Safety and Efficacy of Subcutaneous Daratumumab in Systemic AL Amyloidosis

IF 2.8 3区医学 Q1 Pharmacology, Toxicology and Pharmaceutics

Therapeutics and Clinical Risk Management Pub Date : 2023-12-28 DOI:10.2147/tcrm.s325859

Michael Sang Hughes, Suzanne Lentzsch

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引用次数: 0

Abstract

Introduction: 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.
Areas Covered: 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.
Expert Opinion: 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.

Keywords: plasma cell dyscrasia, daratumumab, AL amyloidosis, adverse events, AE

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皮下注射达拉土单抗治疗系统性 AL 淀粉样变性的安全性和有效性

简介系统性 AL 淀粉样变性是一种浆细胞发育不良症，其特征是产生折叠错误的免疫球蛋白轻链。这些错误折叠的蛋白质聚集成淀粉样纤维并沉积在全身，导致广泛的器官功能障碍，最终导致死亡。快速、最大限度地消除浆细胞克隆对长期生存至关重要。达拉单抗是一种静脉注射的抗CD38单克隆抗体，已被迅速纳入标准一线治疗方案。目前已开发出一种可皮下注射的新型达拉单抗制剂：作为对以前发表的涉及达拉单抗的文章的回顾性定性综述，本研究简要总结了与静脉注射达拉单抗相比，皮下注射达拉单抗的安全性和有效性方面的现有数据。皮下注射达拉单抗似乎能为患者带来与静脉注射达拉单抗相同的疾病获益，同时输液相关反应（IRRs）减少，用药时间缩短，与达拉单抗内在相关的不良事件（AEs）发生率相似：专家意见：与静脉注射达拉单抗相比，首选静脉注射达拉单抗，但最终应由临床情况决定给药途径。有必要进一步研究其成本效益。关键词：浆细胞异常、达拉单抗、AL 淀粉样变性、不良事件、AE

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Therapeutics and Clinical Risk Management HEALTH CARE SCIENCES & SERVICES-

CiteScore

5.30

自引率

3.60%

发文量

139

审稿时长

16 weeks

期刊介绍： Therapeutics and Clinical Risk Management is an international, peer-reviewed journal of clinical therapeutics and risk management, focusing on concise rapid reporting of clinical studies in all therapeutic areas, outcomes, safety, and programs for the effective, safe, and sustained use of medicines, therapeutic and surgical interventions in all clinical areas. The journal welcomes submissions covering original research, clinical and epidemiological studies, reviews, guidelines, expert opinion and commentary. The journal will consider case reports but only if they make a valuable and original contribution to the literature. As of 18th March 2019, Therapeutics and Clinical Risk Management will no longer consider meta-analyses for publication. The journal does not accept study protocols, animal-based or cell line-based studies.