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一项关于200毫克替拉珠单抗治疗中重度银屑病患者的前瞻性真实世界多中心研究:谁是理想患者?

A prospective Real-Life Multicenter Study of Tildrakizumab 200 mg in Patients with Moderate-Severe Psoriasis: Who is the Ideal Patient?

作者信息

Di Brizzi Eugenia Veronica, Caccavale Stefano, Di Caprio Roberta, Cusano Francesco, De Pasquale Rocco, Falcomatà Valeria, Foti Caterina, Giofrè Claudia, Gubinelli Emanuela, Mazzocchetti Giampiero, Nicolini Massimiliano, Palazzo Giovanni, Pescitelli Leonardo, Puca Rosa Valentina, Sarno Oriele, Balato Anna

机构信息

Dermatology Unit, University of Campania "L. Vanvitelli".

Department of Dermatology, San Pio Hospital, Benevento, Italy.

出版信息

Dermatol Pract Concept. 2024 Oct 30;14(4):e2024284. doi: 10.5826/dpc.1404a284.

Abstract

INTRODUCTION

Tildrakizumab, a humanized monoclonal antibody targeting the p19 subunit of interleukin 23 (IL-23), has shown promise in the management of moderate-to-severe plaque psoriasis, offering potential improvements in clinical outcomes and quality of life.

OBJECTIVES

The study aimed to identify patient characteristics that indicate the initiation of a 200 mg dosage of tildrakizumab in a real-world setting, focusing on factors that enhance treatment effectiveness and safety.

METHODS

This prospective study included 54 adult patients with moderate-to-severe plaque psoriasis treated with tildrakizumab 200 mg from March 2023 to March 2024 across 13 Italian Dermatology Units. Data collected included demographics, disease duration, comorbidities, and previous treatments. PASI, BSA, and DLQI scores were recorded at baseline and at weeks 4, 16, and 28. Safety was assessed through adverse event reporting. Univariate analysis was performed to identify baseline characteristics significantly associated with achieving PASI ≤ 5 at week 16.

RESULTS

Significant reductions in PASI scores were observed at week 4 (9 ± 6.9, P < 0.001), with further improvements at weeks 16 (3.9 ± 4.2, P < 0.001) and 28 (2.9 ± 4.4, P < 0.001). Univariate analysis showed that obese patients (BMI > 30) had higher odds (OR = 4.333, P < 0.05) of achieving PASI ≤ 5. Longer disease duration and starting with a 100 mg dosage also correlated with better outcomes. The safety profile was favorable, with minimal adverse events reported.

CONCLUSIONS

Tildrakizumab 200 mg is effective and safe for moderate-to-severe psoriasis, particularly in obese patients. These findings support its use as a long-term treatment option.

摘要

引言

替拉珠单抗是一种靶向白细胞介素23(IL-23)p19亚基的人源化单克隆抗体,在中重度斑块状银屑病的治疗中显示出前景,有望改善临床结局和生活质量。

目的

本研究旨在确定在现实环境中提示开始使用200mg替拉珠单抗剂量的患者特征,重点关注提高治疗有效性和安全性的因素。

方法

这项前瞻性研究纳入了2023年3月至2024年3月期间在意大利13个皮肤科单位接受200mg替拉珠单抗治疗的54例中重度斑块状银屑病成年患者。收集的数据包括人口统计学、病程、合并症和既往治疗情况。在基线以及第4、16和28周记录银屑病面积和严重程度指数(PASI)、体表面积(BSA)和皮肤病生活质量指数(DLQI)评分。通过不良事件报告评估安全性。进行单因素分析以确定与第16周时达到PASI≤5显著相关的基线特征。

结果

在第4周时观察到PASI评分显著降低(9±6.9,P<0.001),在第16周(3.9±4.2,P<0.001)和第28周(2.9±4.4,P<0.001)进一步改善。单因素分析显示,肥胖患者(体重指数>30)达到PASI≤5的几率更高(比值比=4.333,P<0.05)。病程较长以及起始剂量为100mg也与更好的结局相关。安全性良好,报告的不良事件极少。

结论

200mg替拉珠单抗对中重度银屑病有效且安全,尤其是在肥胖患者中。这些发现支持将其用作长期治疗选择。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/87bf/11620192/fa9a1172227e/dp1404a284g001.jpg

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