Efficacy and Safety of Low-dose IL-2 in Patients With SLE: a Multicenter, Randomised, Placebo-controlled Trial

Active SLE patients at 18 to 75 years of age were enrolled. Patients were randomly assigned (in a 1:1:1:1 ratio) to one of the four arms (placebo or IL-2 at 0.2 MIU, 0.5 MIU or 1 MIU) in the study. IL-2 (0.2 MIU, 0.5 MIU or 1 MIU) or placebo was administered subcutaneously every other day for the first 12 weeks , and then was adjusted to once a week for the second 12 weeks. Follow-up visits occurred on weeks 4, 8,12,16,20 and 24. The end points were safety and clinical and immunologic response.

Inclusion criteria

• Meet the 1997 revised classification criteria of the American College of Rheumatology
• SLE disease activity index(SLEDAI) ≥ 8
• age:18 to 75 years, weight 45-80Kg
• Patients had an inadequate response to standard treatment for ≥ 3 months. The background treatment included corticosteroids (≤1.0 mg/kg), hydroxychloroquine, cyclophosphamide , mycophenolate mofetil or other immunosuppressants.
• Negative urine pregnancy test
• Written informed consent form

Exclusion criteria

• allergic to IL-2, corticosteroids, hydroxychloroquine, cyclophosphamide or mycophenolate mofetil
• active severe neuropsychiatric manifestations of SLE;
• hepatic insufficiency (alanine aminotransferase or aspartate aminotransferase ≥ 2 times of the upper limit of the normal range);
• pregnancy or lactation in females.
• Cancer or history of cancer cured for less than five years (except in situ carcinoma of the cervix or Basocellular carcinoma);
• Serious infection such as bacteremia, sepsis;history of chronic infection;
• active infection (hepatitis B or C virus, Epstein-Barr virus, human immunodeficiency virus or Mycobacterium tuberculosis);
• history vision and visual field disorders, cataract；
• severe comorbidities including heart failure (≥ grade III NYHA)
• active peptic ulcers；
• complicated with other autoimmune diseases;
• History of administration of rituximab or other biologics within 6 months;
• therapy with other immunosuppressors;
• participate in other clinical trial within 4 weeks;