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Last Updated: April 19, 2024

Claims for Patent: 8,636,997

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Summary for Patent: 8,636,997

Title:	Method of treating multiple sclerosis with interferon-beta and an 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:	13/612,763
Patent Claims:	1. A method of treating a subject that has multiple sclerosis comprising, administering to the subject a therapeutically effective amount of interferon-beta and a therapeutically effective amount of an antibody that specifically binds an interleukin 2 receptor, 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 an interleukin 2 receptor is a humanized antibody. 6. The method of claim 5, wherein the humanized antibody is daclizumab. 7. The method of claim 1, wherein the interleukin 2 receptor is the alpha subunit of the human high-affinity interleukin-2 receptor. 8. The method of claim 1, wherein the antibody that specifically binds an interleukin 2 receptor is a humanized antibody and the interleukin 2 receptor is the alpha subunit of the human high-affinity interleukin-2 receptor. 9. The method of claim 1, wherein the antibody that specifically binds an interleukin 2 receptor is daclizumab and the interleukin 2 receptor is the alpha subunit of the human high-affinity interleukin-2 receptor. 10. The method of claim 1, wherein the antibody that specifically binds an interleukin 2 receptor is a chimeric antibody. 11. The method of claim 1, wherein the antibody that specifically binds an interleukin 2 receptor is a chimeric antibody and the interleukin 2 receptor is the alpha subunit of the human high-affinity interleukin-2 receptor. 12. The method of claim 1, wherein the interferon-beta is administered weekly and said antibody that specifically binds the interleukin 2 receptor is administered biweekly or monthly. 13. The method of claim 1, wherein the interferon-beta is administered every other day and said antibody is administered biweekly or monthly. 14. The method of claim 1, wherein the multiple sclerosis is relapsing-remitting or secondary-progressive. 15. The method of claim 6, wherein the daclizumab is administered at a dose of about 0.5 to about 8 mg/kg. 16. The method of claim 1, wherein the interferon-beta is administered subcutaneously or intramuscularly. 17. The method of claim 6, wherein daclizumab is administered subcutaneously. 18. The method of claim 6, wherein daclizumab is administered intravenously. 19. The method of claim 15, wherein daclizumab is administered at a dose of about 2 mg/kg. 20. The method of claim 15, wherein daclizumab is administered at a dose of about 1 mg/kg.

Details for Patent 8,636,997

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Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Hoffmann-la Roche Inc.	ZENAPAX	daclizumab	Injection	103749	12/10/1997	⤷ Try a Trial	2022-06-28
Biogen Inc.	ZINBRYTA	daclizumab	Injection	761029	05/27/2016	⤷ Try a Trial	2022-06-28
Biogen Inc.	ZINBRYTA	daclizumab	Injection	761029	05/26/2017	⤷ Try a Trial	2022-06-28
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

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