Phase IV safety evaluation of voclosporin in lupus nephritis patients using the FAERS database for a 42-month period (2021 - 2024).

Objective: Voclosporin, a novel calcineurin inhibitor (CNI), was FDA-approved in 2021 for treating lupus nephritis (LN). However, post-marketing studies and reports on adverse events (AEs) associated with voclosporin remain limited. This study analyzes voclosporin-associated AEs using FDA Adverse Event Reporting System (FAERS) data.

Materials and methods: AEs with voclosporin as the primary suspected (PS) drug were extracted from the FAERS database, covering the period from the first quarter of 2021 to the second quarter of 2024. Disproportionality analysis, including the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS), was used to analyze AE signals.

Results: We identified 3,785 reports of AEs associated with voclosporin as PS, encompassing a total of 10,795 AEs. After applying 4 disproportionality algorithms, 6 system organ classes (SOCs) and 88 preferred terms (PTs) were detected, respectively. AEs with the strongest signal intensities included: glomerular filtration rate decreased, urine protein/creatinine ratio increased, hypertension, diarrhea, headache, and blood potassium increased. The median onset time for AEs was 56 days (interquartile range 4 - 208 days), with ~ 43% of AEs occurring within the first month of commencing voclosporin therapy.

Conclusion: Our findings are consistent with AEs reported in previous clinical trials and outlined in the drug's labeling. The study results further confirm the reliability of the adverse reactions listed in the prescribing information.