Signal Mining and Analysis of Adverse Reactions Associated with Atezolizumab and Durvalumab Based on FAERS
Objective To provide a reference for the safe use of atezolizumab and durvalumab in clinical practice.Methods The OpenVigil 2.1 platform was used to extract adverse drug event(ADE)reports associated with atezolizumab and durvalumab from January 1,2016 to September 30,2023 in the FDA Adverse Event Reporting System(FAERS).The preferred term(PT)were matched with system organ classification(SOC)by the Medical Dictionary for Regulatory Activities(MedDRA 24.0).The reporting odds ratio(ROR)and proportional reporting ratio(PRR)methods were used to mine adverse drug reaction(ADR)signals.Results A total of 19 835 ADE reports were obtained(19 835 cases),including 13 420 of atezolizumab(13 420 cases)and 6 415 of durvalumab(6 415 cases),involving 814 ADR signals of atezolizumab and 315 of durvalumab,in which 49 were not mentioned in the corresponding drug instructions,such as autoimmune myocarditis and fulminant type 1 diabetes of atezolizumab,radiation esophagitis and bronchial fistula of durvalumab.A total of 192 overlapping ADR signals were obtained,including 21 of gastrointestinal diseases,21 of respiratory,thoracic and mediastinal diseases,18 of various examinations,18 of skin and subcutaneous tissue diseases and others.The signal of peripheral sensory neuropathy induced by atezolizumab was much stronger than that induced by durvalumab,with a difference of nearly five times in ROR,while the signals of radiation pneumonitis,biliary tract infection,physical decline based on the Eastern Cooperative Oncology Group and superficial thrombophlebitis induced by durvalumab were much stronger than those induced by atezolizumab,with a difference of five to seventy-seven times in ROR.Conclusion We should strengthen the awareness of main and differential ADRs of atezolizumab and durvalumab,focus on the ADRs that are not mentioned in the drug instructions but have strong signals and are likely to lead to adverse outcomes to promote the clinical safe use of these drugs.
atezolizumabdurvalumabadverse drug eventimmune-related adverse reactionsignal miningreporting odds ratioproportional reporting ratioFDA Adverse Event Reporting System
万方数据
维普
