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Ann Rheum Dis. 2019 Sep 19. pii: annrheumdis-2019-215396. doi: 10.1136/annrheumdis-2019-215396. [Epub ahead of print]

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

Author information

1
Department of Rheumatology and Immunology, Peking University People's Hospital, Beijing, China hejing1105@126.com di.yu@anu.edu.au sunxiaolin_sxl@126.com li99@bjmu.edu.cn.
2
Beijing Key Laboratory for Rheumatism and Immune Diagnosis (BZ0135), Beijing, China.
3
Department of Rheumatology and Immunology, Peking University People's Hospital, Beijing, China.
4
Center for Applied Statistics and School of Statistics, Renmin University of China, Beijing, China.
5
Department of Basic Medical Sciences, Tsinghua University School of Medicine, Beijing, China.
6
Department of Medicine, SUNY at Buffalo School of Medicine, Buffalo, New York, USA.
7
Department of Rheumatology and Immunology,China-Australia Centre for Personalised Immunology, Shanghai Renji Hospital, Shanghai JiaoTong University School of Medicine, Shanghai, China.
8
Department of Rheumatology and Immunology,China-Australia Centre for Personalised Immunology, Shanghai Renji Hospital, Shanghai JiaoTong University School of Medicine, Shanghai, China hejing1105@126.com di.yu@anu.edu.au sunxiaolin_sxl@126.com li99@bjmu.edu.cn.
9
Department of Immunology and Infectious Disease, John Curtin School of Medical Research, Australian National University, Shanghai, China.
10
State Key Laboratory of Natural and Biomimetic Drugs, Peking University, Beijing, China.
#
Contributed equally

Abstract

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).

KEYWORDS:

Autoimmune diseases; cytokines; systemic lupus erythematosus; t cells; treatment

PMID:
31537547
DOI:
10.1136/annrheumdis-2019-215396
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