Post-Marketing Analysis of Peripheral Neuropathy Burden with New-Generation Proteasome Inhibitors Using the FDA Adverse Event Reporting System

Autor: Syeda A. Mina, Ibrahim Muhsen, Ethan Burns, Humaira Sarfraz, Sai Ravi Pingali, Jiaqiong Xu, Shahrukh K. Hashmi
Jazyk: angličtina
Rok vydání: 2021
Předmět:
Zdroj: Turkish Journal of Hematology, Vol 38, Iss 3, Pp 218-221 (2021)
Druh dokumentu: article
ISSN: 1308-5263
DOI: 10.4274/tjh.galenos.2021.2021.0052
Popis: Proteasome inhibitors (PIs) are an integral component of multiple myeloma therapies. Peripheral neuropathy (PN) is a well-known consequence of PIs, most frequently reported with earlier generations such as Bortezomib (BTZ). There is a paucity of data highlighting the risk of developing PN in the newer generation PIs Carfilzomib (CFZ) and Ixazomib (IZB). This study queried reports of PN reported with all three PIs using the Food and Drug Administration (FDA) Adverse Event (AE) Reporting System (FAERS). Signal disproportionality analysis was reported using a reporting odds ratio (ROR) and 95% confidence interval (CI). PN was reported in a total of 2.1%, 5.0%, and 10.9% of AE with CFZ, IZB, and BTZ, respectively. The ROR (95% CI) for peripheral neuropathy secondary to BTZ, CFZ, and IZB was 34.10 (32.76-35.49), 6.37 (5.50- 7.37), and 14.97 (13.63-16.44) respectively. Compared to BTZ, CFZ and IZB have a lower rate of reported PN, with RORs of 0.19 (0.16-0.22) and 0.48 (0.43-0.54), respectively.
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