Kothari Megha, Mudireddy Prashant, Swaminath Arun
Division of Gastroenterology and Hepatology, Lenox Hill Hospital-NSLIJ, New York, NY, USA.
Ther Clin Risk Manag. 2015 Aug 19;11:1235-42. doi: 10.2147/TCRM.S65650. eCollection 2015.
Ulcerative colitis (UC) is a subtype of inflammatory bowel disease which causes inflammation of the large intestine and affects approximately 7.6-24.6 per 100,000 persons. The therapeutic goal for UC patients is inducing remission, maintaining remission, and ideally, obtaining mucosal healing. Vedolizumab, approved by the US Food and Drug Administration in May 2014 for the treatment of moderate-to-severe UC and Crohn's disease, is a newly developed anti-integrin therapy. This review focuses on the preclinical development of vedolizumab and data from early trials, and details the results of the landmark trails that led to its approval in the USA with a specific focus on the management of UC. Additionally, data on safety and the current UC management protocols are also discussed.
溃疡性结肠炎(UC)是炎症性肠病的一种亚型,可导致大肠炎症,每10万人中约有7.6 - 24.6人受其影响。UC患者的治疗目标是诱导缓解、维持缓解,理想情况下实现黏膜愈合。维多珠单抗于2014年5月获美国食品药品监督管理局批准用于治疗中重度UC和克罗恩病,是一种新开发的抗整合素疗法。本综述重点关注维多珠单抗的临床前研发及早期试验数据,并详细阐述了使其在美国获批的关键试验结果,特别聚焦于UC的管理。此外,还讨论了安全性数据及当前的UC管理方案。