Vunakizumab for the Treatment of Mild to Moderate Systemic Lupus Erythematosus

Exclusion Criteria

• •1. SLE with major organ dysfunction including Encephalopathy/cognitive impairment, Renal insufficiency, Cardiac insufficiency (NYHA class III-IV), Pulmonary hypertension/interstitial lung disease
• •2. Active SLE-related organ involvement: Lupus cerebritis, Active lupus nephritis (proteinuria ≥1g/24h), Myocardial involvement, Gastrointestinal vasculitis, Diffuse alveolar hemorrhage, Thrombocytopenic purpura, Hemophagocytic syndrome, Retinopathy
• •3. Concurrent autoimmune diseases affecting efficacy assessment (e.g., rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis).
• •4. Liver dysfunction: ALT/AST \>1.5×ULN or total bilirubin \>1×ULN.
• •5. Active malignancy within 5 years or history of malignancy.
• •6. Comorbidities requiring corticosteroids (e.g., asthma, Crohn's disease).
• •7. Active infections requiring treatment:Tuberculosis, HBV/HCV/HIV/CMV infections
• •8. Major surgery within 3 months prior to screening.
• •9. Hypersensitivity or intolerance to funakizumab.
• •10. Pregnancy, lactation, or planned pregnancy.
• •11. Biologic therapy within 3 months (anti-CD20 agents, belimumab, TNF-α inhibitors).
• •12. Recent intensive therapies: Systemic corticosteroids within 3 months/ Plasmapheresis/IVIG/cyclophosphamide within 3 months
• •13. Any condition deemed by investigators to compromise study completion or patient safety.