Tocilizumab, Sarilumab Associated With Liver Injury Risk in COVID-19 Treatment

Interleukin-6 inhibitors are associated with the occurrence of adverse events related to tocilizumab and sarilumab.

Monitoring of liver injury may be needed among patients with poor liver function who receive tocilizumab (TCZ) or sarilumab (SAR) for COVID-19 treatment, according to study findings published in BMC Infectious Diseases.

Researchers in China conducted a retrospective study and sourced data from the United States (US) Food and Drug Administration Adverse Event Reporting System (FAERS). Incidences of drug-induced liver injury (DILI) associated with TCZ and SAR during COVID-19 were evaluated.

A total of 2486 adverse events from monoclonal antibody treatments for COVID-19 were reported between May 2020 and December 2021. Of these, 192 and 83 were DILI events attributed to TCZ and SAR, respectively.

Most demographic information about SAR recipients were not reported (96.39%). A substantial proportion of TCZ recipient data were also missing (40.67%-41.67%). Among the patients who received TCZ, with available information, 46.35% were men and 30.21% were aged between 45 to 64 years.

Clinicians should strictly monitor this potential DILI when treating COVID-19 patients with IL-6 receptor antagonists.

Risk for DILI was more strongly associated with SAR (reported odds ratio [ROR], 12.94; 95% CI, 9.6-17.44) than with TCZ (ROR, 1.33; 95% CI, 1.14-1.55).

The onset of DILI typically occurred within the first 2 days after receiving TCZ, whereas onset was slightly more delayed with SAR, peaking at 3 to 4 days.

The outcomes of TCZ included other serious or important medical events (78%), death (17%), and hospitalization or prolonged hospitalization (15%). For SAR, the outcomes included other serious or important medical events (66%), hospitalization or prolonged hospitalization (45%), and death (37%).

The major limitation of this analysis was the large proportion of missing data.

The study authors conclude, “Clinicians should strictly monitor this potential DILI when treating COVID-19 patients with IL-6 receptor antagonists.”

This article originally appeared on Gastroenterology Advisor


Gao Q, Yin X, Tan B, et al. Drug‑induced liver injury following the use of tocilizumab or sarilumab in patients with coronavirus disease 2019. BMC Infect Dis. 2022;22(1):929. doi:10.1186/s12879-022-07896-0