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首页> 外文期刊>The Journal of dermatology >Long‐term efficacy and safety of secukinumab in Japanese patients with moderate to severe plaque psoriasis: 3‐year results of a double‐blind extension study
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Long‐term efficacy and safety of secukinumab in Japanese patients with moderate to severe plaque psoriasis: 3‐year results of a double‐blind extension study

机译：Secukinumab在日本人中度至重度斑块牛皮癣患者的长期疗效和安全性：双盲延伸研究的3年结果

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Abstract Secukinumab, a fully human monoclonal antibody neutralizing interleukin‐17A, has been shown to have significant efficacy in the treatment of moderate to severe psoriasis. Long‐term (3‐year) efficacy and safety of secukinumab in Japanese patients with moderate to severe psoriasis were evaluated in an extension study of a large phase 3 global study ( SCULPTURE ). In the core study, 52 Japanese patients with 75% improvement of Psoriasis Area and Severity Index ( PASI ‐75) response at week 12 were re‐randomized to a fixed interval ( FI ; every 4?weeks) schedule and retreatment as needed ( RAN ), in which patients received placebo until start of relapse, at which time secukinumab was reinitiated. Fifty Japanese patients completed the 52‐week core study, and 47 patients entered the extension study with the same double‐blind regimens up to week 152. All patients in the secukinumab 300?mg FI and seven patients in 150?mg FI groups completed 3?years of treatment. PASI ‐90 and ‐100 at the end of year 3 were achieved in 69.2% and 53.8%, respectively, in 300?mg FI and 42.9% and 42.9%, respectively, in 150?mg FI , indicating high sustained response in 300?mg FI . Mean absolute PASI was continually low in 300?mg FI and numerically higher in 150?mg FI . Dermatology Life Quality Index of 0/1 was maintained by approximately two‐thirds of 300?mg FI patients, and all EuroQoL 5‐Dimension Health Questionnaire domain measures were also improved. FI dosing was consistently more efficacious than RAN . The safety profile of secukinumab remained favorable, with no new safety concerns identified.
机译：摘要Secukinumab是一种中和中和白细胞介素-17a的完全人体单克隆抗体，在治疗中度至严重牛皮癣时具有显着的功效。在大阶段3全球研究（雕塑）的扩展研究中，评估了日本中度至严重牛皮癣患者Secukinumab的长期（3年）的疗效和安全性。在核心研究中，52名日本患有75％患者的牛皮癣面积和严重程度指数（PASI -75）响应的日本患者重新随机分配到固定的间隔（FI;每4个？周）计划和撤退（RAN ），其中患者接受安慰剂直至复发开始，此时Secukinumab重新产生。 50日患者完成了52周的核心研究，47名患者进入延长研究，同一双盲方案长达152周。Secukinumab 300？MG Fi和七名患者150名患者（150名患者）完成3 ？多年的治疗。第3年底的PASI -90和-100分别在150？MG FI中分别在300×MG FI和42.9％和42.9％的情况下实现了69.2％和53.8％，表明300的高持续反应？ mg fi。平均促使300毫克持续低低，在150毫克/ mg fi中数量更高。皮肤科生活质量指数0/1维持约三分之二的300岁患者，所有Euroqol 5维度健康问卷调查域措施也得到了改善。除了跑的情况下，给药始终如一。 Secukinumab的安全性曲线仍然有利，没有确定新的安全问题。

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