Hughes Michael Sang, Lentzsch Suzanne
Department of Hematology-Oncology, Columbia University Irving Medical Center, New York, NY, USA.
Ther Clin Risk Manag. 2023 Dec 28;19:1063-1074. doi: 10.2147/TCRM.S325859. eCollection 2023.
Systemic AL amyloidosis, a plasma cell dyscrasia, is characterized by the production of misfolded immunoglobulin light chain. These misfolded proteins aggregate into amyloid fibrils and deposit throughout the body, resulting in widespread organ dysfunction and ultimately death. Achieving rapid and maximal elimination of the plasma cell clone is crucial to long-term survival. Daratumumab, an anti-CD38 monoclonal antibody delivered intravenously, has been swiftly incorporated into standard first-line treatment regimens. A novel formulation of daratumumab has been developed that can be injected subcutaneously.
As a retrospective qualitative review of prior publications involving daratumumab, this work briefly summarizes the existing data regarding the safety and efficacy of subcutaneous (SC) daratumumab, compared to intravenous (IV) daratumumab. SC daratumumab appears to deliver the same disease benefit as IV daratumumab to patients with decreased infusion-related reactions (IRRs), decreased time for administration, and similar rates of adverse events (AEs) intrinsically related to daratumumab.
SC daratumumab is preferred over IV daratumumab, but the clinical situation ultimately should determine route of administration. Further investigation into cost-effectiveness benefit is warranted.
系统性AL淀粉样变性是一种浆细胞异常增殖性疾病,其特征是产生错误折叠的免疫球蛋白轻链。这些错误折叠的蛋白质聚集成淀粉样纤维,并沉积于全身,导致广泛的器官功能障碍,最终导致死亡。实现浆细胞克隆的快速和最大程度清除对于长期生存至关重要。达雷妥尤单抗是一种静脉注射的抗CD38单克隆抗体,已迅速纳入标准一线治疗方案。现已开发出一种可皮下注射的达雷妥尤单抗新剂型。
作为一项对先前涉及达雷妥尤单抗的出版物的回顾性定性综述,本研究简要总结了与静脉注射达雷妥尤单抗相比,皮下注射达雷妥尤单抗的安全性和有效性的现有数据。皮下注射达雷妥尤单抗似乎能为患者带来与静脉注射达雷妥尤单抗相同的疾病获益,输液相关反应(IRR)减少,给药时间缩短,且与达雷妥尤单抗本质相关的不良事件(AE)发生率相似。
皮下注射达雷妥尤单抗优于静脉注射达雷妥尤单抗,但最终的给药途径应根据临床情况确定。有必要进一步研究其成本效益。