文献检索文档翻译深度研究
Suppr Zotero 插件Zotero 插件
邀请有礼套餐&价格历史记录

新学期,新优惠

限时优惠:9月1日-9月22日

30天高级会员仅需29元

1天体验卡首发特惠仅需5.99元

了解详情
不再提醒
插件&应用
Suppr Zotero 插件Zotero 插件浏览器插件Mac 客户端Windows 客户端微信小程序
高级版
套餐订阅购买积分包
AI 工具
文献检索文档翻译深度研究
关于我们
关于 Suppr公司介绍联系我们用户协议隐私条款
关注我们

Suppr 超能文献

核心技术专利:CN118964589B侵权必究
粤ICP备2023148730 号-1Suppr @ 2025

司库奇尤单抗治疗中重度头皮银屑病的疗效:一项 24 周、随机、双盲、安慰剂对照的 3b 期研究结果。

The effect of secukinumab on moderate-to-severe scalp psoriasis: Results of a 24-week, randomized, double-blind, placebo-controlled phase 3b study.

机构信息

Psoriasis Treatment Center of Central New Jersey, East Windsor, New Jersey.

Department of Dermatology, University of Utah, Salt Lake City, Utah.

出版信息

J Am Acad Dermatol. 2017 Oct;77(4):667-674. doi: 10.1016/j.jaad.2017.05.033. Epub 2017 Aug 2.


DOI:10.1016/j.jaad.2017.05.033
PMID:28780364
Abstract

BACKGROUND: Moderate-to-severe scalp psoriasis has not been evaluated in prospective trials of patients without moderate-to-severe body psoriasis. OBJECTIVE: Evaluate the efficacy and safety of secukinumab in moderate-to-severe scalp psoriasis. METHODS: In this 24-week, double-blind, phase 3b study, 102 patients were randomized 1:1 to subcutaneous secukinumab 300 mg or placebo at baseline, weeks 1, 2, and 3, and then every 4 weeks from week 4 to 20. The primary efficacy variable was 90% improvement of Psoriasis Scalp Severity Index (PSSI 90) score from baseline to week 12. RESULTS: At week 12, PSSI 90 (secukinumab 300 mg vs placebo, 52.9% vs 2.0%) and Investigator's Global Assessment modified 2011 scalp responses of 0 or 1 (secukinumab 300 mg vs placebo, 56.9% vs 5.9%) were significantly greater with secukinumab 300 mg than placebo (P < .001 for both). In addition, significantly more patients achieved complete clearance of scalp psoriasis at week 12 with secukinumab 300 mg than placebo (35.3% vs 0%; P < .001). The median time to 50% reduction in PSSI score was 3.29 weeks with secukinumab 300 mg. The safety profile of secukinumab was consistent with previous phase 3 studies. LIMITATIONS: There was no active comparator arm. CONCLUSION: Secukinumab is efficacious and well-tolerated for patients with extensive moderate-to-severe scalp psoriasis.

摘要

背景:中重度头皮银屑病患者在不伴中重度体银屑病的患者的前瞻性研究中尚未得到评估。

目的:评估司库奇尤单抗治疗中重度头皮银屑病的疗效和安全性。

方法:在这项为期 24 周的、双盲、3b 期研究中,102 例患者按 1:1 的比例随机分组,分别于基线、第 1、2 和 3 周及第 4 周开始每 4 周皮下注射司库奇尤单抗 300mg 或安慰剂,直至第 20 周。主要疗效变量为从基线到第 12 周时头皮银屑病严重程度指数(PSSI 90)评分改善 90%。

结果:第 12 周时,司库奇尤单抗 300mg 组 PSSI 90(52.9% vs. 2.0%)和改良 2011 年研究者全球评估头皮反应 0 或 1(56.9% vs. 5.9%)的比例显著高于安慰剂组(均 P < 0.001)。此外,司库奇尤单抗 300mg 组在第 12 周时达到头皮银屑病完全清除的患者比例显著高于安慰剂组(35.3% vs. 0%;P < 0.001)。司库奇尤单抗 300mg 组 PSSI 评分降低 50%的中位数时间为 3.29 周。司库奇尤单抗的安全性与之前的 3 期研究一致。

局限性:没有活性对照臂。

结论:司库奇尤单抗治疗广泛中重度头皮银屑病患者疗效确切,耐受性良好。

相似文献

[1]
The effect of secukinumab on moderate-to-severe scalp psoriasis: Results of a 24-week, randomized, double-blind, placebo-controlled phase 3b study.

