PMID- 38035014
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231202
IS  - 1663-9812 (Print)
IS  - 1663-9812 (Electronic)
IS  - 1663-9812 (Linking)
VI  - 14
DP  - 2023
TI  - Parasitic infections related to anti-type 2 immunity monoclonal antibodies: a 
      disproportionality analysis in the food and drug administration's adverse event 
      reporting system (FAERS).
PG  - 1276340
LID - 10.3389/fphar.2023.1276340 [doi]
LID - 1276340
AB  - Introduction: Monoclonal antibodies (mAbs) targeting immunoglobulin E (IgE) 
      [omalizumab], type 2 (T2) cytokine interleukin (IL) 5 [mepolizumab, reslizumab], 
      IL-4 Receptor (R) alpha [dupilumab], and IL-5R [benralizumab]), improve quality of 
      life in patients with T2-driven inflammatory diseases. However, there is a 
      concern for an increased risk of helminth infections. The aim was to explore 
      safety signals of parasitic infections for omalizumab, mepolizumab, reslizumab, 
      dupilumab, and benralizumab. Methods: Spontaneous reports were used from the Food 
      and Drug Administration's Adverse Event Reporting System (FAERS) database from 
      2004 to 2021. Parasitic infections were defined as any type of parasitic 
      infection term obtained from the Standardised Medical Dictionary for Regulatory 
      Activities((R)) (MedDRA((R))). Safety signal strength was assessed by the Reporting 
      Odds Ratio (ROR). Results: 15,502,908 reports were eligible for analysis. Amongst 
      175,888 reports for omalizumab, mepolizumab, reslizumab, dupilumab, and 
      benralizumab, there were 79 reports on parasitic infections. Median age was 55 
      years (interquartile range 24-63 years) and 59.5% were female. Indications were 
      known in 26 (32.9%) reports; 14 (53.8%) biologicals were reportedly prescribed 
      for asthma, 8 (30.7%) for various types of dermatitis, and 2 (7.6%) for 
      urticaria. A safety signal was observed for each biological, except for 
      reslizumab (due to lack of power), with the strongest signal attributed to 
      benralizumab (ROR = 15.7, 95% Confidence Interval: 8.4-29.3). Conclusion: 
      Parasitic infections were disproportionately reported for mAbs targeting IgE, T2 
      cytokines, or T2 cytokine receptors. While the number of adverse event reports on 
      parasitic infections in the database was relatively low, resulting safety signals 
      were disproportionate and warrant further investigation.
CI  - Copyright (c) 2023 Pera, Brusselle, Riemann, Kors, Van Mulligen, Parry, de Wilde, 
      Rijnbeek and Verhamme.
FAU - Pera, Victor
AU  - Pera V
AD  - Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, 
      Netherlands.
FAU - Brusselle, Guy G
AU  - Brusselle GG
AD  - Department of Respiratory Medicine, Ghent University Hospital, Ghent, Belgium.
AD  - Departments of Epidemiology and Respiratory Medicine, Erasmus University Medical 
      Center, Rotterdam, Netherlands.
FAU - Riemann, Sebastian
AU  - Riemann S
AD  - Department of Respiratory Medicine, Ghent University Hospital, Ghent, Belgium.
FAU - Kors, Jan A
AU  - Kors JA
AD  - Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, 
      Netherlands.
FAU - Van Mulligen, Erik M
AU  - Van Mulligen EM
AD  - Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, 
      Netherlands.
FAU - Parry, Rowan
AU  - Parry R
AD  - Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, 
      Netherlands.
FAU - de Wilde, Marcel
AU  - de Wilde M
AD  - Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, 
      Netherlands.
FAU - Rijnbeek, Peter R
AU  - Rijnbeek PR
AD  - Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, 
      Netherlands.
FAU - Verhamme, Katia M C
AU  - Verhamme KMC
AD  - Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, 
      Netherlands.
LA  - eng
PT  - Journal Article
DEP - 20231114
PL  - Switzerland
TA  - Front Pharmacol
JT  - Frontiers in pharmacology
JID - 101548923
PMC - PMC10682182
OTO - NOTNLM
OT  - FAERS
OT  - biologicals
OT  - disproportionality analysis
OT  - helminth infections
OT  - monoclonal antibodies
OT  - parasitic infections
OT  - pharmacovigilance
OT  - spontaneous reporting
COIS- The research group from the Department of Medical Informatics receives/received 
      unconditional research grants from Chiesi, GlaxoSmithKline (GSK), UCB, and Amgen, 
      Johnson and Johnson, and the European Medicines Agency, none of which relate to 
      the content of this manuscript. GB received payment/honoraria for lectures, 
      presentations, speakers bureaus, manuscript writing or educational events from 
      Astra Zeneca, Boehringer-Ingelheim, Chiesi, GSK, Merck Sharp & Dohme (MSD), 
      Novartis, and Sanofi, none of which relate to the content of this manuscript. The 
      remaining 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- 2023/11/30 18:45
MHDA- 2023/11/30 18:46
PMCR- 2023/11/14
CRDT- 2023/11/30 17:42
PHST- 2023/08/11 00:00 [received]
PHST- 2023/10/31 00:00 [accepted]
PHST- 2023/11/30 18:46 [medline]
PHST- 2023/11/30 18:45 [pubmed]
PHST- 2023/11/30 17:42 [entrez]
PHST- 2023/11/14 00:00 [pmc-release]
AID - 1276340 [pii]
AID - 10.3389/fphar.2023.1276340 [doi]
PST - epublish
SO  - Front Pharmacol. 2023 Nov 14;14:1276340. doi: 10.3389/fphar.2023.1276340. 
      eCollection 2023.