Crooks Benjamin, Barnes Tom, Limdi Jimmy K
Division of Diabetes, Endocrinology and Gastroenterology, University of Manchester, Manchester M13 9PL, UK.
Section of IBD - Division of Gastroenterology, The Pennine Acute Hospitals NHS Trust, Manchester, UK.
Drugs Context. 2020 Mar 2;9. doi: 10.7573/dic.2019-10-2. eCollection 2020.
Inflammatory bowel diseases, comprising Crohn's disease (CD) and ulcerative colitis (UC), are chronic, relapsing and remitting immune-mediated inflammatory diseases affecting the gastrointestinal tract. Vedolizumab is the first licensed drug in a group of 'gut-selective' biological agents used to treat inflammatory bowel diseases. The GEMINI registrational trials established the efficacy of vedolizumab for the induction and maintenance of remission in both CD and UC, with the most favourable results in tumour necrosis factor (TNF)-antagonist-naive patients. In recent years, a wealth of 'real-world' data has emerged supporting positive clinical, endoscopic and histological outcomes in patients treated with vedolizumab (VDZ) as well as reassuring safety data. More recently, the results of the first head-to-head trials of VDZ and TNF antagonists have been reported, as well as the results of a number of studies exploring the role of therapeutic drug monitoring with VDZ. This review brings together data reported on VDZ to date, including from the GEMINI trials, real-world data and emerging studies regarding therapeutic drug monitoring and immunogenicity. The safety profile of VDZ is also reviewed. Evolving treatment paradigms are explored, including data regarding the role of VDZ in perianal CD, post-operative complications and recurrence, extraintestinal manifestations and pregnancy.
炎症性肠病，包括克罗恩病（CD）和溃疡性结肠炎（UC），是影响胃肠道的慢性、复发性和缓解性免疫介导的炎症性疾病。维多珠单抗是用于治疗炎症性肠病的一组“肠道选择性”生物制剂中的首个获批药物。GEMINI注册试验确立了维多珠单抗在诱导和维持CD和UC缓解方面的疗效，在未使用过肿瘤坏死因子（TNF）拮抗剂的患者中取得了最有利的结果。近年来，出现了大量“真实世界”数据，支持接受维多珠单抗（VDZ）治疗的患者在临床、内镜和组织学方面取得积极结果，以及可靠的安全性数据。最近，报道了VDZ与TNF拮抗剂的首个头对头试验结果，以及多项探索VDZ治疗药物监测作用的研究结果。本综述汇集了迄今为止报道的关于VDZ的数据，包括来自GEMINI试验、真实世界数据以及有关治疗药物监测和免疫原性的新出现研究。还对VDZ的安全性概况进行了综述。探讨了不断演变的治疗模式，包括关于VDZ在肛周CD、术后并发症和复发、肠外表现及妊娠中的作用的数据。
