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乌司奴单抗药物治疗银屑病患者的生存情况:真实临床实践的回顾性研究。

Ustekinumab Drug Survival in Patients with Psoriasis: A retrospective Study of Real Clinical Practice.

机构信息

Department of Dermatology, Hospital Universitario Central de Asturias, 33011 Oviedo, Spain.

Clinical Management Unit, UGC Farmacia, Hospital Universitario Central de Asturias, 33011 Oviedo, Asturias, Spain.

出版信息

Medicina (Kaunas). 2020 Oct 30;56(11):584. doi: 10.3390/medicina56110584.

DOI:10.3390/medicina56110584
PMID:33143166
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7693782/
Abstract

The efficacy and safety of ustekinumab have been proved in clinical trials. In daily clinical practice, knowing the factors that determine survival differences of biological drugs allows psoriasis treatment to be optimized as a function of patient characteristics. The main objectives of this work are to understand ustekinumab drug survival in patients diagnosed with plaque psoriasis in the Hospital Universitario Central de Asturias (HUCA Dermatology Department, and to identify the predictors of drug discontinuation. : A retrospective hospital-based study, including data from 148 patients who were receiving ustekinumab (Stelara) between 1 February 2009 and 30 November 2019, were collected. Survival curves were approximated through the Kaplan-Meier estimator and compared using the log-rank test. Proportional hazard Cox regression models were used for multivariate analyses while both unadjusted and adjusted hazard ratios (HR) were used for summarizing the studied differences. The average duration of the treatment before discontinuation was 47.57 months (SD 32.63 months; median 41 months). The retention rates were 82% (2 years), 66% (5 years), and 58% (8 years). Median survival was 80 months (95% confidence interval. CI 36.9 to 123.01 months). The survival study revealed statistically significant differences between patients with arthritis (log-rank test, < 0.001) and those who had previously received biological treatment (log-rank test, = 0.026). The five-year prevalence in patients still under treatment was 80% (those without arthritis) and 54% (arthritis patients). In the multivariate analysis, only the patients with arthritis had a lower rate of drug survival. No statistically significant differences were observed for any of the other comorbidities studied. The first and second most frequent causes of discontinuation were secondary failure and arthritis inefficacy, respectively. Ustekinumab is a biological drug conferring high survival in plaque psoriasis patients. Ustekinumab survival is lower in patients with arthritis.

摘要

乌司奴单抗的疗效和安全性已在临床试验中得到证实。在日常临床实践中,了解决定生物药物生存差异的因素可以使银屑病的治疗根据患者的特征进行优化。这项工作的主要目的是了解在 Hospital Universitario Central de Asturias(HUCA 皮肤科)诊断为斑块型银屑病的患者中乌司奴单抗的药物生存情况,并确定停药的预测因素。

这是一项回顾性的基于医院的研究,纳入了 2009 年 2 月 1 日至 2019 年 11 月 30 日期间接受乌司奴单抗(Stelara)治疗的 148 例患者的数据。通过 Kaplan-Meier 估计器近似生存曲线,并使用对数秩检验进行比较。多变量分析采用比例风险 Cox 回归模型,同时使用未经调整和调整后的风险比(HR)来总结研究差异。

在停药前,治疗的平均持续时间为 47.57 个月(SD 32.63 个月;中位数 41 个月)。保留率为 82%(2 年)、66%(5 年)和 58%(8 年)。中位生存时间为 80 个月(95%置信区间:36.9 至 123.01 个月)。生存研究表明,关节炎患者(对数秩检验,<0.001)和之前接受过生物治疗的患者(对数秩检验,=0.026)之间存在统计学显著差异。仍在接受治疗的患者中,五年的患病率为 80%(无关节炎)和 54%(关节炎患者)。在多变量分析中,只有关节炎患者的药物生存率较低。对于研究的其他任何合并症,均未观察到统计学显著差异。停药的第一个和第二个最常见原因分别是继发失效和关节炎无效。

乌司奴单抗是一种在斑块型银屑病患者中具有高生存能力的生物药物。乌司奴单抗在关节炎患者中的生存能力较低。

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