A Pilot-Study With Low-dose hrIL-2 for the Treatment of Systemic Lupus Erythematosus
A Pilot-Study With Low-dose hrIL-2 for the Treatment of Systemic Lupus Erythematosus
Dysfunction of regulatory T (Treg) cells has been detected in diverse autoimmune diseases,
 which can be promoted by interleukin-2 (IL-2). In a previous small sample trail performed by
 the investigator's group, the investigators found that the Low-dose IL-2 was effective and
 well tolerated in active SLE, and the effect was associated with selective modulation of CD4+
 T cell subsets.

 This clinical study will confirm the efficacy and safety of low dose IL-2 treatment in SLE.

 The investigators perform a single-centre, double-blind pilot trial with hrIL-2 in SLE.The
 investigators evaluate the effectiveness and safeness of low-dose hrIL-2 for Systemic lupus
 erythematosus by randomized controlled study (hrIL-2 (N = 30) versus placebo group (N = 30)).
Each SLE patients (n=60) with Scores>=8 on SLEDAI received low-dose IL-2 or placebo (active
 group: placebo group =1:1, 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 cycles. The
 end points were safety and clinical and immunologic response.
Inclusion Criteria:

 -  Meet the American College of Rheumatology criteria for the diagnosis of SLE，1997.

 -  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.

 -  Negative urine pregnancy test.

 -  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.