古舍库单抗在欧洲掌跖脓疱病患者中的疗效和安全性：多中心、单臂临床试验（GAP 研究）

JAAD International Pub Date : 2024-10-02 DOI:10.1016/j.jdin.2024.09.001

Dagmar Wilsmann-Theis MD, PhD , Selina Patt , Andreas Pinter MD, PhD , Sascha Gerdes MD, PhD , Nina Magnolo MD , Robert Németh PhD , Jennifer Schmitz MSc , Cornelia Paul MD , Matthias Augustin MD, PhD , Petra Staubach MD, PhD , Ansgar Weyergraf MD , Ulrike Hüffmeier MD , Kerstin Wolk PhD , Robert Sabat MD, PhD , Rotraut Mößner MD, PhD

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引用次数: 0

摘要

背景掌跖脓疱病（PPP）是一种慢性炎症性皮肤病，好发于手掌和足底。患者会出现明显的疼痛、瘙痒和日常活动障碍。日本已批准使用白细胞介素-23抑制剂 Guselkumab 治疗掌跖脓疱病。方法开展了一项多中心、单臂、II 期研究（GAP），50 名中重度 PPP 患者接受了为期 24 周的 100 毫克古舍库单抗皮下注射治疗。主要终点是第24周时掌跖脓疱病银屑病面积和严重程度指数（PPPASI）与基线相比有所下降。次要终点包括医生评估和患者报告。结果与基线相比，主要终点在第24周时的PPPASI中位数显著降低了59.6%（P< .001）。第 24 周达到 PPPASI-50 和 PPPASI-75 的患者比例分别为 66.0% 和 34.0%。皮肤科生活质量指数中位数从基线时的 15 降至第 24 周时的 5（P < .001）。第4周白细胞介素-19血清水平的变化可预测第24周的临床反应。

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Efficacy and safety of guselkumab in European patients with palmoplantar pustulosis: A multi-center, single-arm clinical trial (GAP study)

Background

Palmoplantar pustulosis (PPP) is a chronic inflammatory skin disorder that affects palms and soles. Patients suffer significant pain, itching, and daily activity impairment. Guselkumab, an interleukin-23 inhibitor, has been approved for PPP treatment in Japan. However, there is no effective therapy licensed for PPP in Europe and the USA.

Objective

To explore the efficacy and safety of guselkumab in patients with moderate-to-severe PPP in the Caucasian population.

Methods

A multicenter, single-arm, phase II study involving 50 patients with moderate-to-severe PPP treated with 100 mg guselkumab subcutaneously for 24 weeks was conducted (GAP). Primary endpoint was the reduction of palmoplantar-pustulosis psoriasis area and severity index (PPPASI) at week 24 compared to baseline. Secondary endpoints included physician-assessed and patient-reported measures. Serum samples were taken for exploratory studies.

Results

The primary endpoint was met with a significant median PPPASI reduction by 59.6% at week 24 compared to baseline (P < .001). The proportions of patients achieving PPPASI-50 and PPPASI-75 at week 24 were 66.0% and 34.0%, respectively. Median dermatology life quality index dropped from 15 at baseline to 5 at week 24 (P < .001). Week 4 changes in interleukin-19 serum levels predicted week 24 clinical response.