Efficacy of Ixekizumab in Chinese Patients with Moderate-to-Severe Psoriasis and Special Body Area Involvement: Sub-analysis of a Randomized, Double-Blind, Multicenter Phase 3 Study.

IF 3.4 3区医学 Q2 MEDICINE, RESEARCH & EXPERIMENTAL Advances in Therapy Pub Date : 2024-09-30 DOI:10.1007/s12325-024-02976-w

Xia Li, Yangfeng Ding, Chunlei Zhang, Yan Lu, Fuqiu Li, Weili Pan, Shuping Guo, Jinnan Li, Bilian Zhao, Jie Zheng

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Abstract

Introduction: Special body area involvement is common in psoriasis and can be challenging to treat. We investigated the efficacy of ixekizumab (IXE) in Chinese patients with moderate-to-severe psoriasis and fingernail, scalp, or palmoplantar involvement.

Methods: A post-hoc sub-analysis of a phase 3 trial, in which patients were randomized to receive placebo, IXE 80 mg every 2 (IXE Q2W) or 4 (IXE Q4W) weeks. At Week 12, patients classified as IXE responders [static Physician's Global Assessment (sPGA) score of 0 or 1 [0,1)] were re-randomized (2:1) to IXE Q4W or placebo until Week 60. Efficacy was assessed by body-region specific parameters including Nail Psoriasis Severity Index (NAPSI), Psoriasis Scalp Severity Index (PSSI), and Palmoplantar Psoriasis Area Severity Index (PPASI).

Results: Of 438 patients, 99.1% (434) had ≥ 1 special area involvement [fingernail (76.5%, 335), scalp (97.3%, 426), palmoplantar (27.9%, 122)]. Significantly greater improvements from baseline in NAPSI score were observed with IXE Q4W and Q2W at Week 12 versus placebo (p < 0.001 for both). These improvements were further increased and sustained over 60 weeks in IXE Q4W and Q2W responders who were re-randomized to IXE Q4W, who achieved a 77.9% and 89.7% improvement from baseline, respectively, at Week 60. Significantly higher proportions of patients receiving IXE Q4W and Q2W achieved NAPSI 50 at Week 12 versus placebo (44.4%, 36.6% vs. 14.1%; p < 0.001 and < 0.01, respectively). Similarly, significantly higher proportions of patients receiving IXE Q4W and Q2W achieved PSSI 100 and PPASI 100 at Week 12 versus placebo (60.6% and 65.1% vs. 1.2%, and 67.4%, 84.3% vs. 21.4%, respectively; p < 0.001 for all comparisons). Improvements across all outcomes were sustained in patients re-randomized to IXE Q4W until Week 60.

Conclusion: IXE led to a rapid onset of action and sustained efficacy over 60 weeks in Chinese patients with moderate-to-severe psoriasis and special body area involvement.

Clinicaltrials: gov identifier, NCT03364309.

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伊昔单抗对中重度银屑病和特殊体质患者的疗效：一项随机、双盲、多中心 3 期研究的子分析。

简介：特殊身体部位受累是银屑病的常见症状，治疗起来具有挑战性。我们研究了ixekizumab（IXE）对中国中重度银屑病患者以及指甲、头皮或掌跖受累患者的疗效：对一项三期试验进行事后子分析，患者被随机分配接受安慰剂、IXE 80 毫克，每两周一次（IXE Q2W）或四周一次（IXE Q4W）。第12周时，被归类为IXE应答者（静态医生总体评估（sPGA）评分为0或1 [0,1)）的患者被重新随机分配（2:1）至IXE Q4W或安慰剂，直至第60周。疗效通过身体区域特定参数进行评估，包括指甲银屑病严重程度指数（NAPSI）、头皮银屑病严重程度指数（PSSI）和掌跖银屑病面积严重程度指数（PPASI）：在 438 名患者中，99.1%（434 人）有≥ 1 个特殊部位受累[指甲（76.5%，335 人）、头皮（97.3%，426 人）、掌跖（27.9%，122 人）]。与安慰剂相比，IXE Q4W 和 Q2W 在第 12 周的 NAPSI 评分与基线相比有显著提高（p 结论：IXE 在第 12 周的 NAPSI 评分与基线相比有显著提高：IXE对中重度银屑病和特殊身体部位受累的中国患者起效迅速，疗效持续60周。

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来源期刊

Advances in Therapy 医学-药学

CiteScore

7.20

自引率

2.60%

发文量

353

审稿时长

6-12 weeks

期刊介绍： Advances in Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all therapeutic areas. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Advances in Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.