Clareo Health | The Efficacy and Safety of Biologics (Belimumab/ Telitacicept) Induction Therapy in Proliferative Lupus Nephritis Patients for 6 Months Compared With Mycophenolate Mofetil Treatment
The Efficacy and Safety of Biologics (Belimumab/ Telitacicept) Induction Therapy in Proliferative Lupus Nephritis Patients for 6 Months Compared With Mycophenolate Mofetil Treatment
1.Signed written informed consent form. 2.Age 14-65 years (inclusive), any gender. 3.Meets the American College of Rheumatology (ACR) SLE diagnostic criteria (1997).
4.All patients have biopsy-confirmed class III/IV ± V LN within the past six months.
5.SLE-DAI score \> 6. 6.Urine protein quantification \> 1.0 g/d.
You may not be if
1.Estimated glomerular filtration rate (eGFR) ≥45 ml/min/1.73 m². 2.Patients who have received renal replacement therapy, plasma exchange, immunoadsorption, or high-dose intravenous immunoglobulin (100g) within the past 2 months.
3.Patients with concomitant critical organ damage or lupus crisis (e.g., pulmonary hemorrhage, encephalopathy, heart failure) deemed unsuitable for clinical trial participation by the investigator.
4.Hematological abnormalities: White blood cells \<3000/μL, absolute neutrophil count \<1500/μL, or lymphocytes \<800/μL, platelet count \<50,000/μL (unless due to SLE activity).
5.Liver function abnormalities: ALT, AST, or bilirubin levels exceeding 2 times the upper limit of normal.
6.Known allergy or contraindication to any component of belimumab and/or telitacicept.
7.Active infection or intravenous antibiotic use within 1 month prior to enrollment.
8.Pregnant or breastfeeding women. 9.Current or within the past 3 months: Active hepatitis B, hepatitis C, tuberculosis, cytomegalovirus pneumonia, active fungal infection, syphilis infection, or HIV infection; active peptic ulcer; history of drug abuse or alcoholism; severe malnutrition (BMI \<16 kg/m²).
10.Other conditions: Severe cardiovascular disease potentially life-threatening; chronic obstructive pulmonary disease, or asthma/allergic diseases requiring long-term oral steroid treatment; malignant hypertension; history of malignancy within the past 5 years (except for completely treated basal cell or squamous cell skin cancer or cervical intraepithelial neoplasia).
11.Other situations deemed unsuitable for enrollment by the investigator.
