Real World Evidence of Anifrolumab in Systemic Lupus Erythematosus: Investigator Initiated, Observational, Multicenter Study Evaluating Effectiveness and Safety of Anifrolumab in Active SLE Patients

BACKGROUND AND RATIONALE. The role of type I interferons (IFN) in innate and adaptive immunity has been extensively studied, establishing a key role for type I IFNs in immune homeostasis. With growing evidence that type I IFNs play an important role in autoimmune diseases, inhibition of type I IFN biological activity with Anifrolumab represents a significant therapeutic option in SLE. Phase II and III clinical trials have demonstrated the efficacy and safety of the drug in patients with moderate-to-severe active disease. OBJECTIVES. The primary objective of the study is to evaluate the clinical efficacy and incidence of adverse events associated with Anifrolumab therapy in a multicenter cohort of patients with SLE. Secondary objectives of the study are: - to evaluate the efficacy of therapy on different types of clinical manifestations; - to assess the impact of therapy on quality of life and other patient-reported outcome measures (PROMs); - to evaluate the steroid-sparing potential of therapy; - to assess the speed of therapeutic action on different clinical manifestations; - to identify predictive variables of clinical response to therapy; - to evaluate drug retention rate; - to assess the efficacy of therapy in reducing organ damage accumulation. PRIMARY AND SECONDARY ENDPOINTS. Primary efficacy endpoints: - Percentage of patients in remission (DORIS criteria) at 6, 12, 24, 36, 48, and 60 months; - Percentage of patients in low disease activity state (LLDAS) at 6, 12, 24, 36, 48, and 60 months. Secondary efficacy endpoints: - Incidence of disease flares according to the modified SFI; - Percentage of patients with organ damage accumulation (SLICC/DI \> 0) compared to baseline at 12, 24, 36, 48, and 60 months; - Longitudinal changes in disease activity indices SLEDAI-2K and SLE-DAS; - Percentage of patients on steroid therapy ≤5 mg prednisone equivalent and percentage of patients who discontinued steroids at 6, 12, 24, 36, 48, and 60 months; - Longitudinal chang