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A Novel Clinical Grade Isolation Method for Human Kidney Perivascular Stromal Cells
Published on: August 7, 2017
CAR-T Cells and the Kidney: Insights from the WHO Safety Database
Alexandre O Gérard1,2,3, Diane Merino2, Alexis Charbinat3
1Department of Nephrology-Dialysis-Transplantation, University Hospital Centre of Nice, Nice, France.
Background:
Chimeric antigen receptor T (CAR-T) cells have proven to be a game changer for treating several hematologic malignancies. Randomized controlled trials have highlighted potential life-threatening adverse drug reactions (ADRs), including cytokine release syndrome (CRS). Acute renal failure (ARF) has also been reported in 20% of the patients treated. However, an analysis of renal safety supported by large-scale real-life data seems warranted.
Patients And Methods:
We queried VigiBase® for all reports of the Standardised MedDRA Query "acute renal failure" (ARF) involving a CAR-T cell, registered until 24 July 2022. Disproportionality for this ADR was analyzed through calculation of the Information Component [IC (95% confidence interval)]. A positive lower end of the 95% confidence interval of the IC is the threshold used in statistical signal detection in VigiBase®. The same analysis was carried out for various hydroelectrolytic disorders.
Results:
We gathered 224 reports of ARF, and 125 reports of hydroelectrolytic disorders involving CAR-T cells. CAR-T cells were disproportionately reported with ARF [IC 1.5 (1.3-1.7)], even after excluding reports mentioning CRS. A significant disproportionate reporting was also found for hypernatremia [IC 3.1 (2.2-3.8)], hyperphosphatemia [IC 3.1 (1.8-3.9)], hypophosphatemia [IC 2.0 (0.6-2.9)], metabolic acidosis [IC 1.8 (1.2-2.2)], hyponatremia [IC 1.6 (1.1-2.0)], and hypercalcemia [IC 1.4 (0.5-2.1)]. There was no disproportionate reporting of dyskalemia.
Conclusions:
This study is limited by the inherent flaws of pharmacovigilance approaches. Nonetheless, our findings suggest that ARF and an array of hydroelectrolytic disorders are potential ADRs of CAR-T cell therapy, in real-life settings and in a nonselected population.
Insights
Chimeric antigen receptor T-cell (CAR-T) therapy is linked to acute renal failure (ARF) and electrolyte imbalances. Real-world data analysis identified ARF and various hydroelectrolytic disorders as potential adverse drug reactions (ADRs) of CAR-T cell treatments.
Area of Science:
- Pharmacovigilance
- Oncology
- Nephrology
Background:
- Chimeric antigen receptor T-cell (CAR-T) therapy has revolutionized hematologic malignancy treatment.
- Adverse drug reactions (ADRs), including cytokine release syndrome (CRS), are known risks.
- Acute renal failure (ARF) affects up to 20% of patients, necessitating further real-world safety analysis.
Purpose of the Study:
- To analyze real-world data on the renal safety of CAR-T cell therapy.
- To investigate the association between CAR-T cells and ARF and hydroelectrolytic disorders.
Main Methods:
- Utilized VigiBase® database for reports of ARF and hydroelectrolytic disorders associated with CAR-T cells until July 2022.
- Employed disproportionality analysis using the Information Component (IC) with a 95% confidence interval (CI) for signal detection.
- Assessed ARF reports, excluding those mentioning CRS, and analyzed various electrolyte disorders.
Main Results:
- Identified 224 reports of ARF and 125 reports of hydroelectrolytic disorders linked to CAR-T cells.
- CAR-T cells showed disproportionate reporting for ARF (IC 1.5 [1.3-1.7]), even excluding CRS cases.
- Significant disproportionality observed for hypernatremia, hyperphosphatemia, hypophosphatemia, metabolic acidosis, hyponatremia, and hypercalcemia.
Conclusions:
- Acute renal failure (ARF) and several hydroelectrolytic disorders are potential adverse drug reactions (ADRs) associated with CAR-T cell therapy.
- Findings are based on real-world data, highlighting risks in a non-selected population.
- Pharmacovigilance limitations are acknowledged, but the signals warrant attention for clinical practice.
![Dynamic Imaging of Chimeric Antigen Receptor T Cells with [18F]Tetrafluoroborate Positron Emission Tomography/Computed Tomography](/_next/image?url=https%3A%2F%2Fcloudfront.jove.com%2FCDNSource%2Fteasers%2F62334.jpg&w=3840&q=50)
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