Full Papers
Clinical adverse events to voclosporin: a real-world drug safety study based on FDA Adverse Event Reporting System
J. Zhang1, Y. Wan2, L. Liu3, R. Chen4, Y. Shi5, Y. Tang6, P. Li7, H. Huang8
- State Key Laboratory of Bioactive Substance and Function of Natural Medicines, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing; and Department of Pharmacy, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.
- State Key Laboratory of Bioactive Substance and Function of Natural Medicines, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing; and Diabetes Research Center of Chinese Academy of Medical Sciences, Beijing, China.
- State Key Laboratory of Bioactive Substance and Function of Natural Medicines, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing; and Diabetes Research Center of Chinese Academy of Medical Sciences, Beijing, China.
- Department of Pulmonary and Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.
- Department of Pulmonary and Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.
- Department of Pharmacy, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.
- State Key Laboratory of Bioactive Substance and Function of Natural Medicines, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing; and Diabetes Research Center of Chinese Academy of Medical Sciences, Beijing, China.
- Department of Pulmonary and Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China. pumchhh@126.com
CER18652
Full Papers
PMID: 40737084 [PubMed]
Received: 23/02/2025
Accepted : 07/07/2025
In Press: 30/07/2025
Abstract
OBJECTIVES:
Voclosporin, a novel calcineurin inhibitor, is emerging as a promising treatment for lupus nephritis (LN). It inhibits T and B cell activation with unique pharmacokinetic profile and superior safety. To optimise clinical management, a comprehensive assessment of real-world safety is urgently needed.
METHODS:
A retrospective observational study was performed that analysed data from the FDA adverse event reporting system (FAERS) database from 2021Q4 to 2024Q3. Advanced data mining techniques were utilised to identify safety signals associated with voclosporin. The research focused on instances where voclosporin was considered the primary suspect (PS) drug, and incidents of adverse events (AEs) were categorised utilising the Medical Dictionary for Regulatory Activities standardised preferred terms and system organ class classifications (SOCs).
RESULTS:
The analysis of FAERS database identified 11,851 reports in which voclosporin was the PS drug. The median time to onset (TTO) of AEs is 54.50 days. These reports highlighted significant safety signals across various SOCs, especially in vascular disorders, skin and subcutaneous tissue diseases, and gastrointestinal disorders. Furthermore, several previously unreported adverse events associated with voclosporin were discovered, such as hypertensive urgency (ROR: 27.96, 95%IC: 11.53, 67.81), hypertrichosis (ROR: 15.17, 95%IC:5.66, 40.65), and gingival swelling (ROR: 16.38, 95%IC: 8.78, 30.57).
CONCLUSIONS:
The present research provides a significant assessment of the postmarketing safety profile of voclosporin. However, additional studies are needed to corroborate and solidify these observations. Clinicians are advised to remain highly vigilant about the potential AEs associated with voclosporin and to carefully consider the appropriate dosing regimens when utilising this medication in clinical practice.
