Claims for Patent: 8,420,330

Summary for Patent: 8,420,330

Title:	Diagnosis and treatment of cardiac troponin 1 (cTn1) autoantibody-mediated heart disease
Abstract:	Provided herein are, inter alia, methods of diagnosing and treating autoimmune cardiomyopathy in subjects, based upon the detection of IgG4 autoantibodies to cardiac troponin I (cTnI).
Inventor(s):	Lipes; Myra A. (Brookline, MA), Cornivelli; Lizbeth (Medford, MA)
Assignee:
Application Number:	13/184,115
Patent Claims:	1. A method for diagnosing the presence of, or risk of developing, autoimmune heart disease in a subject, the method comprising: providing a sample comprising serum of a subject; and performing an assay to detect a level, presence, or absence in the sample of IgG4 autoantibodies to cardiac troponin I (cTnI), wherein the presence of IgG4 autoantibodies to cTnI indicates that the subject has or is at risk of developing autoimmune heart disease; selecting a subject who has or is at risk of developing autoimmune heart disease; and administering to the subject a therapy for autoimmune heart disease. 2. The method of claim 1, wherein the subject has cardiac arrhythmia, idiopathic dilated cardiomyopathy, ischemic cardiomyopathy or unexplained heart failure. 3. The method of claim 1, wherein autoantibodies that bind to an epitope within residues 92-164 of SEQ ID NO:1 are detected. 4. The method of claim 3, wherein autoantibodies that bind to epitopes within residues 92-101, 127-136, or 155-164 of SEQ ID NO:1 are detected. 5. A method for diagnosing the presence of, or risk of developing, autoimmune heart disease in a subject, the method comprising: providing a sample comprising cardiac tissue of a subject; and performing an assay to detect deposition of IgG4 autoantibodies to cardiac troponin I (cTnI), on cardiac myocytes in the sample, wherein the deposition of IgG4 autoantibodies to cTnI indicates that the subject has or is at risk of developing autoimmune heart disease; selecting a subject who has or is at risk of developing autoimmune heart disease; and administering to the subject a therapy for autoimmune heart disease. 6. The method of claim 5, wherein the sample is an endomyocardial biopsy. 7. The method of claim 5, wherein the subject has cardiac arrhythmia, idiopathic dilated cardiomyopathy, ischemic cardiomyopathy or unexplained heart failure. 8. The method of claim 5, wherein autoantibodies that bind to an epitope within residues 92-164 of SEQ ID NO:1 are detected. 9. The method of claim 8, wherein autoantibodies that bind to epitopes within residues 92-101, 127-136, or 155-164 of SEQ ID NO:1 are detected. 10. The method of claim 1, wherein the therapy depletes or inactivates B lymphocytes in the subject. 11. The method of claim 10, wherein the therapy comprises administration of an effective amount of rituximab or other B-cell depleting or B-cell inactivating agents. 12. The method of claim 10, wherein the therapy comprises treating the subject with plasmapheresis or administering intravenous immunoglobulin. 13. A method for monitoring the efficacy of a treatment for autoimmune heart disease, the method comprising: providing a first sample comprising serum of a subject; performing an assay to detect a level of IgG4 autoantibodies to cardiac troponin I (cTnI) in the first sample, administering a therapy for autoimmune heart disease to the subject; providing a subsequent sample comprising serum of the subject; performing an assay to detect a level IgG4 autoantibodies to cTnI in the subsequent sample; comparing the level of IgG4 autoantibodies to cTnI in the first sample to the level of IgG4 autoantibodies to cTnI in the subsequent sample, wherein a decrease in level of IgG4 autoantibodies to cTnI from the first to the subsequent sample indicates that the therapy is effective. 14. The method of claim 13, wherein the therapy comprises administration of an effective amount of rituximab or other B-cell depleting or B-cell inactivating agents. 15. The method of claim 13, wherein the therapy comprises treating the subject with plasmapheresis or administering intravenous immunoglobulin.

Details for Patent 8,420,330

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	RITUXAN	rituximab	Injection	103705	11/26/1997		2039-03-29
Idec Pharmaceuticals Corp.	RITUXAN	rituximab	Injection	103737	02/19/2002		2039-03-29
Genentech, Inc.	RITUXAN HYCELA	rituximab and hyaluronidase human	Injection	761064	06/22/2017		2039-03-29