The efficacy of anti-TNF in rheumatoid arthritis, a comparison between randomised controlled trials and clinical practice
The efficacy of anti-TNF in rheumatoid arthritis, a comparison between randomised controlled trials and clinical practice
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DOI：
10.1136/ard.2007.072447
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发表时间：
2007-11-01
影响因子：
27.4
通讯作者：
van Riel, P. L. C. M.
中科院分区：
文献类型：
--
作者：
Kievit, W.;Fransen, J.;van Riel, P. L. C. M.
背景：评价肿瘤坏死因子α拮抗剂疗效的随机对照试验(RCT)显示，接受活性药物治疗的类风湿性关节炎(RA)患者的应答率较高。目的：比较类风湿关节炎(RA)患者在随机对照试验(RCT)中和在日常临床实践中的疗效，重点是对符合和不符合接受肿瘤坏死因子α拮抗剂(RCT)治疗的患者的疗效。方法：首先，通过系统评价，选择依那西普、英夫利昔单抗和阿达利单抗治疗类风湿关节炎(RA)的英文随机安慰剂对照试验。其次，使用了DREAM(荷兰类风湿性关节炎监测)首次开始使用其中一种肿瘤坏死因子阻滞剂的患者登记。结果：在11项比较中，有10项在日常临床实践中ACR20的应答率低于RCT活性药物组，在11项比较中有5项达到显著水平。在接受检查的几项随机对照试验中，只有34-79%的梦想患者符合疾病活动性的选择标准。符合随机对照试验条件的梦想患者的应答率高于不符合条件的梦想患者。符合条件的DREAM患者的ACR20反应百分率与RCT活性药物组的ACR20反应百分率在11项对照中有10项具有可比性。结论：在临床实践中，肿瘤坏死因子阻滞剂在RCT中的疗效优于这两种药物。然而，在临床实践中，与RCT相比，使用肿瘤坏死因子阻滞剂治疗的疾病活动性较低的患者更多。对于有资格接受随机对照试验的日常实践患者，反应更类似于随机对照试验中达到的反应。
Background: Randomised controlled trials ( RCTs) evaluating the efficacy of antagonists to tumour necrosis factor alpha ( TNF alpha) showed high response percentages in the groups treated with active drugs.Objective: To compare the efficacy of anti- TNF treatments for rheumatoid arthritis ( RA) patients in RCTs and in daily clinical practice, with an emphasis on the efficacy for patients eligible and not eligible for RCTs of antiTNF treatments.Methods: First, randomised placebo- controlled trials written in English for etanercept, infliximab and adalimumab for patients with RA were selected by a systematic review. Second, the DREAM ( Dutch Rheumatoid Arthritis Monitoring) register with patients starting for the first time on one of the TNF- blocking agents was used. Patient characteristics, doses of medication and co- medication as well as the ACR20 response percentages were compared between RCTs and DREAM data, stratified for trial eligibility.Results: In 10 of 11 comparisons, the ACR20 response percentages were lower in daily clinical practice than in the RCT active drug group, which was significant in five of 11 comparisons. Only 34 - 79% of DREAM patients fulfilled the selection criteria for disease activity in the several RCTs examined. DREAM patients eligible for RCTs had higher response percentages than ineligible DREAM patients. ACR20 response percentages of eligible DREAM patients were comparable with the ACR20 response percentages of the RCT active drug group in 10 of 11 comparisons.Conclusion: The efficacy of TNF- blocking agents in RCTs exceeded the efficacy of these drugs in clinical practice. However, in clinical practice more patients with lower disease activity were treated with TNF-blocking agents compared with those treated in RCTs. For daily practice patients who were eligible for RCTs, responses were more similar to responses reached in RCTs.