Early effectiveness of anifrolumab in systemic lupus erythematosus: real-life data a 3 and 6 months from RALESA registry.

Systemic lupus erythematosus (SLE) is an autoimmune disease with numerous immune defects described. Anifrolumab (ANF) is an effective and safe biologic drug approved for SLE after completion of a rigorous clinical development program. By building on the experience gained in clinical practice, it is possible to expand the knowledge of real-world benefits. The aim of the study is to study the efficacy and safety of ANF in real life. Observational study conducted in hospitals in the autonomous community of Andalusia on the early efectiveness and safety of ANF treatment in 56 patients with SLE. Indicators of activity and chronicity were determined at baseline and at 3 and 6 months. The main clinical domains were mucocutaneous (80.4%) and osteoarticular (37.5%). At 3 and 6 months, response rates were SRI-4: 48% and 66%, BICLA: 57% and 77%, CLASI-A50: 85% and 93%, LLDAS: 71% and 66%, and DORIS remission, 36% and 43%, respectively. There was a decrease in mean daily prednisone dose after ANF initiation, with 76.8% and 80.3% of patients at a dose ≤ 7.5mg/day at 3 and 6 months respectively. No significant adverse effects were observed. In SLE, especially in patients with mucocutaneous and joint involvement, ANF is an effectiveness and safe therapeutic option in real clinical practice, with improvement of activity markers at 3 and 6 months of treatment.