Aspirin use increases risk of immune-related adverse events in cancer patients treated with immunotherapy: analysis of the FAERS database

Abstract

Background The promise of immunotherapy in cancer treatment is tempered by the occurrence of immune-related adverse events (irAEs). Many patients undergoing immunotherapy also take aspirin, but the impact of aspirin on irAEs is not well understood. This study aimed to investigate the association between aspirin use and irAEs in patients receiving immunotherapy.Methods This study analyzed adverse reaction data associated with the use of immune checkpoint inhibitors (ICIs) in the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database, from the approval date of each drug until October 1, 2022. Multivariate logistic regression was employed to assess the effect of aspirin use on irAEs in patients receiving ICIs. .Results The analysis included 123,104 patients who underwent immunotherapy, of whom 5359 also received aspirin. The results showed that aspirin use was associated with an increased risk of irAEs in the pan-cancer analysis, and this association was more pronounced in specific cancer types such as lung cancer, mesothelioma, and pancreatic cancer. Additionally, aspirin use was correlated with an elevated risk of certain irAEs such as anaemia, colitis, myocarditis, myositis, pancreatitis, pericarditis and pneumonitis.Conclusions These findings suggest that aspirin exposure is associated with a higher risk of irAEs in patients undergoing cancer immunotherapy. Moreover, different cancer types and the ICI types can also impact irAEs.