Safety assessment of voclosporin: a real-world disproportionality analysis of the FAERS database.

BACKGROUND

Voclosporin was approved from the United States Food and Drug Administration (FDA) for treating adults with active lupus nephritis, in combination with a background immunosuppressive therapy regimen. Due to the limitations of clinical trials, real-world safety data on voclosporin in large samples are currently lacking. Therefore, this study aims to evaluate adverse events (AEs) associated with voclosporin.

RESEARCH DESIGN AND

METHODS

We retrospectively extracted reports on voclosporin-related AEs from the FDA's Adverse Event Reporting System (FAERS) database from January 2021 to December 2023. Various signal quantification techniques, including reporting odds ratios (ROR), proportional reporting ratio, Bayesian confidence propagation neural network, and multi-item gamma poisson shrinker, were employed for analysis.

RESULTS

A total of 2,932 AEs of voclosporin were observed. 27 system organ classes and 87 preferred terms about voclosporin-induced AE signals were observed. The most frequent AEs associated with voclosporin were hypertension, headache, and therapy interrupted. Notably, we identified the absence of immediate treatment response exhibited the strongest signal intensity in the ROR algorithm.

CONCLUSION

These initial findings undeniably serve as a helpful point of reference for future study and safety oversight.