Cheng Yuzhe, Ma Jingyi, Niu Jun
Department of Dermatology, General Hospital of Northern Theater Command, Shenyang, China.
Graduate School, China Medical University, Shenyang, China.
BMC Rheumatol. 2025 Jul 21;9(1):90. doi: 10.1186/s41927-025-00545-4.
Anifrolumab, a monoclonal antibody targeting the type I interferon-α receptor, has been approved for the treatment of moderate-to-severe systemic lupus erythematosus (SLE). This study aimed to assess its safety profile in real-world settings.
This study analyzed all adverse events reports involving anifrolumab as the primary suspected drug from the quarter of 2021 to the third quarter of 2024 in the FDA Adverse Event Reporting System database. Disproportionality analyses were conducted using reporting odds ratio, proportional reporting ratio, multi-item gamma Poisson shrinker, and Bayesian confidence propagation neural network. The temporal risk of AEs was modeled using the Weibull distribution.
The most frequently reported AEs included upper respiratory tract infection, bronchitis, infusion-related reactions, herpes zoster, cough, hypersensitivity, and nasopharyngitis. Potential adverse reactions not listed in the product label were identified, such as dyspnea, pyrexia, vomiting, pruritus, dizziness, abnormal feeling, chest pain, urticaria, alopecia, increased blood pressure, swelling, and migraine. AEs primarily occurred within the initial month of treatment.
This study provides valuable safety data on the real-world application of anifrolumab, confirming known AEs and revealing additional potential risks. The findings offer critical safety information for clinicians prescribing anifrolumab for the treatment of SLE, aiding in the optimization of patient management and treatment decision-making.
阿尼鲁单抗是一种靶向I型干扰素-α受体的单克隆抗体，已被批准用于治疗中度至重度系统性红斑狼疮（SLE）。本研究旨在评估其在实际临床环境中的安全性。
本研究分析了美国食品药品监督管理局（FDA）不良事件报告系统数据库中2021年第一季度至2024年第三季度所有以阿尼鲁单抗为主要可疑药物的不良事件报告。使用报告比值比、比例报告比值、多项伽马泊松收缩器和贝叶斯置信传播神经网络进行不成比例分析。采用威布尔分布对不良事件的时间风险进行建模。
最常报告的不良事件包括上呼吸道感染、支气管炎、输液相关反应、带状疱疹、咳嗽、超敏反应和鼻咽炎。识别出产品标签中未列出的潜在不良反应，如呼吸困难、发热、呕吐、瘙痒、头晕、异常感觉、胸痛、荨麻疹、脱发、血压升高、肿胀和偏头痛。不良事件主要发生在治疗的最初一个月内。
本研究提供了关于阿尼鲁单抗实际应用的宝贵安全性数据，证实了已知的不良事件并揭示了其他潜在风险。这些发现为临床医生开具阿尼鲁单抗治疗SLE提供了关键的安全信息，有助于优化患者管理和治疗决策。
