Efficacy of etanercept in an integrated multistudy database of patients with psoriasis
Efficacy of etanercept in an integrated multistudy database of patients with psoriasis
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DOI：
10.1016/j.jaad.2005.11.1088
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发表时间：
2006-03-01
影响因子：
13.8
通讯作者：
Chang, T
中科院分区：
文献类型：
--
作者：
Gordon, K;Korman, N;Chang, T
背景：在3项临床试验中，肿瘤坏死因子(TNF)抑制剂依那西普被证明是安全有效的治疗慢性斑块型银屑病。目的：通过3项研究的整合，在较大人群规模的基础上完善依那西普的疗效结果，并确定所有3项研究的疗效曲线是否与个别试验中观察到的疗效曲线一致。方法：在这些综合分析中，将来自3个盲法治疗组的1187名患者的数据合并在一起，比较12周时的疗效：每周皮下注射依那西普50 mg(相当于每周2次25 mg)，皮下注射依那西普50 mg，每周皮下注射2次，以及安慰剂。所有3项研究的主要疗效终点至少是牛皮癣面积和严重程度指数(PASI 75)改善75%。其他测量包括PASI 50，PASI 90，患者和皮肤科医生的全球评估，以及皮肤病患者的生活质量指数。结果：在综合分析中，与安慰剂组(3%，P<；0.05)相比，每周服用50 mg依那西普50 mg(33%)和每周两次服用50 mg(49%)的患者在12周时PASI 75有显著的、密切相关的改善。在12周时，所有次级终点(PASI 50和PASI 90反应、患者和皮肤科医生的全球评估以及皮肤科生活质量指数)也有显著改善。基线患者特征的亚组分析表明，没有统计学意义的协变量治疗交互作用。限制：这些综合分析的局限性是相对较短的时间框架(12周)。结论：依那西普对银屑病患者的疗效在多项研究中是一致的，主要和次要终点的综合分析显示。依那西普在所有研究中都显示出疾病严重程度和生活质量的快速、密切相关的改善。
Background: The tumor necrosis factor (TNF) inhibitor etanercept has been demonstrated to be safe and effective for treating chronic plaque psoriasis in 3 clinical trials.Objectives: To refine efficacy results for etanercept on the basis of a larger population size through the integration of the 3 studies, and to determine if the efficacy profile across all 3 studies is consistent with efficacy profiles observed for individual trials.Methods: In these integrated analyses, data for 1187 patients from 3 blinded treatment groups were pooled to compare efficacy at 12 weeks: etanercept 50 mg weekly (equivalent to 25 mg twice weekly) subcutaneously, etanercept 50 ing twice weekly subcutaneously, and placebo. The primary efficacy end point in all 3 studies was at least-a 75% improvement in the Psoriasis Area and Severity Index (PASI 75). Other measurements included PASI 50, PASI 90, patient's and dermatologist's global assessments, and Dermatology Life Quality index.Results: In the integrated analyses, statistically significant, close-dependent improvements in PASI 75 at 12 weeks were observed in patients treated with etanercept 50 mg weekly (33%) and 50 mg twice weekly (49%), compared with the placebo group (3%-, P < .05). Significant improvements also were seen in all secondary end points (PASI 50 and PASI 90 responses, patient's and dermatologist's global assessments, and Dermatology Life Quality Index) at 12 weeks. Subgroup analyses of baseline patient characteristics demonstrated that there were no statistically significant treatment-by-covariate interactions.Limitations: A limitation of these integrated analyses is the relatively short (12-week) time frame.Conclusion: The efficacy profile of etanercept in patients with psoriasis was consistent across multiple studies as shown in the integrated analyses of the primary and secondary end points. Etanercept demonstrated rapid, close-dependent improvements in disease severity and quality of life consistently over all studies.