrane Library, Embase, Google Scholar, CINAHL, Clinicaltrials.gov, and WHO trials registry (ICTRP). Randomized controlled trials (RCTs) comparing ADA or VDZ with placebo in participants with active CD or UC were included. The primary outcomes were the clinical response and remission at induction and maintenance phases and mucosal healing. The secondary outcome was the incidence of profound negative events. The research used Comprehensive Meta-Analysis version 3 (Biostat Inc., USA).
Eighteen RCTs were incorporated, in which 11 studies described the usefulness and safeness of ADA or VDZ in CD patients, and seven studies investigated the efficacy and safety of ADA or VDZ in UC patients. The meta-analysis revealed that both ADA and VDZ treatments were superior to placebo for producing clinical remission and eliciting clinical response at induction and maintenance phases in individuals with moderately to severely active CD or UC. Interestingly, we found that ADA was superior to VDZ as first-line treatment for patients with CD, but not UC.
ADA and VDZ are effective and safe in CD and UC patients. However, RCTs of a larger number of patients are still required for better assessing the safety profile of ADA and VDZ.
许多炎症性肠病（IBD）患者对传统治疗或生物治疗无反应。根据某些研究，阿达木单抗（ADA）和维多珠单抗（VDZ）可能是这些患者有用的替代治疗方法。本研究的目的是评估使用ADA和VDZ治疗中度至重度IBD：克罗恩病（CD）和溃疡性结肠炎（UC）的有效性和安全性。
我们检索了PubMed、Medline、科学网、Scopus、Cochrane图书馆、Embase、谷歌学术、护理学与健康领域数据库（CINAHL）、Clinicaltrials.gov和世界卫生组织试验注册库（ICTRP）。纳入了比较ADA或VDZ与安慰剂治疗活动性CD或UC患者的随机对照试验（RCT）。主要结局是诱导期和维持期的临床反应和缓解以及黏膜愈合。次要结局是严重不良事件的发生率。本研究使用了综合荟萃分析第3版（美国Biostat公司）。
纳入了18项RCT，其中11项研究描述了ADA或VDZ在CD患者中的有效性和安全性，7项研究调查了ADA或VDZ在UC患者中的疗效和安全性。荟萃分析显示，在中度至重度活动性CD或UC患者中，ADA和VDZ治疗在诱导期和维持期产生临床缓解和引发临床反应方面均优于安慰剂。有趣的是，我们发现ADA作为CD患者的一线治疗优于VDZ，但对UC患者并非如此。
ADA和VDZ对CD和UC患者有效且安全。然而，仍需要更多患者的RCT来更好地评估ADA和VDZ的安全性。
