Zhang Genshan, Zhang Haokun, Fu Jie, Cao Zhixin
Department of Gastrointestinal Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, People's Republic of China.
School of Public Health and Health Management, Gannan Medical University, Ganzhou, People's Republic of China.
Cancer Med. 2024 Dec;13(23):e70478. doi: 10.1002/cam4.70478.
Mogamulizumab is a monoclonal antibody targeting the C-C chemokine receptor 4, used to treat T-cell malignancies such as cutaneous T-cell lymphoma, adult T-cell leukemia/lymphoma, and peripheral T-cell lymphoma. However, real-world studies on mogamulizumab-associated adverse events (AEs) are limited.
Disproportionality analyses were performed to assess the safety profile of mogamulizumab based on data from the US Food and Drug Administration Adverse Event Reporting System (FAERS) database for the period spanning from October 2018 to December 2023. The research investigated demographic characteristics, the onset timing of AEs, and the safety implications associated with mogamulizumab use.
A total of 1182 significant preferred terms were identified among the 3661 mogamulizumab-associated AE reports collected from the FAERS database. The frequently reported AEs including rash, infusion-related reaction, and pyrexia were in line with drug instruction. Notably, several unexpectedly significant AEs were also found, including pemphigoid (ROR = 5.69 [95% CI 1.83-17.66]), unstable angina (ROR = 20.56 [95% CI 8.54-49.5]), bulbar palsy (ROR = 238.36 [95% CI 75.22-755.31]), myositis (ROR = 12.65 [95% CI 5.67-28.19]), and various autoimmune diseases such as autoimmune hepatitis (ROR = 21.33 [95% CI 11.08-41.07]), myocarditis (ROR = 15.29 [95% CI 8.67-26.97]), glomerulonephritis (ROR = 22.49 [95% CI 7.24-69.9]), nephrotic syndrome (ROR = 7.63 [95% CI 2.46-23.67]), myasthenia gravis (ROR = 8.54 [95% CI 3.2-22.77]), and autoimmune thyroiditis (ROR = 11.81 [95% CI 3.8-36.68]).
This study replicated previously identified AEs associated with mogamulizumab and uncovered additional signals of AEs, particularly emphasizing the risks associated with autoimmune diseases. It is essential to exercise vigilance in monitoring the occurrence of these AEs during the use of mogamulizumab in clinical practice.
莫加莫拉单抗是一种靶向C-C趋化因子受体4的单克隆抗体，用于治疗皮肤T细胞淋巴瘤、成人T细胞白血病/淋巴瘤和外周T细胞淋巴瘤等T细胞恶性肿瘤。然而，关于莫加莫拉单抗相关不良事件（AE）的真实世界研究有限。
基于美国食品药品监督管理局不良事件报告系统（FAERS）数据库2018年10月至2023年12月期间的数据，进行不成比例分析以评估莫加莫拉单抗的安全性。该研究调查了人口统计学特征、AE的发病时间以及与使用莫加莫拉单抗相关的安全影响。
从FAERS数据库收集的3661份莫加莫拉单抗相关AE报告中，共识别出1182个显著优先术语。经常报告的AE包括皮疹、输液相关反应和发热，与药物说明书一致。值得注意的是，还发现了一些意外显著的AE，包括类天疱疮（风险比[ROR]=5.69[95%置信区间1.83-17.66]）、不稳定型心绞痛（ROR=20.56[95%置信区间8.54-49.5]）、延髓麻痹（ROR=238.36[95%置信区间75.22-755.31]）、肌炎（ROR=12.65[95%置信区间5.67-28.19]）以及各种自身免疫性疾病，如自身免疫性肝炎（ROR=21.33[95%置信区间11.08-41.07]）、心肌炎（ROR=15.29[95%置信区间8.67-26.97]）、肾小球肾炎（ROR=22.49[95%置信区间7.24-69.9]）、肾病综合征（ROR=7.63[95%置信区间2.46-23.67]）、重症肌无力（ROR=8.54[95%置信区间3.2-22.77]）和自身免疫性甲状腺炎（ROR=11.81[95%置信区间3.8-36.68]）。
本研究重复了先前确定的与莫加莫拉单抗相关的AE，并发现了额外的AE信号，特别强调了与自身免疫性疾病相关的风险。在临床实践中使用莫加莫拉单抗期间，必须警惕监测这些AE的发生。
