To review the mechanisms of action and the available clinical trial data on emerging drug therapies for IBD.
Pubmed, Medline and Cochrane databases were queried up to July 2021 using keywords \"inflammatory bowel disease,\" \"IBD,\" \"Crohn\'s disease,\" \"ulcerative colitis\" and \"trial,\" \"phase\" and \"study.\" In addition, we manually reviewed the grey literature including clinical trial registries and abstracts from major gastroenterology conferences in 2020 and 2021 to include pertinent information.
In ulcerative colitis (UC), phase 2b and/or phase 3 studies met primary endpoints for S1P receptor agonists (estrasimod, ozanimod), anti-IL-23 agent (mirikizumab), anti-lymphocyte trafficking agents (ontamalimab, subcutaneous vedolizumab), JAK inhibitors (upadacitinib, filgotinib) and TLR9 agonist (cobitolimod). In Crohn\'s disease (CD), anti-IL-23 agents (risankizumab, mirikizumab, guselkumab), JAK inhibitors (upadacitinib, filgotinib) and anti-lymphocyte trafficking agents (ontamalimab, etrolizumab) met primary endpoints in randomised controlled clinical trials.
Several new IBD drug therapies have positive efficacy and safety data in early clinical trials, and there are several drugs in the therapeutic pipeline. As more treatments for CD and UC are approved for clinical use, research to assess predictors of response to therapy and head-to-head trials is needed to inform providers on how to best position therapeutic options for patients with IBD.
回顾IBD新兴药物治疗的作用机制和现有临床试验数据。
已发布,截至2021年7月,Medline和Cochrane数据库使用关键词“炎症性肠病,\"\"IBD,克罗恩病,\"\"溃疡性结肠炎\"和\"试验,\"\"阶段\"和\"研究。\"此外,我们手动审查了灰色文献,包括2020年和2021年主要胃肠病学会议的临床试验注册和摘要,以纳入相关信息.
在溃疡性结肠炎(UC)中,2b期和/或3期研究达到S1P受体激动剂的主要终点(estrasimod,ozanimod),抗IL-23药物(mirikizumab),抗淋巴细胞贩运剂(奥他马利玛,皮下维多珠单抗),JAK抑制剂(upadacitinib,filgotinib)和TLR9激动剂(cobitolimod)。在克罗恩病(CD),抗IL-23药物(risankizumab,mirikizumab,guselkumab),JAK抑制剂(upadacitinib,filgotinib)和抗淋巴细胞贩运剂(ontamalimab,etrolizumab)在随机对照临床试验中达到了主要终点。
几种新的IBD药物疗法在早期临床试验中具有积极的疗效和安全性数据,有几种药物在治疗管道中。随着更多CD和UC的治疗方法被批准用于临床,需要进行研究以评估对治疗和头对头试验的反应预测因子,以告知提供者如何为IBD患者提供最佳治疗方案.