J Am Acad Dermatol. 2017-8-2

[2]
Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate-to-severe plaque psoriasis up to 1 year: Results from the CLEAR study.

J Am Acad Dermatol. 2016-9-20

[3]
Secukinumab shows significant efficacy in palmoplantar psoriasis: Results from GESTURE, a randomized controlled trial.

J Am Acad Dermatol. 2016-10-1

[4]
Efficacy and safety of secukinumab in the treatment of moderate-to-severe plaque psoriasis: a randomized, double-blind, placebo-controlled phase II dose-ranging study.

Br J Dermatol. 2013-1-18

[5]
Efficacy, safety and usability of secukinumab administration by autoinjector/pen in psoriasis: a randomized, controlled trial (JUNCTURE).

J Eur Acad Dermatol Venereol. 2014-9-22

[6]
Secukinumab in plaque psoriasis--results of two phase 3 trials.

N Engl J Med. 2014-7-9

[7]
Secukinumab for moderate-to-severe palmoplantar pustular psoriasis: Results of the 2PRECISE study.

J Am Acad Dermatol. 2019-2-1

[8]
Secukinumab administration by pre-filled syringe: efficacy, safety and usability results from a randomized controlled trial in psoriasis (FEATURE).

Br J Dermatol. 2014-12-11

[9]
Secukinumab efficacy and safety in Japanese patients with moderate-to-severe plaque psoriasis: subanalysis from ERASURE, a randomized, placebo-controlled, phase 3 study.

J Dermatol. 2014-12

[10]
Sustained response with ixekizumab treatment of moderate-to-severe psoriasis with scalp involvement: results from three phase 3 trials (UNCOVER-1, UNCOVER-2, UNCOVER-3).

J Dermatolog Treat. 2017-6

引用本文的文献

[1]
Guselkumab for Moderate to Severe Scalp Psoriasis Across All Skin Tones: Cohort B of the VISIBLE Randomized Clinical Trial.

JAMA Dermatol. 2025-6-25

[2]
Psoriatic Alopecia: Clinical Features, Pathogenesis, and Emerging Treatment Strategies.

Skin Appendage Disord. 2025-5-28

[3]
Biologic and Non-Biologic Therapies for Scalp Psoriasis: A Network Meta-analysis of Randomized Controlled Trials.

Dermatol Pract Concept. 2025-4-1

[4]
Biologics for the Treatment of Moderate-to-Severe Plaque Psoriasis: A Systematic Review and Network Meta-analysis.

Dermatol Ther (Heidelb). 2025-5-6

[5]
From the Masterclasses in Dermatology 2024 Meeting: Updates in Psoriasis Treatments.

J Clin Aesthet Dermatol. 2025-2

[6]
The Impact of Interleukin-17 Inhibitors on Major Adverse Cardiovascular Events in Psoriasis or Psoriatic Arthritis Patients Naive to Biologic Agents: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Cureus. 2024-5-24

[7]
A Real-Life 208 Week Single-Centred, Register-Based Retrospective Study Assessing Secukinumab Survival and Long-Term Efficacy and Safety Among Greek Patients with Moderate to Severe Plaque Psoriasis, Including Difficult-to-Treat Manifestations Such as Genitals and Scalp.

Dermatol Pract Concept. 2024-4-1

[8]
Tobacco smoking negatively influences the achievement of greater than three-quarters reduction in psoriasis area and severity index after eight weeks of treatment among patients with psoriasis: Findings from a prospective study.

Tob Induc Dis. 2024-4-11

[9]
Effects of secukinumab and ixekizumab on major adverse cardiovascular events in patients with psoriasis: a meta-analysis of randomized controlled trials.

Front Med (Lausanne). 2024-3-6

[10]
Guselkumab in Patients with Scalp Psoriasis: A post hoc Analysis of the VOYAGE 2 Phase III Randomized Clinical Trial.

Acta Derm Venereol. 2024-3-4

文献AI研究员

20分钟写一篇综述,助力文献阅读效率提升50倍

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

推荐工具

医学文档翻译智能文献检索