布达鲁单抗治疗中重度斑块状银屑病患者的真实世界数据:来自捷克共和国 BIOREP 登记处的观察性研究。

IF 3.4 3区 医学 Q2 MEDICINE, RESEARCH & EXPERIMENTAL
Martina Kojanova, Barbora Turkova, Spyridon Gkalpakiotis, Petra Cetkovska, Jorga Fialova, Tomas Dolezal, Alena Machovcova, Eydna Didriksen Apol
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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)].</p><h3>Results</h3><p>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. 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引用次数: 0

摘要

简介:这项多中心观察性研究旨在利用 BIOREP 登记处的数据,评估捷克共和国中重度斑块状银屑病患者使用布达鲁单抗治疗的实际情况:研究纳入了273名年龄≥18岁、接受过布达鲁单抗治疗的中重度银屑病患者。终点是药物存活率(从开始治疗到停药的时间)、疗效[银屑病面积和严重程度指数(PASI)]和健康相关生活质量[皮肤科生活质量指数(DLQI)]:6 个月时的预测药物存活率为 92.4% [95% 置信区间 (CI):89.1, 95.7%],12 个月时为 84.2% (95% CI 79.5, 89.1%);24 个月时仍为 80.4% (95% CI 74.5, 86.8%) [80.4%(95% CI 74.5, 86.8%)]。年龄越小、体重指数越高以及既往未接受过生物治疗与药物存活期越长有显著相关性。89.8% 的患者在 3 个月后 PASI 绝对值≤3;分别有 92.4%、77.8% 和 59.1% 的患者达到 PASI 75、PASI 90 和 PASI 100。12 个月后,141 名患者中有 96.5% 的患者 PASI 绝对值≤ 3。12个月后,达到DLQI 0/1的患者比例为87.3%:这项研究表明,使用布达鲁单抗治疗病情相对较重的患者,药物存活率高且持续时间长,皮肤清除率高,生活质量得到改善。在实际生活中,早在治疗开始后 3 个月就能观察到改善,并可持续长达 24 个月。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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

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

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.

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来源期刊
Advances in Therapy
Advances in Therapy 医学-药学
CiteScore
7.20
自引率
2.60%
发文量
353
审稿时长
6-12 weeks
期刊介绍: Advances in Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all therapeutic areas. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Advances in Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.
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