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.

Gatti M., Fusaroli M., Caraceni P., Poluzzi E., De Ponti F., Raschi E. (2021). Serious adverse events with tocilizumab: Pharmacovigilance as an aid to prioritize monitoring in COVID-19. BRITISH JOURNAL OF CLINICAL PHARMACOLOGY, 87(3), 1533-1540 [10.1111/bcp.14459].

Serious adverse events with tocilizumab: Pharmacovigilance as an aid to prioritize monitoring in COVID-19

Gatti M.;Fusaroli M.;Caraceni P.;Poluzzi E.;De Ponti F.;Raschi E.
2021

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.
2021
Gatti M., Fusaroli M., Caraceni P., Poluzzi E., De Ponti F., Raschi E. (2021). Serious adverse events with tocilizumab: Pharmacovigilance as an aid to prioritize monitoring in COVID-19. BRITISH JOURNAL OF CLINICAL PHARMACOLOGY, 87(3), 1533-1540 [10.1111/bcp.14459].
Gatti M.; Fusaroli M.; Caraceni P.; Poluzzi E.; De Ponti F.; Raschi E.
File in questo prodotto:
File Dimensione Formato  
Gatti_AM_2021.pdf

accesso aperto

Tipo: Postprint
Licenza: Licenza per accesso libero gratuito
Dimensione 652.55 kB
Formato Adobe PDF
652.55 kB Adobe PDF Visualizza/Apri

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11585/849806
 Attenzione

Attenzione! I dati visualizzati non sono stati sottoposti a validazione da parte dell'ateneo

Citazioni
  • ???jsp.display-item.citation.pmc??? 30
  • Scopus 39
  • ???jsp.display-item.citation.isi??? 36
social impact