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CAR-T Cells and the Kidney: Insights from the WHO Safety Database

BioDrugs, ISSN: 1179-190X, Vol: 37, Issue: 4, Page: 521-530
2023
  • 6
    Citations
  • 0
    Usage
  • 18
    Captures
  • 0
    Mentions
  • 0
    Social Media
Metric Options:   Counts1 Year3 Year

Metrics Details

  • Citations
    6
    • Citation Indexes
      6
  • Captures
    18

Article Description

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.

Bibliographic Details

Gérard, Alexandre O; Merino, Diane; Charbinat, Alexis; Fournier, Joseph; Destere, Alexandre; Loschi, Michael; Cluzeau, Thomas; Sicard, Antoine; Drici, Milou-Daniel

Springer Science and Business Media LLC

Biochemistry, Genetics and Molecular Biology; Pharmacology, Toxicology and Pharmaceutics; Medicine

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