Anti-infection of Low-does IL-2 in SLE
Anti-infection of Low-does IL-2 in SLE
The objective of this clinical study is to evaluate the potential effect of anti-infection of
 low-does IL-2 in patients with SLE.
Systemic lupus erythematosus (SLE) is a chronic autoimmune syndrome affecting various
 organs.Many feel that glucocorticoid and immunosuppressor are the standard therapy for
 patients with SLE. While it can improve the risk of infection among SLE patients. A novel
 therapy to treat SLE with low-does IL-2 has been identified recently. IL-2 also used to
 against some virus infect. So we hypothesized that low-dose IL-2 could reduce risk of
 infection in SLE patients.

 Methods: A total of SLE patients (n=30) were divided into two groups randomly. One received
 standard therapy, while another one administrate with low-does IL-2 plus standard
 therapy.Each patient will be treated with low-dose IL-2. The end points are clinical and
 immunologic response.

 Expected Results: This trail wlii provide both clinical and basic profe that low-dose IL-2
 plus standard therapy have lower infection risk 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.