PMID- 37708442
OWN - NLM
STAT- MEDLINE
DCOM- 20231225
LR  - 20231225
IS  - 1029-2403 (Electronic)
IS  - 1026-8022 (Linking)
VI  - 64
IP  - 13
DP  - 2023 Dec
TI  - Chimeric antigen receptor T-cell immunotherapies adverse events reported to FAERS 
      database: focus on cytopenias.
PG  - 2071-2080
LID - 10.1080/10428194.2023.2254430 [doi]
AB  - Chimeric antigen receptor (CAR) T-cell therapy presents a promising treatment for 
      hematologic malignancies, displaying high efficacy but not being exempt from 
      toxicity. In this observational study, we assessed adverse events (AEs) reported 
      to the Food and Drug Adverse Event Reporting System (FAERS) including any of the 
      six approved CAR T-cell therapies. A total of 5249 reports mentioning a CAR 
      T-cell as a suspect product were retrieved from the FAERS database, containing a 
      total of 24333 AEs, of which 3236 (13.3%) were cytopenias. The highest number of 
      AEs mentioned by the report was observed for tisagenlecleucel (mean = 6.7), with 
      the lowest for ciltacabtagene (mean = 1.3). Among all reports, hematopoietic 
      leukopenia was the most frequently reported AEs (n = 1386, 5.7%), with 
      hematopoietic erytropenia the least reported (n = 291, 1.2%). Tisagenlecleucel 
      showed a high reporting odds ratio for hematopoietic erythropenia (27.28, 95%CI 
      14.04-53.00), leukopenia (4.04, 95%CI 3.52-4.64), and thrombocytopenia (4.01, 
      95%CI 3.19-5.03). Cytopenias represent one of the most frequently reported AEs in 
      FAERS, a CAR T-cell therapy is indicated, with haematopoetic leukopenia being the 
      most common. When comparing different CAR-T cell therapies, the cytopenias' 
      reporting odds ratio was particularly high for tisagenlecleucel, especially in 
      relation to hematopoietic erythropenia.
FAU - Gomez-Lumbreras, Ainhoa
AU  - Gomez-Lumbreras A
AD  - Department of Pharmacotherapy, College of Pharmacy, University of Utah, Salt Lake 
      City, UT, USA.
FAU - Mercadal Vilchez, Santiago
AU  - Mercadal Vilchez S
AD  - Transplant and Cellular Therapy Program, Huntsman Cancer Institute, University of 
      Utah, UT, USA.
AD  - Cellular Therapy and Regenerative Medicine, University of Utah, UT, USA.
FAU - Villa-Zapata, Lorenzo
AU  - Villa-Zapata L
AD  - Department of Clinical and Administrative Pharmacy, College of Pharmacy, 
      University of Georgia, Athens, GA, USA.
FAU - Malone, Daniel C
AU  - Malone DC
AD  - Department of Pharmacotherapy, College of Pharmacy, University of Utah, Salt Lake 
      City, UT, USA.
FAU - Couriel, Daniel R
AU  - Couriel DR
AD  - Transplant and Cellular Therapy Program, Huntsman Cancer Institute, University of 
      Utah, UT, USA.
AD  - Cellular Therapy and Regenerative Medicine, University of Utah, UT, USA.
LA  - eng
PT  - Journal Article
PT  - Observational Study
DEP - 20230914
PL  - United States
TA  - Leuk Lymphoma
JT  - Leukemia & lymphoma
JID - 9007422
RN  - 0 (Receptors, Chimeric Antigen)
SB  - IM
MH  - Humans
MH  - United States
MH  - *Receptors, Chimeric Antigen
MH  - *Cytopenia
MH  - *Drug-Related Side Effects and Adverse Reactions/epidemiology/etiology
MH  - Immunotherapy, Adoptive/adverse effects
MH  - *Leukopenia/etiology
MH  - *Thrombocytopenia
MH  - United States Food and Drug Administration
MH  - T-Lymphocytes
OTO - NOTNLM
OT  - Receptors
OT  - adverse drug reaction reporting systems
OT  - chimeric antigen
OT  - drug-related side effects and adverse reactions
OT  - hematologic diseases
OT  - pharmacovigilance
EDAT- 2023/09/14 18:43
MHDA- 2023/12/25 06:43
CRDT- 2023/09/14 16:03
PHST- 2023/12/25 06:43 [medline]
PHST- 2023/09/14 18:43 [pubmed]
PHST- 2023/09/14 16:03 [entrez]
AID - 10.1080/10428194.2023.2254430 [doi]
PST - ppublish
SO  - Leuk Lymphoma. 2023 Dec;64(13):2071-2080. doi: 10.1080/10428194.2023.2254430. 
      Epub 2023 Sep 14.