Modern Dermatology, A Baylor Health Texas Affiliate, Dallas, TX, USA.
Expert Rev Clin Immunol. 2011 Jan;7(1):9-13. doi: 10.1586/eci.10.92.
The first biologic therapy for psoriasis was approved in 2003. Other approvals followed, including TNF-α inhibitors, and in addition to providing new treatment options that were greatly needed, these therapies increased our understanding of the immunopathogenesis of psoriasis. Clinical trial activity increased, but all biologic trials were placebo controlled with no active comparators. In 2009, ustekinumab, a new agent that targets the p40 subunit of cytokines IL-12 and IL-23, was approved. In 2010, the Active Comparator (CNTO1275/Enbrel) Psoriasis Trial (ACCEPT) was published, the first active comparator trial of psoriasis biologic agents, comparing ustekinumab and the TNF antagonist etanercept. Here, we describe the results of the ACCEPT trial and offer an expert commentary on the results and implications for psoriasis treatment and research.
2003 年，第一种用于治疗银屑病的生物制剂获得批准。此后又有其他批准，包括 TNF-α 抑制剂，这些疗法除了提供急需的新治疗选择外，还提高了我们对银屑病免疫发病机制的理解。临床试验活动增加，但所有生物制剂试验均为安慰剂对照，无活性对照剂。2009 年，靶向细胞因子 IL-12 和 IL-23 的 p40 亚单位的新型药物乌司奴单抗获得批准。2010 年，发表了比较银屑病生物制剂的主动对照试验（ACCEPT），即对照药物（CNTO1275/Enbrel）银屑病试验，这是首个比较银屑病生物制剂的主动对照试验，比较乌司奴单抗和 TNF 拮抗剂依那西普。在这里，我们描述了 ACCEPT 试验的结果，并对结果及其对银屑病治疗和研究的意义进行了专家评论。
