Observational Study to Evaluate Serious Infections and Cancer Risks in Adults with Moderate to Severe Systemic Lupus Erythematosus Using Anifrolumab

What this Trial Is About

Researchers are observing the risk of malignancies and serious infections in patients with moderate to severe systemic lupus erythematosus SLE who receive anifrolumab compared with similar patients receiving standard care without anifrolumab. The study aims to gather real-world safety data on anifrolumab use in this population over an extended period. Participants who have been prescribed anifrolumab as part of their routine care are included, with the first anifrolumab prescription marking the start of observation. The study also follows a comparable group of moderate to severe SLE patients who do not initiate anifrolumab, comparing outcomes between these groups. No treatments are assigned by the study instead, data on serious infections and malignancies are collected up to November 2031. Throughout the study, participants health records are reviewed to monitor for malignancies, serious infections, infections leading to hospitalization, and infection-related deaths. The main outcomes are tracked from the index date first anifrolumab prescription or comparable date up to 2031 for malignancies and until 2027 for infections. This observational design allows for long-term safety assessment without altering participants usual care.

Anifrolumab Malignancy and Serious Infections Study