Table 2 Exclusion criteria of iGeLU study

1

Severe manifestations of SLE, including:

a. Neuropsychiatric lupus within 1 month before screening.

b. Extensive crescentic glomerulonephritis confirmed by biopsy with a ratio of crescents higher 50%.

c. Estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73m² (calculated by the EPI formula) at least two tests within 30 days before screening and at least 14 days between the two tests.

d. Evidence of significant abnormal laboratory value in peripheral blood not related to lupus (white blood cells (WBC) < 3 × 10⁹/L, platelets (PLT) < 50 × 10⁹/L) within 1 week before screening.

e. Moderate to severe anemia within one week before screening.

f. AST and ALT values more than two times the upper limit of normal within one week before screening.

2

Participant has been diagnosed with another autoimmune disorder, including but not limited to: rheumatoid arthritis, Sjogren’s syndrome, inflammatory myositis, systemic sclerosis, autoimmune liver disease.

3

Prior use of the following agents within 3 months of screening.

a. MMF or CNIs for more than 14 days in accumulation.

b. Anti-TNF-α, anti-interleukin-6 (IL-6), anti-IL1 or JAK inhibitor.

c. B cell depletion therapy (e.g., anti-CD20 monoclonal antibody) or anti-B lymphocyte stimulator therapy (e.g., belimumab)

d. High dose of glucocorticoid therapy (> 100 mg/d calculated by prednisone).

e. Plasma exchange, blood adsorption, hemodialysis, or mesenchymal stem cell translation.

4

Gene test for AZA demonstrates a high risk of side effects.

5

Active bacterial, viral, fungal, or opportunistic infection during the screening period.

6

Active viral hepatitis.

7

Active tuberculosis.

8

Receipt of a live or live-attenuated vaccine within 4 weeks of screening.

9

History of peptic ulcer or upper gastrointestinal hemorrhage, prior use of warfarin or other anticoagulant drugs.

10

Suspected or confirmed history of alcohol or drug abuse within two years

11

History of malignant neoplasm except carcinoma in situ, basal cell carcinoma and cured carcinoma.

12

Severe, progressive, or uncontrolled pulmonary, cardiac, or hypertension medical condition.

13

Participant suspected of mental disability.

14

Participant with epilepsy or nervous system dysfunction.

15

Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.