Claims for Patent: 9,982,302

Summary for Patent: 9,982,302

Title:	Biological markers and methods for predicting response to B-cell antagonists
Abstract:	Biological markers that predict patient responsiveness to B-cell antagonists are provided. Also provided are methods of using such biological markers. In addition, methods for identifying patients suffering from an autoimmune disease, e.g., rheumatoid arthritis, who are not likely to respond to B-cell antagonists are provided, as are methods of treating such patients. Methods for selecting therapeutic agents to treat such patients are also provided.
Inventor(s):	Behrens; Timothy W. (Burlingame, CA), Owczarczyk; Kasia (London, GB), Townsend; Michael J. (San Jose, CA)
Assignee:	Genentech, Inc. (South San Francisco, CA)
Application Number:	15/019,615
Patent Claims:	1. A method of treating rheumatoid arthritis in a human patient, comprising: (a) obtaining a blood sample from the human patient; (b) measuring mRNA expression of at least one gene in cells of the blood sample using a reverse transcriptase-quantitative polymerase chain reaction (RT-qPCR), wherein the at least one gene comprises IgJ, FCRL5 and CD19; (c) determining that the cells from the blood sample from the human patient express IgJ at an elevated level, and both FCRL5 and CD19 at a reduced level as compared to the expression of IgJ, FCRL5 and CD19 in a blood sample obtained from a control subject with rheumatoid arthritis who exhibits a favorable response to an anti-CD20 antibody, or to threshold values for IgJ, FCRL5 and CD19; and (d) administering a therapeutically effective amount of a therapeutic agent other than the anti-CD20 antibody to the human patient to treat the rheumatoid arthritis if the blood sample obtained from the human patient has been determined to express IgJ at an elevated level, and both FCRL5 and CD19 at a reduced level as compared to the control subject or to the threshold values in step (c), and wherein the therapeutic agent is an interleukin-6-receptor antagonist or abatacept. 2. The method of claim 1, wherein the anti-CD20 antibody is rituximab. 3. The method of claim 1, wherein the anti-CD20 antibody is ocrelizumab. 4. The method of claim 1, wherein the therapeutic agent other than the anti-CD20 antibody is an interleukin-6-receptor antagonist. 5. The method of claim 1, wherein the therapeutic agent other than the anti-CD20 antibody is abatacept. 6. The method of claim 1, wherein the threshold values are relative abundance values of greater than or equal to 0.1 IgJ, less than 0.02 FCRL5, and less than 0.05 CD19 when mRNA expression is normalized to mRNA expression of a housekeeping gene.

Details for Patent 9,982,302

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	RITUXAN	rituximab	Injection	103705	11/26/1997		2031-02-28
Bristol-myers Squibb Company	ORENCIA	abatacept	For Injection	125118	12/23/2005		2031-02-28
Bristol-myers Squibb Company	ORENCIA	abatacept	Injection	125118	07/29/2011		2031-02-28