IP Library Granted Patent US 9,284,370
Granted Patent B1
US 9,284,370 · App. 14/679,476 · Granted Mar 15, 2016

Methods for treating juvenile idiopathic arthritis

Inventors: John R. Medich (Highland Park, IL); Susan K. Paulson (Downers Grove, IL); Peter A. Noertersheuser (Gro-Karlbach, DE)
Assignee: AbbVie Biotechnology Ltd.
C07K16/241A61K31/155A61K39/3955
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Quick Facts
Patent No.
US 9,284,370
App. No.
14/679,476
Granted
Mar 15, 2016
Kind
B1
Abstract

The invention provides methods and compositions for the treatment of juvenile idiopathic arthritis (JIA) where a TNFα inhibitor, such as a human TNFα antibody, or antigen-binding portion thereof, is used to treat JIA. In particular, the invention is directed to methods and compositions relating to a fixed dosing regimen for treating JIA with a TNFα inhibitor.

Claims (39)

1. A method for treating polyarticular juvenile idiopathic arthritis in a subject comprising subcutaneously administering adalimumab to the subject every other week, wherein 20 mg of adalimumab is administered to the subject every other week if the subject weighs at least 15 kg and less than 30 kg, or wherein 40 mg of adalimumab is administered to the subject every other week if the subject weighs more than or equal to 30 kg.

2. The method of claim 1 , wherein the adalimumab is administered in combination with methotrexate.

3. The method of claim 1 , wherein the subject is at least 4 years of age.

4. The method of claim 1 , wherein the 20 mg of adalimumab or 40 mg of adalimumab is in a pre-filled vessel.

5. The method of claim 4 , wherein the pre-filled vessel is a pre-filled syringe.

6. The method of claim 4 , wherein the 20 mg of adalimumab or 40 mg of adalimumab is at a concentration of 50 mg/ml.

7. The method of claim 1 , wherein the subject weighs more than or equal to 30 kg.

8. The method of claim 1 , wherein the subject weighs at least 15 kg and less than 30 kg.

9. The method of claim 1 , wherein the subject weights 30 kg.

10. The method of claim 2 , wherein the subject is at least 4 years of age.

11. The method of claim 2 , wherein the 20 mg of adalimumab or 40 mg of adalimumab is in a pre-filled vessel.

12. The method of claim 11 , wherein the pre-filled vessel is a pre-filled syringe.

13. The method of claim 1 , wherein the 20 mg of adalimumab or 40 mg of adalimumab is at a concentration of 50 mg/ml.

14. The method of claim 2 , wherein the subject weighs more than or equal to 30 kg.

15. The method of claim 2 , wherein the subject weighs at least 15 kg and less than 30 kg.

16. The method of claim 2 , wherein the subject weights 30 kg.

17. A method for treating polyarticular juvenile idiopathic arthritis in a subject comprising subcutaneously administering adalimumab to the subject, wherein a mean steady state trough serum concentration of adalimumab is about 6 to 7 μg/mL or about 10 to 11 μg/mL,

wherein 20 mg of adalimumab is administered to the subject if the subject weighs at least 15 kg and less than 30 kg, or wherein 40 mg of adalimumab is administered to the subject if the subject weighs more than or equal to 30 kg.

18. The method of claim 17 , wherein the adalimumab is administered in combination with methotrexate.

19. The method of claim 17 , wherein the subject is at least 4 years of age.

20. The method of claim 17 , wherein the 20 mg of adalimumab or 40 mg of adalimumab is in a pre-filled vessel.

21. The method of claim 20 , wherein the pre-filled vessel is a pre-filled syringe.

22. The method of claim 20 , wherein the 20 mg of adalimumab or 40 mg of adalimumab is at a concentration of 50 mg/ml.

23. The method of claim 17 , wherein the subject weighs more than or equal to 30 kg.

24. The method of claim 17 , wherein the subject weighs at least 15 kg and less than 30 kg.

25. The method of claim 17 , wherein the subject weights 30 kg.

26. The method of claim 17 , wherein said method is a monotherapy with adalimumab, and the mean steady state trough serum concentration of adalimumab is about 6 to 7 μg/mL.

27. The method of claim 17 , wherein the adalimumab is administered in combination with methotrexate, and the mean steady state trough serum concentration of adalimumab is about 10 to 11 μg/mL.

28. The method of claim 17 , wherein the adalimumab is administered to the subject every other week.

29. The method of claim 28 , wherein the adalimumab is administered in combination with methotrexate.

30. The method of claim 28 , wherein the subject is at least 4 years of age.

31. The method of claim 28 , wherein the 20 mg of adalimumab or 40 mg of adalimumab is in a pre-filled vessel.

32. The method of claim 31 , wherein the pre-filled vessel is a pre-filled syringe.

33. The method of claim 31 , wherein the 20 mg of adalimumab or 40 mg of adalimumab is at a concentration of 50 mg/ml.

34. The method of claim 28 , wherein the subject weighs more than or equal to 30 kg.

35. The method of claim 28 , wherein the subject weighs at least 15 kg and less than 30 kg.

36. The method of claim 28 , wherein the subject weights 30 kg.

37. The method of claim 28 , wherein said method is a monotherapy with adalimumab, and the mean steady state trough serum concentration of adalimumab is about 6 to 7 μg/mL.

38. The method of claim 28 , wherein the adalimumab is administered in combination with methotrexate, and the mean steady state trough serum concentration of adalimumab is about 10 to 11 μg/mL.

Assignments (4)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 4, 2015
From: MEDICH, JOHN R.
To: ABBOTT BIOTECHNOLOGY LTD.
Reel/Frame 035784/0197 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 4, 2015
From: NOERTERSHEUSER, PETER A.
To: ABBOTT BIOTECHNOLOGY LTD.
Reel/Frame 035784/0213 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 4, 2015
From: PAULSON, SUSAN K.
To: ABBOTT BIOTECHNOLOGY LTD.
Reel/Frame 035820/0216 →
CHANGE OF NAME Recorded Jun 4, 2015
From: ABBOTT BIOTECHNOLOGY LTD.
To: ABBVIE BIOTECHNOLOGY LTD.
Reel/Frame 035820/0234 →
Continuity (4)
Continuation 12157599 · Jun 10, 2008
Provisional Application 61066943 · Feb 25, 2008
Provisional Application 61002125 · Nov 5, 2007
Provisional Application 60934310 · Jun 11, 2007