Drug-induced liver injury following the use of tocilizumab or sarilumab in patients with coronavirus disease 2019
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 t...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2022-12-01
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| Series: | BMC Infectious Diseases |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12879-022-07896-0 |
| _version_ | 1798005395909771264 |
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| author | Qian Gao Xuedong Yin Boyu Tan Junshi Wang Jiayan Chen Bin Zhao Qiaoling Yang Zhiling Li |
| author_facet | Qian Gao Xuedong Yin Boyu Tan Junshi Wang Jiayan Chen Bin Zhao Qiaoling Yang Zhiling Li |
| author_sort | Qian Gao |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-11T12:38:49Z |
| format | Article |
| id | doaj.art-581ff79c85da47f5b83a2d2c01ca0d9b |
| institution | Directory Open Access Journal |
| issn | 1471-2334 |
| language | English |
| last_indexed | 2024-04-11T12:38:49Z |
| publishDate | 2022-12-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Infectious Diseases |
| spelling | doaj.art-581ff79c85da47f5b83a2d2c01ca0d9b2022-12-22T04:23:33ZengBMCBMC Infectious Diseases1471-23342022-12-0122111110.1186/s12879-022-07896-0Drug-induced liver injury following the use of tocilizumab or sarilumab in patients with coronavirus disease 2019Qian Gao0Xuedong Yin1Boyu Tan2Junshi Wang3Jiayan Chen4Bin Zhao5Qiaoling Yang6Zhiling Li7Department of Pharmacy, Shanghai Children’s Hospital, School of Medicine, Shanghai Jiao Tong UniversityDepartment of Pharmacy, Shanghai Children’s Hospital, School of Medicine, Shanghai Jiao Tong UniversityDepartment of Pharmacy, Shanghai Children’s Hospital, School of Medicine, Shanghai Jiao Tong UniversityMacau University of Science and TechnologySchool of Nursing and Health, Shanghai Zhongqiao Vocational and Technical UniversityDepartment of Pharmacy, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical SciencesDepartment of Pharmacy, Shanghai Children’s Hospital, School of Medicine, Shanghai Jiao Tong UniversityDepartment of Pharmacy, Shanghai Children’s Hospital, School of Medicine, Shanghai Jiao Tong UniversityAbstract 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.https://doi.org/10.1186/s12879-022-07896-0Coronavirus disease 2019 (COVID-19)TocilizumabSarilumabDrug Induced Liver InjuryFAERSEpidemiology |
| spellingShingle | Qian Gao Xuedong Yin Boyu Tan Junshi Wang Jiayan Chen Bin Zhao Qiaoling Yang Zhiling Li Drug-induced liver injury following the use of tocilizumab or sarilumab in patients with coronavirus disease 2019 BMC Infectious Diseases Coronavirus disease 2019 (COVID-19) Tocilizumab Sarilumab Drug Induced Liver Injury FAERS Epidemiology |
| title | Drug-induced liver injury following the use of tocilizumab or sarilumab in patients with coronavirus disease 2019 |
| title_full | Drug-induced liver injury following the use of tocilizumab or sarilumab in patients with coronavirus disease 2019 |
| title_fullStr | Drug-induced liver injury following the use of tocilizumab or sarilumab in patients with coronavirus disease 2019 |
| title_full_unstemmed | Drug-induced liver injury following the use of tocilizumab or sarilumab in patients with coronavirus disease 2019 |
| title_short | Drug-induced liver injury following the use of tocilizumab or sarilumab in patients with coronavirus disease 2019 |
| title_sort | drug induced liver injury following the use of tocilizumab or sarilumab in patients with coronavirus disease 2019 |
| topic | Coronavirus disease 2019 (COVID-19) Tocilizumab Sarilumab Drug Induced Liver Injury FAERS Epidemiology |
| url | https://doi.org/10.1186/s12879-022-07896-0 |
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