アブストラクト | Although the immunotherapy advent has revolutionized cancer treatment, it, unfortunately, does not spare cancer patients from possible immune-related adverse events (irAEs), which can also involve the peripheral nervous system. Immune checkpoint inhibitors (ICIs), blocking cytotoxic T-lymphocyteassociated protein 4 (CTLA-4), programmed cell death protein 1 (PD-1), or programmed cell death ligand 1 (PD-L1), can induce an immune imbalance and cause different peripheral neuropathies (PNs). Considering the wide range of PNs and their high impact on the safety and quality of life for cancer patients and the availability of large post-marketing surveillance databases, we chose to analyze the characteristics of ICI-related PNs reported as suspected drug reactions from 2010 to 2020 in the European real-world context. We analyzed data collected in the European pharmacovigilance database, Eudravigilance, and conducted a systematic and disproportionality analysis. In our study, we found 735 reports describing 766 PNs occurred in patients treated with ICIs. These PNs included Guillain-Barre syndrome, Miller-Fisher syndrome, neuritis, and chronic inflammatory demyelinating polyradiculoneuropathy. These ADRs were often serious, resulting in patient disability or hospitalization. Moreover, our disproportionality analysis revealed an increased reporting frequency of PNs with tezolizumab compared to other ICIs. Guillain-Barre syndrome is a notable potential PN related to ICIs, as it is associated with a significant impact on patient safety and has had unfavorable outcomes, including a fatal one. Continued monitoring of the safety profile of ICIs in real-life settings is necessary, especially considering the increased frequency of PNs associated with atezolizumab compared with other ICIs. |
ジャーナル名 | Frontiers in immunology |
Pubmed追加日 | 2023/4/4 |
投稿者 | Ruggiero, Rosanna; Balzano, Nunzia; Di Napoli, Raffaella; Fraenza, Federica; Pentella, Ciro; Riccardi, Consiglia; Donniacuo, Maria; Tesorone, Marina; Danesi, Romano; Del Re, Marzia; Rossi, Francesco; Capuano, Annalisa |
組織名 | Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, Naples,;Italy.;Department of Experimental Medicine - Section of Pharmacology "L. Donatelli",;University of Campania "L. Vanvitelli", Naples, Italy.;Local Health Services "Napoli 1 Centro", Naples, Italy.;Clinical Pharmacology and Pharmacogenetics Unit, Department of Clinical and;Experimental Medicine, University Hospital of Pisa, Pisa, Italy. |
Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/37006303/ |