Immune Checkpoint Inhibitor Associated Kidney Transplant Rejection: A Real World Pharmacovigilance Analysis Using the FAERS Database
Aydan Mütiş Alan1, Özkan Alan21Department of Nephrology, Kartal Dr. Lütfi Kırdar City Hospital, Istanbul, Türkiye, 2Department of Internal Medicine, Division of Medical Oncology, Cerrahpaşa Faculty of Medicine, Istanbul University-Cerrahpaşa, Istanbul, Türkiye
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 transplant 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 patients (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)
Cite This Article
Mütiş Alan A, Alan Ö. Immune Checkpoint Inhibitor Associated Kidney Transplant Rejection: A Real World Pharmacovigilance Analysis Using the FAERS Database. EJMI. 2025; 9(3): 176-181
Corresponding Author: Aydan Mütiş Alan