真实世界中生物制剂治疗中重度斑块状银屑病的疗效：对台湾 75 例患者的分析。
Real-world efficacy of biological agents in moderate-to-severe plaque psoriasis: An analysis of 75 patients in Taiwan.
机构信息
Department of Dermatology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.
International Center for Wound Repair and Regeneration, National Cheng Kung University, Tainan, Taiwan.
出版信息
PLoS One. 2020 Dec 29;15(12):e0244620. doi: 10.1371/journal.pone.0244620. eCollection 2020.
BACKGROUND
Real-world clinical data on psoriasis patients receiving different biological agents is needed, especially in Asian populations.
OBJECTIVES
Our aim is to compare and analyze the efficacy and safety profile of four biological agents (etanercept, adalimumab, ustekinumab and secukinumab) in a real-world setting in Taiwan.
METHODS
We retrospectively analyzed the clinical data of all patients with moderate-to-severe plaque psoriasis (Psoriasis Area and Severity Index (PASI) ≥ 10) who received etanercept, adalimumab, ustekinumab or secukinumab between January 2011 and December 2018 in a tertiary hospital in Taiwan.
RESULTS
A total of 119 treatment episodes in 75 patients were included in this study. Ustekinumab was used in 49 treatment episodes, followed by secukinumab in 46 treatment episodes, adalimumab in 14 treatment episodes and etanercept in 10 treatment episodes. The proportion of the biologic-naïve was highest in etanercept (100%) and lowest in secukinumab (23.9%). The PASI-75, -90 and -100 were the highest in secukinumab (91.3%, 82.6%, 41.3%, respectively), followed by ustekinumab (79.6%, 44.9%, 16.3%), adalimumab (64.3%, 28.6%, 7.1%) and etanercept (50.0%, 30.0%, 0%). The rate of adverse events that required treatment was highest for secukinumab (15.2%), followed by adalimumab (14.3%), ustekinumab (8.2%), and etanercept (0%), including 4 cases of infections, 2 cases of cardiovascular diseases and 4 cases of cancers.
CONCLUSIONS
This real world data showed differential efficacy and safety of the four biological agents.
背景
需要真实世界的临床数据来了解接受不同生物制剂治疗的银屑病患者，尤其是在亚洲人群中。
目的
我们旨在比较和分析四种生物制剂（依那西普、阿达木单抗、乌司奴单抗和司库奇尤单抗）在台湾真实环境中的疗效和安全性。
方法
我们回顾性分析了 2011 年 1 月至 2018 年 12 月在台湾一家三级医院接受依那西普、阿达木单抗、乌司奴单抗或司库奇尤单抗治疗的中重度斑块型银屑病（银屑病面积和严重程度指数（PASI）≥10）患者的临床数据。
结果
本研究共纳入 75 例患者的 119 个治疗周期。乌司奴单抗的使用次数最多（49 次），其次是司库奇尤单抗（46 次）、阿达木单抗（14 次）和依那西普（10 次）。依那西普的生物制剂初治比例最高（100%），而司库奇尤单抗的比例最低（23.9%）。司库奇尤单抗的 PASI-75、-90 和 -100 应答率最高（分别为 91.3%、82.6%和 41.3%），其次是乌司奴单抗（79.6%、44.9%和 16.3%）、阿达木单抗（64.3%、28.6%和 7.1%）和依那西普（50.0%、30.0%和 0%）。需要治疗的不良反应发生率最高的是司库奇尤单抗（15.2%），其次是阿达木单抗（14.3%）、乌司奴单抗（8.2%）和依那西普（0%），包括 4 例感染、2 例心血管疾病和 4 例癌症。
结论
本真实世界数据显示了这四种生物制剂的疗效和安全性存在差异。
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