Vunakizumab治疗对中重度斑块性银屑病患者报告结果的详细维度的影响：一项随机对照试验的事后分析（NCT04839016）。

IF 3.6 4区医学 Q2 PHARMACOLOGY & PHARMACY

Clinical therapeutics Pub Date : 2025-09-01 DOI:10.1016/j.clinthera.2025.06.017

Lijing Lv MM, Yan Zhang MDPhD

{"title":"Vunakizumab治疗对中重度斑块性银屑病患者报告结果的详细维度的影响：一项随机对照试验的事后分析（NCT04839016）。","authors":"Lijing Lv MM, Yan Zhang MDPhD","doi":"10.1016/j.clinthera.2025.06.017","DOIUrl":null,"url":null,"abstract":"<div><h3>Purpose</h3><div>This post-hoc analysis aimed to explore the effect of vunakizumab treatment on detailed dimensions of patient-reported outcomes (PROs) in moderate-to-severe plaque psoriasis patients.</div></div><div><h3>Methods</h3><div>This post-hoc analysis derived data from a randomized controlled trial (NCT04839016), which compared the efficacy and safety of vunakizumab with placebo in patients with moderate-to-severe plaque psoriasis. Patients were randomized 2:1 to receive vunakizumab 240 mg or placebo subcutaneously. At week (W)12, patients on placebo were switched to vunakizumab 240 mg. A total of 461 moderate-to-severe plaque psoriasis patients receiving vunakizumab and 229 patients receiving placebo were included in this post-hoc analysis. PROs included the Dermatology Life Quality Index (DLQI), itch numeric rating scale, EuroQol five-dimensional five-level (EQ-5D-5L), and Short Form-36 (SF-36). Items related to anxiety, depression, pruritus, pain, physical function, vitality, and health transitions were extracted from the DLQI, EQ-5D-5L, and SF-36.</div></div><div><h3>Findings</h3><div>DLQI and itch numeric rating scale scores at W4, W8, and W12 were lower in the vunakizumab group than in the placebo group (all <em>P</em> < 0.001). EQ-5D-5L and SF-36 mental/physical component scores at W4, W8, and W12 were higher in the vunakizumab group than in the placebo group (all <em>P</em> < 0.001). The mean DLQI (W0: 11.3 ± 6.9, W12: 2.2 ± 3.0, W52: 1.5 ± 3.1) and itch numeric rating scale (W0: 5.6 ± 2.6, W12: 1.6 ± 1.7, W52: 1.0 ± 1.5) scores were decreased from W0 to W52 after vunakizumab treatment. EQ-5D-5L scores (W0: 80.3 ± 16.3, W12: 90.4 ± 8.0, W52: 92.4 ± 8.1) as well as SF-36 mental (W0: 47.8 ± 10.2, W12: 53.7 ± 7.1, W52: 54.5 ± 6.9) and physical (W0: 51.4 ± 6.3, W12: 55.6 ± 4.5, W52: 55.7 ± 5.0) component scores increased from W0 to W52 after vunakizumab treatment. Anxiety, depression, pruritus, and pain were attenuated after vunakizumab treatment. Physical function, vitality, and health transitions were enhanced after vunakizumab treatment.</div></div><div><h3>Implications</h3><div>Vunakizumab sustainedly improves overall PROs in Chinese moderate-to-severe plaque psoriasis patients, especially in the dimensions of mental, neurological, and behavioral feelings.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 9","pages":"Pages 729-739"},"PeriodicalIF":3.6000,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Effects of Vunakizumab Treatment on Detailed Dimensions of Patient-Reported Outcomes in Moderate-to-Severe Plaque Psoriasis Patients: A Post-Hoc Analysis of a Randomized Controlled Trial (NCT04839016)\",\"authors\":\"Lijing Lv MM, Yan Zhang MDPhD\",\"doi\":\"10.1016/j.clinthera.2025.06.017\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Purpose</h3><div>This post-hoc analysis aimed to explore the effect of vunakizumab treatment on detailed dimensions of patient-reported outcomes (PROs) in moderate-to-severe plaque psoriasis patients.</div></div><div><h3>Methods</h3><div>This post-hoc analysis derived data from a randomized controlled trial (NCT04839016), which compared the efficacy and safety of vunakizumab with placebo in patients with moderate-to-severe plaque psoriasis. Patients were randomized 2:1 to receive vunakizumab 240 mg or placebo subcutaneously. At week (W)12, patients on placebo were switched to vunakizumab 240 mg. A total of 461 moderate-to-severe plaque psoriasis patients receiving vunakizumab and 229 patients receiving placebo were included in this post-hoc analysis. PROs included the Dermatology Life Quality Index (DLQI), itch numeric rating scale, EuroQol five-dimensional five-level (EQ-5D-5L), and Short Form-36 (SF-36). Items related to anxiety, depression, pruritus, pain, physical function, vitality, and health transitions were extracted from the DLQI, EQ-5D-5L, and SF-36.</div></div><div><h3>Findings</h3><div>DLQI and itch numeric rating scale scores at W4, W8, and W12 were lower in the vunakizumab group than in the placebo group (all <em>P</em> < 0.001). EQ-5D-5L and SF-36 mental/physical component scores at W4, W8, and W12 were higher in the vunakizumab group than in the placebo group (all <em>P</em> < 0.001). The mean DLQI (W0: 11.3 ± 6.9, W12: 2.2 ± 3.0, W52: 1.5 ± 3.1) and itch numeric rating scale (W0: 5.6 ± 2.6, W12: 1.6 ± 1.7, W52: 1.0 ± 1.5) scores were decreased from W0 to W52 after vunakizumab treatment. EQ-5D-5L scores (W0: 80.3 ± 16.3, W12: 90.4 ± 8.0, W52: 92.4 ± 8.1) as well as SF-36 mental (W0: 47.8 ± 10.2, W12: 53.7 ± 7.1, W52: 54.5 ± 6.9) and physical (W0: 51.4 ± 6.3, W12: 55.6 ± 4.5, W52: 55.7 ± 5.0) component scores increased from W0 to W52 after vunakizumab treatment. Anxiety, depression, pruritus, and pain were attenuated after vunakizumab treatment. Physical function, vitality, and health transitions were enhanced after vunakizumab treatment.</div></div><div><h3>Implications</h3><div>Vunakizumab sustainedly improves overall PROs in Chinese moderate-to-severe plaque psoriasis patients, especially in the dimensions of mental, neurological, and behavioral feelings.</div></div>\",\"PeriodicalId\":10699,\"journal\":{\"name\":\"Clinical therapeutics\",\"volume\":\"47 9\",\"pages\":\"Pages 729-739\"},\"PeriodicalIF\":3.6000,\"publicationDate\":\"2025-09-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical therapeutics\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S0149291825002346\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical therapeutics","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0149291825002346","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}

