Etanercept, infliximab, and leflunomide in established rheumatoid arthritis: clinical experience using a structured follow up programme in southern Sweden
Etanercept, infliximab, and leflunomide in established rheumatoid arthritis: clinical experience using a structured follow up programme in southern Sweden
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DOI：
10.1136/ard.61.9.793
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发表时间：
2002-09-01
影响因子：
27.4
通讯作者：
Saxne, T
中科院分区：
文献类型：
--
作者：
Geborek, P;Crnkic, M;Saxne, T
目的：探讨在临床实践中使用结构化方案前瞻性监测英夫利西单抗、依那西普和来氟米特在已确诊的类风湿关节炎（RA）患者中的疗效和耐受性的可行性。方法：瑞典南部7个中心的所有RA患者，其中至少有两种疾病缓解抗风湿药物（包括甲氨蝶呤）失败或不耐受，开始接受英夫利昔单抗、依那西普或来氟米特治疗的患者。使用标准化方案在预定时间对他们进行评价，包括评价对美国流变学学院（ACR）或EULAR标准的反应所需的项目。使用世界卫生组织术语记录所有不良事件。伴随治疗和生存，而接受药物recorded.Results：在这项研究中，166例患者接受依那西普，135英夫利昔单抗，103来氟米特。根据ACR和EULAR反应标准确定的肿瘤坏死因子（TNF）阻滞剂的治疗反应相似。根据反应标准和药物生存分析，TNF阻滞剂的疗效明显优于来氟米特。因此，79%和75%的患者在20个月后继续接受依那西普或英夫利昔单抗治疗，而22%的患者开始接受来氟米特治疗。副作用的范围与之前在临床试验中报告的没有不同。依那西普，英夫利西单抗，来氟米特上市后监测的协议的最初两年的经验表明，一个结构化的协议与中央数据处理，可用于在临床实践中记录新推出的drugs.Conclusions的性能：TNF阻滞剂的疗效数据符合临床试验的结果，而来氟米特表现不如在临床试验中。需要长期监测以确定可能的罕见副作用。
Objective: To explore the feasibility of prospectively monitoring treatment efficacy and tolerability of infliximab, etanercept, and leflunomide over a two year period in patients with established rheumatoid arthritis (RA) in clinical practice using a structured protocol.Methods: All patients with RA at seven centres in southern Sweden, for whom at least two disease modifying antirheumatic drugs, including methotrexate, had failed or not been tolerated, who started treatment with either infliximab, etanercept, or leflunomide were included. They were evaluated at pre-defined times using a standardised protocol including items required for evaluating response to the American College of Rheumatology (ACR) or EULAR criteria. All adverse events were recorded using World Health Organisation terminology. Concomitant treatment and survival while receiving a drug were recorded.Results: During the study 166 patients were treated with etanercept, 135 with infliximab, and 103 with leflunomide. Treatment response as determined by the ACR and EULAR response criteria was similar for the tumour necrosis factor (TNF) blockers. The TNF blockers performed significantly better than leflunomide both as determined by the response criteria and by survival on drug analysis. Thus 79% and 75% continued to receive etanercept or infliximab compared with 22% of patients who started leflunomide after 20 months. The spectrum of side effects did not differ from those previously reported in the clinical trials. The initial two year experience of a protocol for postmarketing surveillance of etanercept, infliximab, and leflunomide shows that a structured protocol with central data handling can be used in clinical practice for documenting the performance of newly introduced drugs.Conclusions: Efficacy data for the TNF blockers comply with results in clinical trials, whereas leflunomide appeared to perform worse than in clinical trials. Prolonged monitoring is required to identify possible rare side effects.