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2023•Annals of Medical and Clinical OncologyOpen access

Peripheral Neuropathies in Checkpoint Inhibitor Therapy: An In-depth Investigation through Pharmacovigilance Data-driven Analysis

Abrahao A, Pedro Henrique de Magalhães Tenório, Rodrigues M, Freitas Lz, Nascimento Oj

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Abstract

Background: In recent years, the advent of immunotherapeutic drugs, particularly checkpoint inhibitors (CIs), has revolutionized the landscape of cancer treatment, offering unprecedented hope and improved outcomes for patients.Given the increasing use of these immunotherapies, in addition to the impact on patient survival and quality of life, it is necessary to better understand adverse events related to CIs.Objective: search and analyze data contained in an important pharmacovigilance database (FAERS), in order to understand the incidence of peripheral neuropathies, as an adverse event, in patients undergoing therapy with CIs in a real-world context.Methods: This observational study analyzes post-marketing pharmacovigilance data on CIs, The study focuses on adverse events within the (FAERS) database and IQVIA Analytics databases supplied sales data from 2018 to 2022, with queries conducted in May 2023 for the evaluation period spanning January 1, 2018, to December 31, 2022.Results: Atezolizumab displayed the highest reported neuropathy instances, succeeded by Ipilimumab.Pembrolizumab consistently maintained a low rate of neuropathies per 10,000 sales.The outcomes concerning "Peripheral neuropathies NEC," with Avelumab exhibiting the highest likelihood of reporting.Subsequent inferences ranked Atezolizumab as the second highest, followed by Pembrolizumab, Ipilimumab and Novolumab.Atezolizumab displayed the highest reporting odds ratio when contrasted with Ipilimumab, signifying a heightened likelihood of adverse event reporting associated with the former.The analysis revealed noteworthy RORs for Pembrolizumab versus Nivolumab, and Pembrolizumab versus Ipilimumab.The only drug that exhibited a reporting ROR surpassing the threshold of 2 was Avelumab.Conclusion: Atezolizumab and Ipilimumab exhibited desproportionality in the neuropathy incidence, while Pembrolizumab showed consistent low rates.

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Background: In recent years, the advent of immunotherapeutic drugs, particularly checkpoint inhibitors (CIs), has revolutionized the landscape of cancer treatment, offering unprecedented hope and improved outcomes for patients.Given the increasing use of these immunotherapies, in addition to the impact on patient survival and quality of life, it is necessary to better understand adverse events related to CIs.Objective: search and analyze data contained in an important pharmacovigilance database (FAERS), in order to understand the incidence of peripheral neuropathies, as an adverse event, in patients undergoing therapy with CIs in a real-world context.Methods: This observational study analyzes post-marketing pharmacovigilance data on CIs, The study focuses on adverse events within the (FAERS) database and IQVIA Analytics databases supplied sales data from 2018 to 2022, with queries conducted in May 2023 for the evaluation period spanning January 1, 2018, to December 31, 2022.Results: Atezolizumab displayed the highest reported neuropathy instances, succeeded by Ipilimumab.Pembrolizumab consistently maintained a low rate of neuropathies per 10,000 sales.The outcomes concerning "Peripheral neuropathies NEC," with Avelumab exhibiting the highest likelihood of reporting.Subsequent inferences ranked Atezolizumab as the second highest, followed by Pembrolizumab, Ipilimumab and Novolumab.Atezolizumab displayed the highest reporting odds ratio when contrasted with Ipilimumab, signifying a heightened likelihood of adverse event reporting associated with the former.The analysis revealed noteworthy RORs for Pembrolizumab versus Nivolumab, and Pembrolizumab versus Ipilimumab.The only drug that exhibited a reporting ROR surpassing the threshold of 2 was Avelumab.Conclusion: Atezolizumab and Ipilimumab exhibited desproportionality in the neuropathy incidence, while Pembrolizumab showed consistent low rates.

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Available abstract

Background: In recent years, the advent of immunotherapeutic drugs, particularly checkpoint inhibitors (CIs), has revolutionized the landscape of cancer treatment, offering unprecedented hope and improved outcomes for patients.Given the increasing use of these immunotherapies, in addition to the impact on patient survival and quality of life, it is necessary to better understand adverse events related to CIs.Objective: search and analyze data contained in an important pharmacovigilance database (FAERS), in order to understand the incidence of peripheral neuropathies, as an adverse event, in patients undergoing therapy with CIs in a real-world context.Methods: This observational study analyzes post-marketing pharmacovigilance data on CIs, The study focuses on adverse events within the (FAERS) database and IQVIA Analytics databases supplied sales data from 2018 to 2022, with queries conducted in May 2023 for the evaluation period spanning January 1, 2018, to December 31, 2022.Results: Atezolizumab displayed the highest reported neuropathy instances, succeeded by Ipilimumab.Pembrolizumab consistently maintained a low rate of neuropathies per 10,000 sales.The outcomes concerning "Peripheral neuropathies NEC," with Avelumab exhibiting the highest likelihood of reporting.Subsequent inferences ranked Atezolizumab as the second highest, followed by Pembrolizumab, Ipilimumab and Novolumab.Atezolizumab displayed the highest reporting odds ratio when contrasted with Ipilimumab, signifying a heightened likelihood of adverse event reporting associated with the former.The analysis revealed noteworthy RORs for Pembrolizumab versus Nivolumab, and Pembrolizumab versus Ipilimumab.The only drug that exhibited a reporting ROR surpassing the threshold of 2 was Avelumab.Conclusion: Atezolizumab and Ipilimumab exhibited desproportionality in the neuropathy incidence, while Pembrolizumab showed consistent low rates.

Key concepts: Pembrolizumab, Ipilimumab, Pharmacovigilance, Nivolumab, Atezolizumab, Medicine, Adverse Event Reporting System, Adverse effect

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