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老年患者中曲罗芦单抗剂量优化的长期疗效及潜在预测因素:一项多中心研究

Long-Term Efficacy and Potential Predictors of Tralokinumab Dose Optimization in Elderly Patients: A Multicentre Study.

作者信息

Melgosa Ramos Francisco Javier, Alarcón Sergio Santos, Motilla Jose María Sánchez, Mercader Pedro

机构信息

Department of Dermatology, University Hospital Doctor Peset, Valencia, Spain.

Department of Dermatology, Hospital Lluís Alcanyís, Xátiva, Valencia, Spain.

出版信息

Dermatol Ther (Heidelb). 2025 May;15(5):1251-1257. doi: 10.1007/s13555-025-01405-2. Epub 2025 Apr 15.

Abstract

INTRODUCTION

Atopic dermatitis (AD) is a chronic inflammatory skin disease that significantly affects elderly patients, particularly those with multiple comorbidities. Tralokinumab, an IL- 13-neutralizing monoclonal antibody, is approved at 300 mg every 2 weeks (Q2 W), with the option to optimize to a once-monthly (Q4 W) regimen in patients achieving optimal disease control. This study evaluates its long-term efficacy and safety in elderly patients (> 65 years) and explores predictors of treatment response and optimization.

METHODS

A retrospective multicenter study was conducted across four Spanish hospitals, including patients > 65 years old with moderate-to-severe AD treated with tralokinumab. The primary endpoints were treatment efficacy and safety at weeks 16, 24, and 52, while secondary endpoints included identifying predictors of treatment response and successful dose optimization.

RESULTS

A total of 24 patients (mean age 75.3 ± 8.4 years, 45.8% male) were included. A significant reduction in EASI (Eczema Area and Severity Index), Pruritus NRS (Numerical Rating Scale), DLQI (Dermatology Life Quality Index), and BSA (Body Surface Area) scores was observed at weeks 16, 24, and 52 (p < 0.05). Dose optimization to 300 mg Q4 W was achieved in 25% of patients. Male sex (p = 0.042) and higher baseline EASI (p = 0.004) were associated with poorer early response, whereas a shorter time to systemic treatment initiation (p = 0.023) increased the likelihood of dose optimization. No serious adverse events or neoplasm progression were reported.

CONCLUSION

Tralokinumab demonstrated sustained efficacy and safety in elderly patients with moderate-to-severe AD, even with multiple comorbidities. Dose optimization to Q4 W was feasible in a subset of patients. Early systemic treatment initiation was linked to better outcomes, emphasizing the need for proactive disease management.

摘要

引言

特应性皮炎(AD)是一种慢性炎症性皮肤病,对老年患者影响显著,尤其是那些患有多种合并症的患者。曲罗芦单抗是一种抗白细胞介素-13单克隆抗体,获批剂量为每2周300毫克(Q2W),对于疾病控制达到最佳状态的患者,可优化为每月一次(Q4W)的治疗方案。本研究评估了其在老年患者(>65岁)中的长期疗效和安全性,并探索治疗反应和优化的预测因素。

方法

在西班牙四家医院开展了一项回顾性多中心研究,纳入年龄>65岁、接受曲罗芦单抗治疗的中重度AD患者。主要终点为第16、24和52周时的治疗疗效和安全性,次要终点包括确定治疗反应和成功剂量优化的预测因素。

结果

共纳入24例患者(平均年龄75.3±8.4岁,45.8%为男性)。在第16、24和52周时,湿疹面积和严重程度指数(EASI)、瘙痒数字评定量表(Pruritus NRS)、皮肤病生活质量指数(DLQI)和体表面积(BSA)评分均显著降低(p<0.05)。25%的患者实现了剂量优化至300毫克Q4W。男性(p=0.042)和更高的基线EASI(p=0.004)与较差的早期反应相关,而开始全身治疗的时间较短(p=0.023)增加了剂量优化的可能性。未报告严重不良事件或肿瘤进展。

结论

曲罗芦单抗在患有中重度AD的老年患者中显示出持续的疗效和安全性,即使患者有多种合并症。对一部分患者来说,优化至Q4W剂量是可行的。早期开始全身治疗与更好的结果相关,强调了积极进行疾病管理的必要性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f76f/12033154/6c264109b443/13555_2025_1405_Fig1_HTML.jpg

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