Tagami Nami, Uchiyama Michihiro, Suzuki Kenshi, Shirai Heigoroh, Seto Takeshi, Iida Shinsuke
Oncology Medical in Specialty Care, Sanofi K.K., Tokyo, Japan.
Department of Hematology, Japanese Red Cross Society Suwa Hospital, Suwa, Japan.
Int J Hematol. 2025 Apr;121(4):476-482. doi: 10.1007/s12185-024-03904-y. Epub 2024 Dec 27.
This post-marketing surveillance (PMS) assessed the safety and effectiveness of isatuximab plus pomalidomide and dexamethasone (Isa-Pd) for relapsed or refractory multiple myeloma (RRMM) in frail individuals during real-world use in Japan. Data from all individuals with RRMM treated with Isa-Pd in Japan between October 2020 and October 2021 were collected, with follow-up continued up to 12 months after starting Isa-Pd or until discontinuation. In the overall PMS population, 40 participants were classified as frail (33.3%) and 29 as fit/intermediate (24.2%), and 51 had no frailty score (42.5%). Incidence of adverse drug reactions in each group was 77.5%, 65.5%, and 37.3%. In frail versus fit/intermediate participants, bone-marrow suppression occurred in 72.5% versus 44.8%, infectious diseases in 17.5% versus 10.3%, and infusion-related reactions in 7.5% versus 3.5%. Heart failure occurred in one participant with no frailty score. The rates of overall response and very good partial response or better were higher (p = 0.101) in fit/intermediate participants (56.0% and 36.0%) than in frail participants (38.5% and 18.0%). Rates of treatment discontinuation due to disease progression were similar between groups. These findings support the safety and effectiveness of Isa-Pd for frail individuals with RRMM in real-life settings in Japan.
这项上市后监测（PMS）评估了isatuximab联合泊马度胺和地塞米松（Isa-Pd）在日本实际应用中对体弱个体复发或难治性多发性骨髓瘤（RRMM）的安全性和有效性。收集了2020年10月至2021年10月期间在日本接受Isa-Pd治疗的所有RRMM患者的数据，随访持续至开始Isa-Pd治疗后12个月或直至停药。在整个PMS人群中，40名参与者被归类为体弱（33.3%），29名被归类为健康/中等（24.2%），51名没有体弱评分（42.5%）。每组药物不良反应的发生率分别为77.5%、65.5%和37.3%。在体弱与健康/中等参与者中，骨髓抑制的发生率分别为72.5%和44.8%，传染病的发生率分别为17.5%和10.3%，输液相关反应的发生率分别为7.5%和3.5%。一名没有体弱评分的参与者发生了心力衰竭。健康/中等参与者（56.0%和36.0%）的总体缓解率和非常好的部分缓解率或更高缓解率高于体弱参与者（38.5%和18.0%）（p = 0.101）。两组因疾病进展导致的治疗中断率相似。这些发现支持了Isa-Pd在日本现实生活环境中对体弱RRMM患者的安全性和有效性。
