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| Content Provider | Springer Nature : BioMed Central |
|---|---|
| Author | Gao, Qian Yin, Xuedong Tan, Boyu Wang, Junshi Chen, Jiayan Zhao, Bin Yang, Qiaoling Li, Zhiling |
| 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. |
| Related Links | https://bmcinfectdis.biomedcentral.com/counter/pdf/10.1186/s12879-022-07896-0.pdf |
| Ending Page | 11 |
| Page Count | 11 |
| Starting Page | 1 |
| File Format | HTM / HTML |
| ISSN | 14712334 |
| DOI | 10.1186/s12879-022-07896-0 |
| Journal | BMC Infectious Diseases |
| Issue Number | 1 |
| Volume Number | 22 |
| Language | English |
| Publisher | BioMed Central |
| Publisher Date | 2022-12-12 |
| Access Restriction | Open |
| Subject Keyword | Infectious Diseases Parasitology Medical Microbiology Tropical Medicine Internal Medicine Coronavirus disease 2019 (COVID-19) Tocilizumab Sarilumab Drug Induced Liver Injury FAERS Epidemiology |
| Content Type | Text |
| Resource Type | Article |
| Subject | Infectious Diseases |
| Journal Impact Factor | 3.4/2023 |
| 5-Year Journal Impact Factor | 3.3/2023 |
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