Claims for Patent: 8,728,730

Summary for Patent: 8,728,730

Title:	Methods for treating, diagnosing, and monitoring rheumatoid arthritis
Abstract:	Methods of identifying, diagnosing, and prognosing rheumatoid arthritis are provided, as well as methods of treating rheumatoid arthritis. Also provided are methods for identifying effective rheumatoid arthritis therapeutic agents and predicting responsiveness to rheumatoid arthritis therapeutic agents.
Inventor(s):	Dennis, Jr.; Glynn (Fairfield, CA), Martin; Flavius (Hayward, CA), Townsend; Michael J. (San Jose, CA)
Assignee:	Genentech, Inc. (South San Francisco, CA)
Application Number:	12/874,972
Patent Claims:	1. A method of predicting the response of a subject to a RA therapeutic agent comprising measuring in a biological sample obtained from the subject expression of one or a combination of genes, or expression of one or a combination of proteins encoded by the one or the combination of genes, wherein the one or the combination is selected from FcRH5 and sFcRH5, wherein elevated expression of the one or the combination of genes, or elevated expression of the one or the combination of proteins, is predictive of response of the subject to the RA therapeutic agent. 2. The method of claim 1, wherein the biological sample is serum and the protein is sFcRH5, and wherein the method further comprises measuring the expression of CXCL13. 3. The method of claim 2, further comprising measuring RF in the serum and determining whether the serum is positive for RF or negative for RF. 4. The method of any one of claims 1-3, wherein the measuring comprises using an immunoassay. 5. The method of claim 4, wherein the immunoassay is an ELISA. 6. The method of any one of claims 1-3, wherein the RA therapeutic agent is a B-cell antagonist. 7. The method of claim 6, wherein the B-cell antagonist is selected from an antibody to CD22, an antibody to CD20, an antibody to BR3, and a BR3-Fc immunoadhesin. 8. The method of claim 7, wherein the B-cell antagonist is an antibody to CD20. 9. The method of claim 8, wherein the antibody to CD20 is selected from rituximab, ibritumomab tiuxetan, tositumomab, 1F5, 2H7, and A20. 10. The method of claim 5, further comprising determining an amount of the one or the combination of proteins measured. 11. The method of claim 10, wherein an amount of CXCL13 is determined and wherein the amount of CXCL13 is determined as greater than 116.6 pg/ml. 12. The method of claim 10, wherein the amount of sFcRH5 is determined as greater than 126.7 ng/ml. 13. The method of claim 3, wherein the serum is determined as positive for RF. 14. The method of any one of claims 1-3, wherein the subject is predicted to respond effectively to rituximab. 15. A method for predicting whether a subject with rheumatoid arthritis will respond to a B-cell antagonist, the method comprising determining whether a serum sample from the subject contains an amount of CXCL13 greater than 116.6 pg/ml, or an amount of sFcRH5 greater than 126.7 ng/ml, or a combination of these amounts, wherein the amount or amounts of CXCL13, sFcRH5, or combination thereof indicates that the subject will respond to the antagonist. 16. The method of claim 15, further comprising measuring RF in the serum and determining whether the serum is positive for RF or negative for RF and wherein the serum is determined as positive for RF. 17. A method of predicting whether a subject with rheumatoid arthritis will respond effectively to treatment with a B-cell antagonist, comprising assessing as a biomarker in a serum sample from the patient the amount of CXCL13, sFcRH5, or both, and predicting the subject will respond effectively to treatment with the antagonist, wherein an amount of CXCL13 greater than 116.6 pg/ml, or an amount of sFcRH5 greater than 126.7 ng/ml, or a combination of these amounts indicates that the subject is likely to respond effectively to treatment with the antagonist. 18. The method of claim 17, further comprising measuring RF in the serum and determining whether the serum is positive for RF or negative for RF and wherein the serum is determined as positive for RF.

Details for Patent 8,728,730

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	RITUXAN	rituximab	Injection	103705	11/26/1997		2029-09-03
Idec Pharmaceuticals Corp.	RITUXAN	rituximab	Injection	103737	02/19/2002		2029-09-03
Glaxosmithkline Llc	BEXXAR	tositumomab and iodine i-131 tositumomab	Injection	125011	06/27/2003		2029-09-03
Acrotech Biopharma Llc	ZEVALIN	ibritumomab tiuxetan	Injection	125019	02/19/2002		2029-09-03
Genentech, Inc.	RITUXAN HYCELA	rituximab and hyaluronidase human	Injection	761064	06/22/2017		2029-09-03