Compositions for the treatment of rheumatoid arthritis and methods of using same

Patent metadata

Field	Value
Publication number	US-10927435-B2
Application number	US-201214350973-A
Country	US
Kind code	B2
Filing date	Oct 10, 2012
Priority date	Oct 11, 2011
Publication date	Feb 23, 2021
Grant date	Feb 23, 2021

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) with a DMARD.

First claim

The invention claimed is:

1. A method of treating rheumatoid arthritis in a subject previously ineffectively treated by administering methotrexate, the method comprising subcutaneously administering to the subject 150 mg to 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 wherein the subject achieves at least a 20% improvement in the American College of Rheumatology core set disease index after treatment.

2. The method of claim 1 , further comprising administering methotrexate to the subject.

3. The method of claim 2 , further comprising administering between 6 to 25 mg of methotrexate per week.

4. The method of claim 1 , wherein the subject achieves at least a 20% improvement in the American College of Rheumatology core set disease index after 12 weeks of treatment.

5. The method of claim 1 , 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 claim 1 , wherein the subject achieves at least a 70% improvement in the American College of Rheumatology core set disease index after 12 weeks of treatment.

7. The method of claim 1 , wherein the subject achieves at least a 20% improvement in the American College of Rheumatology core set disease index after 24 weeks of treatment.

8. The method of claim 1 , wherein the antibody is sarilumab.

9. A method of treating rheumatoid arthritis in a subject previously ineffectively treated by administering methotrexate, the method comprising subcutaneously administering to the subject 150 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, wherein the subject achieves at least a 20% improvement in the American College of Rheumatology core set disease index after treatment.

10. The method of claim 9 , wherein the subject achieves at least a 20% improvement in the American College of Rheumatology core set disease index after 12 weeks of treatment.

11. The method of claim 9 , wherein the subject achieves at least a 50% improvement in the American College of Rheumatology core set disease index after 12 weeks of treatment.

12. The method of claim 9 , wherein the subject achieves at least a 70% improvement in the American College of Rheumatology core set disease index after 12 weeks of treatment.

13. The method of claim 9 , wherein the subject achieves at least a 20% improvement in the American College of Rheumatology core set disease index after 24 weeks of treatment.

14. A method of treating rheumatoid arthritis in a subject previously ineffectively treated by administering methotrexate, the method comprising subcutaneously administering to the subject 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, wherein the subject achieves at least a 20% improvement in the American College of Rheumatology core set disease index after treatment.

15. The method of claim 14 , wherein the subject achieves at least a 20% improvement in the American College of Rheumatology core set disease index after 12 weeks of treatment.

16. The method of claim 14 , wherein the subject achieves at least a 50% improvement in the American College of Rheumatology core set disease index after 12 weeks of treatment.

17. The method of claim 14 , wherein the subject achieves at least a 70% improvement in the American College of Rheumatology core set disease index after 12 weeks of treatment.

18. The method of claim 14 , wherein the subject achieves at least a 20% improvement in the American College of Rheumatology core set disease index after 24 weeks of treatment.

Assignees

• Sanofi Biotechnology
• Regeneron Pharma

Inventors

• Huang Xiaohong
• Jasson Martine
• Marks Vanessa
• Radin Allen

Classifications

• A61K2039/545

  characterised by the dose, timing or administration schedule · CPC title

• A61K2039/54

  characterised by the route of administration · CPC title

• A61K31/635

  having a heterocyclic ring, e.g. sulfadiazine · CPC title

• A61K31/4706

  4-Aminoquinolines; 8-Aminoquinolines, e.g. chloroquine, primaquine · CPC title

• A61K39/395

  Antibodies (agglutinins A61K38/36 {; as drug carriers A61K47/50}); Immunoglobulins; Immune serum, e.g. antilymphocytic serum · CPC title