Department of Internal Medicine, School of Medicine, Konyang University, Daejeon, South Korea.
Konyang University Myunggok Medical Research Institute, Daejeon, South Korea.
Sci Rep. 2024 Feb 1;14(1):2660. doi: 10.1038/s41598-024-52822-w.
This study aimed to detect signals of adverse drug reactions (ADRs) associated with biological disease-modifying antirheumatic drugs (DMARDs) and targeted therapies in rheumatoid arthritis (RA) and ankylosing spondylitis (AS) patients. Utilizing the KOrean College of Rheumatology BIOlogics & Targeted Therapy Registry (KOBIO) data, we calculated relative risks, excluded previously reported drug-ADR pairs, and externally validated remaining pairs using US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) and single centre's electronic health records (EHR) data. Analyzing data from 2279 RA and 1940 AS patients, we identified 35 significant drug-ADR pairs in RA and 26 in AS, previously unreported in drug labels. Among the novel drug-ADR pairs from KOBIO, 15 were also significant in the FAERS data. Additionally, 2 significant drug-laboratory abnormality pairs were found in RA using CDM MetaLAB analysis. Our findings contribute to the identification of 14 novel drug-ADR signals, expanding our understanding of potential adverse effects related to biological DMARDs and targeted therapies in RA and AS. These results emphasize the importance of ongoing pharmacovigilance for patient safety and optimal therapeutic interventions.
本研究旨在检测与类风湿关节炎（RA）和强直性脊柱炎（AS）患者中生物疾病修饰抗风湿药物（DMARDs）和靶向治疗相关的不良反应（ADR）信号。利用韩国风湿病学院生物制剂和靶向治疗登记处（KOBIO）的数据，我们计算了相对风险，排除了先前报告的药物-ADR 对，并使用美国食品和药物管理局（FDA）不良事件报告系统（FAERS）和单中心电子健康记录（EHR）数据对其余的药物-ADR 对进行了外部验证。通过对 2279 例 RA 和 1940 例 AS 患者的数据进行分析，我们在 RA 中确定了 35 对以前未在药物标签中报告的显著药物-ADR 对，在 AS 中确定了 26 对。在 KOBIO 的新药物-ADR 对中，有 15 对在 FAERS 数据中也有显著意义。此外，通过 CDM MetaLAB 分析还发现了 RA 中 2 对显著的药物-实验室异常对。我们的研究结果确定了 14 种新的药物-ADR 信号，加深了我们对 RA 和 AS 中生物 DMARDs 和靶向治疗相关潜在不良反应的认识。这些结果强调了持续进行药物警戒以确保患者安全和优化治疗干预的重要性。
