Claims for Patent: 8,080,248

Summary for Patent: 8,080,248

Title:	Method of treating rheumatoid arthritis with an 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 Diego, 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 (Camarillo, CA)
Assignee:	Regeneron Pharmaceuticals, Inc. (Tarrytown, NY)
Application Number:	12/780,006
Patent Claims:	1. A method for reducing the symptoms associated with rheumatoid arthritis (RA) in a patient, said method comprising administering to the patient a therapeutically effective amount of a human antibody or antigen-binding fragment thereof which specifically binds to human interleukin-6 receptor (hIL-6R), wherein the human antibody or antigen-binding fragment thereof comprises the complementarity determining regions (CDRs) of a heavy chain variable region (HCVR) having the amino acid sequence of SEQ ID NO:19, and the CDRs of a light chain variable region (LCVR) having the amino acid sequence of SEQ ID NO:27; wherein the patient exhibits a decrease in at least one RA-associated biomarker at day 8 following administration of the human antibody or antigen binding fragment thereof as compared to the level of the biomarker in the patient prior to the administration. 2. The method of claim 1, wherein the human antibody or antigen-binding fragment comprises a HCVR and a LCVR, wherein the HCVR comprises heavy chain CDRs (HCDR1-HCDR2-HCDR3) having the amino acid sequences of SEQ ID NOs:21-23-25, and wherein the LCVR comprises light chain CDRs (LCDR1-LCDR2-LCDR3) having the amino acid sequences of SEQ ID. NOs:29-31-32. 3. The method of claim 1, wherein the antibody or antigen-binding fragment comprises a HCVR having the amino acid sequence of SEQ ID NO:19 and a LCVR having the amino acid sequence of SEQ ID NO:27. 4. The method of claim 1, wherein the human antibody or antigen-binding fragment is administered to the patient subcutaneously. 5. The method of claim 1, further comprising administering a second therapeutic agent to the patient. 6. The method of claim 5, wherein the second therapeutic agent is a non-steroidal anti-inflammatory drug (NSAID), a glucocorticoid, a disease-modifying anti-rheumatic drug (DMARD), a TNF-.alpha. antagonist, a T-cell blocker, an anti-CD20 antibody, an IL-1 antagonist, or any combination thereof. 7. The method of claim 5, wherein the second therapeutic agent is selected from the group consisting of: methotrexate; sulfasalazine; hydroxychloroquine; leflunomide; etanercept; infliximab; adalimumab; golimumab; rilonacept; anakinra; abatacept; cetiolizumab; and rituximab. 8. The method of claim 1, wherein the therapeutically effective amount of the human antibody or antigen-binding fragment thereof is about 50 mg to about 200 mg. 9. The method of claim 1, wherein the RA-associated biomarker is selected from the group consisting of high-sensitivity C-reactive protein (hsCRP), serum amyloid A (SAA), erythrocyte sedimentation rate (ESR) and serum hepcidin. 10. The method of claim 9, wherein the RA-associated biomarker is serum hepcidin. 11. The method of claim 10, wherein the patient exhibits at least a 60% decrease in serum hepcidin level at day 8 following administration of the human antibody or antigen binding fragment as compared to the level serum hepcidin in the patient prior to the administration.

Details for Patent 8,080,248

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
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Immunex Corporation	ENBREL	etanercept	For Injection	103795	05/27/1999		2026-06-02
Immunex Corporation	ENBREL	etanercept	Injection	103795	09/27/2004		2026-06-02