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Use of low dose IL-2 for treating autoimmune-related or inflammatory disorders

An autoimmune disease and immune-related technology, which is applied in the application field of low-dose IL-2 for the treatment of autoimmune-related diseases or inflammatory diseases, and can solve problems such as exacerbation of diseases

Pending Publication Date: 2019-03-08
公共事业救济局-巴黎医院 +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Indeed, the ability of IL-2 to stimulate Teff carries the risk of exacerbating the disease by activating the very effector T cells that mediate the disease

Method used

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  • Use of low dose IL-2 for treating autoimmune-related or inflammatory disorders
  • Use of low dose IL-2 for treating autoimmune-related or inflammatory disorders
  • Use of low dose IL-2 for treating autoimmune-related or inflammatory disorders

Examples

Experimental program
Comparison scheme
Effect test

specific Embodiment approach

[0222] The following examples are offered for purposes of illustration and not limitation.

Embodiment 1

[0224] Example 1: Low Dose IL-2 in HCV-Associated Vasculitis

[0225] Here, we provide the first evidence in human subjects that IL-2 can be used to induce Tregs without inducing Teffs in patients with autoimmunity. Here we report the first demonstration of in vivo expansion of very potent suppressive Tregs by IL-2 immunotherapy in human autoimmune diseases, leading to clinical improvement. The primary endpoint of our study, increased Treg at the end of IL-2 therapy, was met as well as all secondary priorities, including clinical response. We show that low-dose IL-2 is well tolerated, induces a sharp and selective increase in Treg cells, and causes clinical improvement in 80% of patients. This is the first demonstration of Treg induction and recovery in vivo following IL-2 immunotherapy in a human autoimmune disease. Furthermore, we show for the first time a significant anti-inflammatory effect of low-dose IL-2 in humans.

[0226] method

[0227] patient

[0228] Inclus...

Embodiment 2

[0271] Example 2: Low Dose IL-2 in Type 1 Diabetes

[0272] The present inventors initiated an IL-2 dose-finding clinical trial in T1D, which aimed to determine the lowest active dose capable of safely inducing Tregs in adult T1D patients.

[0273] The DF-IL2 trial was double-blind and compared placebo, 0.3, 1 and 3mIU / day Dose (cumulative doses were 1.5, 5 and 15mIU).

[0274] The aim of the trial was to preserve residual endogenous insulin secretion in newly diagnosed T1D patients.

[0275] Key patient characteristics: adult, both sexes, T1D diagnosis per WHO-ADA, disease duration less than 12 weeks from diagnosis at first IL-2 dose, and C-peptide available at entry detection.

[0276] To achieve a clinically meaningful effect, the currently recommended goal is to preserve at least the pancreatic β-cell mass with active therapy, ie maintain an AUC of C-peptide relative to baseline of 0-120.

[0277] All 24 patients were included. Although investigators remain blinded t...

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Abstract

The present invention relates to use of low dose IL-2 for treating autoimmune-related and immune-related diseases or inflammatory disorders among human being objects, wherein in the objects, the IL-2is administrated according to the quantity for adjusting the balance (Treg / Teff ratio) between T-lymphocytes (Treg) and effector T lymphocytes (Teff). More specifically, the present invention relatesto a use of low dose interleukin-2 for the treatment of type I diabetes and other autoimmune and / or inflammatory diseases.

Description

[0001] This application is an international application PCT / EP2012 / 054174 that entered the national phase in China on September 11, 2013. The application number is 201280012853.6, and the title of the invention is "Application of low-dose IL-2 for the treatment of autoimmune-related diseases or inflammatory diseases." divisional application. technical field [0002] The present invention relates to novel IL-2 based therapies for human diseases. More specifically, the invention relates to low dose IL-2 therapy in human subjects for autoimmune, immune-related or inflammatory diseases, including inflammation. Background technique [0003] Interleukin-2 (IL-2) was identified almost 30 years ago [1] and was originally called a T-cell growth factor due to its ability to stimulate T lymphocytes in vitro. It is a protein with a reported molecular weight between about 13 kda and 17 kda [2] and an isoelectric point of about 6 to 8.7. [0004] Clinically, IL-2 has been used to enhanc...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/20A61P37/02A61P29/00
CPCA61K38/2013A61K38/00A61K38/12A61P3/10A61P9/00A61P37/06A61K38/20
Inventor 大卫·克拉茨曼大卫·萨阿顿帕特里斯·卡库米谢勒·罗森瓦吉埃利亚内·皮亚焦吉尔贝·邦西蒙克洛德·贝尔纳
Owner 公共事业救济局-巴黎医院
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