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在第 3 阶段 NAVIGATE 试验中,接受乌司奴单抗治疗后仍有持续性轻度银屑病的患者在转换为古塞丽珠单抗后,皮肤清除率和患者报告结局有更大的改善。

Patients with Persistent Mild Psoriasis after Treatment with Ustekinumab Achieved Greater Improvements in Skin Clearance and Patient-reported Outcomes after Switching to Guselkumab in the Phase 3 NAVIGATE Trial.

机构信息

University Hospital "Santa Maria della Misericordia," Udine, Italy.

Department of Dermatology, Medical University of Graz, Graz, Austria.

出版信息

Acta Derm Venereol. 2024 Sep 5;104:adv41053. doi: 10.2340/actadv.v104.41053.

Abstract

Mild psoriasis may be burdensome; if symptoms are inadequately controlled, switching therapy may be warranted. In the Phase 3 NAVIGATE trial, patients with moderate-to-severe plaque psoriasis received ustekinumab for 16 weeks. Patients with inadequate response (Investigator's Global Assessment [IGA] ≥ 2) were randomized to switch to guselkumab or continue ustekinumab. This post-hoc analysis evaluated the patient subgroup with residual mild psoriasis (IGA = 2) after initial ustekinumab therapy. Outcomes assessed included the Psoriasis Area and Severity Index (PASI), Dermatology Life Quality Index (DLQI), and Psoriasis Symptoms and Signs Diary (PSSD). Initially, 871 patients received ustekinumab. At Week 16, 161 randomized patients had residual mild psoriasis (IGA = 2). Among guselkumab- vs ustekinumab-treated patients at Week 28, 59.0% vs 27.7% achieved PASI 90, and 50.0% vs 21.0% achieved DLQI 0/1. Mean changes from baseline in PSSD score were -44 vs -28 and -50 vs -32, respectively, with thresholds of -40 considered clinically meaningful. Mean changes in PSSD itch score were -4.6 vs -2.9, with reductions ≥ 4.0 considered clinically meaningful. Treatment differences were maintained/increased through Week 52. Among patients with residual mild psoriasis after 16 weeks of ustekinumab, those switching to guselkumab had greater improvements in skin clearance, health-related quality of life, and patient-reported symptoms and signs than those continuing ustekinumab.

摘要

轻度银屑病可能会带来负担;如果症状控制不佳,可能需要转换治疗。在 3 期 NAVIGATE 试验中,中重度斑块型银屑病患者接受乌司奴单抗治疗 16 周。对治疗应答不足的患者(研究者全球评估 [IGA] ≥ 2)随机分为切换至古塞库单抗或继续乌司奴单抗组。本事后分析评估了初始乌司奴单抗治疗后仍存在轻度银屑病(IGA = 2)的患者亚组。评估的结局包括银屑病面积和严重程度指数(PASI)、皮肤病生活质量指数(DLQI)和银屑病症状和体征日记(PSSD)。最初,871 例患者接受乌司奴单抗治疗。在第 16 周,161 例随机患者仍存在轻度银屑病(IGA = 2)。在第 28 周,与乌司奴单抗治疗相比,古塞库单抗治疗患者 PASI90 应答率分别为 59.0%和 27.7%,DLQI0/1 应答率分别为 50.0%和 21.0%。PSSD 评分自基线的平均变化分别为-44 和-28,-50 和-32,认为-40 具有临床意义。PSSD 瘙痒评分的平均变化分别为-4.6 和-2.9,认为减少≥4.0 具有临床意义。治疗差异在第 52 周仍保持/增加。在乌司奴单抗治疗 16 周后仍存在轻度银屑病的患者中,与继续乌司奴单抗相比,切换至古塞库单抗的患者在改善皮肤清除率、健康相关生活质量以及患者报告的症状和体征方面有更大的改善。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b238/11388105/ce67946dbba1/ActaDV-104-41053-g005.jpg

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