Performance of response criteria for assessing peripheral arthritis in patients with psoriatic arthritis: analysis of data from randomised controlled trials of two tumour necrosis factor inhibitors
Performance of response criteria for assessing peripheral arthritis in patients with psoriatic arthritis: analysis of data from randomised controlled trials of two tumour necrosis factor inhibitors
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DOI：
10.1136/ard.2006.051706
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发表时间：
2006-10-01
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：
Fransen, J.;Antoni, C.;Van Riel, P. L. C. M.
背景资料：在最近的银屑病关节炎（PsA）患者的临床试验中，已使用的反应标准和疾病活动性指标是为类风湿性关节炎制定的。然而，这些尚未在PsA中得到验证。目的：比较银屑病关节炎反应标准（PsARC）、美国风湿病学会（ACR）和欧洲抗风湿联盟（EULAR）反应标准以及疾病活动评分（DAS）和核心集指标在银屑病关节炎和外周关节炎患者中的反应性和区分能力，使用的数据从两个随机安慰剂对照试验的肿瘤坏死因子inhibitors.Methods：在英夫利西单抗试验，104例患者与活动性银屑病患者随机接受安慰剂或英夫利西单抗16周。在一项依那西普试验中，60名活动性PsA患者随机接受安慰剂或依那西普治疗12周。使用了每项研究的基线和干预阶段结束时的数据。使用标准化反应平均值和效应量评估反应性。使用t值或卡方检验评估活性药物和安慰剂之间的区分能力。结果：EULAR标准在区分活性药物和安慰剂方面优于ACR 20改善标准，而ACR 20改善标准又优于PsARC。它还发现，汇总指数（DAS和DAS 28）一般更敏感，更好地区分活性药物从安慰剂，比单一的核心集measures.Conclusion：响应标准和汇总指数开发类风湿关节炎是有用的评估关节炎的PsA临床试验。
Background: In recent clinical trials in patients with psoriatic arthritis (PsA), the response criteria and disease activity measures that have been used were those developed for rheumatoid arthritis. However, these have not yet been validated in PsA.Objective: To compare the responsiveness and discriminative capacity of the psoriatic arthritis response criteria (PsARC), American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) response criteria and the Disease Activity Score (DAS) and core-set measures in patients with PsA and peripheral arthritis, using the data from two randomised placebo-controlled trials of tumour necrosis factor inhibitors.Methods: In an infliximab trial, 104 patients with active PsA were randomised to receive placebo or infliximab for 16 weeks. In an etanercept trial, 60 patients with active PsA were randomised to receive placebo or etanercept for 12 weeks. Data from baseline and the end of the intervention phase were used from each study. Responsiveness was assessed using the standardised response mean and effect size. Capacity to discriminate between the active drug and placebo was assessed using t values or a chi(2) test. Measures were ranked in order of their t value or chi(2) value.Results: The EULAR criteria performed better in discriminating the active drug from placebo than the ACR20 improvement criteria, which in turn performed better than the PsARC. It was also found that the pooled indices (DAS and DAS28) were generally more responsive, and performed better in discriminating active drug from placebo, than the single core-set measures.Conclusion: Response criteria and pooled indices developed for rheumatoid arthritis are useful for the assessment of arthritis in PsA clinical trials.