Department of Biomedical Sciences, Humanitas University, Milan, Italy.
Department of Gastroenterology, Humanitas Clinical and Research Center, Milan, Italy.
J Crohns Colitis. 2017 Oct 1;11(10):1258-1266. doi: 10.1093/ecco-jcc/jjx079.
Biological medicines have revolutionised the treatment of Crohn's disease [CD]. Yet, the management of patients not responding to tumour necrosis factor [TNF] antagonists remains a clinical challenge. Ustekinumab is a human monoclonal antibody blocking the biological activity of interleukins 12 and 23, which regulate the immune system and immune-mediated inflammatory disorders. Ustekinumab has recently been approved for the treatment of adult patients with moderately to severely active CD, who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNF antagonist, or have medical contraindications to such therapies. Herein, we review the new biological drug's efficacy and safety data reported from randomised controlled trials and real-world observational studies conducted in populations with CD, in order to identify the patient groups most likely to benefit, and to appropriately place ustekinumab into treatment algorithms for CD.
生物制剂改变了克罗恩病 [CD] 的治疗方式。然而，对于那些对肿瘤坏死因子 [TNF] 拮抗剂无应答的患者的管理仍然是一个临床挑战。乌司奴单抗是一种人源化单克隆抗体，可阻断白细胞介素 12 和 23 的生物学活性，这些细胞因子调节免疫系统和免疫介导的炎症性疾病。乌司奴单抗最近被批准用于治疗中度至重度活动期 CD 的成年患者，这些患者对常规治疗或 TNF 拮抗剂应答不足、失去应答或不耐受，或有这些治疗方法的医学禁忌证。本文综述了在 CD 患者中进行的随机对照试验和真实世界观察研究报告的新型生物药物的疗效和安全性数据，以确定最有可能受益的患者群体，并将乌司奴单抗适当地纳入 CD 的治疗方案。
