Assessment of adverse events related to anti-interleukin-6 receptor monoclonal antibodies using the FDA adverse event reporting system: a real-world pharmacovigilance study

ABSTRACT

Background

Interleukin-6 (IL-6) monoclonal antibodies are commonly acknowledged for their efficacy in managing coronavirus disease 2019 (COVID-19); however, there remains a paucity of comprehensive studies on their potential adverse effects.

Research design and methods

This is a retrospective pharmacovigilance investigation. We employed FAERS using OpenVigil FDA to detect adverse reactions linked to the interleukin-6 antagonist tocilizumab and sarilumab.

Results

Completely 67,976 reports were identified as ‘primary suspected (PS)’ adverse events (AEs) for tocilizumab, and 12,560 reports for sarilumab. 109 significant disproportionality preferred terms (PTs) of tocilizumab and 158 PTs of sarilumab were retained. A higher incidence of adverse reactions occurred in females aged 45-64 years, with a higher rate of subsequent hospitalization. Both drugs exhibited adverse reactions consistent with previously reported side effects, such as leukopenia, elevated liver enzymes, and hypercholesterolemia. Additionally, there was a strong correlation with gastrointestinal issues. Unexpected significant adverse events, including diabetes, fluctuations in blood pressure, drug ineffectiveness, malignancies, and disorders of the nervous system, were also observed. Gender and age differences existed in AEs signals related to IL-6RAs.

Conclusion

Our study identified significant new AE signals for interleukin-6 receptor antagonists, potentially supporting clinical monitoring and risk identification for this class of drugs.

KEYWORDS:

• Interleukin-6 receptor antagonists
• tocilizumab
• sarilumab
• FDA adverse event reporting system
• pharmacovigilance

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Ethics statement

Ethics approval was not necessary for this study as it did not involve any human participants and utilized anonymous data obtained from a publicly accessible source.

Author contribution statement

Jing Hu: Data curation, Investigation, Writing-original draft, Writing – reviewing and editing; Yao Sun: Resources, Formal analysis, Validation, Visualization, Writing – review and editing; Xiangrong Zuo: Conceptualization, Data curation, Formal analysis, Funding acquisition, Methodology, Supervision, Validation, Writing – review and editing; Ying Zou: Conceptualization, Resources, Project administration, Writing – reviewing and editing.

Additional information

Funding

This paper was not funded.