Abstract 1283P
Background
With the increasing application of immune checkpoint inhibitors (ICIs) in tumor immunotherapy, the side effects on the immune system, known as immune-related adverse reactions (irAEs), also pose a key challenge to the clinical use of ICIs. Prior to this study, there was yet to be a comprehensive and systematic analysis of the relationship between ICIs, psychiatric complications and their influencing factors.
Methods
A decade of ICI data (2012-2021) submitted to the FDA Adverse Events Reporting System (FAERS) database was retrieved to show the basic incidence of psychiatric adverse events of ICIs. The relationship between ICIs and psychiatric complications is evaluated using the reporting odds ratio (ROR) algorithm. Univariate Logistic regression was used to calculate the odds ratio (OR) of ICI-related pAEs under different ICI treatment strategies and clinical features.
Results
The overall incidence of psychiatric complications related to ICIs in the past ten years was 4.7%, and was relatively constant every year (3.8-4.9%). 14 psychiatric complications shown to have strong correlation to treatment with ICIs were defined as ICI-related psychiatric adverse events (ICI-related pAEs). A total of 2373 patients with ICI-related pAEs were identified. Among them, the elderly patients (60.13%, older than 65 years old) and male patients (58.67%) are the main part. The main cancer sites of indications are the lungs (27.6%) and skin (18.64%). Elderly patients with ICI-related pAEs have a higher mortality rate. The risk of ICI-related pAEs was the highest when combination therapy (OR = 0.71[0.61-0.81], p = 2.6e-06) were used, followed by anti-PD-1 antibodies. Older patients have a higher risk of ICI-related pAEs.
Conclusions
Our research summarized the incidence of psychiatric complications of ICIs and found 14 ICI-related pAEs and their influencing factors. This is a good reference in clinical practice, which can help clinical workers to better identify the possible psychiatric complications related to ICIs. In the future, more clinical research and mechanism exploration are needed for psychiatric complications related to ICIs.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.