古塞库单抗治疗欧洲掌跖脓疱病患者的疗效和安全性：一项多中心、单臂临床试验（GAP研究）。
Efficacy and safety of guselkumab in European patients with palmoplantar pustulosis: A multi-center, single-arm clinical trial (GAP study).
作者信息
Wilsmann-Theis Dagmar, Patt Selina, Pinter Andreas, Gerdes Sascha, Magnolo Nina, Németh Robert, Schmitz Jennifer, Paul Cornelia, Augustin Matthias, Staubach Petra, Weyergraf Ansgar, Hüffmeier Ulrike, Wolk Kerstin, Sabat Robert, Mößner Rotraut
机构信息
Department of Dermatology and Allergology, University Medical Center Bonn, Bonn, Germany.
Department of Dermatology, Venereology and Allergology, University Hospital Frankfurt am Main, Frankfurt am Main, Germany.
出版信息
JAAD Int. 2024 Oct 2;18:69-78. doi: 10.1016/j.jdin.2024.09.001. eCollection 2025 Feb.
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 ( < .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 ( < .001). Week 4 changes in interleukin-19 serum levels predicted week 24 clinical response.
CONCLUSION
Guselkumab may be a promising therapeutic option for PPP in Caucasian patients.
背景
掌跖脓疱病（PPP）是一种影响手掌和脚底的慢性炎症性皮肤病。患者遭受严重疼痛、瘙痒和日常活动受限。古塞库单抗是一种白细胞介素-23抑制剂，已在日本获批用于PPP治疗。然而，在欧洲和美国，尚无获批用于PPP的有效疗法。
目的
探讨古塞库单抗在白种人中重度PPP患者中的疗效和安全性。
方法
开展一项多中心、单臂、II期研究（GAP），纳入50例中重度PPP患者，皮下注射100mg古塞库单抗，疗程24周。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）较基线的降低情况。次要终点包括医生评估和患者报告的指标。采集血清样本进行探索性研究。
结果
达到主要终点，第24周时PPPASI较基线显著降低，中位数降低59.6%（<0.001）。第24周时达到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（<0.001）。第4周白细胞介素-19血清水平变化可预测第24周的临床反应。
结论
对于白种人PPP患者，古塞库单抗可能是一种有前景的治疗选择。
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