Department of Dermatology, IIB Sant Pau, Hospital de Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain.
Dermatology, Department of Biomedical Sciences, Humanitas University, Milan, Italy.
Am J Clin Dermatol. 2024 Mar;25(2):315-325. doi: 10.1007/s40257-023-00816-1. Epub 2023 Oct 7.
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.
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.
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.
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.
NCT02207231.
与传统非生物制剂相比,古塞库单抗等生物制剂治疗中重度斑块状银屑病的疗效更为显著。然而,鉴于患者的多样性,更深入地了解患者特征、阳性临床结果和对生物制剂的长期反应之间的关系对于优化治疗选择至关重要。
这项对为期 5 年的 VOYAGE 1 临床试验的事后分析比较了在所有访视中连续 156 周以上 PASI 评分均为 0 的患者(PASI = 0 组)与从未达到 PASI = 0 的患者(对照组)的基线特征,使用描述性统计和多逻辑回归模型。在这两个反应组中,从第 4 周到第 156 周评估了古塞库单抗的血浆谷浓度。
在开始古塞库单抗治疗的患者中,有 22.7%(112/494)在连续 156 周以上达到 PASI = 0。PASI = 0 组和对照组之间在基线特征方面存在数值差异,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。PASI = 0 组的古塞库单抗血浆水平始终较高。多逻辑回归分析显示,无糖尿病、基线时皮肤病生活质量指数评分较低、第 4 周古塞库单抗血浆浓度较高与 PASI = 0 组显著相关(p < 0.05)。
在 VOYAGE 1 临床试验中,相当数量(22.7%)接受古塞库单抗治疗的患者连续 156 周以上达到完全皮肤清除。与这一结果相关的因素可能表明整体治疗方法具有临床益处。
NCT02207231。