DAHLIA: Achievement of Low Level of Disease Activity With a Dose of Corticosteroids Less Than or Equal to 5 mg (LLDAS5) in Patients With Systemic Lupus Erythematosus Treated With Anifrolumab in Italy

What this Trial Is About

Researchers are studying patients with systemic lupus erythematosus (SLE) in Italy who are treated with anifrolumab. This observational, multicenter, prospective study aims to evaluate how well patients achieve and maintain a low disease activity state with corticosteroid doses of 5 mg/day or less, called LLDAS5. The study also looks at corticosteroid tapering strategies, remission definitions, and depressive symptoms in these patients. Participants will receive anifrolumab treatment as part of their clinical care, following the approved Italian label and reimbursement rules. The study tracks patients over time to observe the effectiveness of anifrolumab in real-life settings. It measures outcomes such as achievement of LLDAS5, glucocorticosteroid dose reductions, joint inflammation scores, remission rates according to DORIS criteria, and depression scales. During the study, patients will be followed for up to 104 weeks with assessments at multiple time points. Researchers will collect data on disease activity, steroid use, joint evaluations, and patient-reported depression symptoms. The primary outcome is the number and percentage of patients reaching LLDAS5 at 52 weeks. Secondary outcomes include longer-term measures of disease control, remission, and corticosteroid tapering. Patient consent and completion of questionnaires are also part of the study process.

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