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Last Updated: March 28, 2024

Claims for Patent: 8,568,721


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Summary for Patent: 8,568,721
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:13/462,938
Patent Claims:1. A method for treating rheumatoid arthritis (RA) in a subject, said method comprising administering to the subject a therapeutically effective amount of a human antibody or antigen-binding fragment thereof which specifically binds to human interleukin-6 (hIL-6R), wherein the human antibody or antigen-binding fragment comprises the complementarity determining region (CDR) sequences of a heavy chain variable region (HCVR) and light chain variable region (LCVR) pair (HCVR/LCVR) set forth in SEQ ID NO:19/27.

2. The method of claim 1, wherein the antibody or antigen-binding fragment comprises a CDR sequence combination set forth in SEQ ID NO:21/23/25/29/31/33.

3. The method of claim 1, wherein the antibody or antigen-binding fragment comprises a HCVR/LCVR pair set forth in SEQ ID NO:19/27.

4. The method of claim 1, wherein the human antibody or antigen-binding fragment is administered to the subject subcutaneously.

5. The method of claim 1, further comprising administering a second therapeutic agent to the subject.

6. The method of claim 5, wherein the antibody or antigen-binding fragment and the second therapeutic agent are administered simultaneously or sequentially.

7. The method of claim 5, wherein the wherein the second therapeutic agent is a non-steroidal anti-inflammatory drug (NSAID), a glucocorticoid, a disease-modifying anti-rheumatic drug (DMARD), a TNF-a antagonist, a T-cell blocker, an anti-CD20 antibody, an IL-1 antagonist, or any combination thereof.

8. 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.

9. The method of claim 1, wherein the therapeutically effective amount of the antibody or antigen-binding fragment is 50 mg to 200 mg.

Details for Patent 8,568,721

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Genentech, Inc. RITUXAN rituximab Injection 103705 11/26/1997 ⤷  Try a Trial 2026-06-02
Idec Pharmaceuticals Corp. RITUXAN rituximab Injection 103737 02/19/2002 ⤷  Try a Trial 2026-06-02
Janssen Biotech, Inc. REMICADE infliximab For Injection 103772 08/24/1998 ⤷  Try a Trial 2026-06-02
Immunex Corporation ENBREL etanercept For Injection 103795 11/02/1998 ⤷  Try a Trial 2026-06-02
Immunex Corporation ENBREL etanercept For Injection 103795 05/27/1999 ⤷  Try a Trial 2026-06-02
Immunex Corporation ENBREL etanercept Injection 103795 09/27/2004 ⤷  Try a Trial 2026-06-02
Immunex Corporation ENBREL etanercept Injection 103795 02/01/2007 ⤷  Try a Trial 2026-06-02
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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