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首页> 外文期刊>The New England journal of medicine >Brodalumab, an anti-interleukin-17-receptor antibody for psoriasis
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Brodalumab, an anti-interleukin-17-receptor antibody for psoriasis

机译：Brodalumab，一种抗牛皮癣的抗白介素17受体抗体

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BACKGROUND: In this phase 2, randomized, double-blind, placebo-controlled, dose-ranging study, we assessed the efficacy and safety of brodalumab (AMG 827), a human anti- interleukin-17-receptor monoclonal antibody, for the treatment of moderate-tosevere plaque psoriasis. METHODS:We randomly assigned patients with a score of 12 or higher on the psoriasis area-and-severity index (PASI, on which scores range from 0 to 72, with higher scores indicating more severe disease) and with 10% or more of their body-surface area affected by psoriasis to receive brodalumab (70 mg, 140 mg, or 210 mg at day 1 and weeks 1, 2, 4, 6, 8, and 10 or 280 mg monthly) or placebo. The primary end point was the percentage improvement from baseline in the PASI score at week 12. Secondary end points included improvement of at least 75% and at least 90% in the PASI score and the score on the static physician's global assessment at week 12. RESULTS: A total of 198 patients underwent randomization. At week 12, the mean percentage improvements in the PASI score were 45.0% among patients receiving 70 mg of brodalumab, 85.9% among those receiving 140 mg, 86.3% among those receiving 210 mg, 76.0% among those receiving 280 mg, and 16.0% among those receiving placebo (P<0.001 for all comparisons with placebo). An improvement of at least 75% and at least 90% in the PASI score at week 12 was seen in 77% and 72%, respectively, of the patients in the 140-mg brodalumab group and in 82% and 75%, respectively, of the patients in the 210-mg group, as compared with 0% in the placebo group (P<0.001 for all comparisons). The percentage of patients with a static physician's global assessment of clear or minimal disease was 26%, 85%, 80%, and 69% with the 70-mg, 140-mg, 210-mg, and 280-mg doses, respectively, of brodalumab, as compared with 3% with placebo (P<0.01 for all comparisons with placebo). Two cases of grade 3 neutropenia were reported in the 210-mg brodalumab group. The most commonly reported adverse events in the combined brodalumab groups were nasopharyngitis (8%), upper respiratory tract infection (8%), and injection-site erythema (6%). CONCLUSIONS:Brodalumab significantly improved plaque psoriasis in this 12-week, phase 2 study. (Funded by Amgen; ClinicalTrials.gov number, NCT00975637.)
机译：背景：在该阶段2中，我们进行了随机，双盲，安慰剂对照，剂量范围研究，评估了人类抗白介素17受体单克隆抗体Brodalumab（AMG 827）的疗效和安全性中度至重度斑块状牛皮癣方法：我们随机分配银屑病面积和严重程度指数（PASI，分数从0到72，分数越高表示疾病越严重）的得分为12分或更高的患者，并且他们的10％或更高受牛皮癣影响的身体表面积，以接受溴达单抗（第1天和第1、2、4、6、8和10或280 mg每月一次，每天70 mg，140 mg或210 mg）或安慰剂。主要终点是在第12周时PASI得分较基线提高的百分比。次要终点包括第12周时PASI得分和静态医师的整体评估得分分别提高了至少75％和至少90％。结果：总共198例患者接受了随机分组。在第12周，PASI评分的平均改善百分比在接受溴达单抗70 mg的患者中为45.0％，接受140 mg的患者为85.9％，接受210 mg的患者为86.3％，接受280 mg的患者为76.0％，以及16.0％在接受安慰剂的患者中（与安慰剂进行的所有比较，P <0.001）。 140 mg溴达单抗组的患者在第12周时的PASI评分分别提高了至少75％和至少90％，分别为82％和75％，分别为77％和72％。 210毫克治疗组中有90％的患者接受治疗，而安慰剂治疗组为0％（所有比较的P <0.001）。静态医师对明确或轻微疾病进行整体评估的患者百分比分别为70毫克，140毫克，210毫克和280毫克，分别为26％，85％，80％和69％，与安慰剂组相比为3％（与安慰剂的所有比较，P <0.01）。在210 mg溴达单抗组中报告了2例3级中性粒细胞减少症。在合并的Brodalumab组中，最常见的不良事件是鼻咽炎（8％），上呼吸道感染（8％）和注射部位红斑（6％）。结论：在这项为期12周的2期研究中，Brodalumab显着改善了斑块状牛皮癣。 （由Amgen资助; ClinicalTrials.gov编号，NCT00975637。）

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