A Pilot-Study With Low-dose hrIL-2 for the Treatment of Systemic Lupus Erythematosus

Peking University People's Hospital60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Systemic Lupus Erythematosus

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Number of Participants Who Were SLE Responders (SRI)

SRI response was defined as (1) a ≥ 4-point reduction in SELENA-SLEDAI score, (2) no new BILAG A score or ≤ 1 new BILAG B score, and (3) no deterioration from baseline in the physician's global assessment by ≥ 0.3 points.

Time frame: week 24

Evaluation of the safety (type and number of adverse events and serious adverse events) of low-doseIL-2 in patients with SLE

Adverse events includes injection site reactions, influenza-like symptoms, infection, fever, tumor, cardiovascular event，drug-induced liver and kidney damage.

Time frame: 24 weeks