Guselkumab治疗连续156周皮肤完全清除的斑块型银屑病患者:VOYAGE 1临床试验的事后分析。

IF 8.6 1区 医学 Q1 DERMATOLOGY American Journal of Clinical Dermatology Pub Date : 2023-10-07 DOI:10.1007/s40257-023-00816-1
Luis Puig, Antonio Costanzo, Elke M. G. J. de Jong, Tiago Torres, Richard B. Warren, Robert Wapenaar, Sven Wegner, Patricia Gorecki, Talia Gramiccia, Maria Jazra, Jozefien Buyze, Curdin Conrad
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引用次数: 0

摘要

背景:与传统的非生物治疗相比,用生物制剂(如古斯库单抗)治疗中度至重度斑块型银屑病已显示出更大的疗效。然而,考虑到患者的多样性,更好地了解患者特征、积极的临床结果和对生物制品的长期反应之间的关系对于优化治疗选择至关重要。材料和方法:这项为期5年的VOYAGE 1临床试验的事后分析使用描述性统计和多元逻辑回归模型,比较了连续156周在所有就诊中保持银屑病面积和严重程度指数(PASI)评分为0的患者(PASI=0组)和从未达到PASI=0的患者(对照组)的基线特征。从第4-156周开始评估两个反应组的古selkumab血浆谷浓度。结果:在从安慰剂切换到第0周或第16周开始接受古selku单抗治疗的患者中,22.7%(112/494)的患者连续156周保持PASI=0。PASI=0组和对照组在基线特征(包括年龄、肥胖、糖尿病、PASI评分、疾病持续时间、吸烟状况和银屑病关节炎合并症)方面存在数字差异。PASI=0组的血浆guselkumab水平始终较高。多元逻辑回归分析显示,没有糖尿病,基线时皮肤病学生活质量指数评分较低,第4周古斯库单抗血浆浓度较高,具有显著性(p结论:在VOYAGE 1临床试验中,大量(22.7%)古斯库治疗的患者连续≥156周保持完全皮肤清除。与这一结果相关的因素可能表明整体治疗方法的临床益处。试验注册号:NCT02207231。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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Guselkumab-Treated Patients with Plaque Psoriasis Who Achieved Complete Skin Clearance for ≥ 156 Consecutive Weeks: A Post-Hoc Analysis From the VOYAGE 1 Clinical Trial

Background

Treatment of moderate-to-severe plaque psoriasis with biologics, such as guselkumab, has demonstrated greater efficacy over traditional non-biologic treatments. However, given patient diversity, greater understanding of the relationship between patient characteristics, positive clinical outcomes, and long-term response to biologics is crucial for optimizing treatment choices.

Materials and Methods

This post-hoc analysis of the 5-year VOYAGE 1 clinical trial compares baseline characteristics of patients maintaining a Psoriasis Area and Severity Index (PASI) score of 0 at all visits for ≥ 156 consecutive weeks (PASI = 0 group) with those that never achieve PASI = 0 (comparator group), using descriptive statistics and a multiple logistic regression model. Guselkumab plasma trough concentrations in both response groups were assessed from Weeks 4–156.

Results

Of patients who started guselkumab treatment at Week 0 or at Week 16 after switching from placebo, 22.7% (112/494) maintained PASI = 0 for ≥ 156 consecutive weeks. Numerical differences in baseline characteristics, including age, obesity, diabetes, PASI score, disease duration, smoking status, and psoriatic arthritis comorbidity, were identified between the PASI = 0 group and comparator group. Plasma guselkumab levels were consistently higher in the PASI = 0 group. Multiple logistic regression analysis revealed absence of diabetes, lower Dermatology Life Quality Index score at baseline, and higher Week 4 guselkumab plasma concentration as significantly (p < 0.05) associated with the PASI = 0 group.

Conclusion

A substantial (22.7%) number of guselkumab-treated patients in the VOYAGE 1 clinical trial maintained complete skin clearance for a consecutive period of ≥ 156 weeks. Factors associated with this outcome may suggest clinical benefits of holistic treatment approaches.

Trial Registration

NCT02207231.

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来源期刊
CiteScore
15.20
自引率
2.70%
发文量
84
审稿时长
>12 weeks
期刊介绍: The American Journal of Clinical Dermatology is dedicated to evidence-based therapy and effective patient management in dermatology. It publishes critical review articles and clinically focused original research covering comprehensive aspects of dermatological conditions. The journal enhances visibility and educational value through features like Key Points summaries, plain language summaries, and various digital elements, ensuring accessibility and depth for a diverse readership.
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