Claims for Patent: 8,828,668

Summary for Patent: 8,828,668

Title:	Markers for determination of patient responsiveness
Abstract:	Compositions and methods are provided for prognostic classification of inflammatory diseases, e.g. inflammatory demyelinating disease, patients into subtypes, which subtypes are informative of the patient\'s need for therapy and responsiveness to a therapy of interest. The patterns of cytokines provides for a signature pattern that can identify patients likely to benefit from therapeutic intervention as well as discriminate patients that have a high probability of responsiveness to a therapy from those that have a low probability of responsiveness. Assessment of this signature pattern thus allows improved methods of care. In one embodiment of the invention, the autoimmune disease is multiple sclerosis or neuromyelitis optica.
Inventor(s):	Axtell; Robert C. (Menlo Park, CA), Steinman; Lawrence (Stanford, CA), Han; May H. (Menlo Park, CA), de Jong; Brigit A. (Nijmegen, NL), Raman; Chander (Birmingham, AL), Walker; Michael (Carlsbad, CA), Shi; Jing (Carlsbad, CA)
Assignee:	The Board of Trustees of the Leland Stanford Junior University (Palo Alto, CA)
Application Number:	13/026,173
Patent Claims:	1. A method for assessing prognosis for responsiveness of a human multiple sclerosis patient to interferon beta, comprising: analyzing a blood sample from said patient with an antibody-based assay and detecting the quantity of IL-17F present in the sample to provide a quantitative dataset for IL-17F; comparing the quantity of IL-17F in the sample to a control quantity, wherein the control quantity is the quantity of IL-17F in a blood sample from a human multiple sclerosis subject that is responsive to interferon beta, detecting an increased the quantity of IL-17F in the sample as compared to the control quantity; correlating the increased quantity of IL-17F in the sample as compared to the control quantity with an assessment that the patient is a non-responder to interferon beta; providing to said multiple sclerosis patient an assessment of responsiveness to interferon beta, and administering a non-interferon beta multiple sclerosis therapeutic agent to the patient. 2. The method of claim 1, wherein the dataset further comprises quantitative data for the marker PDGFBB. 3. The method of claim 1, wherein the dataset further comprises quantitative data for the marker IL-13. 4. The method of claim 1, wherein the dataset further comprises quantitative data for the marker IL-7. 5. The method of claim 1, wherein the dataset further comprises quantitative data for at least one marker selected from the group consisting of: IL-17A, interferon beta, eotaxin, IL-12p70, RANTES, IL-1alpha, MCP3, TGFbeta, NGF, IL-5, MIP-1beta, HGF, IL-23, IL-8, and IL-6. 6. The method of claim 1, wherein the dataset further comprises quantitative data for at least one marker selected from the group consisting of: IL-7, PDGFBB, IL-13, IL-17A, interferon beta, eotaxin, IL-12p70, RANTES, IL-1alpha, MCP3, TGFbeta, NGF, IL-5, MIP-1beta, HGF, IL-23, IL-8, and IL-6. 7. A method for assessing prognosis for responsiveness of a human relapsing remitting multiple sclerosis (RRMS) patient to interferon beta, comprising: analyzing a blood sample from said patient with an antibody-based assay and detecting the quantity of IL-17F present in the sample to provide a quantitative dataset for IL-17F; comparing the quantity of IL-17F in the sample to a control quantity, wherein the control quantity is the quantity of IL-17F in a blood sample from a human RRMS subject that is responsive to interferon beta; detecting a quantity of IL-17F in the sample that is not increased as compared to the control quantity; correlating the quantity of IL-17F in the sample as compared to the control quantity with an assessment that the patient is a responder to interferon beta; and administering an interferon beta to the patient. 8. The method of claim 7, wherein said interferon beta is Betaseron. 9. The method of claim 7, wherein said interferon beta is Rebif. 10. The method of claim 7, wherein said interferon beta is Extavia. 11. A method for assessing prognosis for responsiveness of a human multiple sclerosis patient to interferon beta, comprising: analyzing a blood sample from said patient with an antibody-based assay and detecting the quantity of IL-17F present in the sample to provide a quantitative dataset for IL-17F; comparing the quantity of IL-17F in the sample to a control quantity, wherein the control quantity is the quantity of IL-17F in a blood sample from a human multiple sclerosis subject that is responsive to interferon beta, detecting an increased the quantity of IL-17F in the sample as compared to the control quantity; correlating the increased quantity of IL-17F in the sample as compared to the control quantity with an assessment that the patient is a non-responder to interferon beta; providing to said multiple sclerosis patient an assessment of responsiveness to interferon beta, and administering glatiramer acetate to the patient. 12. The method of claim 1, further comprising administering BG-12 to the patient. 13. The method of claim 1, further comprising administering an anti-IL-12/23 drug to the patient. 14. The method of claim 13, wherein said anti-IL-12/23 drug is ustekinumab. 15. The method of claim 13, wherein said anti-IL-12/23 drug is briakinumab. 16. The method of claim 1, wherein the multiple sclerosis is Relapsing Remitting Multiple Sclerosis. 17. The method of claim 1, wherein the multiple sclerosis is Secondary Progressive Multiple Sclerosis. 18. The method of claim 1, wherein the multiple sclerosis is Primary Progressive Multiple Sclerosis. 19. The method of claim 1, further comprising assessing a clinical factor in the patient.

Details for Patent 8,828,668

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Bayer Healthcare Pharmaceuticals Inc.	BETASERON	interferon beta-1b	For Injection	103471	07/23/1993		2039-03-29
Emd Serono, Inc.	REBIF	interferon beta-1a	Injection	103780	03/07/2002		2039-03-29
Emd Serono, Inc.	REBIF	interferon beta-1a	Injection	103780	12/17/2004		2039-03-29
Emd Serono, Inc.	REBIF	interferon beta-1a	Injection	103780	12/21/2012		2039-03-29
Janssen Biotech, Inc.	STELARA	ustekinumab	Injection	125261	09/25/2009		2039-03-29
Janssen Biotech, Inc.	STELARA	ustekinumab	Injection	125261	12/30/2009		2039-03-29