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
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;
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;
Adult patients with Systemic Lupus Erythematous (SLE) according to 2019 EULAR/ACR classification criteria, treated with anifrolumab as per clinical practices.
Cohort
Prospective
Anifrolumab
Biological/Vaccineanifrolumab - fully human monoclonal antibody target type I INF
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.
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.
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
Median (range) cumulative dose of GCS
Median cumulative dose of GCS calculated at each 6 month period following T0
Mean(SD) change in tender and swollen joint count
Mean change in tender and swollen joint count using Disease Activity Score 28 (DAS28) map at different timepoints compared to baseline (w0). DAS28 ranges from 0 (no-activity) to 10 (high disease activity)
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