背景:这次观测的目的,多中心研究旨在评估在捷克共和国使用brodalumab治疗中度至重度斑块状银屑病的实际情况,使用BIOREP注册表中的数据。
方法:该研究包括273名年龄≥18岁的中度至重度银屑病患者,他们接受了Brodalumab治疗。终点是药物存活(从治疗开始到停药的时间),有效性[牛皮癣面积和严重程度指数(PASI)],和健康相关的生活质量[皮肤病生活质量指数(DLQI)]。
结果:预测的药物生存概率在6个月时为92.4%[95%置信区间(CI):89.1,95.7%],在12个月时为84.2%(95%CI79.5,89.1%);在24个月时维持[80.4%(95%CI74.5,86.8%)]。年龄更小,较高的体重指数,以前没有生物治疗与更长的药物生存期显著相关.89.8%的患者在3个月后达到绝对PASI≤3;92.4%,77.8%,59.1%分别达到PASI75、PASI90和PASI100。12个月后,141例患者中,96.5%的患者的绝对PASI≤3。12个月时达到DLQI0/1的患者比例为87.3%。
结论:这项研究表明,在接受brodalumab治疗的相对严重疾病患者中,药物的高生存率和持续生存率以及高皮肤清除率和生活质量的改善。早在治疗开始后3个月观察到改善,并在现实生活中持续长达24个月。
BACKGROUND: 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.
CONCLUSIONS: 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.