Gaudet Veronique, Turchin Irina, Lynde Charles W, Kelly Virginie, Sajic Dusan, Hassan Shazia, Yap Belinda, Barakat Maxime, Prajapati Vimal H
Department of Medical Affairs, Bausch Health, Canada Inc., 2150 St. Elzear Blvd. West, Laval, QC, H7L 4A8, Canada.
Brunswick Dermatology Centre, Fredericton, NB, Canada.
Dermatol Ther (Heidelb). 2025 Apr;15(4):949-962. doi: 10.1007/s13555-025-01369-3. Epub 2025 Mar 18.
Psoriasis, a chronic inflammatory skin disease, affects approximately one million Canadians, with plaque psoriasis (PsO) being the most common subtype. While brodalumab has shown efficacy and safety in phase III clinical trials, Canadian real-world evidence remains limited. This retrospective cohort study aims to report on the real-world outcomes of Canadian patients with PsO who initiated treatment with brodalumab within the 4-year period following its approval by Health Canada.
Data from patients with PsO initiating brodalumab treatment in the Canadian patient support program between July 1, 2018 and June 30, 2022 were analyzed. The primary objective evaluated the proportion of patients achieving a 100% reduction in the Psoriasis Area and Severity Index (PASI 100) at selected time windows. Secondary and exploratory objectives included assessing the 90% reduction in PASI score (PASI 90), changes from baseline in mean PASI, body surface area (BSA), and Dermatology Life Quality Index (DLQI) scores, as well as treatment persistence.
A total of 2482 patients (58.5% male; mean age 51.0 years) were included, with over half being biologic-naïve (56.9%). In a subset of patients with baseline and at least one follow-up data, 66.1% and 53.2% achieved PASI 90 and PASI 100, respectively, within the first 3 months. These rates were sustained, with 68.1% and 52.2% achieving PASI 90 and PASI 100, respectively, beyond 24 months. Significant improvements from baseline were observed for PASI, BSA, and DLQI scores, and these improvements were maintained over time. Among all patients, the 1-year persistence rate was 73.4%.
This study provides valuable insights into the profile of patients treated with brodalumab in Canada. While the rapid and sustained skin clearance, as well as improvements in PASI, BSA, and DLQI scores, support the therapeutic benefits of brodalumab beyond clinical trials, further research on long-term effectiveness and safety is warranted.
银屑病是一种慢性炎症性皮肤病，约有100万加拿大人受其影响，其中斑块状银屑病（PsO）是最常见的亚型。虽然布罗达单抗在III期临床试验中已显示出疗效和安全性，但加拿大的真实世界证据仍然有限。这项回顾性队列研究旨在报告在加拿大卫生部批准后的4年内开始使用布罗达单抗治疗的PsO患者的真实世界结局。
分析了2018年7月1日至2022年6月30日期间在加拿大患者支持项目中开始使用布罗达单抗治疗的PsO患者的数据。主要目标评估了在选定时间窗口内达到银屑病面积和严重程度指数（PASI）降低100%（PASI 100）的患者比例。次要和探索性目标包括评估PASI评分降低90%（PASI 90）、平均PASI、体表面积（BSA）和皮肤病生活质量指数（DLQI）评分相对于基线的变化，以及治疗持续性。
共纳入2482例患者（58.5%为男性；平均年龄51.0岁），其中超过一半患者此前未使用过生物制剂（56.9%）。在有基线数据和至少一次随访数据的患者亚组中，分别有66.1%和53.2%的患者在最初3个月内达到PASI 90和PASI 100。这些比率得以维持，超过24个月时，分别有68.1%和52.2%的患者达到PASI 90和PASI 100。观察到PASI、BSA和DLQI评分相对于基线有显著改善，且这些改善随时间持续。在所有患者中，1年持续治疗率为73.4%。
本研究为加拿大使用布罗达单抗治疗的患者情况提供了有价值的见解。虽然快速且持续的皮肤清除以及PASI、BSA和DLQI评分的改善支持了布罗达单抗在临床试验之外的治疗益处，但仍有必要对其长期有效性和安全性进行进一步研究。