引用次数: 0

摘要

目的：本事后分析旨在探讨vunakizumab治疗对中重度斑块型银屑病患者报告结果（PROs）的详细维度的影响。方法：这项事后分析数据来自一项随机对照试验（NCT04839016），该试验比较了vunakizumab与安慰剂在中重度斑块型银屑病患者中的疗效和安全性。患者按2:1随机分组接受vunakizumab 240mg皮下注射或安慰剂。在第12周，服用安慰剂的患者改用vunakizumab 240mg。这项事后分析共纳入461名接受vunakizumab治疗的中重度斑块型银屑病患者和229名接受安慰剂治疗的患者。PROs包括Dermatology Life Quality Index （DLQI）、瘙痒数值评定量表、EuroQol五维五级（EQ-5D-5L）和brief -36 （SF-36）。从DLQI、EQ-5D-5L和SF-36中提取与焦虑、抑郁、瘙痒、疼痛、身体功能、活力和健康转变相关的项目。结果：vunakizumab组的DLQI和瘙痒数值评定量表评分在W4、W8和W12时低于安慰剂组（均P < 0.001）。vunakizumab组在W4、W8和W12时EQ-5D-5L和SF-36精神/身体成分评分高于安慰剂组（均P < 0.001）。vunakizumab治疗后DLQI （W0: 11.3±6.9,W12: 2.2±3.0,W52: 1.5±3.1）和瘙痒数值评定量表（W0: 5.6±2.6,W12: 1.6±1.7,W52: 1.0±1.5）评分均值由W0降至W52。经vunakizumab治疗后，EQ-5D-5L评分（W0: 80.3±16.3,W12: 90.4±8.0,W52: 92.4±8.1）、SF-36精神评分（W0: 47.8±10.2,W12: 53.7±7.1,W52: 54.5±6.9）、生理评分（W0: 51.4±6.3,W12: 55.6±4.5,W52: 55.7±5.0）由W0提高至W52。vunakizumab治疗后，焦虑、抑郁、瘙痒和疼痛减轻。vunakizumab治疗后，身体功能、活力和健康转变得到增强。结论：Vunakizumab持续改善中国中重度斑块型银屑病患者的总体PROs，特别是在精神、神经和行为感受方面。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

