PMID- 38245663
OWN - NLM
STAT- MEDLINE
DCOM- 20240325
LR  - 20240325
IS  - 2210-7711 (Electronic)
VI  - 46
IP  - 2
DP  - 2024 Apr
TI  - Exploring the safety profile of tremelimumab: an analysis of the FDA adverse 
      event reporting system.
PG  - 480-487
LID - 10.1007/s11096-023-01678-7 [doi]
AB  - BACKGROUND: Despite the approval of tremelimumab in 2022, there is a lack of 
      pharmacovigilance studies investigating its safety profile in real-world settings 
      using the FDA Adverse Event Reporting System (FAERS) database. AIM: This 
      pharmacovigilance study aimed to comprehensively explore the adverse events (AEs) 
      associated with tremelimumab using data mining techniques on the FAERS database. 
      METHOD: The study utilized data from the FAERS database, covering the period from 
      the first quarter of 2004 to the third quarter of 2022. Disproportionality 
      analysis, the Benjamini Hochberg adjustment method and volcano plots were used to 
      identify and evaluate AE signals associated with tremelimumab. RESULTS: The study 
      uncovered 233 AE cases associated with tremelimumab. Among these cases, 
      pyrexia (n = 39), biliary tract infection (n = 23), and sepsis (n = 21) were the 
      three main AEs associated with tremelimumab use. The study also investigated the 
      system organ classes associated with tremelimumab-related AEs. The top three 
      classes were gastrointestinal disorders (17.9%), infections and infestations 
      (16.6%), and general disorders and administration site infections (11.2%). 
      Several AEs were identified that were not listed on the drug label of 
      tremelimumab. These AEs included pyrexia, biliary tract infection, sepsis, 
      dyspnea, infusion site infection, hiccup, appendicitis, hypotension, dehydration, 
      localised oedema, presyncope, superficial thrombophlebitis and thrombotic 
      microangiopathy. CONCLUSION: This pharmacovigilance study identified several 
      potential adverse events signals related to tremelimumab including some adverse 
      events not listed on the drug label. However, further basic and clinical 
      research studies are needed to validate these results.
CI  - (c) 2024. The Author(s), under exclusive licence to Springer Nature Switzerland AG.
FAU - Zhao, Yibei
AU  - Zhao Y
AD  - The Key Laboratory of Biochemistry and Molecular Pharmacology, Department of 
      Pharmacology, Chongqing Medical University, Chongqing, 400016, China.
FAU - Jiang, Huiming
AU  - Jiang H
AD  - Department of Pharmacy, The First Affiliated Hospital of Chongqing Medical 
      University, Chongqing, 400016, China.
FAU - Xue, Lifen
AU  - Xue L
AD  - Department of Pharmacy, The First Affiliated Hospital of Chongqing Medical 
      University, Chongqing, 400016, China.
FAU - Zhou, Mi
AU  - Zhou M
AD  - Department of Pharmacy, The First Affiliated Hospital of Chongqing Medical 
      University, Chongqing, 400016, China.
FAU - Zhao, Xiaobing
AU  - Zhao X
AD  - The Key Laboratory of Biochemistry and Molecular Pharmacology, Department of 
      Pharmacology, Chongqing Medical University, Chongqing, 400016, China.
FAU - Liu, Fei
AU  - Liu F
AD  - Department of Pharmacy, Shihezi People's Hospital, XingJiang, 832000, China.
FAU - Jiang, SongJiang
AU  - Jiang S
AD  - The People's Hospital of Qijiang District, Chongqing, 401420, China.
FAU - Huang, Jing
AU  - Huang J
AD  - Department of Respiratory and Critical Care Medicine, The First Affiliated 
      Hospital of Chongqing Medical University, Chongqing, 400016, China. 
      janej006@163.com.
FAU - Meng, Long
AU  - Meng L
AD  - Department of Pharmacy, The First Affiliated Hospital of Chongqing Medical 
      University, Chongqing, 400016, China.
LA  - eng
GR  - 2023QNXM039/Chongqing Science & Technology Commission/
PT  - Journal Article
DEP - 20240120
PL  - Netherlands
TA  - Int J Clin Pharm
JT  - International journal of clinical pharmacy
JID - 101554912
RN  - QEN1X95CIX (tremelimumab)
RN  - 0 (Antibodies, Monoclonal, Humanized)
SB  - IM
MH  - Humans
MH  - United States/epidemiology
MH  - Adverse Drug Reaction Reporting Systems
MH  - *Drug-Related Side Effects and Adverse Reactions/epidemiology
MH  - Pharmacovigilance
MH  - *Sepsis
MH  - United States Food and Drug Administration
MH  - Fever
MH  - *Antibodies, Monoclonal, Humanized
OTO - NOTNLM
OT  - Adverse event
OT  - CTLA-4
OT  - FAERS
OT  - Immunotherapy
OT  - Pharmacovigilance
OT  - Safety profile
OT  - Tremelimumab
EDAT- 2024/01/21 00:42
MHDA- 2024/03/25 06:43
CRDT- 2024/01/20 23:24
PHST- 2023/07/31 00:00 [received]
PHST- 2023/11/19 00:00 [accepted]
PHST- 2024/03/25 06:43 [medline]
PHST- 2024/01/21 00:42 [pubmed]
PHST- 2024/01/20 23:24 [entrez]
AID - 10.1007/s11096-023-01678-7 [pii]
AID - 10.1007/s11096-023-01678-7 [doi]
PST - ppublish
SO  - Int J Clin Pharm. 2024 Apr;46(2):480-487. doi: 10.1007/s11096-023-01678-7. Epub 
      2024 Jan 20.