Serious adverse events with tocilizumab: Pharmacovigilance as an aid to prioritize monitoring in COVID-19.
Br J Clin Pharmacol
; 87(3): 1533-1540, 2021 03.
Article
in English
| MEDLINE | ID: covidwho-635720
ABSTRACT
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.
Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Antibodies, Monoclonal, Humanized
/
COVID-19
/
COVID-19 Drug Treatment
Type of study:
Observational study
/
Prognostic study
/
Randomized controlled trials
Topics:
Long Covid
Limits:
Adult
/
Aged
/
Female
/
Humans
/
Male
/
Middle aged
/
Young adult
Country/Region as subject:
North America
Language:
English
Journal:
Br J Clin Pharmacol
Year:
2021
Document Type:
Article
Affiliation country:
Bcp.14459
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