1. Serious adverse events with tocilizumab: Pharmacovigilance as an aid to prioritize monitoring in COVID‐19
- Author
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Paolo Caraceni, Michele Fusaroli, Emanuel Raschi, Fabrizio De Ponti, Milo Gatti, Elisabetta Poluzzi, Gatti M., Fusaroli M., Caraceni P., Poluzzi E., De Ponti F., and Raschi E.
- Subjects
Male ,Databases, Factual ,Pulmonary Fibrosis ,disproportionality ,030226 pharmacology & pharmacy ,Pharmacovigilance ,chemistry.chemical_compound ,Adverse Event Reporting System ,0302 clinical medicine ,Retrospective Studie ,Odds Ratio ,Medicine ,Pharmacology (medical) ,030212 general & internal medicine ,Aged, 80 and over ,Middle Aged ,Cytokine release syndrome ,Female ,Chemical and Drug Induced Liver Injury ,Cytokine Release Syndrome ,liver injury ,Human ,United State ,Adult ,medicine.medical_specialty ,Pulmonary Fibrosi ,Antibodies, Monoclonal, Humanized ,tocilizumab ,Young Adult ,03 medical and health sciences ,Tocilizumab ,Internal medicine ,Adverse Drug Reaction Reporting Systems ,Humans ,Adverse effect ,Aged ,Monitoring, Physiologic ,Retrospective Studies ,Pharmacology ,Pancreatiti ,United States Food and Drug Administration ,business.industry ,COVID-19 ,Retrospective cohort study ,Odds ratio ,medicine.disease ,United States ,COVID-19 Drug Treatment ,Clinical trial ,Pancreatitis ,chemistry ,Adverse Drug Reaction Reporting System ,business - 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.
- Published
- 2020