A Real-world Pharmacovigilance Study of the FAERS Database: Safety Signals of Common Medications for Non-infectious Uveitis.

INTRODUCTION

While a range of immunomodulatory medications are used for non-infectious uveitis (NIU), real-world pharmacovigilance data focusing on their safety profiles are lacking. This study aimed to evaluate the safety of commonly used medications for NIU and provide insights into their associated adverse events (AEs).

METHODS

Data on medications used for NIU (from the fourth quarter of 2014 to the second quarter of 2024) were obtained from the Food and Drug Administration Adverse Event Reporting System (FAERS) database. Reporting Odds Ratio (ROR) and Bayesian Confidence Propagation Neural Network (BCPNN) were calculated for AEs signal detection. A significant safety signal was defined only when it was concurrently identified by both algorithms.

RESULTS AND DISCUSSION: Among ten medications for NIU, adalimumab accounted for the highest number of AEs reports (N=5,842), followed by infliximab (N=1,199), prednisone (N=749), and methotrexate (N=427). Common AEs were observed in the present study. For instance, AEs of infections (N=293) and endocrine disorders (N=47) were reported in prednisone. We also found several AEs which had not been reported in NIU patients before, with splenomegaly as an example (ROR 95% CI lower bound: 4.66; IC025: 1.35; P<0.001). Moreover, some rare AEs were identified. The disproportionality analysis identified a significant signal for neoplasms associated with biologics (ROR 95% CI lower bound:1.42; IC025: 0.66; P<0.001). This disproportionality analysis provides real-world evidence for a more comprehensive safety spectrum of NIU medications.

CONCLUSION

Medications for NIU cause AEs across multiple systems. This study provides valuable insights into the similarities and differences in the safety of NIU medications, including common, novel, and rare AEs. Clinicians should carefully weigh the visual benefits against risks and tailor individual treatment plans for patients with NIU.