Claims for Patent: 7,575,742

Summary for Patent: 7,575,742

Title:	Method of treating autoimmune diseases with interferon-beta and IL-2R antagonist
Abstract:	Disclosed is a method of administering an interleukin-2 receptor (IL-2R) antagonist to a subject to treat an autoimmune disease. In particular embodiments, the IL-2R antagonist is an anti-IL-2R monoclonal antibody specific for one or more chains of the IL-2R, such as the alpha-chain, for example daclizumab. In other particular embodiments the autoimmune disease is multiple sclerosis. In certain embodiments administration of interferon-beta is combined with administration of an antagonist of the IL-2R to provide significant clinical improvement in a subject with an autoimmune disease.
Inventor(s):	Martin; Roland (Bethesda, MD), McFarland; Henry (Gaithersburg, MD), Bielekova; Bibiana (Kensington, MD), Waldmann; Thomas (Silver Spring, MD)
Assignee:	The United States of America as represented by the Secretary of the Department of Health and Human Services (Washington, DC) N/A (N/A)
Application Number:	10/519,311
Patent Claims:	1. A method of treating a subject that has multiple sclerosis comprising: administering to the subject that has multiple sclerosis a therapeutically effective amount of interferon-beta and a therapeutically effective amount of an antibody that specifically binds the interleukin 2 receptor, wherein the antibody that specifically binds the interleukin 2 receptor is administered every other week for two weeks and then monthly; once a week; every other week; or once a month, and wherein the subject has been treated previously with interferon-beta alone and has failed to respond to treatment with interferon-beta alone, thereby treating the subject. 2. The method of claim 1, wherein the interferon-beta comprises interferon-beta 1a. 3. The method of claim 1, wherein the interferon-beta comprises interferon-beta 1b. 4. The method of claim 1, wherein the interferon-beta comprises a combination of interferon-beta 1a and interferon-beta 1b. 5. The method of claim 1, wherein the antibody that specifically binds the interleukin 2 receptor is an anti-Tac antibody. 6. The method of claim 1, wherein the interferon-beta is administered weekly. 7. The method of claim 6, wherein the interferon-beta is interferon-beta 1b and the antibody that specifically binds the interleukin 2 receptor is anti-Tac. 8. The method of claim 1, wherein the interferon-beta is administered every other day. 9. The method of claim 1, wherein the antibody that specifically binds the interleukin 2 receptor is daclizumab. 10. The method of claim 1, wherein the multiple sclerosis is relapsing-remitting or secondary-progressive. 11. The method of claim 1, wherein the interferon-beta comprises interferon-beta 1a, interferon-beta 1b, or combinations thereof, and wherein the antibody that specifically binds the interleukin 2 receptor is anti-Tac. 12. The method of claim 9, wherein the daclizumab is administered at a dose of about 0.5 to about 8 mg/kg. 13. The method of claim 1, wherein the interferon-beta is administered subcutaneously. 14. A method of treating a subject that has multiple sclerosis, comprising: selecting a subject that has multiple sclerosis that has been previously treated with interferon-beta alone and has failed to respond to treatment with interferon-beta alone; administering to the subject that has multiple sclerosis daclizumab at a dose of 1 to 2 mg/kg every other week for two weeks and then monthly and administering to the subject interferon beta-1b at a dose of 0.006 mg to 2 mg by subcutaneous injection every other day. 15. A method of treating a subject with multiple sclerosis, comprising: selecting a subject that has multiple sclerosis that has been previously treated with interferon-beta alone and has failed to respond to treatment with interferon-beta alone; and administering to the subject with multiple sclerosis daclizumab at a dose of 1 to 2 mg/kg every other week for two weeks and then monthly and administering to the subject interferon beta-1a intramuscularly at a dose of 15 to 75 ug once a week. 16. The method of claim 1, wherein the antibody that specifically binds the interleukin 2 receptor is administered subcutaneously. 17. The method of claim 16, wherein the antibody that specifically binds the interleukin 2 receptor is administered every other week or every month. 18. The method of claim 1, wherein the antibody that specifically binds the interleukin 2 receptor is administered at a dose of about 0.5 to about 8 mg/kg. 19. The method of claim 16, wherein the antibody that specifically binds the interleukin 2 receptor is administered at a dose of about 0.5 to about 8 mg/kg. 20. The method of claim 1, wherein the antibody that specifically binds the interleukin 2 receptor is administered every other week for two weeks and then monthly. 21. The method of claim 12, wherein daclizumab is administered at a dose of about 2 mg/kg. 22. The method of claim 12, wherein daclizumab is administered at a dose of about 1 mg/kg.

Details for Patent 7,575,742

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Bayer Healthcare Pharmaceuticals Inc.	BETASERON	interferon beta-1b	For Injection	103471	07/23/1993		2022-06-28
Biogen Inc.	AVONEX	interferon beta-1a	For Injection	103628	05/17/1996		2022-06-28
Biogen Inc.	AVONEX	interferon beta-1a	Injection	103628	05/28/2003		2022-06-28
Biogen Inc.	AVONEX	interferon beta-1a	Injection	103628	02/27/2012		2022-06-28
Hoffmann-la Roche Inc.	ZENAPAX	daclizumab	Injection	103749	12/10/1997		2022-06-28
Emd Serono, Inc.	REBIF	interferon beta-1a	Injection	103780	03/07/2002		2022-06-28
Emd Serono, Inc.	REBIF	interferon beta-1a	Injection	103780	12/17/2004		2022-06-28