Vunakizumab for the Treatment of Mild to Moderate Systemic Lupus Erythematosus

Korábbi kezelés

• Concurrent autoimmune diseases affecting efficacy assessment (e.g., rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis).
• Major surgery within 3 months prior to screening.
• Biologic therapy within 3 months (anti-CD20 agents, belimumab, TNF-α inhibitors).
• Recent intensive therapies: Systemic corticosteroids within 3 months/ Plasmapheresis/IVIG/cyclophosphamide within 3 months

Más betegség

• SLE with major organ dysfunction including Encephalopathy/cognitive impairment, Renal insufficiency, Cardiac insufficiency (NYHA class III-IV), Pulmonary hypertension/interstitial lung disease
• 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
• Active malignancy within 5 years or history of malignancy.
• Comorbidities requiring corticosteroids (e.g., asthma, Crohn's disease).
• Active infections requiring treatment:Tuberculosis, HBV/HCV/HIV/CMV infections
• Hypersensitivity or intolerance to funakizumab.
• Any condition deemed by investigators to compromise study completion or patient safety.

Laborértékek

• Liver dysfunction: ALT/AST >1.5×ULN or total bilirubin >1×ULN.

Egyéb

• Pregnancy, lactation, or planned pregnancy.

• Patients aged 18-65 years meeting the 2019 EULAR/ACR classification criteria for SLE.
• SLEDAI score was within 2-12 scores (with clinical SLEDAI [cSLEDAI] ≠ 0).
• Occurence of new or recurrent mucocutaneous or joint involvement.
• Stable standard treatment regimen prior to study entry but not effect: Prednisone or equivalent corticosteroid dose ≤ 20 mg per day for more than 4 weeks; Immunosuppressant less than 1 type for more than 12 weeks, including methotrexate ≤15 mg per week, azathioprine ≤100mg per day, mycophenolate mofetil ≤1.5 g per day, tacrolimus ≤2 mg per day, cyclosporine ≤150 mg per day). Antimalarials was permitted.
• Body mass index (BMI) 18-35 kg/m² at screening.
• Clinically eligible for Vunakizumab combination therapy with corticosteroids after investigator assessment.
• Willing to provide written informed consent with demonstrated compliance.