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真实世界中博乐达单抗治疗中重度斑块状银屑病患者的疗效数据:来自捷克共和国 BIOREP 登记处的观察性研究。

Real-World Data on Brodalumab Treatment in Patients with Moderate-to-Severe Plaque Psoriasis: An Observational Study from the Czech Republic BIOREP Registry.

机构信息

Department of Dermatovenereology, First Faculty of Medicine and General University Hospital, Charles University, Prague, Czech Republic.

Value Outcomes, Prague, Czech Republic.

出版信息

Adv Ther. 2024 Oct;41(10):3951-3971. doi: 10.1007/s12325-024-02952-4. Epub 2024 Aug 29.

Abstract

INTRODUCTION

The aim of this observational, multicenter study was to assess the real-world use of brodalumab for the treatment of moderate-to-severe plaque psoriasis in patients in the Czech Republic, using data from the BIOREP registry.

METHODS

The study included 273 patients aged ≥ 18 years with moderate-to-severe psoriasis who received brodalumab. Endpoints were drug survival (time from treatment initiation to discontinuation), effectiveness [Psoriasis Area and Severity Index (PASI)], and health-related quality-of-life [Dermatology Life Quality Index (DLQI)].

RESULTS

Predicted drug survival probability was 92.4% [95% confidence interval (CI): 89.1, 95.7%] at 6 months and 84.2% (95% CI 79.5, 89.1%) at 12 months; this was maintained at 24 months [80.4% (95% CI 74.5, 86.8%)]. Younger age, higher body mass index, and no previous biologic treatment were significantly associated with longer drug survival. Absolute PASI ≤ 3 after 3 months was achieved by 89.8% of patients; 92.4%, 77.8%, and 59.1% reached PASI 75, PASI 90, and PASI 100, respectively. After 12 months, 96.5% of 141 patients had an absolute PASI ≤ 3. The proportion of patients achieving DLQI 0/1 was 87.3% at 12 months.

CONCLUSION

This study demonstrated high and sustained drug survival with high rates of skin clearance and improved quality of life in patients with relatively severe disease treated with brodalumab. Improvements were observed as early as 3 months post-treatment initiation and were sustained for up to 24 months in a real-life setting.

摘要

简介

本观察性、多中心研究旨在使用 BIOREP 登记处的数据评估在捷克共和国中度至重度斑块型银屑病患者中使用布罗达卢单抗的真实世界应用,评估终点包括药物存续时间(从治疗开始到停药的时间)、疗效( psoriasis area and severity index,PASI)和健康相关生活质量( dermatology life quality index,DLQI)。

方法

该研究纳入了 273 名年龄≥18 岁的中重度银屑病患者,他们接受了布罗达卢单抗治疗。主要研究终点为药物存续时间(从治疗开始到停药的时间)、疗效( psoriasis area and severity index,PASI)和健康相关生活质量( dermatology life quality index,DLQI)。

结果

6 个月时,预测药物存续概率为 92.4%(95%置信区间:89.1%,95.7%),12 个月时为 84.2%(95%置信区间:79.5%,89.1%);24 个月时仍保持 80.4%(95%置信区间:74.5%,86.8%)。年龄较小、体重指数较高、无既往生物治疗与药物存续时间较长显著相关。治疗 3 个月后,89.8%的患者达到绝对 PASI≤3,92.4%、77.8%和 59.1%的患者分别达到 PASI75、PASI90 和 PASI100。治疗 12 个月后,141 例患者中有 96.5%达到绝对 PASI≤3。12 个月时,达到 DLQI0/1 的患者比例为 87.3%。

结论

本研究显示,在真实环境中,布罗达卢单抗治疗相对严重的斑块型银屑病患者具有较高和持续的药物存续时间,且皮肤清除率高,生活质量改善。治疗后 3 个月即可观察到改善,24 个月内持续改善。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7fc6/11399213/a708144ac47f/12325_2024_2952_Fig1_HTML.jpg

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