Low-dose IL-2( Interleukin-2) Treatment in SLE
Low-dose IL-2( Interleukin-2) Treatment in SLE
This clinical study will test the efficacy and safety of low dose IL-2 treatment in Systemic
 lupus erythematosus.
Systemic lupus erythematosus (SLE) is a chronic autoimmune syndrome affecting various organs.
 While available therapies, such as corticosteroids and immunosuppressive agents have improved
 the outcome of patients, there remains a significant unmet need for safe and more effective
 treatments. Dysfunction of regulatory T (Treg) cells has been detected in diverse autoimmune
 diseases, which can be promoted by interleukin-2 (IL-2). We hypothesized that low-dose IL-2
 could be a novel therapy in active SLE patients.

 This is a single center, uncontrolled, open-label study to assess the efficacy/safety of low
 dose IL-2 plus standard therapy in active SLE.

 Methods: Each SLE patients (n=40) with Scores>=8 on the Safety of Estrogens in Lupus
 Erythematosus National Assessment (AELENA) version of the SLE Disease Activity Index (SLEDAI)
 that was refractory or relaps to glucocorticoid therapy received low-dose IL-2 (1 million
 units every other day subcutaneously (HrIL-2 1X 106, ip, Qod) for a period of 14 days. After
 a 14-day rest, another cycle started) for 3-6 cycles according to the situation of the
 disease. The end points were safety and clinical and immunologic response.

 Expected Results: This trail will define low-dose IL-2 plus standard therapy is efficacy and
 safety with active lupus patients, which could be relevant to the amelioration the abnormity
 of T help cells in SLE patients.
Inclusion Criteria:

 -  Meet the American College of Rheumatology criteria for the diagnosis of SLE.

 -  Under standard treatment (≥ 2 months) at the time of inclusion

 -  Background treatment failed to control flares or to permit prednisone tapering

 -  With at least one of the following manifestations: thrombocytopenia,
 disease-associated rash, mouth ulcer, non-infectious type of fever, active vasculitis,
 renal disorder(proteinuria>0.5g/day), neuropsychiatric SLE.

 -  Positive for at least one of the following laboratory tests: ANA>1:160, anti-dsDNA,
 immunoglobulin>20g/L, decreased C3 or C4, leukopenia<3×10^9/L,
 thrombocytopenia<100×10^9/L;

 -  SLE disease activity index(SLEDAI) ≥ 8.

 -  Negative HIV test.

 -  Negative for hepatitis B and C virus.

 -  Written informed consent form.

 Exclusion Criteria:

 -  Sever chronic liver, kidney, lung or heart dysfunction; (heart failure (≥ grade III
 NYHA), hepatic insufficiency (transaminases> 3N) )

 -  Serious infection such as bacteremia, sepsis;

 -  Cancer or history of cancer cured for less than five years (except in situ carcinoma
 of the cervix or Basocellular carcinoma);

 -  High-dose steroid pulse therapy (>1.5mg/kg) or IV bolus of corticosteroids in the last
 2 months.

 -  History of administration of rituximab or other biologics;

 -  Purified protein derivative (tuberculin) >10mm

 -  Mental disorder or any other chronic illness or drug-abuse that could interfere with
 the ability to comply with the protocol or to give information;

 -  Inability to comply with IL-2 treatment regimen.