The purpose of the SUNFLOWER study is to describe clinical outcomes, including DORIS remission, achieved following the initiation of anifrolumab 120 mg SC once weekly (QW) as add-on therapy to an anti-malarial, with or without GC; in patients not in LLDAS at enrolment.
Patients will be naïve to any prior conventional immunosuppressant including prior biologic therapy at enrolment. The study will also employ a tapering protocol for a systematic approach to GC tapering, seeking to understand better the proportion of patients in remission who can successfully withdraw chronic GC completely.
Males or females aged 18 to 70 years of age.
Participants who have a diagnosis of SLE confirmed by a rheumatologist.
Must be on the standard therapy regimen: antimalarials with or without OCSs
Clinical SLEDAI-2K ≥ 4 points OR
Subjects with history of, or current diagnosis of, a clinically significant non-SLE related vasculitis syndrome.
Subjects with antiphospholipid antibody syndrome on stable anticoagulant therapy at an effective dose (e.g., if on warfarin, an international normalized ratio [INR] target 2 to 3 or as appropriate for the clinical situation) are only allowed if this is not the sole or the predominant feature of their SLE.
Subjects with a serious thrombotic event (e.g., pulmonary embolism stroke, deep vein thrombosis) or unexplained pregnancy loss within 1 year before the screening visit are excluded.
Subjects with a history of catastrophic antiphospholipid syndrome or saddle embolism.
AstraZeneca
Lead sponsor
ICON plc
Collaborator