Claims for Patent: 8,268,566

Summary for Patent: 8,268,566

Title:	Enhanced FC receptor-mediated tumor necrosis factor superfamily MRNA expression in peripheral blood leukocytes in patients with rheumatoid arthritis
Abstract:	A method for predicting patient responsiveness to rheumatoid arthritis treatments involving altering expression of tumor necrosis factor superfamily (\"TNFSF\")-2, TNFSF-8, or TNFSF-15 is disclosed. A method for monitoring the effectiveness of such therapy is also disclosed. Furthermore, a method of screening compounds for use in the treatment of rheumatoid arthritis is disclosed. A method of monitoring the disease state over time in rheumatoid arthritis patients is also disclosed.
Inventor(s):	Mitsuhashi; Masato (Irvine, CA), Endo; Katsuya (Ibaraki, JP), Obara; Kazuhiko (Ibaraki, JP), Izutsu; Hiroshi (Ibaraki, JP), Ohta; Shuji (Ibaraki, JP)
Assignee:	Hitachi Chemical Research Center, Inc. (Irvine, CA) Hitachi Chemical Co., Ltd. (Shinjuku-ku, Tokyo, JP)
Application Number:	12/743,220
Patent Claims:	1. A method of determining whether a patient having rheumatoid arthritis is likely to respond to anti-TNF therapy, comprising: stimulating the Fc receptors of leukocytes in vitro in a first sample from said patient for a period of four hours or longer; measuring the amount of an mRNA encoding a tumor necrosis factor superfamily member 2 ("TNFSF-2") protein in the first sample after the stimulation; exposing leukocytes in vitro in a second sample to a control stimulus; measuring the amount of said mRNA in the second sample; determining a ratio of the amount of mRNA in the first sample to the amount of mRNA in the second sample; and determining that the patient is likely to respond to the therapy if the ratio is about 2:1 or greater. 2. The method of claim 1, wherein stimulating leukocytes in the first sample comprises intermixing heat-aggregated human IgG with the first sample. 3. The method of claim 1, wherein at least one of the first and second samples comprises whole blood. 4. The method of claim 1, wherein the control stimulus is phosphate-buffered saline. 5. The method of claim 1, wherein the therapy comprises administration of an agent selected from the group consisting of infliximab and etanercept.

Details for Patent 8,268,566

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Janssen Biotech, Inc.	REMICADE	infliximab	For Injection	103772	08/24/1998		2039-02-26
Immunex Corporation	ENBREL	etanercept	For Injection	103795	11/02/1998		2039-02-26
Immunex Corporation	ENBREL	etanercept	For Injection	103795	05/27/1999		2039-02-26
Immunex Corporation	ENBREL	etanercept	Injection	103795	09/27/2004		2039-02-26
Immunex Corporation	ENBREL	etanercept	Injection	103795	02/01/2007		2039-02-26
Immunex Corporation	ENBREL MINI	etanercept	Injection	103795	09/14/2017		2039-02-26
Immunex Corporation	ENBREL	etanercept	Injection	103795			2039-02-26