Effect of Telitacicept on Transitional Regulatory B Cells in Patients With Systemic Lupus Erythematosus

Study Overview
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Brief Summary
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The effect of Telitacicept treatment on the changes of transitional regulatory B lymphocyte T1, T2B cell subsets and plasma blasts and the expression levels of cytokines IL-10, IL-35, April and BAFF in SLE.

Official Title
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Effect of Telitacicept on Transitional Regulatory B Cells in Patients With Systemic Lupus Erythematosus

Conditions
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Telitacicept, Systemic Lupus Erythematosus, Therapy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The diagnosis meets the 2019 EULAR/ACR classification criteria for SLE; Age 18-70 years old; To be on a stable SLE regimen, participants were required to receive standard treatment at least 1 month prior to treatment with a biologic (Telitacicept); Lupus activity Index score (SELENA-SLEDAI) ≥ 8 at screening; Positive anti-nuclear antibody or anti-DSDNA antibody; Combined antiphospholipid syndrome should meet the diagnostic criteria: that is, meet one clinical criterion and one laboratory criterion. Exclusion Criteria: Active infections (such as shingles, HIV infection, active tuberculosis, etc.) during the screening period; Central nervous system disease (including epilepsy, psychosis, organic encephalopathy syndrome, cerebrovascular accident, encephalitis, central nervous system vasculitis) caused by SLE or not caused by SLE in the last 2 months; Have active hepatitis or a history of severe liver disease; Patients with immune deficiency, uncontrolled severe infection, and active or recurrent digestive ulcer; Pregnant women, breastfeeding women and men or women who have planned to have a baby in the last 12 months; Allergic reaction: history of allergic reaction to human biological products; Those who received live vaccine within the last month; Participants who have participated in any clinical trial within 28 days prior to initial screening/or 5 times the half-life of the study compound (taking an older time); B cell targeted therapy, such as rituximab or epazumab, within one year; Use tumor necrosis factor inhibitors and interleukin-receptor blockers within one year; Patients receiving intravenous gamma globulin (IVIG), prednisone ≥ 100 mg/d for more than 14 days within one month or undergoing plasmapheresis; Psychopaths with depression or suicidal thoughts.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Exposed group<br>Standard treatment for SLE + Telitacicept 160 mg qw | |
| Control group<br>Standard treatment for SLE | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of transitional regulatory B cells | A subset of B cells, including T1 and T2 B cells, that secrete immunosuppressive factors and act as negative immune regulators. | prior treatment | 
| Number of transitional regulatory B cells | A subset of B cells, including T1 and T2 B cells, that secrete immunosuppressive factors and act as negative immune regulators. | After 12 weeks of treatment | 
| Number of transitional regulatory B cells | A subset of B cells, including T1 and T2 B cells, that secrete immunosuppressive factors and act as negative immune regulators. | After 24 weeks of treatment | 
| Number of transitional regulatory B cells | A subset of B cells, including T1 and T2 B cells, that secrete immunosuppressive factors and act as negative immune regulators. | After 36 weeks of treatment |