IBD Center, Gastroenterology, IRCCS Humanitas, Rozzano, Milan, Italy.
Internal Medicine and Gastroenterology Unit, Complesso Integrato Columbus, Catholic University of Rome, Italy.
Curr Drug Targets. 2018;19(7):748-756. doi: 10.2174/1389450117666160527142719.
In the last decade, the introduction of the first anti-tumor necrosis factor (TNF)-α agent infliximab has revolutionized the treatment of ulcerative colitis (UC). However, this drug is not a magic bullet since up to 50% of UC patients do not respond (primary failure) or lose response to infliximab (secondary failure). Hence the demand for novel drugs to fill the unmet medical need.
The aim of this review is to discuss the data from randomized controlled trials (RCTs) of available biological agents for the treatment of moderate-to-severe UC in adults, in order to support clinical decision making.
New biological agents are now available for the treatment of moderate-tosevere UC. Adalimumab and golimumab are anti-TNF-α monoclonal antibodies, as is infliximab, whereas vedolizumab blocks the integrin α4β7/mucosal addressin cell adhesion molucule-1 (MAd- CAM). Additions to the therapeutic arsenal boost the chances of successful treatment of UC, but lead to difficulty choosing the most appropriate biological drug: which biologic to use first and when and how to switch. In the absence of head-to-head trials to answer these questions, a network metaanalysis of the available RCTs can provide estimates of relative efficacy between interventions. Other factors, including convenience and satisfaction for the patient, route of administration, the cost of treatment, and the safety and efficacy profile, should all be considered.
在过去的十年中,首个抗肿瘤坏死因子(TNF)-α 制剂英夫利昔单抗的问世彻底改变了溃疡性结肠炎(UC)的治疗方法。然而,这种药物并非灵丹妙药,因为多达 50%的 UC 患者对此无应答(原发性失败)或对英夫利昔单抗失去应答(继发性失败)。因此,人们迫切需要新的药物来满足尚未满足的医疗需求。
本综述旨在讨论成人中用于治疗中重度 UC 的现有生物制剂的随机对照试验(RCT)数据,以支持临床决策。
目前有新的生物制剂可用于治疗中重度 UC。阿达木单抗和古利昔单抗是抗 TNF-α 的单克隆抗体,与英夫利昔单抗相同,而维得利珠单抗则可阻断整合素 α4β7/黏膜地址素细胞黏附分子-1(MAd-CAM)。治疗武器的增加增加了成功治疗 UC 的机会,但也导致了选择最合适的生物药物变得困难:首先使用哪种生物制剂,何时以及如何进行转换。在缺乏头对头试验来回答这些问题的情况下,对现有 RCT 的网络荟萃分析可以提供干预措施之间相对疗效的估计。其他因素,包括患者的便利性和满意度、给药途径、治疗成本以及安全性和疗效概况,都应加以考虑。