6363 University of Ottawa, ON, Canada.
793812365 Division of Dermatology, Department of Medicine, University of Toronto, ON, Canada.
J Cutan Med Surg. 2020 Sep/Oct;24(5):468-473. doi: 10.1177/1203475420928907. Epub 2020 May 22.
Systemic therapy for atopic dermatitis (AD) has been challenging with limited safe and efficacious long-term treatment options. In 2017, dupilumab was approved in the United States, Europe, and Canada as the first targeted therapy for patients with moderate-to-severe AD. Despite promising efficacy and safety results in clinical trials, our understanding of dupilumab in clinical practice remains limited with few studies outside clinical trials in literature.
The aim of this study is to evaluate the efficacy and safety of dupilumab in clinical practice and discuss any differences in results between clinical trials and real-world results.
A retrospective chart review was conducted of consecutive patients receiving dupilumab treatment at two tertiary hospitals in Toronto, Canada, between December 2017 and May 2019. The primary efficacy endpoint was measured by Investigator's Global Assessment (IGA) score of 0/1 at 16 weeks and all adverse events (AEs) experienced by patients were recorded.
Of the 93 patients included in the study, 51 (55%) reached IGA 0/1 and 38 (41%) experienced ≥1 AE. There were no severe AEs or discontinuation prior to 16 weeks due to an AE.
These findings suggest a higher IGA-based efficacy profile with no newly identified safety concerns in patients treated with dupilumab at two tertiary hospitals in Toronto, Canada, compared to those in randomized controlled trials.
特应性皮炎(AD)的系统治疗具有挑战性,安全且有效的长期治疗选择有限。2017 年,度普利尤单抗在美国、欧洲和加拿大获得批准,成为中重度 AD 患者的首个靶向治疗药物。尽管临床试验显示出有希望的疗效和安全性结果,但我们对度普利尤单抗在临床实践中的了解仍然有限,文献中几乎没有临床试验之外的研究。
本研究旨在评估度普利尤单抗在临床实践中的疗效和安全性,并讨论临床试验结果与真实世界结果之间的任何差异。
对 2017 年 12 月至 2019 年 5 月在加拿大多伦多的两家三级医院接受度普利尤单抗治疗的连续患者进行了回顾性病历审查。主要疗效终点为 16 周时研究者全球评估(IGA)评分达到 0/1,记录所有患者经历的不良事件(AE)。
在纳入研究的 93 例患者中,51 例(55%)达到 IGA 0/1,38 例(41%)发生≥1 例 AE。没有严重 AE,也没有因 AE 在 16 周前停药。
与随机对照试验相比,在加拿大多伦多的两家三级医院接受度普利尤单抗治疗的患者,其 IGA 疗效更高,且无新的安全性问题。