tetano
Editor, Senior Moderator
BMC Infect Dis
. 2022 Dec 12;22(1):929.
doi: 10.1186/s12879-022-07896-0.
Drug-induced liver injury following the use of tocilizumab or sarilumab in patients with coronavirus disease 2019
Qian Gao[SUP] #[/SUP][SUP] 1 2 [/SUP], Xuedong Yin[SUP] #[/SUP][SUP] 1 2 [/SUP], Boyu Tan[SUP] 1 [/SUP], Junshi Wang[SUP] 3 [/SUP], Jiayan Chen[SUP] 4 [/SUP], Bin Zhao[SUP] 5 [/SUP], Qiaoling Yang[SUP] 6 7 [/SUP], Zhiling Li[SUP] 8 [/SUP]
Affiliations
Abstract
Backgrounds: Interleukin-6 (IL-6) blockers including tocilizumab and sarilumab were approved by the U.S. Food and Drug Administration (FDA) in June 2021 for the treatment of patients with moderate to severe COVID-19. The use of sarilumab or tocilizumab in COVID-19 patients has been related to a reduction in mortality compared to standard care. Recent evidence has emerged concerning drug-induced liver injury (DILI) after sarilumab or tocilizumab applications in COVID-19 patients.
Aims: The study aimed to estimate DILI associated with sarilumab or tocilizumab in treating moderate to severe patients infected with SARS-Cov-2.
Methods: We conducted a retrospective pharmacovigilance study by data mining of the FDA's adverse event reporting systems (FAERS) database from the first quarter of 2004 to the fourth quarter of 2021 in confirmed COVID-19 patients. We analyzed DILI cases associated with tocilizumab or sarilumab in treating COVID-19 patients from the FAERS during this period. Disproportionality analysis and Bayesian analysis of COVID-19 patients were utilized for case analysis, and we also next compared the onset time and fatality rates of DILI following tocilizumab or sarilumab.
Results: A total of 275 cases of TCZ or SAR-related DILI reports were extracted. A total of 192 AEs cases were related to tocilizumab (TCZ), and 83 were related to sarilumab (SAR). In patients treated with TCZ, most were < 75 years old (51.57%), with more male than female (46.35% vs. 13.02%). The correlation between IL-6 receptor antagonists and DILI was stronger in SAR (ROR = 12.94; 95%CI 9.6-17.44) than in TCZ (ROR = 1.33; 95%CI 1.14-1.55). The onset time of DILI was different between TCZ and SAR, and a significant difference was observed in TCZ than SAR (P < 0.0001). A significant difference was observed in the mortality rate of TCZ and SAR (P = 0.0009). DILI associated with COVID-19 patients treated with TCZ appeared to have earlier onset-time (1(0-46) day) VS. SAR (3.5(0-27) day).
Conclusion: This study shows strict monitor ought to be paid for TCZ or SAR when used for COVID-19 patients with poor liver function.
Keywords: Coronavirus disease 2019 (COVID-19); Drug Induced Liver Injury; Epidemiology; FAERS; Sarilumab; Tocilizumab.
. 2022 Dec 12;22(1):929.
doi: 10.1186/s12879-022-07896-0.
Drug-induced liver injury following the use of tocilizumab or sarilumab in patients with coronavirus disease 2019
Qian Gao[SUP] #[/SUP][SUP] 1 2 [/SUP], Xuedong Yin[SUP] #[/SUP][SUP] 1 2 [/SUP], Boyu Tan[SUP] 1 [/SUP], Junshi Wang[SUP] 3 [/SUP], Jiayan Chen[SUP] 4 [/SUP], Bin Zhao[SUP] 5 [/SUP], Qiaoling Yang[SUP] 6 7 [/SUP], Zhiling Li[SUP] 8 [/SUP]
Affiliations
- PMID: 36503381
- DOI: 10.1186/s12879-022-07896-0
Abstract
Backgrounds: Interleukin-6 (IL-6) blockers including tocilizumab and sarilumab were approved by the U.S. Food and Drug Administration (FDA) in June 2021 for the treatment of patients with moderate to severe COVID-19. The use of sarilumab or tocilizumab in COVID-19 patients has been related to a reduction in mortality compared to standard care. Recent evidence has emerged concerning drug-induced liver injury (DILI) after sarilumab or tocilizumab applications in COVID-19 patients.
Aims: The study aimed to estimate DILI associated with sarilumab or tocilizumab in treating moderate to severe patients infected with SARS-Cov-2.
Methods: We conducted a retrospective pharmacovigilance study by data mining of the FDA's adverse event reporting systems (FAERS) database from the first quarter of 2004 to the fourth quarter of 2021 in confirmed COVID-19 patients. We analyzed DILI cases associated with tocilizumab or sarilumab in treating COVID-19 patients from the FAERS during this period. Disproportionality analysis and Bayesian analysis of COVID-19 patients were utilized for case analysis, and we also next compared the onset time and fatality rates of DILI following tocilizumab or sarilumab.
Results: A total of 275 cases of TCZ or SAR-related DILI reports were extracted. A total of 192 AEs cases were related to tocilizumab (TCZ), and 83 were related to sarilumab (SAR). In patients treated with TCZ, most were < 75 years old (51.57%), with more male than female (46.35% vs. 13.02%). The correlation between IL-6 receptor antagonists and DILI was stronger in SAR (ROR = 12.94; 95%CI 9.6-17.44) than in TCZ (ROR = 1.33; 95%CI 1.14-1.55). The onset time of DILI was different between TCZ and SAR, and a significant difference was observed in TCZ than SAR (P < 0.0001). A significant difference was observed in the mortality rate of TCZ and SAR (P = 0.0009). DILI associated with COVID-19 patients treated with TCZ appeared to have earlier onset-time (1(0-46) day) VS. SAR (3.5(0-27) day).
Conclusion: This study shows strict monitor ought to be paid for TCZ or SAR when used for COVID-19 patients with poor liver function.
Keywords: Coronavirus disease 2019 (COVID-19); Drug Induced Liver Injury; Epidemiology; FAERS; Sarilumab; Tocilizumab.