Real-life Study of Anifrolumab in Adults With Systemic Lupus Erythematosus to Achieve Low Disease Activity and Reduced Steroid Use

What this Trial Is About

Researchers are studying patients with systemic lupus erythematosus SLE who are receiving anifrolumab treatment in Italy. This observational, multicenter, and prospective study aims to evaluate how well anifrolumab helps patients achieve and maintain a low level of disease activity with corticosteroid doses of 5 mg per day or less LLDAS5. The study also looks at strategies for reducing corticosteroid use and monitors remission definitions and depressive symptoms in these patients. Participants receive anifrolumab as prescribed according to Italian guidelines for SLE treatment. The study tracks patients over time to assess their disease activity levels and corticosteroid use. The research also measures remission based on DORIS criteria and evaluates changes in depressive symptoms during the study period. Throughout the study, participants undergo regular assessments including joint counts, ultrasound scoring, corticosteroid dose tracking, and depression rating scales. Measurements are taken at multiple time points up to 104 weeks to monitor disease activity, remission status, corticosteroid tapering, and mood symptoms. The main outcome is the number and percentage of patients who achieve LLDAS5 after 52 weeks of treatment. Safety and long-term effects are observed as part of ongoing follow-up.

Achievement of LLDAS5 in Patients With Systemic Lupus Erythematosus Treated With Anifrolumab.