Claims for Patent: 8,728,475

Summary for Patent: 8,728,475

Title:	Methods for treating inflammatory bowel disease
Abstract:	Methods of treating inflammatory disorders, such as rheumatoid arthritis, by modulating TWEAK and TNF-.alpha. are disclosed, as are other methods.
Inventor(s):	Burkly; Linda C. (West Newton, MA), Zheng; Timothy (Boston, MA)
Assignee:	Biogen Idec MA Inc. (Cambridge, MA)
Application Number:	13/246,197
Patent Claims:	1. A method for treating inflammatory bowel disease comprising: administering to a human subject who has inflammatory bowel disease, a TWEAK (TNF-like weak inducer of apoptosis) blocking agent selected from the group consisting of a monoclonal, chimeric, human, or humanized antibody that binds to TWEAK, and a soluble form of a TWEAK receptor, in combination with a TNF-.alpha. blocking agent selected from the group consisting of a monoclonal, chimeric, human, or humanized antibody that binds to TNF-.alpha., and a soluble form of a TNF-.alpha. receptor, in amounts and for a time to provide a therapeutic effect. 2. The method of claim 1, wherein the inflammatory bowel disease is ulcerative colitis. 3. The method of claim 1, wherein the inflammatory bowel disease is Crohn's disease. 4. The method of claim 1, wherein the TWEAK blocking agent and the TNF-.alpha. blocking agent are administered in an amount effective to inhibit TWEAK and TNF-.alpha. pathways in cells that generate inflammatory signals. 5. The method of claim 1, wherein the TWEAK blocking agent and the TNF-.alpha. blocking agent are administered in an amount effective to reduce transcription of genes induced by TWEAK and TNF-.alpha. in cells that generate inflammatory signals. 6. The method of claim 5, wherein the genes induced by TWEAK and TNF-.alpha. are synergistically activated by TWEAK and TNF-.alpha.. 7. The method of claim 1, wherein the TWEAK blocking agent is administered at a dosage that is equal to or less than an amount required for efficacy with the TWEAK blocking agent monotherapy. 8. The method of claim 7, wherein the TWEAK blocking agent is administered at a dosage that is at least 10% less than an amount required for efficacy with the TWEAK blocking agent monotherapy. 9. The method of claim 1, wherein the TNF-.alpha. blocking agent is administered at a dosage that is equal to or less than an amount required for efficacy with the TNF-.alpha. blocking agent monotherapy. 10. The method of claim 9, wherein the TNF-.alpha. blocking agent is administered at a dosage that is at least 10% less than an amount required for efficacy with TNF-.alpha. blocking agent monotherapy. 11. The method of claim 1, wherein the TWEAK blocking agent reduces the ability of TWEAK to bind to a TWEAK receptor. 12. The method of claim 1, wherein the TWEAK blocking agent is a monoclonal, chimeric, human, or humanized antibody that binds to TWEAK. 13. The method of claim 12, wherein the antibody that binds to TWEAK comprises a heavy chain variable domain comprising: a) a complementarity determining region (CDR) 1 set forth as the amino acid sequence of amino acids 26 to 35 of SEQ ID NO:3 (GFTFSRYAMS); b) a CDR 2 set forth as the amino acid sequence of amino acids 50 to 66 of SEQ ID NO:3 (EISSGGSYPYYPDTVTG); and c) a CDR 3 set forth as the amino acid sequence of amino acids 99 to 114 of SEQ ID NO:3 (VLYYDYDGDRIEVMDY); and a light chain variable domain comprising: a) a CDR 1 set forth as the amino acid sequence of amino acids 24 to 39 of SEQ ID NO:4 (RSSQSLVSSKGNTYLH); b) a CDR 2 set forth as the amino acid sequence of amino acids 55 to 61 of SEQ ID NO:4 (KVSNRFS); and c) a CDR 3 set forth as the amino acid sequence of amino acids 94 to 102 of SEQ ID NO:4 (SQSTHFPRT). 14. The method of claim 13, wherein the antibody comprises a first amino acid sequence set forth in SEQ ID NO:5 and a second amino acid sequence set forth in SEQ ID NO:6 or SEQ ID NO:7. 15. The method of claim 1, wherein the TWEAK blocking agent is a soluble form of a TWEAK receptor. 16. The method of claim 15, wherein the soluble form of the TWEAK receptor comprises an antibody Fc region. 17. The method of claim 1, wherein the TNF-.alpha. blocking agent reduces the ability of TNF-.alpha. to bind to a TNF-.alpha. receptor. 18. The method of claim 1, wherein the TNF-.alpha. blocking agent is a monoclonal, chimeric, human, or humanized antibody that binds to TNF-.alpha.. 19. The method of claim 18, wherein the TNF-.alpha. blocking agent is infliximab or adalimumab. 20. The method of claim 1, wherein the TNF-.alpha. blocking agent is a soluble form of a TNF-.alpha. receptor. 21. The method of claim 1, wherein the TNF-.alpha. blocking agent is etanercept. 22. The method of claim 1, wherein the TWEAK blocking agent and the TNF-.alpha. blocking agent are administered to the subject at the same time. 23. The method of claim 22, wherein the TWEAK blocking agent and the TNF-.alpha. blocking agent are administered as a co-formulation. 24. The method of claim 1, wherein the TWEAK blocking agent and the TNF-.alpha. blocking agent are administered sequentially. 25. The method of claim 24, wherein the TWEAK blocking agent is administered to a patient who has already received the TNF-.alpha. blocking agent, wherein the TNF-.alpha. blocking agent is present at a therapeutic level in the subject. 26. The method of claim 24, wherein the TNF-.alpha. blocking agent is administered to a patient who has already received the TWEAK blocking agent, wherein the TWEAK blocking agent is present at a therapeutic level in the subject.

Details for Patent 8,728,475

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Janssen Biotech, Inc.	REMICADE	infliximab	For Injection	103772	08/24/1998		2025-05-10
Immunex Corporation	ENBREL	etanercept	For Injection	103795	11/02/1998		2025-05-10
Immunex Corporation	ENBREL	etanercept	For Injection	103795	05/27/1999		2025-05-10
Immunex Corporation	ENBREL	etanercept	Injection	103795	09/27/2004		2025-05-10
Immunex Corporation	ENBREL	etanercept	Injection	103795	02/01/2007		2025-05-10
Immunex Corporation	ENBREL MINI	etanercept	Injection	103795	09/14/2017		2025-05-10
Immunex Corporation	ENBREL	etanercept	Injection	103795			2025-05-10