Claims for Patent: 9,284,370

Summary for Patent: 9,284,370

Title:	Methods for treating juvenile idiopathic arthritis
Abstract:	The invention provides methods and compositions for the treatment of juvenile idiopathic arthritis (JIA) where a TNF.alpha. inhibitor, such as a human TNF.alpha. 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 TNF.alpha. inhibitor.
Inventor(s):	Medich; John R. (Highland Park, IL), Paulson; Susan K. (Downers Grove, IL), Noertersheuser; Peter A. (Gro-Karlbach, DE)
Assignee:	AbbVie Biotechnology Ltd. (Hamilton, BM)
Application Number:	14/679,476
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,284,370
Patent Claims:	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 .mu.g/mL or about 10 to 11 .mu.g/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 .mu.g/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 .mu.g/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 .mu.g/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 .mu.g/mL.

Details for Patent 9,284,370

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	12/31/2002		2027-06-11
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	02/21/2008		2027-06-11
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	04/24/2013		2027-06-11
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	09/23/2014		2027-06-11
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	11/23/2015		2027-06-11