A Real-World Disproportionality Analysis of FDA Adverse Event Reporting System(FAERS) Event for Belatacept.

Abstract

Objective: This study aims to comprehensively evaluate the safety profile of belatacept administration in real-world clinical settings.

Methods: Disproportionality analysis methodologies, including Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-Item Gamma Poisson Shrinker (MGPS) algorithms, were utilized to quantify real-world adverse event (AE) signals associated with belatacept.

Results: A total of 4631 adverse event reports were extracted from the FDA Adverse Event Reporting System (FAERS) database, of which 2337 adverse events were identified as "primary suspect" (PS) attributed to belatacept. Belatacept-related adverse events involved 27 system organ classes (SOCs). Common adverse reaction preferred terms (PTs) consistent with the FDA label for belatacept identified in FAERS analysis included anemia (PT: 10019281), diarrhea (PT: 10012736), and urinary tract infection (PT: 10046577). Notably, several potential novel or off-label adverse event signals were detected in the analysis, including multiple organ transplant rejection (ROR = 976.42), tertiary syphilis (ROR = 901.31), removal of renal transplant (ROR = 857.72), perinephric fluid collection (ROR = 563.03), graft loss (ROR = 549.26), polyomavirus positive (ROR = 548), subcapsular renal hematoma (ROR = 475.53), renal transplant rejection (ROR = 293.73), renal transplant failure (ROR = 204.27), polyomavirus viremia (ROR = 203.62), renal vein thrombosis (ROR = 171), renal transplant infection (ROR = 168.26), injection (ROR = 154.2), and graft hemorrhage (ROR = 152.17). The distribution of adverse event reports varied across populations. Most reports were submitted by consumers (P = .0099), and females were predominantly represented. There was a significant age difference between female and male patients (P = .035).

Conclusion: This study identifies potential novel adverse event signals for belatacept within the FAERS database, and highlights age, sex differences, and comorbidity complexity in adverse event distribution, providing essential references for clinical drug safety and subsequent mechanistic research.