Efficacy and Immunological Evaluation of Belimumab Plus Low Dose IL-2 in the Treatment of Systemic Lupus Erythematosus

Inclusion Criteria:

• 1. Male or female >18 years of age at screening visits 2. Patients meet theAmerican-European Consensus Group 2002 classification criteria 3. The patient must beinformed in writing of the consent to participate in the trial and the patient is expectedto be able to comply with the requirements of the study follow-up plan and other protocols.

4. Dosing of antimalarials, prednisone or equivalent, cholinergic stimulants, and topicalcyclosporine required to be stable for at least 4 weeks before screening and during study;maximum doses allowed:

• Hydroxychloroquine, 400 mg/day;
• Prednisone, 10 mg/day

Exclusion Criteria:

• 1. Any subject meeting any of the following criteria should be excluded: 1. Laboratoryabnormality: • Hb≤9 g/dl • Neutrophil 10 mg/d) within 1 month.

2. Serious complications: including heart failure (≥ New York Heart Association (NYHA)class III), renal insufficiency (creatinine clearance ≤ 30 ml/min), liver dysfunction (serum Alanine transaminase (ALT) or aspartate aminotransferase (AST) greater thanthree times the upper limit of normal, or total bilirubin greater than Normal upperlimit) 3. Known allergies, hyperreactivity or intolerance of tofacitinib or itsexcipients.
3. Have a serious infection needing hospitalization (including but not limited tohepatitis, pneumonia, bacteremia, pyelonephritis, Epstein-Barr virus (EBV),tuberculosis infection), or use intravenous antibiotics to treat infection in 2 monthsbefore the enrollment.
4. Infection with HIV (HIV antibody positive serology) or hepatitis C (Hep C antibodypositive serology). If seropositive, it is recommended to consult a doctor who hasexpertise in treating HIV or hepatitis C virus infection.
5. Any known history of malignancy in the past 5 years (except for nonmelanoma skincancer, non-melanoma skin cancer or cervical tumor without recurrence within 3 monthsafter surgical cure prior to the first study preparation).
6. Uncontrolled mental or emotional disorders, including a history of drug and alcoholabuse over the past 3 years, may hinder the successful completion of the study.
7. Pregnant, lactating women (WCBP) are reluctant to use medically approvedcontraceptives during treatment and 12 months after treatment.