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Immune Checkpoint Inhibitor-Associated Immune-Mediated Nephropathy: A Real-World Pharmacovigilance Study.
Aydan Mutis Alan1, Ahmet Murt1, Mevlüt Tamer Dinçer1
1Division of Nephrology, Department of Internal Medicine, Cerrahpasa Medical Faculty, Istanbul University-Cerrahpaşa, Istanbul 34098, Turkey.
Journal of Clinical Medicine
|May 27, 2026
Summary
Immune checkpoint inhibitors (ICIs) can cause kidney problems, with PD-1 inhibitors and combination therapies showing higher reporting rates for immune-mediated nephropathy in a large safety study.
Area of Science:
- Nephrology
- Oncology
- Pharmacovigilance
Background:
- Immune checkpoint inhibitors (ICIs) have revolutionized cancer treatment but can cause renal toxicity.
- This toxicity ranges from acute kidney injury to specific immune-mediated nephropathies.
Purpose of the Study:
- To evaluate immune-mediated nephropathy associated with ICIs using real-world data.
- To identify differences in reporting frequencies across various ICIs and treatment regimens.
Main Methods:
- A large-scale pharmacovigilance study using the FAERS database (Jan 2014-Mar 2025).
- Analysis focused on well-defined immune-mediated renal adverse events, excluding nonspecific acute kidney injury.
- Disproportionality analysis (RORs) assessed associations between ICIs, regimens, and nephropathy.
Main Results:
- 2361 (1.12%) of 203,652 ICI-related adverse event reports involved immune-mediated nephropathy.
- Higher reporting was seen in older patients (≥65 years) and those with lung/genitourinary cancers.
- Tubulointerstitial nephritis was the most common subtype; PD-1 inhibitors (cemiplimab, pembrolizumab) and combination PD-1/CTLA-4 regimens showed higher reporting signals.
Conclusions:
- Real-world data reveal significant differences in immune-mediated nephropathy reporting among ICI classes and strategies.
- PD-1 inhibitors and combination therapies may have distinct renal safety profiles.
- Findings are hypothesis-generating for future studies, acknowledging spontaneous reporting limitations.
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