Claims for Patent: 9,943,594

Summary for Patent: 9,943,594

Title:	Methods for the treatment of rheumatoid arthritis
Abstract:	The present invention provides compositions and methods of treating and improving the symptoms of rheumatoid arthritis using an antibody or antigen-binding fragment thereof that specifically binds human interleukin-6 receptor (hIL-6R).
Inventor(s):	Jasson; Martine (Paris, FR), Marks; Vanessa (Paris, FR), Huang; Xiaohong (Tarrytown, NY), Radin; Allen (Tarrytown, NY)
Assignee:	SANOFI BIOTECHNOLOGY (Paris, FR) REGENERON PHARMACEUTICALS, INC. (Tarrytown, NY)
Application Number:	13/648,521
Patent Claims:	1. A method of treating rheumatoid arthritis in a subject previously ineffectively treated by administering methotrexate and previously ineffectively treated by administering a TNF-.alpha. antagonist, the method comprising administering to the subject (a) a therapeutically effective amount of methotrexate, and (b) about 150 mg to about 200 mg of an antibody once every two weeks, wherein the antibody comprises a heavy chain variable region comprising the sequence SEQ ID NO:2 and a light chain variable region comprising the sequence SEQ ID NO:3 and the antibody is administered subcutaneously, wherein the subject achieves at least a 20% improvement in the American College of Rheumatology core set disease index (ACR20) after treatment. 2. A method of treating rheumatoid arthritis in a subject previously ineffectively treated by administering methotrexate and previously ineffectively treated by administering a TNF-.alpha. antagonist, the method comprising administering to the subject: (a) a therapeutically effective amount of methotrexate, and (b) about 150 mg of antibody once every two weeks, wherein the antibody comprises a heavy chain variable region comprising the sequence SEQ ID NO:2 and a light chain variable region comprising the sequence SEQ ID NO:3, and the antibody is administered subcutaneously, wherein the subject achieves at least a 20% improvement in the American College of Rheumatology core set disease index (ACR20) after treatment. 3. A method of treating rheumatoid arthritis in a subject previously ineffectively treated by administering methotrexate and previously ineffectively treated by administering a TNF-.alpha. antagonist, the method comprising administering to the subject: (a) a therapeutically effective amount of methotrexate, and (b) about 200 mg of antibody once every two weeks, wherein the antibody comprises a heavy chain variable region comprising the sequence SEQ ID NO:2 and a light chain variable region comprising the sequence SEQ ID NO:3, and the antibody is administered subcutaneously, wherein the subject achieves at least a 20% improvement in the American College of Rheumatology core set disease index (ACR20) after treatment. 4. The method of any one of claims 1, 2, or 3, wherein the subject achieves at least a 50% improvement in the American College of Rheumatology core set disease index (ACR50) after treatment. 5. The method of claim 4, wherein the subject achieves at least a 50% improvement in the American College of Rheumatology core set disease index after 12 weeks of treatment. 6. The method of any one of claims 1, 2, or 3, wherein the subject achieves at least a 70% improvement in the American College of Rheumatology core set disease index (ACR70) after treatment. 7. The method of claim 6, wherein the subject achieves at least a 70% improvement in the American College of Rheumatology core set disease index after 12 weeks of treatment. 8. The method of any one of claims 1, 2, or 3, wherein the subject was treated with the TNF-.alpha. antagonist for at least 3 months in the last 2 years. 9. The method of any one of claims 1, 2, or 3, wherein the TNF-.alpha. antagonist is a biologic anti-TNF-.alpha.. 10. The method of any of claims 1, 2, or 3, wherein the TNF-.alpha. antagonist is selected from the group consisting of etanercept, infliximab, adalimumab, golimumab and certolizumab pegol. 11. The method of any one of claims 1, 2, or 3, wherein the antibody is sarilumab. 12. The method of any one of claims 1, 2, or 3, wherein the subject achieves at least a 20% improvement in the American College of Rheumatology core set disease index after 12 weeks of treatment. 13. The method of any one of claim 1, 2, or 3, comprising administering between 6 and 25 mg of methotrexate per week.

Details for Patent 9,943,594

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Janssen Biotech, Inc.	REMICADE	infliximab	For Injection	103772	08/24/1998		2031-10-11
Immunex Corporation	ENBREL	etanercept	For Injection	103795	11/02/1998		2031-10-11
Immunex Corporation	ENBREL	etanercept	For Injection	103795	05/27/1999		2031-10-11