PMID- 38143494
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231225
IS  - 1663-9812 (Print)
IS  - 1663-9812 (Electronic)
IS  - 1663-9812 (Linking)
VI  - 14
DP  - 2023
TI  - A real-world disproportionality analysis of mepolizumab based on the FDA adverse 
      event reporting system.
PG  - 1280490
LID - 10.3389/fphar.2023.1280490 [doi]
LID - 1280490
AB  - Background: Mepolizumab has been approved by the FDA for add-on maintenance 
      treatment of severe asthma with an eosinophilic phenotype. Real-world studies on 
      mepolizumab-associated adverse events are limited. The present study aimed to 
      explore mepolizumab-related adverse events based on the US Food and Drug 
      Administration Adverse Event Reporting System (FAERS) database. Methods: A 
      disproportionality analysis was performed to assess the safety profile of 
      mepolizumab based on the reports from the FAERS database between October 2015 and 
      December 2022. Demographic information, the time to onset, the safety of 
      long-term mepolizumab exposure as well as safety in pediatric patients were also 
      investigated. Results: A total of 736 significant preferred terms (PTs) were 
      identified among the 13,497 mepolizumab-associated adverse events (AEs) reports 
      collected from the FAERS database. The frequently reported AEs including dyspnea, 
      fatigue, and headache were in line with drug instruction and previous studies. 
      Unexpected significant AEs such as cough, malaise, and chest discomfort were also 
      identified. Most AEs occurred within the first month after mepolizumab 
      initiation. Pneumonia and wheezing were frequently reported in patients with 
      long-term mepolizumab exposure as well as in the pediatric population. 
      Conclusion: Our results were consistent with the observations in previous 
      clinical and real-world studies. New and unexpected AE signals of mepolizumab 
      were also identified. Close attention should be paid to the long-term safety of 
      mepolizumab as well as safety in the pediatric population. Prospective studies 
      are required for optimal use of mepolizumab.
CI  - Copyright (c) 2023 Li, Wang, Deng and Guo.
FAU - Li, Huqun
AU  - Li H
AD  - Department of Pharmacy, The Central Hospital of Wuhan, Tongji Medical College, 
      Huazhong University of Science and Technology, Wuhan, China.
FAU - Wang, Chongshu
AU  - Wang C
AD  - Department of Otolaryngology-Head and Neck Surgery, Tongji Hospital, Tongji 
      Medical College, Huazhong University of Science and Technology, Wuhan, China.
FAU - Deng, Aiping
AU  - Deng A
AD  - Department of Pharmacy, The Central Hospital of Wuhan, Tongji Medical College, 
      Huazhong University of Science and Technology, Wuhan, China.
FAU - Guo, Cuilian
AU  - Guo C
AD  - Department of Otolaryngology-Head and Neck Surgery, Tongji Hospital, Tongji 
      Medical College, Huazhong University of Science and Technology, Wuhan, China.
LA  - eng
PT  - Journal Article
DEP - 20231207
PL  - Switzerland
TA  - Front Pharmacol
JT  - Frontiers in pharmacology
JID - 101548923
PMC - PMC10748586
OTO - NOTNLM
OT  - asthma
OT  - disproportionality
OT  - long term
OT  - mepolizumab
OT  - pediatric
OT  - pharmacovigilance
COIS- The authors declare that the research was conducted in the absence of any 
      commercial or financial relationships that could be construed as a potential 
      conflict of interest.
EDAT- 2023/12/25 06:41
MHDA- 2023/12/25 06:42
PMCR- 2023/12/07
CRDT- 2023/12/25 04:15
PHST- 2023/08/20 00:00 [received]
PHST- 2023/11/23 00:00 [accepted]
PHST- 2023/12/25 06:42 [medline]
PHST- 2023/12/25 06:41 [pubmed]
PHST- 2023/12/25 04:15 [entrez]
PHST- 2023/12/07 00:00 [pmc-release]
AID - 1280490 [pii]
AID - 10.3389/fphar.2023.1280490 [doi]
PST - epublish
SO  - Front Pharmacol. 2023 Dec 7;14:1280490. doi: 10.3389/fphar.2023.1280490. 
      eCollection 2023.