Real-world data and Mendelian randomization analysis in assessing adverse reactions of rilonacept.

IF 3.2 4区 医学 Q2 PHARMACOLOGY & PHARMACY
Lihong Liu, Zhenfei Chi, Zhe Zhang
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引用次数: 0

Abstract

Background: Rilonacept, an interleukin-1 (IL-1) "trap," is FDA-approved for recurrent pericarditis, but research on its adverse reactions is limited due to its recent introduction.

Aim: This study aimed to identify potential adverse reactions associated with rilonacept using the FDA Adverse Event Reporting System (FAERS) and to evaluate long-term effects through Mendelian randomization (MR) analysis.

Method: We analyzed all adverse event reports related to rilonacept from the FAERS database between January 2021 and June 2024. Positive signals for adverse reactions were extracted using reporting odds ratios (ROR) and information components (IC). MR analysis was conducted using genetic variants as instrumental variables to explore causal relationships between rilonacept and identified adverse reactions, with sensitivity analyses performed for robustness.

Results: A total of 419 adverse event reports were analyzed, documenting 1847 AEs. Common events included COVID-19, injection site rash, pain, and injection site reaction, categorized into 27 System Organ Classes (SOCs). Notable frequencies were found in Infections and Infestations, Nervous System Disorders, and Skin and Subcutaneous Tissue Disorders. Disproportionality analysis identified positive signals primarily in Skin and Subcutaneous Tissue Disorders, Cardiac Disorders, and Immune System Disorders, with 11 AEs showing positive signals in both Preferred Terms (PTs) and SOCs. MR analysis revealed significant associations between IL-1RN (rilonacept) and allergic urticaria (OR: 1.56), rash (OR: 0.64), and myocarditis (OR: 2.26).

Conclusion: Rilonacept is effective for certain inflammatory conditions, but careful monitoring for adverse reactions, particularly involving the immune system, skin, and cardiac issues, is essential.

真实世界数据和孟德尔随机化分析评估利洛那接受不良反应。
背景:rilonaccept是一种白细胞介素-1 (IL-1)“trap”是fda批准用于复发性心包炎的药物,但由于其最近被引入,对其不良反应的研究受到限制。目的:本研究旨在通过FDA不良事件报告系统(FAERS)识别与利洛那普相关的潜在不良反应,并通过孟德尔随机化(MR)分析评估其长期影响。方法:我们分析了2021年1月至2024年6月FAERS数据库中所有与利洛那接受相关的不良事件报告。使用报告优势比(ROR)和信息成分(IC)提取不良反应的阳性信号。使用遗传变异作为工具变量进行MR分析,以探索rilonacept与确定的不良反应之间的因果关系,并进行敏感性分析以保持稳健性。结果:共分析了419例不良事件报告,记录了1847例ae。常见事件包括COVID-19、注射部位皮疹、疼痛和注射部位反应,分为27个系统器官类别(soc)。在感染和感染、神经系统疾病、皮肤和皮下组织疾病中发现显著的频率。歧化分析主要在皮肤和皮下组织疾病、心脏疾病和免疫系统疾病中发现阳性信号,其中11例ae在首选术语(PTs)和soc中均显示阳性信号。MR分析显示IL-1RN (rilonacept)与过敏性荨麻疹(OR: 1.56)、皮疹(OR: 0.64)和心肌炎(OR: 2.26)之间存在显著相关性。结论:利洛那普对某些炎症条件有效,但必须仔细监测不良反应,特别是涉及免疫系统、皮肤和心脏问题的不良反应。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
4.10
自引率
8.30%
发文量
131
审稿时长
4-8 weeks
期刊介绍: The International Journal of Clinical Pharmacy (IJCP) offers a platform for articles on research in Clinical Pharmacy, Pharmaceutical Care and related practice-oriented subjects in the pharmaceutical sciences. IJCP is a bi-monthly, international, peer-reviewed journal that publishes original research data, new ideas and discussions on pharmacotherapy and outcome research, clinical pharmacy, pharmacoepidemiology, pharmacoeconomics, the clinical use of medicines, medical devices and laboratory tests, information on medicines and medical devices information, pharmacy services research, medication management, other clinical aspects of pharmacy. IJCP publishes original Research articles, Review articles , Short research reports, Commentaries, book reviews, and Letters to the Editor. International Journal of Clinical Pharmacy is affiliated with the European Society of Clinical Pharmacy (ESCP). ESCP promotes practice and research in Clinical Pharmacy, especially in Europe. The general aim of the society is to advance education, practice and research in Clinical Pharmacy . Until 2010 the journal was called Pharmacy World & Science.
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