Cunningham Georgina, Samaan Mark A, Irving Peter M
Guy's and St. Thomas's NHS Foundation Trust, IBD Centre, London, UK.
Department of Gastroenterology, Guy's and St. Thomas's NHS Foundation Trust, IBD Centre, First Floor College House, South Wing, St Thomas's Hospital, Westminster Bridge Road, London SE1 7EH, UK.
Therap Adv Gastroenterol. 2019 Jan 28;12:1756284818821266. doi: 10.1177/1756284818821266. eCollection 2019.
Golimumab was approved by the US Food and Drug Administration and the European Medicines Agency for the treatment of moderate-to-severe ulcerative colitis in 2013 and was the third antitumour-necrosis-factor therapy after adalimumab and infliximab licensed for this indication. However, given it is the most recent of these drugs to become available, evidence regarding its optimal use and its positioning in relation to other biological therapies is only now emerging. In this article, we review the efficacy, effectiveness and safety of golimumab both in the setting of clinical trials and in 'real world' observational studies. We also explore the limited data available regarding the possible role of therapeutic-drug monitoring and dose flexibility.
2013年，戈利木单抗获美国食品药品监督管理局和欧洲药品管理局批准用于治疗中重度溃疡性结肠炎，是继阿达木单抗和英夫利昔单抗之后获批该适应症的第三种抗肿瘤坏死因子疗法。然而，鉴于它是这些药物中最晚上市的，有关其最佳使用方法及其与其他生物疗法相比的定位的证据目前才刚刚出现。在本文中，我们回顾了戈利木单抗在临床试验和“真实世界”观察性研究中的疗效、有效性和安全性。我们还探讨了关于治疗药物监测和剂量灵活性可能作用的有限数据。
