Efficacy and safety of low-dose IL-2 in the treatment of systemic lupus erythematosus: A randomised, double-blind, placebo-controlled trial

Jing He, Ruijun Zhang, Miao Shao, Xiaozhen Zhao, Miao Miao, Jiali Chen, Jiajia Liu, Xiaoying Zhang, Xia Zhang, Yuebo Jin, Yu Wang, Shilei Zhang, Lei Zhu, Alexander Jacob, Rulin Jia, Xujie You, Xue Li, Chun Li, Yunshan Zhou, Yue YangHua Ye, Yanying Liu, Yin Su, Nan Shen, Jessy Alexander, Jianping Guo, Julian Ambrus, Xin Lin, Di Yu, Xiaolin Sun, Zhanguo Li*

*Corresponding author for this work

    Research output: Contribution to journalArticlepeer-review

    216 Citations (Scopus)


    Objectives Open-labelled clinical trials suggested that low-dose IL-2 might be effective in treatment of systemic lupus erythematosus (SLE). A double-blind and placebo-controlled trial is required to formally evaluate the safety and efficacy of low-dose IL-2 therapy. Methods A randomised, double-blind and placebo-controlled clinical trial was designed to treat 60 patients with active SLE. These patients received either IL-2 (n=30) or placebo (n=30) with standard treatment for 12 weeks, and were followed up for additional 12 weeks. IL-2 at a dose of 1 million IU or placebo was administered subcutaneously every other day for 2 weeks and followed by a 2-week break as one treatment cycle. The primary endpoint was the SLE Responder Index-4 (SRI-4) at week 12. The secondary endpoints were other clinical responses, safety and dynamics of immune cell subsets. Results At week 12, the SRI-4 response rates were 55.17% and 30.00% for IL-2 and placebo, respectively (p=0.052). At week 24, the SRI-4 response rate of IL-2 group was 65.52%, compared with 36.67% of the placebo group (p=0.027). The primary endpoint was not met at week 12. Low-dose IL-2 treatment resulted in 53.85% (7/13) complete remission in patients with lupus nephritis, compared with 16.67% (2/12) in the placebo group (p=0.036). No serious infection was observed in the IL-2 group, but two in placebo group. Besides expansion of regulatory T cells, low-dose IL-2 may also sustain cellular immunity with enhanced natural killer cells. Conclusions Low-dose IL-2 might be effective and tolerated in treatment of SLE. Trial registration number ClinicalTrials.gov Registries (NCT02465580 and NCT02932137).

    Original languageEnglish
    Pages (from-to)141-149
    Number of pages9
    JournalAnnals of the Rheumatic Diseases
    Issue number1
    Publication statusPublished - 1 Jan 2020


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