Evaluation of Neurological Safety Profile in the Use of Checkpoint Inhibitors: A Real-World Evidence Approach Based on Pharmacovigilance Data

Abstract

The use of immunotherapies based on the concept of checkpoint inhibitors is increasingly becoming a medical practice in oncology. These therapies target some specific factors, inhibiting them, blocking them to stop the multiplication of these altered cells and consequently the tumor. This study focused on the neurological safety profile of the most prescribed checkpoint inhibitors and traced a correlation between the use of these agents and the increase in neurological adverse events in the main indications. Examining pharmacovigilance databases and medication sales, the analysis found a correlation between reported neurological adverse events and medication usage. As the total number of adverse events increased, the number of neurological adverse events also rose linearly, emphasizing the importance of monitoring potential neurological effects. For the analysis of adverse event data, the databases of FDA (FAERS) and EMA (VigiAccess) were consulted, while sales data between 2018 and 2022 were extracted from the IQVIA Analytics databases. Among the studied checkpoint inhibitors (pembrolizumab, ipilimumab, nivolumab, atezolizumab, and avelumab), pembrolizumab had the lowest ratio of reported adverse events, suggesting a relatively safer profile.