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.
Single group
Anifrolumab
DrugPatients will receive Anifrolumab subcutaneous
Attainment of DORIS remission
Proportion of participants who are in DORIS remission at Week 52 will be assessed. DORIS remission is defined as Clinical SLEDAI-2K (sum of all SLEDAI-2K items except for increased deoxyribonucleic acid \[DNA\] binding and low complement) = 0; PGA \[0-3\] \< 0.5, prednisone 5 mg/day or less, and stable antimalarials, ISs, and biologics.
To assess the attainment of low level disease activity
Proportion of participants who are in LLDAS, or LLDAS-5 at Week 28 and 52 will be assessed. Low level disease activity as measured by LLDAS and LLDAS 5 * LLDAS criteria: SLEDAI 2K ≤ 4 without major organ involvement, no new disease activity, PGA ≤ 1 (0 - 3), prednisone 7.5 mg/day or less, and permitted use of the following medications: antimalarials, standard maintenance doses of ISs including biologics * LLDAS-5 criteria: SLEDAI-2K ≤ 4 without major organ involvement, no new disease activity, PGA ≤ 1 (0 - 3), prednisone 5.0 mg/day or less (this is modified LLDAS to include EULAR 2023 recommendations to lower daily maintenance GC ≤ 5.0 mg/day)
Time spent in DORIS remission, LLDAS or LLDAS-5
Time spent in DORIS remission, LLDAS or LLDAS-5 for participants initiated on anifrolumab will be measured.
Sustaining DORIS remission, LLDAS or LLDAS-5
The proportion of participants initiated on anifrolumab, sustaining DORIS remission, LLDAS or LLDAS-5 through to Week 52 will be measured.
Sustaining DORIS remission, LLDAS or LLDAS-5
The proportion of participants initiated on anifrolumab, sustaining DORIS remission, LLDAS or LLDAS-5 for three or more consecutive visits will be measured. Consecutive visits' are defined as three back-to-back completed visits.
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AstraZeneca
Lead sponsor
ICON plc
Collaborator
