Systemic Lupus Erythematosus, Telitacicept, Therapy
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Yanfeng Hou
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Inclusion criteria
1. The diagnosis meets the 2019 EULAR/ACR classification criteria for SLE; 2. Age 18-70 years old; 3. 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); 4. Lupus activity Index score (SELENA-SLEDAI) ≥ 8 at screening; 5. Positive anti-nuclear antibody or anti-DSDNA antibody; 6. Combined antiphospholipid syndrome should meet the diagnostic criteria: that is, meet one clinical criterion and one laboratory criterion.
Exclusion criteria
1. Active infections (such as shingles, HIV infection, active tuberculosis, etc.) during the screening period; 2. 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; 3. Have active hepatitis or a history of severe liver disease; 4. Patients with immune deficiency, uncontrolled severe infection, and active or recurrent digestive ulcer; 5. Pregnant women, breastfeeding women and men or women who have planned to have a baby in the last 12 months; 6. Allergic reaction: history of allergic reaction to human biological products; 7. Those who received live vaccine within the last month; 8. 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); 9. B cell targeted therapy, such as rituximab or epazumab, within one year; 10. Use tumor necrosis factor inhibitors and interleukin-receptor blockers within one year; 11. Patients receiving intravenous gamma globulin (IVIG), prednisone ≥ 100 mg/d for more than 14 days within one month or undergoing plasmapheresis; 12. Psychopaths with depression or suicidal thoughts.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of transitional regulatory B cells | prior treatment | A subset of B cells, including T1 and T2 B cells, that secrete immunosuppressive factors and act as negative immune regulators. |
Countries
China
Contacts
Primary ContactYanfeng Hou, Dr.
Outcome results
None listed