Comparison of Adverse Event Profiles of Tumor Necrosis Factor-Alfa Inhibitors: Analysis of a Spontaneous Reporting Database.
Japanese Adverse Drug Event Report database
TNF-alfa inhibitors
adverse drug events
reporting odds ratio
spontaneous reporting system
Journal
Therapeutics and clinical risk management
ISSN: 1176-6336
Titre abrégé: Ther Clin Risk Manag
Pays: New Zealand
ID NLM: 101253281
Informations de publication
Date de publication:
2020
2020
Historique:
received:
16
01
2020
accepted:
04
06
2020
entrez:
5
9
2020
pubmed:
5
9
2020
medline:
5
9
2020
Statut:
epublish
Résumé
Concerns over safety profiles of tumor necrosis factor (TNF)-alfa inhibitors have been raised. The purpose of this study was to clarify the adverse events associated with TNF-alfa inhibitors using a spontaneous reporting system database. A retrospective pharmacovigilance disproportionality analysis was conducted using the Japanese Adverse Drug Event Report (JADER) database. Adverse event reports submitted to the Pharmaceuticals and Medical Devices Agency between 2004 and 2017 were analyzed, and the reporting odds ratio (ROR) and 95% confidence interval (CI) for each adverse event were calculated. Among the 34,031 reports of adverse events associated with TNF-alfa inhibitors, 65.8% were women, who were frequently in their 60s (28.2%). Signals were detected for pneumonia (ROR, 5.36; 95% CI, 5.14-5.6), interstitial lung disease (ROR, 2.04; 95% CI, 1.95-2.15), pneumocystis jirovecii pneumonia (ROR, 11.8; 95% CI, 11.1-12.5), and herpes zoster (ROR, 6.4; 95% CI, 5.92-6.91) for TNF-alfa inhibitors as a class. There was variability in their signal strength across individual TNF-alfa inhibitors. The strength of the associations of TNF-alfa inhibitors with adverse events is variable, and further studies are required to evaluate the identified signals.
Identifiants
pubmed: 32884275
doi: 10.2147/TCRM.S246328
pii: 246328
pmc: PMC7439489
doi:
Types de publication
Journal Article
Langues
eng
Pagination
741-747Informations de copyright
© 2020 Wakabayashi et al.
Déclaration de conflit d'intérêts
The authors report no conflicts of interest in this work.
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