与免疫检查点抑制剂相关的系统性红斑狼疮的特征:使用FAERS数据库的药物警戒研究。

IF 3.5 2区 医学 Q1 RHEUMATOLOGY
Lan Zhen, Hong Chen, Wuyuan Pan, Jianrong Song, Huan Yi, Hong Zhou
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引用次数: 0

摘要

目的:与免疫检查点抑制剂(ici)相关的SLE是罕见的,ici诱导的SLE的综合概况仍然缺乏表征。本研究旨在探讨ICIs与SLE之间的潜在关联,并描述临床特征。方法:我们从FAERS(美国食品和药物管理局不良事件报告系统)数据库中提取癌症合并SLE患者的不良事件报告(2011年第一季度- 2024年第四季度)。使用报告OR (ROR)和信息成分进行歧化分析,并通过逻辑回归计算调整后的ROR以控制混杂因素。结果:共发现146 066例恶性肿瘤患者ci相关不良事件。其中,209例(IQR)中位年龄63(55.3-71.7)岁;报告SLEs 106例(51%为女性)。我们的分析发现了与ICIs相关的SLE的显著阳性信号,特别是抗程序性细胞死亡蛋白1 (PD-1)和抗程序性死亡配体1治疗。确定了SLE的8个阳性信号,主要是皮肤性狼疮和SLE。女性发生ici相关SLEs的风险明显高于男性。然而,年龄和化疗并不是ici相关SLEs发生的显著危险因素。与其他ICI治疗相比,抗pd -1治疗的风险更高。肺癌、黑色素瘤或乳腺癌患者的风险似乎更高。大多数患者预后严重,死亡率为4.31%(9例)。结论:这项首次药物警戒研究确定了ICI使用与SLE之间的显著关联,表明ICI可能构成一类新的药物诱导SLE触发器。高风险患者(如女性、抗pd -1受体)需要对ICIs进行个性化的长期安全监测。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Characterisation of systemic lupus erythematosus associated with immune checkpoint inhibitors: a pharmacovigilance study using FAERS database.

Objectives: SLE associated with immune checkpoint inhibitors (ICIs) is rare, and a comprehensive profile of ICI-induced SLE remains poorly characterised. This study aimed to explore the potential association between ICIs and SLE and characterise clinical features.

Methods: We extracted adverse event reports of patients with cancer with SLE from the FAERS (US Food and Drug Administration Adverse Event Reporting System) database (Q1 2011-Q4 2024). A disproportionality analysis was conducted using the reporting OR (ROR) and the information component, with adjusted ROR calculated via logistic regression to control for confounders.

Results: 146 066 ICI-related adverse events cases from patients with cancer were identified. Among these, 209 (median (IQR) age 63 (55.3-71.7) years; 106 (51%) female) cases of SLEs were reported. Our analysis detected significant positive signals for SLE associated with ICIs overall, particularly for anti-programmed cell death protein 1 (PD-1) and anti-programmed death-ligand 1 therapy. Eight positive signals of SLEs were identified, predominantly cutaneous lupus and SLE. The risk of ICI-related SLEs was significantly higher in females than in males. However, age and chemotherapy were not significant risk factors for the incidence of ICI-related SLEs. The risk was higher with anti-PD-1 therapy compared with other ICI therapies. Patients with lung cancer, melanoma or breast cancer appeared to be at higher risk. Most patients experienced serious outcomes, with a mortality rate of 4.31% (nine cases).

Conclusion: This first pharmacovigilance study identified a significant association between ICI use and SLEs, suggesting ICIs may constitute a novel class of drug-induced SLE triggers. Personalised long-term safety monitoring for ICIs is warranted for high-risk patients (eg, females, anti-PD-1 recipients).

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来源期刊
Lupus Science & Medicine
Lupus Science & Medicine RHEUMATOLOGY-
CiteScore
5.30
自引率
7.70%
发文量
88
审稿时长
15 weeks
期刊介绍: Lupus Science & Medicine is a global, peer reviewed, open access online journal that provides a central point for publication of basic, clinical, translational, and epidemiological studies of all aspects of lupus and related diseases. It is the first lupus-specific open access journal in the world and was developed in response to the need for a barrier-free forum for publication of groundbreaking studies in lupus. The journal publishes research on lupus from fields including, but not limited to: rheumatology, dermatology, nephrology, immunology, pediatrics, cardiology, hepatology, pulmonology, obstetrics and gynecology, and psychiatry.
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