CAR-T Cells and the Kidney: Insights from the WHO Safety Database
BioDrugs, ISSN: 1179-190X, Vol: 37, Issue: 4, Page: 521-530
2023
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- 18Captures
Metric Options: CountsSelecting the 1-year or 3-year option will change the metrics count to percentiles, illustrating how an article or review compares to other articles or reviews within the selected time period in the same journal. Selecting the 1-year option compares the metrics against other articles/reviews that were also published in the same calendar year. Selecting the 3-year option compares the metrics against other articles/reviews that were also published in the same calendar year plus the two years prior.
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Example: if you select the 1-year option for an article published in 2019 and a metric category shows 90%, that means that the article or review is performing better than 90% of the other articles/reviews published in that journal in 2019. If you select the 3-year option for the same article published in 2019 and the metric category shows 90%, that means that the article or review is performing better than 90% of the other articles/reviews published in that journal in 2019, 2018 and 2017.
Citation Benchmarking is provided by Scopus and SciVal and is different from the metrics context provided by PlumX Metrics.
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
http://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=85159085413&origin=inward; http://dx.doi.org/10.1007/s40259-023-00599-1; http://www.ncbi.nlm.nih.gov/pubmed/37166707; https://link.springer.com/10.1007/s40259-023-00599-1; https://dx.doi.org/10.1007/s40259-023-00599-1; https://link.springer.com/article/10.1007/s40259-023-00599-1
Springer Science and Business Media LLC
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