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

AstraZeneca

Status: Enrolling

Conditions: Lupus Erythematosus, Systemic

Treatments: Biological: Anifrolumab

Study type: Observational

Funder types: Industry

Identifiers

NCT07330245

D3461R00093

Details and patient eligibility

About

This is an observational, multicenter, prospective study on patients with systemic lupus erythematosus treated with anifrolumab in Italy aimed at evaluating the achievement of LLDAS5

Full description

DAHLIA study aims to expand real-world evidence on anifrolumab role in clinical practice, specifically evaluating its effectiveness in achieving and maintenance of LLDAS with a dose of corticosteroids less than or equal to 5 mg/day (LLDAS5). Moreover it will provide data on corticosteroid tapering strategies. Additionally, will be also evaluated the Definitions Of Remission In SLE (DORIS) remission during the study period, as well as the depressive symptoms of these patients.

Enrollment: 218 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Provided informed consent to participate in the study;
• Aged 18 years or older;
• Fulfilled the 2019 EULAR/ACR classification criteria for SLE at the time of study entry;
• Prescribed anifrolumab for SLE treatment for the first time, according to the approved Italian label and reimbursement criteria;

Exclusion criteria

• Patients who are at LLDAS5 at the time of study entry;
• Previous exposure to anifrolumab;
• Documented diagnosis of severe or rapidly progressive Class III or IV glomerulonephritis requiring induction therapy [mycophenolate mofetil (MMF)/cyclophosphamide (CYC) + high dose steroids], isolated Class V lupus nephritis, or active severe or unstable neuropsychiatric lupus
• Currently participating in any interventional clinical trial with an investigational product;
• Inability to understand and sign the informed consent and to fill in patient questionnaires