Incidence and Frequency of Immune-Related Nephropathy in Patients Treated with Immune Checkpoint Inhibitors A FAERS Database Analysis (2020–2024)

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Mütiş Alan A., Alan Ö.

62nd ERA Congress , Vienna, Avusturya, 4 - 07 Haziran 2025, ss.3330, (Özet Bildiri)

Özet

INTRODUCTION

Immune checkpoint inhibitors (ICIs) have significantly

improved survival in various solid tumors. With the

increasing use of these agents, the number of

autoimmune toxicities—known as immune-related

adverse events (irAEs)—has risen.The incidence of

irAEs in patients receiving ICI therapy is estimated to

range between 60% and 85%.Renal irAEs are less

common compared to dermatologic, gastrointestinal,

and other organ toxicities.

RESULTS

AIM

This study aims to evaluate the incidence and

frequency of immune-related nephropathy among

patients treated with different ICIs, as reported in the

FDA adverse event reporting system (FAERS)

between 2020 and 2024.

METHOD

• The FDA Adverse Event Reporting System

(FAERS) is a publicly accessible database that

collects reports on adverse drug events.

• Data for this study were obtained from the publicly

available version of the FAERS database, covering

the period from January 2020 to December 2024..

• Five ICIs associated with immune-related

nephropathy were included in the analysis:

• AntiPD1agents: pembrolizumab and nivolumab

• Anti-PD-L1agents:atezolizumab,avelumab, and

durvalumab

• A total of 137,286 adverse events were

reported in the FAERS database between

January 2020 and December 2024.

• Immune-related nephropathy was identified

in 6,482 cases (4.7%).

• This condition was most frequently reported:

• In male patients (57.6%)

• In the 65–85 age group (50.9%)

• Distribution of immune-related nephropathy

by ICI (Figure 1):

✓ Pembrolizumab: 2,761 cases (5.1%)

✓ Nivolumab: 2,424 cases (5.3%)

✓ Durvalumab: 257 cases (2.2%)

✓ Atezolizumab: 928 cases (3.7%)

✓ Avelumab: 112 cases (4.7%)

• A statistically significant difference was

observed between individual ICIs (p < 0.01)

• A statistically significant difference in the

incidence of nephropathy was noted

between PD-1 and PD-L1 inhibitor groups

(5.2% vs 3.4%, p < 0.01) (Figure 2).

• No significant difference was found among

PD-1 inhibitors.

• A significant difference was found among

PD-L1 inhibitors;

✓ Avelumab vs Durvalumab: p < 0.01

✓ Avelumab vs Atezolizumab: p = 0.01

✓ Durvalumab vs Atezolizumab: p < 0.01

CONCLUSIONS

• ICI-associated acute kidney injury (ICI-AKI) is

a rare complication, reported in approximately

2–5% of patients receiving ICI therapy

• In our study, the frequency of renal irAEs was

found to be 4.7%

• Our study demonstrates significant variability

in the incidence of immune-related

nephropathy among different ICIs, with higher

frequencies observed in PD-1 inhibitors

• Among PD-L1 inhibitors, notable differences

were also detected, underscoring the

importance of vigilant renal monitoring during

ICI therapy