Macaluso Fabio Salvatore, Renna Sara, Orlando Ambrogio, Cottone Mario
a Di.Bi.M.I.S., Division of Internal Medicine , 'Villa Sofia-Cervello' Hospital , Palermo , Italy.
Expert Opin Biol Ther. 2017 Feb;17(2):175-184. doi: 10.1080/14712598.2017.1271871. Epub 2016 Dec 21.
Tumor necrosis factor α inhibitors dramatically changed the management of moderate-to-severe phenotypes of ulcerative colitis. The recent incoming of vedolizumab, which targets gut-specific leukocyte trafficking, provides a new biologic option for these patients. Areas covered: This review focuses on the rationale of use, efficacy, and safety profile of all biologics currently approved by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) for the treatment of ulcerative colitis, including tumor necrosis factor α inhibitors (Infliximab and biosimilars, adalimumab, and golimumab), and the more recent vedolizumab. Expert opinion: Although biologics have been available in clinical practice for ulcerative colitis for about 15 years, there are several aspects that have not been fully understood yet: we know that they work, but we still don't know which subsets of patients benefit more, and how to optimize their use. All these unresolved problems are at least partly due to the discrepancy observed between phase II/III clinical trials of all biologics currently used in ulcerative colitis and in clinical practice.
肿瘤坏死因子α抑制剂极大地改变了中度至重度溃疡性结肠炎的治疗方式。靶向肠道特异性白细胞迁移的维多珠单抗的近期问世,为这些患者提供了一种新的生物制剂选择。涵盖领域:本综述聚焦于美国食品药品监督管理局(FDA)和欧洲药品管理局(EMA)目前批准用于治疗溃疡性结肠炎的所有生物制剂的使用原理、疗效和安全性概况,包括肿瘤坏死因子α抑制剂(英夫利昔单抗及其生物类似药、阿达木单抗和戈利木单抗),以及较新的维多珠单抗。专家观点:尽管生物制剂已在溃疡性结肠炎的临床实践中应用了约15年,但仍有几个方面尚未完全明确:我们知道它们有效,但仍不清楚哪些患者亚组获益更多,以及如何优化其使用。所有这些未解决的问题至少部分归因于目前用于溃疡性结肠炎的所有生物制剂在II/III期临床试验与临床实践中观察到的差异。