Secukinumab efficacy and safety in Japanese patients with moderate-to-severe plaque psoriasis: Subanalysis from ERASURE, a randomized, placebo-controlled, phase 3 study
Secukinumab efficacy and safety in Japanese patients with moderate-to-severe plaque psoriasis: Subanalysis from ERASURE, a randomized, placebo-controlled, phase 3 study
复制标题
DOI：
10.1111/1346-8138.12668
复制
发表时间：
2014-12-01
影响因子：
3.1
通讯作者：
Nakagawa, Hidemi
中科院分区：
文献类型：
--
作者：
Ohtsuki, Mamitaro;Morita, Akimichi;Nakagawa, Hidemi
苏金单抗是一种全人源抗IL-17 A单克隆抗体，可中和银屑病发病机制中的关键细胞因子IL-17 A。作为一项大型III期全球研究（ERASURE）的一部分，在日本中度至重度斑块状银屑病患者中评价了阿基诺单抗的疗效和安全性。在这项为期52周的双盲研究（ClinicalTrials.gov标识符：NCT 01365455，JapicCTI-111529）中，87例来自日本的患者（占总体研究人群中随机分配的738例患者的11.8%）被随机平均分配至基线和第1、2、3和4周每周一次接受300 mg或150 mg或安慰剂，然后每4周一次。协同主要终点（第12周）为银屑病面积和严重程度指数（PASI 75）较基线改善75%，5分研究者总体评估量表（伊加mod 2011 0/1）评分为0（清除）或1（几乎清除），与安慰剂相比。第12周时，300 mg或150 mg组的PASI 75和伊加mod 2011 0/1应答率（分别为82.8%和55.2%）优于安慰剂组（分别为6.9%和3.4%; P
Secukinumab, a fully human anti-IL-17A monoclonal antibody, neutralizes IL-17A, a key cytokine in the pathogenesis of psoriasis. Efficacy and safety of secukinumab was evaluated in Japanese patients with moderate-to-severe plaque psoriasis as part of a large Phase 3 global study (ERASURE). In this 52-week, double-blind study (ClinicalTrials.gov Identifier: NCT01365455, JapicCTI-111529), 87 patients from Japan (11.8% of 738 patients randomized in the overall study population) were equally randomized to receive secukinumab 300mg or 150mg, or placebo once weekly at baseline and at Weeks 1, 2, 3 and 4, then every 4weeks. Co-primary endpoints (Week 12) were 75% improvement in psoriasis area-and-severity index (PASI 75) from baseline and a score of 0 (clear) or 1 (almost clear) on a 5-point Investigator's Global Assessment scale (IGA mod 2011 0/1) versus placebo. PASI 75 and IGA mod 2011 0/1 responses at Week 12 were superior with secukinumab 300mg (82.8% and 55.2%, respectively) or 150mg (86.2% and 55.2%, respectively) versus placebo (6.9% and 3.4%, respectively; P