A Real-world Pharmacovigilance Study of the FAERS Database: Safety Signals of Common Medications for Non-infectious Uveitis.
Biologics for non-infectious uveitis show a significant safety signal for neoplasms
A Real-world Pharmacovigilance Study of the FAERS Database: Safety Signals of Common Medications for Non-infectious Uveitis.
While a range of immunomodulatory medications are used for non-infectious uveitis (non-infectious uveitis), real-world pharmacovigilance data focusing on their safety profiles are lacking.
This study aimed to evaluate the safety of commonly used medications for non-infectious uveitis and provide insights into their associated adverse events (adverse events).
Data on medications used for non-infectious uveitis (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.
Among ten medications for non-infectious uveitis, adalimumab accounted for the highest number of adverse events reports (N=5,842), followed by infliximab (N=1,199), prednisone (N=749), and methotrexate (N=427).
Common adverse events were observed in the present study.
For instance, adverse events of infections (N=293) and endocrine disorders (N=47) were reported in prednisone.
We also found several adverse events which had not been reported in non-infectious uveitis patients before, with splenomegaly as an example (Reporting Odds Ratio 95% CI lower bound: 4.66; IC025: 1.35; P<0.001).
Medications for non-infectious uveitis cause adverse events across multiple systems.
This study provides valuable insights into the similarities and differences in the safety of non-infectious uveitis medications, including common, novel, and rare adverse events.
Clinicians should carefully weigh the visual benefits against risks and tailor individual treatment plans for patients with non-infectious uveitis.