Akademik Veri Yönetim Sistemi
The Eurasian Journal of Medical Investigation , cilt.9, sa.3, ss.176-181, 2025 (TRDizin)
Objectives: This study aims to characterize kidney transplant rejection events associated with immune checkpoint
inhibitor (ICI) therapy using real-world pharmacovigilance data from the FDA Adverse Event Reporting System (FAERS).
Methods: We conducted a retrospective pharmacovigilance analysis using the FAERS to identify cases of kidney trans-
plant rejection associated with ICIs reported between January 1, 2012, and March 30, 2025. Reports were included if an
FDA-approved ICI was the primary suspect and "kidney transplant rejection" was listed as the adverse event.
Results: Among 215,907 ICI-related adverse event reports reports, 99 cases (0.04%) of kidney transplant rejection were
identified. The median age was 68 years; 63.6% were male. Nivolumab (54.5%) and pembrolizumab (24.2%) were the
most frequently reported ICIs. Malignant melanoma was the most common underlying malignancy (41.4%). Most pa-
tients (86.9%) received single-agent ICI therapy, while 13.1% received combination therapy with CTLA-4 inhibitors.
Death due to adverse events occurred in 25.3% of cases.
Conclusion: Our findings align with previous literature, which reports high rejection rates, particularly among patients
with melanoma.
Keywords: Adverse drug reaction, Allograft rejection, Kidney transplantation; Kidney transplant rejection, Immune
checkpoint inhibitors, Pharmacovigilance, FAERS (FDA Adverse Event Reporting System)