Composition for treating rheumatoid arthritis and method for using the same

JP2026098010APending Publication Date: 2026-06-16SANOFI BIOTECH SAS +1

Patent Information

Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
SANOFI BIOTECH SAS
Filing Date
2026-03-11
Publication Date
2026-06-16

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Abstract

To provide effective treatment methods for patients with rheumatoid arthritis. [Solution] A method is provided for treating rheumatoid arthritis in a subject who has previously received treatment with methotrexate, leflunomide, sulfasalazine and / or hydroxychloroquine, comprising administering an effective dose of sarilumab (SAR153191) to the subject.
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Claims

1. A method for treating rheumatoid arthritis in a subject who has previously received treatment with methotrexate, leflunomide, sulfasalazine and / or hydroxychloroquine, comprising administering an effective dose of sarilumab (SAR153191) to the subject.

2. The method according to claim 1, wherein the subject has previously received ineffective treatment for rheumatoid arthritis by administering methotrexate, leflunomide, sulfasalazine and / or hydroxychloroquine.

3. The method according to claim 2, wherein methotrexate, leflunomide, sulfasalazine and / or hydroxychloroquine are administered together with sarilumab.

4. The method according to claim 3, wherein sarilumab and methotrexate are administered together.

5. The method according to claim 4, wherein methotrexate is administered at a dose of 6 mg to 25 mg per week.

6. The method according to any one of claims 1 to 5, wherein sarilumab is administered at a dose of 50 mg to 150 mg per week.

7. The method according to any one of claims 1 to 6, wherein sarilumab is administered at a dose of 100 mg to 200 mg every two weeks.

8. The method according to any one of claims 1 to 7, wherein sarilumab is administered at a dose of 150 mg or 200 mg per two weeks.

9. The method according to claim 8, wherein the subject achieves a 20% improvement in the American College of Rheumatology Core Set Disease Index after 12 weeks of treatment.

10. The method according to claim 8, wherein the subject achieves a 50% improvement in the American College of Rheumatology Core Set Disease Index after 12 weeks of treatment.

11. The method according to claim 8, wherein the subject achieves a 70% improvement in the American College of Rheumatology Core Set Disease Index after 12 weeks of treatment.

12. The method according to any one of claims 1 to 3, wherein the subject has previously received ineffective treatment for rheumatoid arthritis by administering a TNF-α antagonist.

13. The method according to claim 11, wherein the subject has been treated with an anti-TNF-α antagonist for at least three months in the past two years, or the subject was intolerant to at least one TNF-α antagonist.

14. The method according to claim 11 or 12, wherein the TNF-α antagonist is a biological anti-TNF-α.

15. The method according to claim 13, wherein the TNF-α antagonist is selected from the group consisting of etanercept, infliximab, adalimumab, golimumab, and / or certolizumab pegol.

16. A pharmaceutical composition comprising an effective amount of sarilumab and one of the group consisting of methotrexate, leflunomide, sulfasalazine, and hydroxychloroquine.

17. For continuous or simultaneous use as a medicine, a. Pharmaceutical compositions containing sarilumab, and b. Pharmaceutical compositions comprising methotrexate, leflunomide, sulfasalazine, or hydroxychloroquine A combination.