Systemic Lupus Erythematosus
Conditions
Keywords
Systemic Lupus Erythematosus, Telitacicept, Belimumab, Efficacy and Safety
Brief summary
The objective of this observational study is to compare the efficacy and safety of telitacicept versus belimumab in systemic lupus erythematosus (SLE) patients aged 18-65 years. The primary questions it aims to answer are: * In the overall SLE population: What are the SRI-4 response rates for both drugs? * In the lupus nephritis subgroup: What are the major renal response rates for both drugs? Participants will autonomously select their treatment regimen (add-on telitacicept or belimumab) based on: * The patient's objective clinical condition at enrollment * Physician's assessment * Joint decision-making between physicians and patients/family members As an observational study, no active intervention will be implemented.
Interventions
None listed
Sponsors
Yipeng Liu
Renmin Hospital of Wuhan University
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age range: 18 - 65 years old; * Meets the revised SLE classification criteria of the American College of Rheumatology in 1997 or the SLE diagnostic classification criteria issued by EULAR/ACR in 2019; * The SELENA-SLEDAI score is at least 8 points (clinical symptoms are no less than 6 points, excluding positive anti-double-stranded DNA (anti-dsDNA) and low complement); * Has not responded well to hormone and/or immunosuppressant treatment, is intolerant or has recurrence, and is willing to accept tixocortinib/belimumab as a therapeutic drug.
Exclusion criteria
* Any of the following conditions exists: active central nervous system disease, severe active lupus nephritis, HIV infection, hepatitis B or C virus infection, low gamma globulinemia, liver dysfunction; * eGFR \< 30 mL/min/1.73m², or undergoing hemodialysis or kidney transplantation; * Pregnant women, or women who are about to become pregnant in the near future, or lactating women; * Participants who are simultaneously participating in other clinical studies; * Within 1 year before randomization, received B-cell targeted therapy (including belimumab); * During treatment, used traditional Chinese medicine with immunosuppressive effects (such as Tripterygium wilfordii, White Peony Root, etc.) in combination.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The percentage of patients with a Systemic Lupus Erythematosus Response Index-4 (SRI-4) response(the overall SLE population) | From baseline to the end of 2-year treatment period | 1. A reduction of ≥ 4 points in the SELENA-SLEDAI score from baseline; 2. And no new BILAG A-level organ or ≤ 2 new BILAG B-level organs compared to baseline; 3. And no worsening in the physician's global assessment (PGA) (an increase of \< 0.30 points from baseline). |
| The response rate for major kidney treatments(the lupus nephritis subgroup) | From baseline to the end of 2-year treatment period | 1. 24-hour urine PCR ≤ 0.7 g/g (70 mg/mmol); 2. eGFR decline does not exceed 20% of the baseline or is ≥ 60 ml/min/1.73 m2; 3. No rescue treatment was adopted due to treatment failure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete renal response rate(the lupus nephritis subgroup) | From baseline to the end of 2-year treatment period | 1. 24-hour urine PCR \< 0.5 g/g (50 mg/mmol); 2. Stable or improved renal function (not exceeding 10% - 15% of the baseline). |
| Proportion of Participants with Stable SLEDAI and PGA Scores(the overall SLE population) | From baseline to the end of 2-year treatment period | The percentage of study participants whose SLEDAI score decreased by at least 4 points and whose PGA did not worsen. |
| The proportion of participants in the study who had their hormone dosage reduced(the overall SLE population) | From baseline to the end of 2-year treatment period | The ratio of study participants whose prednisone dose was reduced by ≥25% or ≤7.5 mg/day compared to the baseline at 44-48 weeks. |
| The time of recurrence occurrence(the overall SLE population) | From baseline to the end of 2-year treatment period. | The time of the first recurrence or the first severe recurrence. |
Countries
China
Contacts
CONTACTYipeng Liu
Outcome results
None listed