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

Patent metadata

Field	Value
Publication number	US-10293028-B2
Application number	US-201715588226-A
Country	US
Kind code	B2
Filing date	May 5, 2017
Priority date	Mar 11, 2011
Publication date	May 21, 2019
Grant date	May 21, 2019

Abstract

The present invention relates to novel therapies for treating autoimmune and inflammatory diseases. More specifically, the present invention relates to a use of low dose interleukin-2 for the treatment of type I diabetes and other autoimmune and/or inflammatory diseases.

First claim

The invention claimed is:

1. A method for treating systemic lupus erythematous erythematosus, the method comprising:
subcutaneously administering to a human subject in need thereof an effective amount of interleukin-2 (IL-2) at a dose of no more than between 0.1 MIU/day and 3.5 MIU/day, wherein the IL-2 is administered in a first course of treatment followed by a maintenance dose, wherein the first course of treatment consists of an administration of the IL-2 once per day for at least 3 consecutive days, and wherein the maintenance dose is given to the human subject once a week, once a month, or twice a month.

2. The method of claim 1 , wherein the subject is administered IL-2 at a dose of 1 MIU/day to 3.5 MIU/day.

3. The method of claim 1 , wherein the subject is administered IL-2 at a dose of 1.5 MIU/day to 3.5 MIU/day.

4. The method of claim 1 , wherein the subject is administered IL-2 at a dose of 0.5 MIU/day to 1.5 MIU/day.

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

6. The method of claim 1 , wherein the subject is administered des-alanyl-1, serine-125 human interleukin-2.

7. The method of claim 1 , wherein the first course of treatment consists of an administration of the IL 2 once per day for at least 5 consecutive days.

8. The method of claim 1 , wherein the first course of treatment consists of an administration of the IL 2 once per day for 3 to 7 days.

9. The method of claim 1 , wherein the maintenance dose is administered one to four weeks after the last dose of the first course of treatment.

10. The method of claim 1 , wherein the maintenance dose is administered twice a month.

11. A method for stimulating regulatory T lymphocytes (Tregs) in a human subject suffering from systemic lupus erythematosus (SLE), the method comprising:
subcutaneously administering to the subject an effective amount of interleukin-2 (IL-2) at a dose of between 0.1 MIU/day and 3.5 MIU/day, wherein the IL-2 is administered in a first course of treatment followed by a maintenance dose, wherein the first course of treatment consists of an administration of the IL-2 once per day for at least 3 days, and wherein the maintenance dose is given to the human subject once a week, once a month, or twice a month.

12. The method of claim 11 , wherein the subject is administered IL-2 at a dose of 1 MIU/day to 3.5 MIU/day.

13. The method of claim 11 , wherein the subject is administered IL-2 at a dose of 1.5 MIU/day to 3.5 MIU/day.

14. The method of claim 11 , wherein the subject is administered IL-2 at a dose of 0.5 MIU/day to 1.5 MIU/day.

15. The method of claim 11 , wherein the subject is administered IL-2 at a dose of 1.5 MIU/day.

16. The method of claim 11 , wherein the subject is administered des-alanyl-1, serine-125 human interleukin-2.

17. The method of claim 11 , wherein the first course of treatment consists of an administration of the IL-2 once per day for at least 5 consecutive days.

18. The method of claim 11 , wherein the first course of treatment consists of an administration of the IL-2 once per day for 3 to 7 days.

19. The method of claim 11 , wherein the maintenance dose is administered one to four weeks after the last dose of the first course of treatment.

20. The method of claim 11 , wherein the maintenance dose is administered twice a month.

Assignees

• Inst Nat Sante Rech Med
• Assist Publique—Hopitaux De Paris
• Univ Sorbonne

Inventors

• Klatzmann David
• Saadoun David
• Cacoub Patrice
• Rosenzwajg Michéle
• Piaggio Eliane
• Bensimon Gilbert
• Bernard Claude

Classifications

• A61P37/08

  Antiallergic agents (antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14) · CPC title

• A61P9/10

  for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis · CPC title

• A61P37/02

  Immunomodulators · CPC title

• A61P37/06

  Immunosuppressants, e.g. drugs for graft rejection · CPC title

• A61P9/00

  Drugs for disorders of the cardiovascular system · CPC title