Post-marketing Study Of Safety Of Immune Checkpoint Inhibitor Based On Spontaneous Reporting System

safety signals of above-mentioned drug in FAERS database.Emphasis was placed on the analysis and evaluation of immune-related high risk signals for endocrine,gastrointestinal and skin ADEs.Results:1.Among studied databases,the number of ADE ranged from high to low,followed by nivolumab,ipilimumab,pembrolizumab,atezolizumab.After approval for marketing,the number of ADE on all drugs increased year by year,of which nivolumab grew faster and ipilimumab grew slower.The ADE reporting area is mainly located in America and Europe,the occupation of the reporter is mainly other medical personnel and consumers,and the clinical outcome is mainly hospitalization and death.After excluding missing information reports,the gender and age distribution of the patients involved in the ADE reports were similar among drugs.The proportion of male patients was higher than that of females,and the main age of the patients was middle and old age,and the proportion of 45 to 64 years old group was the highest,and the proportion of young people under 18 years old was very low.2.In VigiBase and EudraVigilance databases at the system organ class,the accumulation of ADE frequency associated with ICIs drugs was most common in the gastrointestinal system,general disorders and administration site conditions,neoplasms benign,malignant and unspecified,respiratory,thoracic and mediastinal disorders,endocrine and pembrolizumab(a=14;ROR=255.01).As for skin system,significant signals were only showed in vitiligo(a=30;ROR=62.78)and pemphigoid(a=27;ROR=16.28)for pembrolizumab.Conclusion:1.There was no significant difference in the distribution of ADE between ICIS drugs in terms of sex and age,but the risk of ADE may be higher in male than in female.More attention should be paid to the gender difference of irAEs in clinical ICIs use.2.The clinical manifestations of common ADE of ICIs were distributed widely in several organ systems.CTLA-4 inhibitor ipilimumab showed significant higher signals of ir AEs in the gastrointestinal and endocrine system.Skin system related ir AEs showed lower correlation with each drug.3.Based on the high quality and large spontaneous reporting system database in Europe and the United States could effectively access to post-marketing safety data for ICIs drugs in real clinical settings.Mining and evaluation of safety signals could lay the foundation for further pharmacovigilance.