Nakao Satoshi, Maezawa Mika, Yamashita Moe, Miyasaka Koumi, Hirofuji Sakiko, Ichihara Nanaka, Nokura Yuka, Sugishita Kana, Yamazaki Tomofumi, Tamaki Hirofumi, Suetsugu Kimitaka, Hashimoto Masafumi, Tsuji Toshikazu, Iguchi Kazuhiro, Ieiri Ichiro, Nakamura Mitsuhiro
Laboratory of Drug Informatics, Gifu Pharmaceutical University, Gifu, Japan.
Department of Pharmacy, Kyushu University Hospital, Fukuoka, Japan.
Int J Immunopathol Pharmacol. 2025 Jan-Dec;39:3946320251327618. doi: 10.1177/03946320251327618. Epub 2025 Apr 10.
The aim of this study was to evaluate the country-specific reporting status profile of immunomodulatory drugs (IMiDs)-related adverse events (ImrAEs) in real-world clinical practice, using data from the Japanese Adverse Drug Event Report (JADER) and Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) databases. Immunomodulatory drugs, including thalidomide and its derivatives, are a new class of anticancer and anti-inflammatory drugs. IMiD risk management programs have instituted sufficient measures to prevent fetal effects but do not address adverse effects experienced by patients themselves. To date, no study has compared ImrAE profiles across countries. Adverse events were defined using the preferred terms in the Medical Dictionary for Regulatory Activities. The number of reported adverse events related to IMiDs in each country (the United States and Japan) was investigated. In both Japan and the United States, myelosuppression, pneumonia, and neuropathy peripheral have been reported as adverse events suspected to be associated with IMiDs. Adverse event profiles differed between the countries. The number of adverse event reports for thalidomide increased transiently in the United States in 2008 following the multiple myeloma indication, and then exhibited a downward trend. The number of adverse event reports for lenalidomide and pomalidomide has increased in the United States since their launch. The number of transient reports increased in Japan in 2015, when pomalidomide was launched. In this study, the profile of ImrAEs was revealed using the FAERS and JADER databases. Our comparative safety study indicated the importance of comparing the safety profiles of IMiDs using post-marketing real-world data. It is important to focus on the adverse events experienced by patients taking IMiDs, as well as the effects of IMiDs on fetuses.
本研究旨在利用日本药品不良事件报告（JADER）和美国食品药品监督管理局（FDA）不良事件报告系统（FAERS）数据库中的数据，评估免疫调节药物（IMiDs）相关不良事件（ImrAEs）在真实临床实践中的国别报告状况。免疫调节药物，包括沙利度胺及其衍生物，是一类新型抗癌和抗炎药物。IMiD风险管理计划已制定了充分措施来预防对胎儿的影响，但未涉及患者自身所经历的不良反应。迄今为止，尚无研究对不同国家的ImrAE情况进行比较。不良事件采用《监管活动医学词典》中的首选术语进行定义。调查了每个国家（美国和日本）报告的与IMiDs相关的不良事件数量。在日本和美国，骨髓抑制、肺炎和周围神经病变均被报告为疑似与IMiDs相关的不良事件。两国的不良事件情况有所不同。2008年，美国沙利度胺的不良事件报告数量在其获批用于治疗多发性骨髓瘤后短暂增加，随后呈下降趋势。来那度胺和泊马度胺自上市以来，美国的不良事件报告数量一直在增加。2015年泊马度胺在日本上市时，短暂报告数量有所增加。在本研究中，利用FAERS和JADER数据库揭示了ImrAEs的情况。我们的比较安全性研究表明，利用上市后真实世界数据比较IMiDs安全性情况具有重要意义。关注服用IMiDs患者所经历的不良事件以及IMiDs对胎儿的影响非常重要。
