Claims for Patent: 10,416,159

Summary for Patent: 10,416,159

Title:	Method for treating rheumatoid arthritis
Abstract:	The present invention provides a method for determining whether a Rheumatoid Arthritis (RA) patient is susceptible to treatment with a B cell targeted therapy, which method comprises the step of analyzing B cells and/or germinal center-like structures (GC-LS) in a synovial tissue sample from the patient; wherein a patient whose synovial tissue sample is B cell rich and/or GC-LS negative is determined to be susceptible to treatment with the B cell targeted therapy, whereas a patient whose synovial tissue sample is B-cell poor and/or GC-LS positive is determined to be resistant to treatment with the B cell targeted therapy.
Inventor(s):	Pitzalis; Costantino (London, GB)
Assignee:	Queen Mary University of London (GB)
Application Number:	15/326,620
Patent Claims:	1. A method for treating a Rheumatoid Arthritis (RA) patient susceptible to treatment with a B cell targeted therapy, which method comprises the steps of: (a) identifying an RA patient susceptible to treatment with a B cell targeted therapy by analysing B cells and/or germinal centre-like structures (GC-LS) in a synovial tissue sample from an RA patient, wherein analysing B cells and GC-LS is performed by histological analysis; wherein a patient whose synovial tissue sample is B cell rich and/or GC-LS negative is susceptible to treatment with the B cell targeted therapy; wherein the B cell rich synovial tissue sample comprises a B cell aggregate with a radial cell count of 6 cells or greater measured from a central vessel at the point of widest infiltration; wherein the GC-LS negative synovial tissue sample lacks B cell aggregates within which CD21 is detectable; and (b) administering a B cell targeted therapy to the RA patient susceptible to treatment with the B cell targeted therapy. 2. The method according to claim 1, wherein B cells are analysed by determining CD20 expression in the synovial tissue sample. 3. The method according to claim 1, wherein the B cell targeted therapy is B cell depletion therapy. 4. The method according to claim 1, wherein the B cell targeted therapy is selected from the group consisting of: Rituximab, Ocrelizumab, Veltuzumab, Ofatumumab and Epratuzumab. 5. The method according to claim 4, wherein the B cell targeted therapy is Rituximab. 6. The method according to claim 1, wherein the RA patient is refractory to anti-TNF therapy.

Details for Patent 10,416,159

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	RITUXAN	rituximab	Injection	103705	11/26/1997		2034-07-17
Novartis Pharmaceuticals Corporation	ARZERRA	ofatumumab	Injection	125326	10/26/2009		2034-07-17
Novartis Pharmaceuticals Corporation	ARZERRA	ofatumumab	Injection	125326	04/01/2011		2034-07-17
Novartis Pharmaceuticals Corporation	KESIMPTA	ofatumumab	Injection	125326	08/20/2020		2034-07-17
Genentech, Inc.	OCREVUS	ocrelizumab	Injection	761053	03/28/2017		2034-07-17
Genentech, Inc.	RITUXAN HYCELA	rituximab and hyaluronidase human	Injection	761064	06/22/2017		2034-07-17