PMID- 38164204
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20240306
IS  - 1176-6336 (Print)
IS  - 1178-203X (Electronic)
IS  - 1176-6336 (Linking)
VI  - 19
DP  - 2023
TI  - Safety and Efficacy of Subcutaneous Daratumumab in Systemic AL Amyloidosis.
PG  - 1063-1074
LID - 10.2147/TCRM.S325859 [doi]
AB  - 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.
CI  - (c) 2023 Hughes and Lentzsch.
FAU - Hughes, Michael Sang
AU  - Hughes MS
AD  - Department of Hematology-Oncology, Columbia University Irving Medical Center, New 
      York, NY, USA.
FAU - Lentzsch, Suzanne
AU  - Lentzsch S
AD  - Department of Hematology-Oncology, Columbia University Irving Medical Center, New 
      York, NY, USA.
LA  - eng
GR  - T32 CA203703/CA/NCI NIH HHS/United States
PT  - Journal Article
PT  - Review
DEP - 20231228
PL  - New Zealand
TA  - Ther Clin Risk Manag
JT  - Therapeutics and clinical risk management
JID - 101253281
PMC - PMC10758190
OTO - NOTNLM
OT  - AE
OT  - AL amyloidosis
OT  - adverse events
OT  - daratumumab
OT  - plasma cell dyscrasia
COIS- S.L. is a Consultant and/or Advisor for Adaptive Biotechnologies, Alexion 
      Therapeutics, Bristol-Meyers-Squibb, Caelum Biosciences, Janssen Pharmaceuticals, 
      Karyopharm Therapeutics, Oncopeptides AB, GSK, Abbvie, Janssen, Pfizer, and 
      Takeda Pharmaceutical Company; receives research funding from Celgene, Inc., 
      Sanofi, Zentali; received honoraria from Clinical Care Options and Regeneron 
      Pharmaceuticals; and has Royalties/Patents with Caelum Biosciences. In addition, 
      S.L. has a patent CAEL-101 with royalties paid to Columbia University. The 
      authors report no other disclosures or conflicts of interest in this work.
EDAT- 2024/01/02 11:42
MHDA- 2024/01/02 11:43
PMCR- 2023/12/28
CRDT- 2024/01/02 03:38
PHST- 2023/09/01 00:00 [received]
PHST- 2023/12/04 00:00 [accepted]
PHST- 2024/01/02 11:43 [medline]
PHST- 2024/01/02 11:42 [pubmed]
PHST- 2024/01/02 03:38 [entrez]
PHST- 2023/12/28 00:00 [pmc-release]
AID - 325859 [pii]
AID - 10.2147/TCRM.S325859 [doi]
PST - epublish
SO  - Ther Clin Risk Manag. 2023 Dec 28;19:1063-1074. doi: 10.2147/TCRM.S325859. 
      eCollection 2023.