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Interleukin-2 (IL-2) is crucial for the growth and survival of regulatory T cells (Treg) and, thus, for the control of autoimmunity.1 ,2 In previous studies, we have proven a causal relationship between an acquired IL-2-deficiency, defects in Treg biology and the development of systemic lupus erythematosus (SLE).3 Accordingly, we showed that compensation of IL-2 deficiency by IL-2 therapy corrects associated Treg defects and ameliorates already established disease in lupus-prone mice.3 In line with this, two independent clinical studies showed recently that low-dose IL-2 induced expansion of the Treg pool and reduced clinical symptoms in two different immunological diseases without known IL-2 deficiency.4 ,5 These promising clinical findings in conjunction with preclinical data3 ,6 ,7 provide strong rationales for an IL-2-based immunotherapy of SLE in order to restore Treg activity and, thus, to re-establish endogenous mechanisms of tolerance that can counteract autoimmunity.
Here we report a rapid and robust reduction of disease activity in parallel with a remarkable expansion of the Treg population by low-dose IL-2 therapy in one patient with a long-term history of SLE and increased disease activity refractory …
Funding This study was supported by grants from the Deutsche Forschungsgemeinschaft (SFB650, TP10) and the Charité—University Medicine Berlin.
Contributors Study concept and design: JYH, TA, FH, AR, G-RB, GR. Acquisition of data: JYH, CvS-M, ES. Analysis and interpretation of data: JYH, CvS-M, TA and GR. Drafting of the manuscript: JYH and GR. Study supervision: JYH and GR.
Competing interests None.
Ethics approval This study was announced as ‘off-label’ therapy to the institutional Ethics Committee of the Charité—University Medicine Berlin. Written informed consent was obtained from the patient prior to the initiation of the off-label treatment with aldesleukin according to the Declaration of Helsinki in the revised version of 1996, and the International Conference on Harmonization (ICH) guidelines on Good Clinical Practice (GCP).
Provenance and peer review Not commissioned; externally peer reviewed.
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