Flendrie M, Creemers M C W, Welsing P M J, den Broeder A A, van Riel P L C M
UMC Nijmegen, The Netherlands.
Ann Rheum Dis. 2003 Nov;62 Suppl 2(Suppl 2):ii30-3. doi: 10.1136/ard.62.suppl_2.ii30.
Tumour necrosis factor (TNF) blocking agents are an important advance in the clinical treatment of rheumatoid arthritis (RA). They were introduced into clinical practice while limited safety information was available. This means that intensive monitoring is needed early in the life cycle of these new drugs. Setting up large cohort studies to monitor efficacy, safety, and tolerability in long term use of these so-called biological agents will provide information about the consequences of using TNF blocking agents in chronic rheumatic disease like RA. Currently, a Dutch multicentre registry on biological agents in RA is being set up. This study aimed at investigating the efficacy and toxicity of TNF blocking agents in patients with RA at one participating academic centre by a drug survival analysis. Since 1997 230 patients with RA at the centre have been treated with TNF blocking agents for the first time (94 with adalimumab, 120 with infliximab, and 16 with etanercept). No differences in drug survival between the three TNF blocking agents were found despite the diversity in selection and patient numbers. Adverse events which occurred, leading to discontinuation, were similar to those from previous reports.
肿瘤坏死因子(TNF)阻断剂是类风湿性关节炎(RA)临床治疗中的一项重要进展。它们在仅有有限安全信息的情况下被引入临床实践。这意味着在这些新药的生命周期早期需要进行密集监测。开展大型队列研究以监测这些所谓生物制剂长期使用中的疗效、安全性和耐受性,将提供有关在类风湿性关节炎等慢性风湿性疾病中使用TNF阻断剂的后果的信息。目前,荷兰正在建立一个关于类风湿性关节炎生物制剂的多中心登记处。本研究旨在通过药物生存分析,在一个参与研究的学术中心调查TNF阻断剂对类风湿性关节炎患者的疗效和毒性。自1997年以来,该中心的230例类风湿性关节炎患者首次接受了TNF阻断剂治疗(94例使用阿达木单抗,120例使用英夫利昔单抗,16例使用依那西普)。尽管在选择和患者数量上存在差异,但三种TNF阻断剂之间未发现药物生存率的差异。导致停药的不良事件与先前报告中的相似。