Systemic lupus erythematosus complicated with immune liver cirrhosis
Conditions
Interventions
Teprotumumab Treatment Group:Subcutaneous injection of Teprotumumab 160mg once weekly (dose can be reduced to 80mg/week after disease stabilization)
background therapy: divided into Group 1 (glucocorticoids + hydroxychloroquine) or Group 2 (glucocorticoids + hydroxychloroquine + immunosuppressants: MMF, CsA, Tac)
Sponsors
The First Affiliated Hospital of Nanchang University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 to 70 years old; 2. Patients with a clear diagnosis of SLE, that is, those who meet at least four of the 11 classification criteria for SLE revised by the American College of Rheumatology in 1997 (Appendix 1), or those who meet the SLE classification criteria of EULAR/ACR in 2019 and disease activity (SLEDAI-2K score >=8 points). 3. Immune liver cirrhosis has been diagnosed and is currently in the compensatory stage (Child-Pugh grade A or B, with priority given to grade A. If it is Child-Pugh grade B, the following conditions must be met: total bilirubin <=51.3µmol/L, INR<=1.5, and no hepatic encephalopathy). Diagnosis of autoimmune liver cirrhosis (any of the following subtypes must be met): (1) Primary biliary cholangitis (PBC): AMA-M2 positive + liver biopsy showing non-suppurative cholangitis or disappearance of bile ducts or confirmed by imaging; (2) Autoimmune hepatitis (AIH): Elevated IgG + positive ANA/SMA/LKM-1 + liver biopsy showing interface hepatitis or confirmed by imaging; (3) Lupus secondary immune cirrhosis: Confirmed by imaging or liver biopsy showing cirrhosis + exclusion of other causes. 4. Sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Decompensated liver cirrhosis (Child-Pugh grade C), or a recent (within 6 months) history of hepatic encephalopathy or varicose vein bleeding. 2. Liver diseases with other causes (such as viral hepatitis, alcoholic liver disease, drug-induced liver injury, etc.). 3. At baseline, there were active, severe or uncontrolled infections (such as tuberculosis, hepatitis B, hepatitis C, etc.). 4. Severe dysfunction of the heart, lungs and kidneys (estimated glomerular filtration rate [eGFR] < 30 ml/min/1.73m^2). 5. Pregnant women, lactating women or those planning to become pregnant. 6. Known allergy to telitacicept or any of its components. 7. Other biological agents or clinical trial drugs have been used within the past six months. In addition to the above, the researchers determined that there were other reasons for not being suitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SRI-4 Response Rate;Liver Function Improvement; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in SLEDAI-2K Score;Corticosteroid Tapering Success Rate;Complement C3/C4 Levels;Change in Anti-dsDNA Antibody Levels;Child-Pugh Score;MELD-Na Score;Serum ALT/AST, Total Bilirubin, Albumin, Globulin, ALP, GGT, and IgG Levels;Abdominal Ultrasound Monitoring for Ascites and Splenic Size;SF-36 Quality of Life Assessment;Safety Outcomes (including adverse event rate within 6 months, adverse reactions, SAE incidence, infections (especially opportunistic infections), liver function deterioration (defined as ALT/AST >3× upper limit of normal or total bilirubin >2× upper limit of normal), ascites, hepatic encephalopathy, injection site reactions, complete blood count, urinalysis, renal function, ECG changes); | — |
Countries
China
Contacts
Public ContactChen Liming
The First Affiliated Hospital of Nanchang University
Outcome results
None listed