查看原文本刊更多论文

Effects of Vunakizumab Treatment on Detailed Dimensions of Patient-Reported Outcomes in Moderate-to-Severe Plaque Psoriasis Patients: A Post-Hoc Analysis of a Randomized Controlled Trial (NCT04839016)

Purpose

This post-hoc analysis aimed to explore the effect of vunakizumab treatment on detailed dimensions of patient-reported outcomes (PROs) in moderate-to-severe plaque psoriasis patients.

Methods

This post-hoc analysis derived data from a randomized controlled trial (NCT04839016), which compared the efficacy and safety of vunakizumab with placebo in patients with moderate-to-severe plaque psoriasis. Patients were randomized 2:1 to receive vunakizumab 240 mg or placebo subcutaneously. At week (W)12, patients on placebo were switched to vunakizumab 240 mg. A total of 461 moderate-to-severe plaque psoriasis patients receiving vunakizumab and 229 patients receiving placebo were included in this post-hoc analysis. PROs included the Dermatology Life Quality Index (DLQI), itch numeric rating scale, EuroQol five-dimensional five-level (EQ-5D-5L), and Short Form-36 (SF-36). Items related to anxiety, depression, pruritus, pain, physical function, vitality, and health transitions were extracted from the DLQI, EQ-5D-5L, and SF-36.

Findings

DLQI and itch numeric rating scale scores at W4, W8, and W12 were lower in the vunakizumab group than in the placebo group (all P < 0.001). EQ-5D-5L and SF-36 mental/physical component scores at W4, W8, and W12 were higher in the vunakizumab group than in the placebo group (all P < 0.001). The mean DLQI (W0: 11.3 ± 6.9, W12: 2.2 ± 3.0, W52: 1.5 ± 3.1) and itch numeric rating scale (W0: 5.6 ± 2.6, W12: 1.6 ± 1.7, W52: 1.0 ± 1.5) scores were decreased from W0 to W52 after vunakizumab treatment. EQ-5D-5L scores (W0: 80.3 ± 16.3, W12: 90.4 ± 8.0, W52: 92.4 ± 8.1) as well as SF-36 mental (W0: 47.8 ± 10.2, W12: 53.7 ± 7.1, W52: 54.5 ± 6.9) and physical (W0: 51.4 ± 6.3, W12: 55.6 ± 4.5, W52: 55.7 ± 5.0) component scores increased from W0 to W52 after vunakizumab treatment. Anxiety, depression, pruritus, and pain were attenuated after vunakizumab treatment. Physical function, vitality, and health transitions were enhanced after vunakizumab treatment.

Implications

Vunakizumab sustainedly improves overall PROs in Chinese moderate-to-severe plaque psoriasis patients, especially in the dimensions of mental, neurological, and behavioral feelings.

求助全文

通过发布文献求助，成功后即可免费获取论文全文。去求助

来源期刊

Clinical therapeutics 医学-药学

CiteScore

6.00

自引率

3.10%

发文量

154

审稿时长

9 weeks

期刊介绍： Clinical Therapeutics provides peer-reviewed, rapid publication of recent developments in drug and other therapies as well as in diagnostics, pharmacoeconomics, health policy, treatment outcomes, and innovations in drug and biologics research. In addition Clinical Therapeutics features updates on specific topics collated by expert Topic Editors. Clinical Therapeutics is read by a large international audience of scientists and clinicians in a variety of research, academic, and clinical practice settings. Articles are indexed by all major biomedical abstracting databases.