systemic lupus erythematosus
Conditions
Interventions
Anifrolumab is started within 2 weeks after PSL initiation, and thereafter anifrolumab 300 mg is administered intravenously over 30 minutes every 4 weeks according to the anifrolumab package insert. T
Sponsors
Tsuboi Hiroto
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Diagnosed with SLE based on either the 2019 EULAR/ACR classification criteria or the 1997 ACR classification criteria 2) No history of systemic administration of immunosuppressive or immunomodulatory drugs for SLE and within six months of diagnosis 3) SLEDAI-2K score of 4 or higher, indicating active disease 4) Age 16 years or older and younger than 80 years at the time of obtaining consent 5) Patients who have provided written consent for study participation after receiving a full explanation and understanding (For patients aged 16 years or older but under 18 years, parental consent is also required)
Exclusion criteria
Exclusion criteria: 1) Steroid therapy exceeding a prednisolone equivalent dose of 0.6mg/kg/day as initial treatment 2) Carriers of hepatitis viruses or have active HBV/HCV infections 3) History of HBV/HCV infection (excluding cases with negative nucleic acid quantification tests) 4) Severe liver disease other than that associated with SLE or autoimmune hepatitis (AST (GOT) or ALT (GPT) >= 200 U/L) 5) Severe kidney disease (serum creatinine >=2mg/dL) 6) Active tuberculosis infection 7) Current or history of malignant tumors (excluding cases with no recurrence for more than 5 years, and cervical cancer treated with only with local therapy that remaining in situ and no metastasis for more than 3 years) 8) Suspected active infection 9) Pregnant or may be pregnant female 10) Lactating female 11) Coexisting collagen diseases, excluding Sjogren's syndrome and antiphospholipid antibody syndrome 12) Within 30 days after receiving live vaccine administration 13) Participation in the study is determined as unsuitable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients achieving LLDAS after 12 weeks of anifrolumab initiation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients who discontinued PSL after 24 weeks of anifrolumab initiation Percentage of patients achieving LLDAS after 24 weeks of anifrolumab initiation Percentage of achievement of each component of the LLDAS after 12 and 24 weeks of anifrolumab initiation Change from baseline in SLEDAI-2K after 12 and 24 weeks of anifrolumab initiation Change from baseline in complement (C3, C4, CH50) and anti-DNA antibodies after 12 and 24 weeks of anifrolumab initiation Dose and cumulative dose of PSL at 12 and 24 weeks after anifrolumab initiation Percentage of patients receiving concomitant immunosuppressive drugs and when they were initiated Adverse events associated with anifrolumab Exploratory evaluation of the relationship between the expression level of IFN signature genes, lymphocyte subsets, changes in blood cytokines, etc. and the activity of SLE and response to therapy at baseline, 0, 12, and 24 weeks | — |
Contacts
Public ContactHiroto Tsuboi
University of Tsukuba Hospital
Outcome results
None listed