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Nephrotoxicity of Immune Checkpoint Inhibitors: A Disproportionality Analysis from 2013 to 2020
Jiaming Qu1, Yanming Ding2, Kaiwen Jiang1
1School of Pharmacy, Shenyang Pharmaceutical University.
Abstract:
Nephrotoxicity occasionally occurs during treatment with immune checkpoint inhibitors (ICIs). Few related studies compare the differences between these drugs. This study aimed to systematically characterize nephrotoxicity after ICI initiation. Data were extracted from the US FDA Adverse Event Reporting System (FAERS) database. Disproportionality analysis, including information components (ICs) and reporting odds ratios (RORs), was performed to determine the potential renal toxicity of ICIs. A total of 7,204 reports of renal adverse events (AEs) were identified in the FAERS database. Renal AEs were most commonly reported for nivolumab (46.84%). Strong signals were detected in male patients combined with ICIs. In the clinical application of ICIs, attention should be paid to patients, especially male patients, with acute kidney injury, nephritis, autoimmune nephritis and other nephrotoxic AEs. The use of ICIs is likely to aggravate their condition.
Insights
Immune checkpoint inhibitors (ICIs) can cause kidney damage. This study found nivolumab most frequently associated with renal adverse events, particularly in male patients, highlighting the need for careful monitoring.
Area of Science:
- Nephrology
- Immunology
- Pharmacovigilance
Background:
- Immune checkpoint inhibitors (ICIs) are increasingly used in cancer therapy.
- Nephrotoxicity is a known, albeit infrequent, adverse effect of ICIs.
- Limited comparative data exists on the specific nephrotoxic profiles of different ICIs.
Purpose of the Study:
- To systematically characterize and compare the nephrotoxicity associated with various ICIs.
- To identify specific ICIs with higher reporting rates of renal adverse events.
- To assess demographic factors, such as sex, influencing ICI-related nephrotoxicity.
Main Methods:
- Utilized the US FDA Adverse Event Reporting System (FAERS) database for data extraction.
- Performed disproportionality analysis using information components (ICs) and reporting odds ratios (RORs).
- Analyzed 7,204 reports of renal adverse events (AEs) linked to ICI treatment.
Main Results:
- Renal AEs were most frequently reported for nivolumab (46.84% of identified cases).
- Significant disproportionality signals for nephrotoxicity were observed in male patients treated with ICIs.
- Specific renal AEs included acute kidney injury, nephritis, and autoimmune nephritis.
Conclusions:
- Nivolumab shows a higher reporting frequency for renal adverse events compared to other ICIs.
- Male patients may be at increased risk for ICI-induced nephrotoxicity.
- Clinical vigilance is crucial for identifying and managing nephrotoxic AEs in patients receiving ICIs, especially males.
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