Jahnsen Jørgen, Kaasen Jørgensen Kristin
Department of Gastroenterology, Akershus University Hospital, Lørenskog, Norway.
Dig Dis. 2017;35(1-2):83-90. doi: 10.1159/000449088. Epub 2017 Feb 1.
The first monoclonal antibody biosimilar to be used in clinical practice is the tumour necrosis factor-alpha inhibitor Remsima® (CT-P13). The drug is approved for all indications as the originator infliximab (Remicade®) although clinical efficacy has been demonstrated only in rheumatic diseases. Since the fall of 2013, Remsima® has been available in Norway and from January 2014, it has been the drug of choice when initiating biological treatment in biologics naïve patients with inflammatory bowel disease (IBD). However, many gastroenterologists have been greatly concerned about the extrapolation of indication. Switching between Remsima® and the innovator product is another issue that has been discussed. Key Messages: Good efficacy, tolerability and safety were demonstrated in a prospective observational study of IBD patients with moderate to severe disease activity. After 14 weeks of treatment there was a significant reduction in the Harvey Bradshaw index in patients with Crohns disease (CD) and reduction in the partial Mayo score and simple clinical colitis activity index in patients with ulcerative colitis. In both patient groups, there was also a significant reduction in fecal calprotectin and C-reactive protein (CRP). In another observational study, IBD patients on maintenance treatment with Remicade® were switched to Remsima®. By comparing values before and after switch, no changes in activity indices, CRP or calprotectin were observed. However, a significant increase in infliximab trough levels was shown in the CD group. No unexpected adverse events occurred after switching.
Based on our experience in Norway, Remsima® seems to be efficacious and well tolerated in IBD. The increasing use of Remsima® in clinical practice has also contributed to significant cost savings on the health budget. Results from the NOR-SWITCH study will be available during 2016 and will hopefully contribute to answer some of the important questions that have been raised following the introduction of biosimilars as a treatment option for IBD and other immune-mediated inflammatory diseases.
首个用于临床实践的单克隆抗体生物类似药是肿瘤坏死因子-α抑制剂类克（CT-P13）。尽管仅在风湿性疾病中证实了其临床疗效，但该药物已获批用于类克（英夫利昔单抗）的所有适应症。自2013年秋季起，类克在挪威上市，自2014年1月起，它已成为在未使用过生物制剂的炎症性肠病（IBD）患者中启动生物治疗时的首选药物。然而，许多胃肠病学家对适应症的外推极为关注。在类克和创新产品之间进行转换是另一个已被讨论的问题。关键信息：在一项针对中重度疾病活动的IBD患者的前瞻性观察研究中，证实了类克具有良好的疗效、耐受性和安全性。治疗14周后，克罗恩病（CD）患者的哈维·布拉德肖指数显著降低，溃疡性结肠炎患者的部分梅奥评分和简单临床结肠炎活动指数降低。在这两组患者中，粪便钙卫蛋白和C反应蛋白（CRP）也显著降低。在另一项观察性研究中，接受类克维持治疗的IBD患者转换为使用类克。通过比较转换前后的值，未观察到活动指数、CRP或钙卫蛋白的变化。然而，CD组中显示英夫利昔单抗谷浓度显著升高。转换后未发生意外不良事件。
根据我们在挪威的经验，类克在IBD中似乎有效且耐受性良好。类克在临床实践中的使用增加也为卫生预算节省了大量成本。挪威转换研究（NOR-SWITCH）的结果将于2016年公布，有望有助于回答在将生物类似药作为IBD和其他免疫介导的炎症性疾病的治疗选择引入后所提出的一些重要问题。
