VIOLET is a prospective, single-arm, multi-centre, non-interventional study (NIS) evaluating real-world clinical and patient-reported outcome (PRO) data in adult patients who are initiated on subcutaneous anifrolumab treatment of systemic lupus erythematosus (SLE) in line with the applicable european summary of product characteristics (SmPC) and neither having used anifrolumab subcutaneous (SC) or intravenous (IV) before.
Age ≥18 years at the time of signing the informed consent
Diagnosis of SLE
Prescription of anifrolumab SC in line with the european summary of product characteristics (SmPC)
Prescription of anifrolumab SC was decided prior to and independently of the study
Prior exposure to anifrolumab
Treatment with concurrent biologics
Current or planned participation in a clinical study that does not constitute routine care
Currently experiencing a severe or rapidly progressive Class III or IV glomerulonephritis requiring induction therapy (mycophenolate mofetil [MMF]/cyclophosphamide + high dose steroids), isolated Class V lupus nephritis (in absence of other SLE manifestations, i.e. skin/joint involvement), or active severe or unstable neuropsychiatric lupus
125 patients ≥18 years of age, who have been diagnosed with systemic lupus erythematosus (SLE) and who are initiated on subcutaneous (SC) anifrolumab therapy independently of the study and in line with the applicable european summary of product characteristics (SmPC) within routine clinical practice neither having used subcutaneous nor intravenous (IV) anifrolumab before will be enrolled. Patients must be willing and able to report PROs. Eligible patients will be enrolled into the study after the after the treating physicians' diagnostic and therapeutic decisions.
Cohort
Prospective
Not listed
Proportion and number of patients who fulfill criteria for definition of remission in SLE (DORIS remission)
To assess disease activity at month 24 by evaluating the attainment of DORIS remission following initiation of anifrolumab SC treatment
Proportion and number of patients in DORIS remission
To describe the course of DORIS remission in patients initiating treatment with anifrolumab SC
Proportion and number of patients who ever achieved DORIS remission
To describe the course of DORIS remission in patients initiating treatment with anifrolumab SC
Time (in months) to first DORIS remission among patients achieving DORIS criteria
To describe the course of DORIS remission in patients initiating treatment with anifrolumab SC
Time (in months) spent in DORIS remission among patients achieving DORIS criteria
To describe the course of DORIS remission in patients initiating treatment with anifrolumab SC
Safety: Collection of Adverse Events (AE)
To describe the safety and tolerability of anifrolumab SC treatment. Safety evaluated based on type of Adverse Event (AE), intensity, causal relationship to treatment, duration, handling, outcome, and seriousness
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