PMID- 37294594
OWN - NLM
STAT- MEDLINE
DCOM- 20231102
LR  - 20231102
IS  - 1744-764X (Electronic)
IS  - 1474-0338 (Linking)
VI  - 22
IP  - 10
DP  - 2023 Jul-Dec
TI  - Adverse events of guselkumab in the real world: emerging signals to target 
      preventive strategies from the FDA adverse event reporting system.
PG  - 943-955
LID - 10.1080/14740338.2023.2223956 [doi]
AB  - BACKGROUND: Guselkumab is an IL-23 inhibitor widely used for the treatment of 
      moderate-to-severe plaque psoriasis. Our study aimed to characterize the profile 
      of adverse events (AEs) associated with guselkumab from the FDA adverse event 
      reporting system (FAERS). METHODS: Disproportionality analysis including the 
      proportional reporting ratio (PRR), the reporting odds ratio (ROR), the Bayesian 
      confidence propagation neural network (BCPNN), and the multiitem gamma Poisson 
      shrinker (MGPS) algorithms were used to assess the signals of guselkumab related 
      AE. RESULTS: A total of 22,950,014 reports were collected from the FAERS 
      database, of which 24,312 reports regarding guselkumab as the 'primary suspected 
      (PS)' AEs were identified. AEs induced by guselkumab were distributed in 27 organ 
      systems. In this study, 205 significant disproportionality preferred terms (PTs) 
      that matched four algorithms simultaneously were obtained for analysis. 
      Unexpected significant AEs such as onychomadesis, malignant melanoma in situ, 
      endometrial cancer, and erectile dysfunction were observed. CONCLUSION: The 
      clinical observed AEs, along with potential new AE signals associated with 
      guselkumab were identified based on the analysis of FAERS data, which could 
      provide valuable evidence for clinical monitoring, risk identification, and 
      further safety studies of identification.
FAU - Xiang, Dao-Chun
AU  - Xiang DC
AD  - Department of Pharmacy, Sichuan Academy of Medical Sciences & Sichuan Provincial 
      People's Hospital, School of Medicine, University of Electronic Science and 
      Technology of China, Chengdu, China.
AD  - Personalized Drug Therapy Key Laboratory of Sichuan Province, School of Medicine, 
      University of Electronic Science and Technology of China, Chengdu, China.
AD  - Department of Pharmacy, the Central Hospital of Wuhan, Tongji Medical College, 
      Huazhong University of Science and Technology, Wuhan, China.
FAU - Chen, Wei
AU  - Chen W
AD  - Department of Pharmacy, Sichuan Academy of Medical Sciences & Sichuan Provincial 
      People's Hospital, School of Medicine, University of Electronic Science and 
      Technology of China, Chengdu, China.
AD  - Personalized Drug Therapy Key Laboratory of Sichuan Province, School of Medicine, 
      University of Electronic Science and Technology of China, Chengdu, China.
AD  - Wuhan Union Hospital of China, Huazhong University of Science and Technology, 
      Wuhan, P. R. of China.
FAU - Fu, Zhi-Wen
AU  - Fu ZW
AD  - Wuhan Union Hospital of China, Huazhong University of Science and Technology, 
      Wuhan, P. R. of China.
FAU - Wu, Xin-Hua
AU  - Wu XH
AD  - Wuhan Union Hospital of China, Huazhong University of Science and Technology, 
      Wuhan, P. R. of China.
FAU - Gao, Ping
AU  - Gao P
AD  - Department of Pharmacy, Wuhan Children's Hospital, Tongji Medical College, 
      Huazhong University of Science and Technology, Wuhan, China.
FAU - Wu, Yue
AU  - Wu Y
AD  - Department of Pharmacy, Sichuan Academy of Medical Sciences & Sichuan Provincial 
      People's Hospital, School of Medicine, University of Electronic Science and 
      Technology of China, Chengdu, China.
AD  - Personalized Drug Therapy Key Laboratory of Sichuan Province, School of Medicine, 
      University of Electronic Science and Technology of China, Chengdu, China.
LA  - eng
PT  - Journal Article
DEP - 20230613
PL  - England
TA  - Expert Opin Drug Saf
JT  - Expert opinion on drug safety
JID - 101163027
RN  - 089658A12D (guselkumab)
RN  - 0 (Antibodies, Monoclonal, Humanized)
SB  - IM
MH  - Male
MH  - Humans
MH  - United States
MH  - *Drug-Related Side Effects and Adverse Reactions/epidemiology/prevention & 
      control
MH  - Bayes Theorem
MH  - Antibodies, Monoclonal, Humanized/adverse effects
MH  - *Skin Neoplasms
MH  - Adverse Drug Reaction Reporting Systems
MH  - United States Food and Drug Administration
MH  - Pharmacovigilance
OTO - NOTNLM
OT  - Disproportionality analysis
OT  - FAERS
OT  - data mining
OT  - guselkumab
OT  - pharmacovigilance
EDAT- 2023/06/09 13:41
MHDA- 2023/06/09 13:42
CRDT- 2023/06/09 11:52
PHST- 2023/06/09 13:42 [medline]
PHST- 2023/06/09 13:41 [pubmed]
PHST- 2023/06/09 11:52 [entrez]
AID - 10.1080/14740338.2023.2223956 [doi]
PST - ppublish
SO  - Expert Opin Drug Saf. 2023 Jul-Dec;22(10):943-955. doi: 
      10.1080/14740338.2023.2223956. Epub 2023 Jun 13.