Claims for Patent: 9,308,256

Summary for Patent: 9,308,256

Title:	Method of treating rheumatoid arthritis with an anti-IL-6R antibody
Abstract:	The present invention provides methods of preventing or treating rheumatoid arthritis using a fully human antibody or antigen-binding fragment thereof that specifically binds human interleukin-6 receptor (hIL-6R). The methods of the present invention may include administration of a second therapeutic agent, such as one or more of a non-steroidal anti-inflammatory drug (NSAID), a glucocorticoid, a disease-modifying anti-rheumatic drug (DMARD), or a TNF-alpha antagonist, T-cell blocker, anti-CD20 antibody, an IL-1, JAK or IL-17 antagonist, or any combination thereof.
Inventor(s):	Radin; Allen (New York, NY), Stevens; Sean (San Francisco, CA), Huang; Tammy T. (Goldens Bridge, NY), Martin; Joel H. (Putnam Valley, NY), Fairhurst; Jeanette L. (White Plains, NY), Rafique; Ashique (Yonkers, NY), Smith; Eric (New York, NY), Pobursky; Kevin J. (Beacon, NY), Papadopoulos; Nicholas J. (LaGrangeville, NY), Fandl; James P. (LaGrangeville, NY), Chen; Gang (Yorktown Heights, NY), Karow; Margaret (Santa Rosa Valley, CA)
Assignee:	Regeneron Pharmaceuticals, Inc. (Tarrytown, NY)
Application Number:	14/020,573
Patent Claims:	1. A method for reducing a symptom of rheumatoid arthritis (RA) in a subject, comprising: administering to the subject a therapeutically effective amount of an antibody or antigen-binding fragment thereof which specifically binds to human interleukin-6-receptor (hIL-6R) with a K.sub.D of about 500 pM or less as measured by surface plasmon resonance, wherein the antibody or antigen-binding fragment comprises a complementarity determining region (CDR) sequence combination of SEQ ID NOs:21/23/25/29/31/33. 2. The method of claim 1, wherein the antibody or antigen-binding fragment comprises a HCVR/LCVR pair of SEQ ID NO: 19/27. 3. The method of claim 1, wherein the antibody or antigen-binding fragment specifically binds to human interleukin-6 (hIL-6R) with a K.sub.D of about 300 pM or less as measured b surface s plasmon resonance. 4. The method of claim 1, wherein the antibody or antigen-binding fragment specifically binds to human interleukin-6 (hIL-6R) with a K.sub.D of about 200 pM or less as measured by surface plasmon resonance. 5. The method of claim 1, wherein the antibody or antigen-binding fragment specifically binds to human interleukin-6 (hIL-6R) with a K.sub.D of about 100 pM or less as measured by surface plasmon resonance. 6. The method of claim 5, further comprising: a second therapeutic agent selected from the group consisting of: methotrexate; sulfasalazine; hydroxychloroquine; leflunomide; etanercept; infliximab; adalimumab; golimumab; rilonacept; anakinra; abatacept; cetiolizumab; and rituximab. 7. The method of claim 1, wherein the therapeutically effective amount of the antibody or antigen-binding fragment is about 50 mg to about 200 mg. 8. A method for reducing a symptom of rheumatoid arthritis in a subject, the method comprising: (a) administering to the subject a first dose of a human antibody or antigen-binding fragment thereof which specifically binds to human interleukin-6 receptor (hIL6-R) with a K.sub.D of about 500 pM or less as measured by surface plasmon resonance, and (b) administering to the subject at least one subsequent dose of the human antibody or antigen-binding fragment, wherein the antibody or antigen-binding fragment comprises a complementarity determining region (CDR) sequence combination of SEQ ID NOs:21/23/25/29/31/33. 9. The method of claim 8, wherein the human antibody or antigen-binding fragment comprises a heavy chain variable region (HCVR) and light chain variable region (LCVR) pair (HCVR/LCVR) of SEQ ID NO: 19/27. 10. The method of claim 8, wherein the first dose and the subsequent dose are each about 50 mg to about 200 mg of the human antibody or antigen-binding fragment. 11. The method of claim 8, wherein the first dose and the subsequent dose are administered 1 week to 6 weeks apart. 12. The method of claim 10, wherein the first dose and the subsequent dose are each 50 mg, 100 mg, 150 mg or 200 mg and administered 1 week apart or 2 weeks apart. 13. The method of claim 12, further comprising administering to the subject one or more subsequent doses of the human antibody or antigen-binding fragment at 50 mg, 100 mg, 150 mg, or 200 mg, weekly or biweekly. 14. The method of claim 8, further comprising administering a second therapeutic agent to the subject.

Details for Patent 9,308,256

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	RITUXAN	rituximab	Injection	103705	11/26/1997		2026-06-02
Idec Pharmaceuticals Corp.	RITUXAN	rituximab	Injection	103737	02/19/2002		2026-06-02
Janssen Biotech, Inc.	REMICADE	infliximab	For Injection	103772	08/24/1998		2026-06-02
Immunex Corporation	ENBREL	etanercept	For Injection	103795	11/02/1998		2026-06-02