Department of Internal Medicine, LSUHSC-Shreveport, Shreveport, USA; Division of Cardiology, Department of Medicine, College of Medicine, University of Illinois at Chicago.
Department of Internal Medicine, LSUHSC-Shreveport, Shreveport, USA.
Int J Cardiol. 2024 May 1;402:131819. doi: 10.1016/j.ijcard.2024.131819. Epub 2024 Jan 30.
Psoriasis is a chronic skin condition characterized by hyperproliferation of epidermal keratinocytes, resulting in erythematous and scaling lesions. The US Food and Drug Administration (FDA) has approved nine biologic agents to address the burden of psoriasis, but their cardiovascular risks remain poorly studied.
This retrospective pharmacovigilance study utilized the FDA Adverse Event Reporting System (FAERS) database to analyze adverse events associated with newly approved therapeutic agents for psoriasis. We employed disproportionally signal analysis, calculating the reporting odds ratio (ROR) with a 95% confidence interval.
Among the vast FAERS database, which contained >25 million adverse events, a total of 334,399 events were associated with newly approved therapeutic agents for psoriasis. Cardiac adverse events accounted for 3852 cases, including pericarditis, atrial fibrillation, and coronary artery disease. Secukinumab had the highest number of reported adverse events, followed by brodalumab, while tildrakizumab had the lowest. Coronary artery disease was the most reported adverse event (1438 cases), followed by pericarditis (572 cases) and atrial fibrillation (384 cases). Secukinumab had the highest incidence of coronary artery disease, pericarditis, and atrial fibrillation. Risankizumab was significantly associated with an increased risk of coronary artery disease and atrial fibrillation, while tildrakizumab and Ixekizumab were associated with atrial fibrillation. Secukinumab was associated with an elevated risk of pericarditis.
The study uncovers the cardiovascular adverse effects related to biologic agents used in psoriasis treatment. These findings emphasize the importance of monitoring and evaluating the cardiovascular safety profiles of biological agents used in psoriasis treatment.
银屑病是一种慢性皮肤病，其特征是表皮角质形成细胞过度增殖，导致红斑和鳞屑病变。美国食品和药物管理局（FDA）已批准九种生物制剂来解决银屑病的负担，但它们的心血管风险仍研究不足。
本回顾性药物警戒研究利用 FDA 不良事件报告系统（FAERS）数据库分析与新批准的银屑病治疗药物相关的不良事件。我们采用不成比例信号分析，计算报告比值比（ROR）及其 95%置信区间。
在包含超过 2500 万例不良事件的庞大 FAERS 数据库中，共有 334399 例事件与新批准的银屑病治疗药物相关。心脏不良事件占 3852 例，包括心包炎、心房颤动和冠状动脉疾病。司库珠单抗报告的不良事件数量最多，其次是布罗达卢单抗，而替西单抗报告的不良事件数量最少。冠状动脉疾病是报告最多的不良事件（1438 例），其次是心包炎（572 例）和心房颤动（384 例）。司库珠单抗的冠状动脉疾病、心包炎和心房颤动发生率最高。 risankizumab 与冠状动脉疾病和心房颤动的风险增加显著相关，而替西单抗和依奇珠单抗与心房颤动相关。司库珠单抗与心包炎风险增加相关。
该研究揭示了银屑病治疗中生物制剂相关的心血管不良事件。这些发现强调了监测和评估银屑病治疗中生物制剂心血管安全性的重要性。
