Use of interleukin 2 for treating Sjögren's syndrome

Patent metadata

Field	Value
Publication number	US-11534479-B2
Application number	US-201916965700-A
Country	US
Kind code	B2
Filing date	Feb 18, 2019
Priority date	Feb 16, 2018
Publication date	Dec 27, 2022
Grant date	Dec 27, 2022

Abstract

The invention relates to the use of interleukin-2 in treating Sjögren's syndrome in a subject, wherein IL-2 is to be administered at a low dose of less than about 3.5 MIU/day.

First claim

The invention claimed is:

1. A method for treating Sjögren's syndrome in a subject in need thereof, wherein the subject is administered with Interleukin-2 (IL-2) at a dose of 3.5 MIU/day or less; and wherein the treatment comprises at least a first course, in which the interleukin-2 is administered to the subject once per day during at least 2 or 3 consecutive days, followed by a maintenance treatment, which consists of an administration of IL-2 once or twice a week, every one or two weeks, or once a month, during a period of at least one month.

2. The method according to claim 1 , wherein the IL-2 is administered at a dose of 1-1.5 MIU/day.

3. The method of claim 1 , wherein the interleukin-2 is administered by subcutaneous route.

4. The method of claim 1 , wherein the treatment reduces the number and/or severity of inflammatory episodes.

5. The method of claim 1 , wherein the subject is a human.

6. The method of claim 1 , wherein the IL-2 is conjugated to at least one PEG moiety.

7. The method of claim 1 , wherein the IL-2 is conjugated to an immunoglobulin, or a Fc region of an immunoglobulin.

8. The method of claim 1 , wherein the IL-2 is human IL-2 or an active analogue thereof, which is aldesleukin.

9. The method of claim 8 , wherein the IL-2 is human IL-2.

10. The method according to claim 8 , wherein the IL-2 is aldesleukin.

11. The method according to claim 1 , wherein in the first course, the IL-2 is administered to the subject once per day for 3-7 days.

12. The method according to claim 1 , wherein in the first course, the IL-2 is administered to the subject once per day for 4-5 days.

13. The method according to claim 1 , wherein the first course is followed by the maintenance treatment after about 1 to about 4 weeks.

14. The method according to claim 1 , wherein the maintenance treatment is for about 3 months to about 12 months.

Assignees

• Iltoo Pharma
• Assist Publique—Hopitaux De Paris
• Univ Sorbonne
• Assist Publique—Hoepitaux De Paris

Inventors

• Klatzmann David
• Lorenzon Roberta
• Rosenzwajg Michèle
• Cacoub Patrice
• Mekinian Arsene

Classifications

• A61K38/2013 Primary

  IL-2 · CPC title

• A61P37/00

  Drugs for immunological or allergic disorders · CPC title

• A61K47/68

  the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment · CPC title

• A61K47/60

  the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol · CPC title

• A61P43/00

  Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00 · CPC title