Comparing adverse events of Saphnelo and Benlysta: A real-world observational study based on the FDA adverse event reporting system (FAERS) following STROBE guidelines.

Systemic lupus erythematosus (SLE) is a chronic, multisystem autoimmune disease. In recent years, biologic agents have provided new treatment options for SLE. This study aims to conduct a comparative analysis of the adverse drug events (AEs) associated with anifrolumab (Saphnelo) and belimumab (Benlysta). AEs were extracted from the FDA adverse event reporting system (FAERS) for the period from April 2011 to April 2024. A total of 21,631 cases were collected from the FAERS system (20,819 for belimumab, 812 for anifrolumab). In terms of injury, poisoning, and procedural complications, anifrolumab was more prone to infusion-related reactions (ROR 6.64), while belimumab exhibited unique AEs such as product dose omissions (ROR 12.63), improper device usage techniques (ROR 20.66), and exposure via skin contact (ROR 80.18). In the category of infections and infestations, anifrolumab was more likely to cause herpes zoster (ROR 21.91), whereas belimumab was more commonly associated with influenza (ROR 2.75). Regarding nervous system disorders, anifrolumab showed a higher incidence of headache (ROR 2.83). In skin and subcutaneous tissue disorders, anifrolumab demonstrated strong signals for rash (ROR 2.29). More severely, anifrolumab was associated with a higher risk of pericarditis (ROR 7.92). Additionally, anifrolumab may lead to psychiatric, vascular, renal, and urinary disorders, primarily presenting as confusional state (ROR 2.14), flushing (ROR 2.94), and proteinuria (ROR 10.96). The adverse reactions associated with belimumab are primarily linked to operational factors (such as product dose omissions) and injection site issues (e.g., injection site pain and hemorrhage). AE reports for anifrolumab demonstrated significant complexity and diversity. Enhanced patient monitoring and therapy optimization are urgently required to ensure more effective management of SLE while minimizing risks.