Claims for Patent: 9,657,292

Summary for Patent: 9,657,292

Title:	Compositions and methods for treating or preventing lupus
Abstract:	The invention features compositions comprising agents that inhibit or reduce self-reactive IgE and/or basophils, and related methods of using the compositions for treating or preventing lupus, lupus nephritis, and lupus-related disorders.
Inventor(s):	Rivera; Juan (Mechanicsburg, PA), Charles; Nicolas (Asnieres sur Seine, FR)
Assignee:	The United States of America, as represented by the Secretary, Department of Health & Human Services (Washington, DC)
Application Number:	13/989,744
Patent Claims:	1. A method of inhibiting or reducing the development or progression to lupus nephritis in a subject in need thereof, the method comprising administering to the subject an effective amount of an agent that reduces the expression or biological activity of IgE or an IgE receptor in the subject, wherein the agent is omalizumab and effectuates the amelioration of lupus nephritis. 2. The method of claim 1, wherein the method reduces at least one of the level of autoreactive IgEs, the level of circulating immune complexes, and basophil activation. 3. The method of claim 1, wherein the subject is identified as having a propensity to develop lupus nephritis, and the agent is administered to the identified subject. 4. The method of claim 1, wherein the subject has elevated IgE levels. 5. The method of claim 1, wherein the method further comprises administering to the subject an agent selected from the group consisting of nonsteroidal anti-inflammatory drugs (NSAIDs), hydroxychloroquine, corticosteroids, cyclophosphamide, azthioprine, methotrexate, mycophenolate, belimumab, dehydroepiandrosterone, and rituximab. 6. The method of claim 1, wherein the lupus nephritis is diffuse proliferative lupus nephritis or membranous lupus nephritis. 7. A method of reducing or inhibiting the development or progression to lupus nephritis in a subject in need thereof, the method comprising administering to the subject an effective amount of an agent that decreases the number or activity of basophils or that reduces basophil activation in the subject, wherein the agent is omalizumab and effectuates the amelioration of lupus nephritis. 8. The method of claim 7, wherein the method reduces levels of one or more of CD203c expression, CD62L, and HLA-DR in said subject. 9. A method of reducing or inhibiting the development or progression to lupus nephritis in a subject comprising administering to a subject in need thereof an effective amount of omalizumab, wherein the agent effectuates the amelioration of lupus nephritis. 10. The method of claim 9, wherein the effective amount is between about 75 mg to 500 mg per dose and/or the omalizumab is administered every 1, 2, 3, or 4 weeks at about 150 mg-400 mg per dose. 11. A method of treating lupus nephritis in a subject in need thereof, the method comprising administering to the subject an effective amount of an agent that reduces the expression or biological activity of IgE or an IgE receptor in the subject, wherein the agent is omalizumab and effectuates the amelioration of lupus nephritis. 12. The method of claim 11, wherein the method reduces at least one of: the level of autoreactive IgEs, the level of circulating immune complexes, and basophil activation. 13. The method of claim 11, wherein the subject is identified as having a propensity to develop lupus nephritis, and the agent is administered to the identified subject. 14. The method of claim 11, wherein the subject has elevated IgE levels. 15. The method of claim 11, wherein the method further comprises administering to the subject an agent selected from the group consisting of nonsteroidal anti-inflammatory drugs (NSAIDs), hydroxychloroquine, corticosteroids, cyclophosphamide, azthioprine, methotrexate, mycophenolate, belimumab, dehydroepiandrosterone, and rituximab. 16. A method of treating lupus nephritis in a subject in need thereof, the method comprising administering to the subject an effective amount of an agent that decreases the number or activity of basophils or that reduces basophil activation in the subject, wherein the agent is omalizumab and effectuates the amelioration of lupus nephritis. 17. The method of claim 16, wherein the method reduces levels of one or more of CD203c expression, CD62L, and HLA-DR in said subject. 18. A method of treating lupus nephritis in a subject comprising administering to a subject in need thereof an effective amount of omalizumab, wherein the agent effectuates the amelioration of lupus nephritis. 19. The method of claim 18, wherein the effective amount is between about 75 mg to 500 mg per dose and/or the omalizumab is administered every 1, 2, 3, or 4 weeks at about 150 mg-400 mg per dose.

Details for Patent 9,657,292

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	RITUXAN	rituximab	Injection	103705	11/26/1997		2039-02-26
Idec Pharmaceuticals Corp.	RITUXAN	rituximab	Injection	103737	02/19/2002		2039-02-26
Genentech, Inc.	XOLAIR	omalizumab	For Injection	103976	06/20/2003		2039-02-26
Genentech, Inc.	XOLAIR	omalizumab	Injection	103976	09/28/2018		2039-02-26
Glaxosmithkline Llc	BENLYSTA	belimumab	For Injection	125370	03/09/2011		2039-02-26
Glaxosmithkline Llc	BENLYSTA	belimumab	Injection	761043	07/20/2017		2039-02-26