Methods for the treatment of rheumatoid arthritis

Patent metadata

Field	Value
Publication number	US-9943594-B2
Application number	US-201213648521-A
Country	US
Kind code	B2
Filing date	Oct 10, 2012
Priority date	Oct 11, 2011
Publication date	Apr 17, 2018
Grant date	Apr 17, 2018

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).

First claim

The invention claimed is:

1. A method of treating rheumatoid arthritis in a subject previously ineffectively treated by administering methotrexate and previously ineffectively treated by administering a TNF-α 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-α 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-α 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-α 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-α antagonist is a biologic anti-TNF-α.

10. The method of any of claims 1 , 2 , or 3 , wherein the TNF-α 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.

Assignees

• Sanofi Biotechnology
• Regeneron Pharma

Inventors

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

Classifications

• A61K31/635

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

• A61K31/42

  Oxazoles · CPC title

• A61K2039/545

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

• A61K31/519

  ortho- or peri-condensed with heterocyclic rings · CPC title

• C07K16/2866

  against receptors for cytokines, lymphokines, interferons · CPC title