Vitiligo secondary to immunosuppressants: a pharmacovigilance study of the FDA Adverse Event Reporting System.

BACKGROUND

Vitiligo is an acquired depigmentation disorder affecting individuals worldwide. The potential link between immunosuppressants and the onset or exacerbation of vitiligo remains a topic of clinical concern.

OBJECTIVE

This study aims to evaluate the association between various immunosuppressants and vitiligo using data from the FDA Adverse Event Reporting System (FAERS).

METHODS

A retrospective pharmacovigilance analysis was conducted using FAERS data from January 2004 to June 2024. Vitiligo cases were identified through the Medical Dictionary for Regulatory Activities (MedDRA) terminology. Disproportionality analysis was performed using the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayes Geometric Mean (EBGM) to detect significant drug-event associations.

RESULTS

A total of 435 vitiligo-related adverse event (AE) reports were identified. The United States, Canada, France, Germany, and Brazil contributed the most reports. Vitiligo reports were more frequent in female patients, particularly within the 18-65 age group. The primary indications for immunosuppressant use included psoriasis, rheumatoid arthritis, psoriatic arthropathy, Crohn's disease, and ulcerative colitis. Adalimumab (74 cases) and secukinumab (52 cases) accounted for the highest number of reports. Significant signals were detected for alemtuzumab, ixekizumab, ustekinumab, secukinumab, guselkumab, and risankizumab.

CONCLUSION

This study highlights the importance of continuous pharmacovigilance in monitoring potential adverse events associated with immunosuppressants. The observed association between specific immunosuppressants and vitiligo suggests a need for further research to elucidate underlying mechanisms and develop strategies to mitigate these potential AEs.