Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy.
Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and Vita-Salute San Raffaele University, Milan, Italy.
J Crohns Colitis. 2022 Jun 24;16(5):835-844. doi: 10.1093/ecco-jcc/jjab206.
Filgotinib is a small molecule that selectively inhibits Janus kinase [JAK] type 1. It is already approved for the treatment of rheumatoid arthritis and is being evaluated for the management of patients with moderate to severe ulcerative colitis [UC]. The purpose of this review is to provide an overview of the currently available data on filgotinib and to define how to position this new drug in the treatment algorithm of patients with UC.
The Pubmed, Embase and Scopus databases were searched up to June 25, 2021 in order to identify studies reporting efficacy and safety data of filgotinib in patients with UC.
Data from a phase III study enrolling UC patients with moderate to severe disease show that filgotinib is effective with a reassuring safety profile. Filgotinib treatment is not associated with a greater risk of thrombosis and herpes zoster infections compared to other JAK inhibitors. However, animal studies reported impaired spermatogenesis and histopathological effects on male reproductive organs, making it necessary to deepen this aspect in dedicated human studies.
Filgotinib is an effective and safe drug for treatment of both biologic-naive and biologic-experienced patients with moderate to severe UC and may soon be available.
Filgotinib 是一种小分子，可选择性抑制 Janus 激酶 [JAK] 1 型。它已被批准用于治疗类风湿关节炎，并正在评估用于治疗中重度溃疡性结肠炎 [UC] 患者。本综述的目的是提供关于 Filgotinib 的现有数据概述，并确定如何在 UC 患者的治疗方案中定位这种新药。
检索 Pubmed、Embase 和 Scopus 数据库，以确定截至 2021 年 6 月 25 日报告 Filgotinib 在 UC 患者中的疗效和安全性数据的研究。
一项纳入中重度疾病 UC 患者的 III 期研究的数据表明，Filgotinib 有效，安全性良好。与其他 JAK 抑制剂相比，Filgotinib 治疗与血栓形成和带状疱疹感染的风险增加无关。然而，动物研究报告称精子发生受损和对男性生殖器官的组织病理学影响，因此有必要在专门的人类研究中深入探讨这一方面。
Filgotinib 是一种有效且安全的药物，可治疗生物初治和生物经验丰富的中重度 UC 患者，并且可能很快就会上市。
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