Claims for Patent: 7,976,838

Summary for Patent: 7,976,838

Title:	Therapy of autoimmune disease in a patient with an inadequate response to a TNF-.alpha. inhibitor
Abstract:	The present application describes therapy with antagonists which bind to B cell surface markers, such as CD20. In particular, the application describes the use of such antagonists to treat autoimmune disease in a mammal who experiences an inadequate response to a TNF.alpha.-inhibitor.
Inventor(s):	Benyunes; Mark C. (San Francisco, CA)
Assignee:	Genentech, Inc. (South San Francisco, CA)
Application Number:	12/052,606
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,976,838
Patent Claims:	1. A method of treating rheumatoid arthritis in a human patient who experiences an inadequate response to a TNF.alpha.-inhibitor, comprising administering to the patient an antibody that binds to CD20, wherein the antibody is administered as two intravenous doses of 1000 mg. 2. A method of treating rheumatoid arthritis in a human patient who experiences an inadequate response to a TNF.alpha.-inhibitor, comprising administering to the patient an antibody which binds to CD20 in an amount that is effective to provide an ACR50 response at week 24, ACR70 response at week 24, or no erosive progression at weeks 24 and beyond, wherein the antibody is administered as two intravenous doses of 1000 mg. 3. The method of claim 2 wherein the antibody comprises rituximab. 4. The method of claim 2 wherein the patient is further treated with concomitant methotrexate (MTX). 5. The method of claim 4 wherein the patient is further treated with a corticosteroid regimen. 6. The method of claim 5 wherein the corticosteroid regimen consists of methylprednisolone and prednisone. 7. The method of claim 2 wherein the CD20 antibody is the only B-cell surface marker antibody administered to the patient. 8. A method of treating rheumatoid arthritis in a human patient who experiences an inadequate response to a TNF.alpha.-inhibitor, comprising administering to the patient rituximab, wherein rituximab is administered as two intravenous doses of 1000 mg. 9. The method of claim 8 further comprising administering methotrexate to the patient. 10. A method of treating rheumatoid arthritis in a human patient who experiences an inadequate response to a TNF.alpha.-inhibitor, comprising administering to the patient rituximab, and methotrexate, wherein the patient has no erosive progression at weeks 24 and beyond, and wherein rituximab is administered as two intravenous doses of 1000 mg. 11. A method of achieving a clinical response selected from the group consisting of ACR50 response at week 24, ACR70 response at week 24, and no erosive progression at weeks 24 and beyond, in a human rheumatoid arthritis patient who experiences an inadequate response to a TNF.alpha.-inhibitor, comprising administering to the patient rituximab, and methotrexate, wherein rituximab is administered as two intravenous doses of 1000 mg. 12. The method of claim 11 wherein the clinical response is ACR50 response at week 24. 13. The method of claim 11 wherein the clinical response is ACR70 response at week 24. 14. The method of claim 11 wherein the clinical response is no erosive progression at weeks 24 and beyond.

Details for Patent 7,976,838

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	RITUXAN	rituximab	Injection	103705	11/26/1997		2023-04-09
Idec Pharmaceuticals Corp.	RITUXAN	rituximab	Injection	103737	02/19/2002		2023-04-09
Genentech, Inc.	RITUXAN HYCELA	rituximab and hyaluronidase human	Injection	761064	06/22/2017		2023-04-09