Adalimumab therapy for moderate to severe psoriasis: A randomized, controlled phase III trial
Adalimumab therapy for moderate to severe psoriasis: A randomized, controlled phase III trial
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DOI：
10.1016/j.jaad.2007.09.010
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发表时间：
2008-01-01
影响因子：
13.8
通讯作者：
Papp, Kim
中科院分区：
文献类型：
--
作者：
Menter, Alan;Tyring, Stephen K.;Papp, Kim
背景资料：阿达木单抗是一种全人源单克隆抗体，可与肿瘤坏死因子结合，肿瘤坏死因子是参与银屑病发病机制的关键促炎细胞因子。我们试图评估阿达木单抗的临床疗效和安全性为中度至重度银屑病和调查连续与中断therapy.Methods：我们进行了一项为期52周的多中心研究，1212例患者随机接受阿达木单抗（40毫克）或安慰剂每隔一周的前15周。在多阶段研究中，至少75%的银屑病面积和严重程度指数（PASI）评分改善是进步的标准。第16周时，71%（578/814）的阿达木单抗治疗患者和7%（26/398）的安慰剂治疗患者的PASI评分改善≥ 75%。在第33 - 52周，重新随机分配至安慰剂组的患者中，（定义为PASI反应相对于基线改善< 50%，并且PASI评分从第33周起至少增加6分）为28%，而连续使用阿达木单抗治疗的患者为5%。缺乏一个积极的比较和评价超过52周的反应维持是limitations.Conclusion：阿达木单抗是有效的，在治疗慢性斑块状银屑病的耐受性良好。
Background: Adalimumab is a fully human monoclonal antibody that binds tumor necrosis factor, a key proinflammatory cytokine involved in the pathogenesis of psoriasis.Objective. We sought to evaluate clinical efficacy and safety of adalimumab for moderate to severe psoriasis and investigate continuous versus interrupted therapy.Methods: We conducted a 52-week, multicenter study of 1212 patients randomized to receive adalimumab (40 mg) or placebo every other week for the first 15 weeks. At least 75% improvement in the Psoriasis Area and Severity Index (PASI) score was the criterion for advancement through this multiphase study.Results. At week 16, 71% (578 of 814) of adalimumab- and 7% (26 of 398) of placebo-treated patients achieved greater than or equal to 75% improvement in the PASI score. During weeks 33 to 52, the percentage of patients rerandomized to placebo who lost adequate response (defined as < 50% improvement in the PASI response relative to baseline and at least a 6-point increase in PASI score from week 33) was 28% compared with 5% of patients treated continuously with adalimumab.Limitations: Lack of an active comparator and evaluation of maintenance of response beyond week 52 are limitations.Conclusion: Adalimumab is efficacious and well-tolerated in the treatment of chronic plaque psoriasis.