0.01%丙酸氟倍他索/ 0.045%他沙罗汀洗剂固定剂量联合治疗中重度斑块型银屑病的加拿大临床研究

IF 3.2 4区医学 Q2 PHARMACOLOGY & PHARMACY

Clinical therapeutics Pub Date : 2025-04-18 DOI:10.1016/j.clinthera.2025.03.005

R Vender MD , C Lynde MD , V Prajapati MD , R Zeinab PhD , M Legault PhD , HC-H Hong MD , M Barakat MD PhD

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引用次数: 0

摘要

背景：HP/TAZ的固定剂量联合治疗中重度斑块型银屑病具有良好的安全性和有效性。目的：本单臂、开放标签研究评估HP/TAZ在现实世界中的应用。方法根据加拿大说明书，纳入了患有中重度牛皮癣的成人患者，并使用HP/TAZ进行治疗。主要终点是第8周治疗成功的患者百分比，定义为研究者的总体评估评分为明确或几乎明确，至少有2级改善。结果202例患者接受了至少一剂HP/TAZ治疗，138例患者在基线和第8周进行了疗效评估。治疗成功率分别为26.1%和43.5%（第4周和第8周）。患者评分的平均瘙痒和最严重瘙痒在基线时分别为4.5和5.3分，随后在第8周分别降至1.7和2.1分。患者对HP/TAZ非常满意。应用部位反应（13.4%）和皮炎/湿疹（3.5%）是最常见的不良反应（严重程度为轻中度）。局限性作为一项缺乏安慰剂或比较组的开放标签真实世界证据研究，该研究的设计可能限制了结果的普遍性。结论HP/TAZ对中重度银屑病患者有益。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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A Canadian Real-World Study of Fixed-DOSE combination of Halobetasol Propionate 0.01%/Tazarotene 0.045% Lotion for the Treatment of Moderate-to-Severe Plaque Psoriasis

Background

A fixed-dose combination of HP/TAZ has demonstrated efficacy with a favorable safety profile for treating moderate-to-severe plaque psoriasis.

Objective

The present single-arm, open-label study evaluated the use of HP/TAZ in real-world practice.

Methods

Adults with moderate-to-severe psoriasis were enrolled and treated with HP/TAZ according to the Canadian label. The primary endpoint was the percentage of patients with treatment success at week 8, defined as an Investigator's Global Assessment score of clear or almost clear with a minimum 2-grade improvement.

Results

202 patients received at least one dose of HP/TAZ, 138 patients had efficacy assessments at baseline and week 8. Treatment success was achieved by 26.1% and 43.5% of patients (week 4 and 8 respectively) . Patient-rated average and worst itch were 4.5 and 5.3 points at baseline, with a subsequent reduction to 1.7 and 2.1 points, respectively, at week 8. Patients were satisfied-very satisfied with the HP/TAZ. Application site reactions (13.4%) and dermatitis/eczema (3.5%) were the most frequently reported adverse events (mild-moderate in severity) .

Limitations

The study design may limit generalizability of the results as an open label real world evidence study lacking a placebo or comparator arm.

Conclusion

Results confirm that HP/TAZ can be beneficial moderate-to-severe psoriasis patients.

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来源期刊

Clinical therapeutics 医学-药学

CiteScore

6.00

自引率

3.10%

发文量

154

审稿时长

9 weeks

期刊介绍： Clinical Therapeutics provides peer-reviewed, rapid publication of recent developments in drug and other therapies as well as in diagnostics, pharmacoeconomics, health policy, treatment outcomes, and innovations in drug and biologics research. In addition Clinical Therapeutics features updates on specific topics collated by expert Topic Editors. Clinical Therapeutics is read by a large international audience of scientists and clinicians in a variety of research, academic, and clinical practice settings. Articles are indexed by all major biomedical abstracting databases.