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

AstraZeneca218 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

218

Conditions

Lupus Erythematosus, Systemic

Interventions

AnifrolumabBIOLOGICAL

anifrolumab - fully human monoclonal antibody target type I INF

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (22)

Azienda Ospedaliero-Universitaria di Cagliari Presidio di Monserrato

Outcomes

Primary Outcomes

Number and percentage of patients achieving LLDAS5

proportion of patients with LLDAS5 at 52 weeks, defined as: LLDAS5 is defined as follows: * Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) ≤ 4, with no activity in major organ systems and no haemolytic anaemia or gastrointestinal activity; * No new lupus disease activity compared with previous assessment as defined per protocol; * Physician's Global Assessment (PGA) ≤1; * Current prednisone (-equivalent) dose ≤ 5mg/day; * Well-tolerated standard maintenance dose of immunosuppressive drugs and biologics if any.

Time frame: 52 weeks

Secondary Outcomes

Number and percentage of patients reaching LLDAS5 at each time point

Proportion of patients with LLDAS5, according the following definition: LLDAS5 is defined as follows: * Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) ≤ 4, with no activity in major organ systems and no haemolytic anaemia or gastrointestinal activity; * No new lupus disease activity compared with previous assessment as defined per protocol; * Physician's Global Assessment (PGA) ≤1; * Current prednisone (-equivalent) dose ≤ 5mg/day; * Well-tolerated standard maintenance dose of immunosuppressive drugs and biologics if any.

Time frame: week 24, 76 and 104

Number and percentage of patients achieving a GCS (Glucocorticosterioids) dose reduction

Number and percentage of patients achieving a GCS dose reduction (to ≤ 5 mg/day; to 0 mg/day) at different timepoints (T1, T2, T3, T4, T5, T6) compared to T0

Time frame: week 4, 12, 24, 52, 76, 104 vs baseline

Median (range) cumulative dose of GCS

Median cumulative dose of GCS calculated at each 6 month period following T0

Time frame: from week 0 to week 24; from week 24 to week 52; from week 52 to week 76; from week 76 to week 104

Mean(SD) change in tender and swollen joint count

Central Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479 information.center@astrazeneca.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.