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
AstraZeneca
Lead sponsor