Gottlieb A B, Kubanov A, van Doorn M, Sullivan J, Papp K A, You R, Regnault P, Frueh J A
Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, U.S.A.
State Scientific Center of Dermatology, Venereology and Cosmetology, Moscow, Russia.
Br J Dermatol. 2020 Apr;182(4):889-899. doi: 10.1111/bjd.18331. Epub 2019 Dec 15.
BACKGROUND: Secukinumab has shown sustained efficacy and safety in several manifestations of psoriasis. OBJECTIVES: GESTURE investigated the long-term (2·5-year) safety and efficacy of 150 mg and 300 mg subcutaneous secukinumab in 205 patients with moderate-to-severe palmoplantar psoriasis. METHODS: GESTURE was a randomized, double-blind, placebo-controlled, multicentre, phase IIIb trial conducted across 15 countries. The study was 140 weeks long and consisted of four periods: screening (up to 4 weeks), treatment period 1 (16 weeks), treatment period 2 (116 weeks) and post-treatment follow-up (8 weeks). Eligible patients were aged ≥ 18 years with moderate-to-severe palmoplantar psoriasis and at least one plaque outside of the palms and soles. Efficacy was assessed via a palmoplantar Investigator's Global Assessment (ppIGA) and the palmoplantar Psoriasis Area and Severity Index (PASI). RESULTS: The primary end point, a ppIGA score of 0 or 1, was met at week 16. The effect was sustained over 2·5 years with 59% [95% confidence interval (CI) 43·5-74·1] and 53% (95% CI 35·1-69·6) of patients in the secukinumab 300 mg and 150 mg groups, respectively, achieving clear or almost clear palms and soles (ppIGA 0 or 1). At 2·5 years, the mean palmoplantar PASI percentage was reduced in both the secukinumab 300 mg group (-74·7%) and the secukinumab 150 mg group (-61·6%). A total of 17% (secukinumab 300 mg group) and 18% (secukinumab 150 mg group) of patients experienced no difficulty in hands and feet functionality, as indicated by the palmoplantar quality of life instrument overall scores. The safety profile was favourable. CONCLUSIONS: GESTURE revealed that secukinumab provides a strong and sustained response over 2·5 years in challenging-to-treat palmoplantar psoriasis.
背景:司库奇尤单抗在银屑病的多种表现形式中已显示出持续的疗效和安全性。 目的:GESTURE研究了皮下注射150mg和300mg司库奇尤单抗对205例中重度掌跖银屑病患者的长期(2.5年)安全性和疗效。 方法:GESTURE是一项在15个国家进行的随机、双盲、安慰剂对照、多中心IIIb期试验。该研究为期140周,包括四个阶段:筛查(最长4周)、治疗期1(16周)、治疗期2(116周)和治疗后随访(8周)。符合条件的患者年龄≥18岁,患有中重度掌跖银屑病,手掌和脚底以外至少有一个斑块。通过掌跖研究者整体评估(ppIGA)和掌跖银屑病面积和严重程度指数(PASI)评估疗效。 结果:在第16周达到了主要终点,即ppIGA评分为0或1。这种效果在2.5年中持续存在,司库奇尤单抗300mg组和150mg组分别有59%[95%置信区间(CI)43.5 - 74.1]和53%(95%CI 35.1 - 69.6)的患者手掌和脚底达到清除或几乎清除(ppIGA 0或1)。在2.5年时,司库奇尤单抗300mg组(-74.7%)和司库奇尤单抗150mg组(-61.6%)的平均掌跖PASI百分比均有所降低。根据掌跖生活质量工具总体评分,司库奇尤单抗300mg组有17%的患者和司库奇尤单抗150mg组有18%的患者在手脚功能方面没有困难。安全性良好。 结论:GESTURE研究表明,司库奇尤单抗在治疗具有挑战性的掌跖银屑病方面,2.5年内可提供强烈且持续的反应。
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