Exploratory study for the usefulness of early introduction of anifrolumab in the first remission induction therapy for systemic lupus erythematosus

JRCT ID: jRCTs031230358

Registered date:22/09/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: systemic lupus erythematosus
• Date of first enrollment: 26/12/2023
• Target sample size: 10
• Study type: Interventional
• Intervention(s): 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. The treatment period of anifrolumab specified in the protocol is 24 weeks, but can be continued as usual after the end of the treatment period. Initial dose of PSL (not exceeding 0.6 mg/kg/day) is continued for 2 weeks, followed by weekly dose reductions as a rule, to 7.5 mg/day or less at 12 weeks. However, if clinical symptoms such as fever and skin rash that suggest worsening of disease activity or the appearance of new symptoms are observed, and if improvement in disease activity cannot be expected with the addition of concomitant immunosuppressive drugs, the PSL dose will not be reduced. The principal investigator or subinvestigator will taper PSL flexibly at each visit depending on the condition of the subject. After 12 weeks, the PSL dose can be reduced (or discontinued) at the discretion of the principal investigator or subinvestigator.

Outcome(s)

• Primary Outcome: Percentage of patients achieving LLDAS after 12 weeks of anifrolumab initiation.

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 80age old
• Gender: Both

Include 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 18 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

Exclude 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 (AST or ALT >=100 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

Related Information

• Primary Sponsor: Tsuboi Hiroto
• Source(s) of Monetary Support: University of Tsukuba Hospital