Serious adverse events with tocilizumab: Pharmacovigilance as an aid to prioritize monitoring in COVID-19.
Adult
Adverse Drug Reaction Reporting Systems
Aged
Aged, 80 and over
Antibodies, Monoclonal, Humanized
/ adverse effects
COVID-19
/ complications
Chemical and Drug Induced Liver Injury
/ epidemiology
Cytokine Release Syndrome
/ drug therapy
Databases, Factual
Female
Humans
Male
Middle Aged
Monitoring, Physiologic
Odds Ratio
Pancreatitis
/ chemically induced
Pharmacovigilance
Pulmonary Fibrosis
/ chemically induced
Retrospective Studies
United States
United States Food and Drug Administration
Young Adult
COVID-19 Drug Treatment
COVID-19
disproportionality
liver injury
pharmacovigilance
tocilizumab
Journal
British journal of clinical pharmacology
ISSN: 1365-2125
Titre abrégé: Br J Clin Pharmacol
Pays: England
ID NLM: 7503323
Informations de publication
Date de publication:
03 2021
03 2021
Historique:
received:
01
04
2020
revised:
07
06
2020
accepted:
16
06
2020
pubmed:
9
7
2020
medline:
12
3
2021
entrez:
9
7
2020
Statut:
ppublish
Résumé
Given its approval for the treatment of cytokine release syndrome, tocilizumab is under investigation in severe coronavirus disease-2019. To characterize serious adverse events (AEs) with tocilizumab, we queried the worldwide FDA Adverse Event Reporting System and performed disproportionality analysis, selecting only designated medical events (DMEs) where tocilizumab was reported as suspect, with a focus on hepatic reactions. The reporting odds ratios (RORs) were calculated, deemed significant by a lower limit of the 95% confidence interval (LL 95% CI) > 1. A total of 2,433 reports of DMEs were recorded with tocilizumab, mainly in rheumatic diseases. Statistically significant RORs emerged for 13 DMEs, with drug-induced liver injury (n = 91; LL 95% CI 3.07), pancreatitis (151; 1.41), and pulmonary fibrosis (222; 7.21) as unpredictable AEs. A total of 174 cases of liver-related DMEs were retrieved (proportion of deaths = 18.4%), with median onset of 27.5 days. These serious unpredictable reactions occurring in chronic real-world tocilizumab use may support patient care and monitoring of ongoing clinical trials.
Substances chimiques
Antibodies, Monoclonal, Humanized
0
tocilizumab
I031V2H011
Types de publication
Journal Article
Observational Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
1533-1540Informations de copyright
© 2020 The British Pharmacological Society.
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