This study aims to describe clinical outcomes, with focus on remission, achieved with use of anifrolumab participants with SLE on standard-of-care (as recommended by 2025 China SLE guidelines). Further, it aims to describe outcomes alongside a systematic approach to glucocorticoid (GC) tapering, in terms of effectively minimising GC use, as well as discontinuing GC use, thereby reducing GC exposure.
Informed Consent
Capable of giving signed informed consent. Age
Participant must be 18 to 70 years of age inclusive, at the time of signing the ICF.
Participants who have a diagnosis of SLE according to the 2019 EULAR/American College of Rheumatology (ACR) criteria (Appendix D), confirmed by a rheumatologist
Medical Conditions
History of, or current diagnosis of, a clinically significant non-SLE related vasculitis syndrome Vasculitis due to SLE is allowed in the study.
Non-SLE diseases that potentially require systemic glucocorticoids (e.g. IV or oral), as determined by medical judgment, e.g. asthma, chronic obstructive pulmonary disease (COPD).
Active severe or unstable neuropsychiatric SLE including, but not limited to aseptic meningitis, cerebral vasculitis, myelopathy, demyelination syndromes (ascending, transverse, acute inflammatory demyelinating polyradiculopathy), acute confusional state, impaired level of consciousness, psychosis, acute stroke or stroke syndrome, cranial neuropathy, status epilepticus, cerebellar ataxia, lupus headache and mononeuritis multiplex, where, in the opinion of primary investigator or AstraZeneca, protocol-specified standard therapy is insufficient and utilisation of a more aggressive therapeutic approach, such as adding IV cyclophosphamide and/or high dose IV pulse corticosteroid therapy or other treatments not permitted in the protocol, is indicated.
Single group
Anifrolumab
DrugThe study intervention, anifrolumab will be administered via controlled IV infusion pump into a peripheral vein over a minimum of 30 minutes from Week 0 to Week 48 for a total of 13 doses. Each dose must be at least 14 days apart.
The proportion of patients who achieve DORIS remission at week 52
The proportion of patients who achieve DORIS remission at week 52 DORIS criteria: clinical SLEDAI (sum of all SLEDAI-2K items except for increased deoxyribonucleic acid \[DNA\] binding and low complement) =0, Physician's Global Assessment (PGA) \<0.5 (0-3), prednisolone 5 mg/day or less, and antimalarials, stable immunosuppressives, and biologics
The proportion of patients who achieve DORIS remission at week 12, 24
The proportion of patients who achieve DORIS remission at week 12, 24
Time to first DORIS remission attainment Proportion of time spent in DORI remission: 0, or did not achieve, ≥25%, ≥ 50%, or ≥ 75%
Time to first DORIS remission attainment Proportion of time spent in DORIS remission: 0, or did not achieve, ≥25%, ≥ 50%, or ≥ 75%
The proportion of patients who achieve DORIS-0 remission at week 52
The proportion of patients who achieve DORIS-0 remission at week 52 DORIS-0: clinical SLEDAI=0, PGA \<0.5 (0-3), prednisolone=0, and antimalarials, stable immunosuppressives, and biologics
The proportion of patients who achieve LLDAS at week 12, 24, 52
The proportion of patients who achieve LLDAS at week 12, 24, 52 LLDAS criteria: SLE Disease Activity Index 2000 (SLEDAI-2k) ≤4, with no activity in major organ systems (renal, CNS, cardiopulmonary, vasculitis, fever), no new SLEDAI-2K component that was not present at the previous assessment, PGA \<1 (0-3), prednisolone 7.5 mg/day or less, and antimalarials, stable immunosuppressives, and biologics
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