Early Post-Marketing Safety Signals of Anifrolumab in EudraVigilance: A Belimumab-Comparator Disproportionality Analysis

Background

Anifrolumab is a type I interferon receptor antagonist approved for adults with moderate-to-severe systemic lupus erythematosus (SLE). Although clinical trials established its efficacy and expected safety profile, post-marketing analyses using public EudraVigilance data remain limited. Spontaneous-report pharmacovigilance may identify early signals of disproportionate reporting after approval, particularly for infection-related, immune-mediated, and rare adverse events.