Miyata Koji, Izawa-Ishizawa Yuki, Niimura Takahiro, Yoshioka Toshihiko, Hyodo Mizusa, Itokazu Shuto, Miyata Tatsumi, Aizawa Fuka, Yagi Kenta, Kawada Kei, Hamano Hirofumi, Zamami Yoshito, Goda Mitsuhiro, Ishizawa Keisuke
Department of Clinical Pharmacology and Therapeutics, Graduate School of Biomedical Sciences, Tokushima University, Tokushima 770-8503, Japan.
Clinical Research Center for Developmental Therapeutics, Tokushima University Hospital, Tokushima 770-8503, Japan.
Oncologist. 2025 Jul 4;30(7). doi: 10.1093/oncolo/oyaf201.
Mogamulizumab is a humanized anti-CCR4 monoclonal antibody used for relapsed/refractory adult T-cell leukemia, cutaneous T-cell lymphoma, and/or Sézary syndrome. Reports of immune-related adverse events (irAEs) in these patients are increasing, and the association between irAEs and mogamulizumab remains to be elucidated. This study aimed to evaluate the association between mogamulizumab and immune-related adverse events (irAEs), as well as to characterize the irAEs associated with mogamulizumab using data from a large-scale spontaneous reporting system.
We performed an exploratory hypothesis-generating analysis of patients from 1967 to September 2023 using VigiBase, a World Health Organization spontaneous adverse event reporting system database. We performed a disproportionality analysis and determined the reporting odds ratios and information components between the drugs of interest and each irAE.
Mogamulizumab was associated with some irAEs, including myocarditis, severe cutaneous adverse reactions, hepatitis, and myositis. Mogamulizumab exhibited significantly higher reporting rates of these 4 irAEs compared to the anticancer agents other than mogamulizumab. Conversely, the reporting rate of other irAEs, including endocrine autoimmune diseases induced by immune checkpoint inhibitors, was not significant in patients who received mogamulizumab.
Mogamulizumab is associated with irAEs, including myocarditis, severe cutaneous adverse reactions, hepatitis, and myositis.
莫加莫利单抗是一种人源化抗CCR4单克隆抗体，用于治疗复发/难治性成人T细胞白血病、皮肤T细胞淋巴瘤和/或蕈样肉芽肿综合征。这些患者中免疫相关不良事件（irAE）的报告不断增加，irAE与莫加莫利单抗之间的关联仍有待阐明。本研究旨在评估莫加莫利单抗与免疫相关不良事件（irAE）之间的关联，并使用大规模自发报告系统的数据来描述与莫加莫利单抗相关的irAE特征。
我们使用世界卫生组织自发不良事件报告系统数据库VigiBase，对1967年至2023年9月的患者进行了探索性假设生成分析。我们进行了不成比例分析，并确定了感兴趣药物与每种irAE之间的报告比值比和信息成分。
莫加莫利单抗与一些irAE相关，包括心肌炎、严重皮肤不良反应、肝炎和肌炎。与莫加莫利单抗以外的抗癌药物相比，莫加莫利单抗的这4种irAE报告率显著更高。相反，在接受莫加莫利单抗治疗的患者中，包括免疫检查点抑制剂引起的内分泌自身免疫性疾病在内的其他irAE报告率并不显著。
莫加莫利单抗与irAE相关，包括心肌炎、严重皮肤不良反应、肝炎和肌炎。
