Claims for Patent: 10,519,228

Summary for Patent: 10,519,228

Title:	Methods for reducing drug-induced liver injury
Abstract:	The present disclosure provides methods of treating a patient with infliximab or alternative therapies to reduce the risk of developing, and/or severity of, an adverse drug reaction such as drug-induced liver injury. The methods include identifying patients at risk for developing DILI by determining the presence or absence of one or more HLA alleles in the patients.
Inventor(s):	Srinivasan; Sundar (Corona Del Mar, CA), Chow; Christina (Seattle, WA)
Assignee:	TEN PEAKS LLC (Corona Del Mar, CA)
Application Number:	16/406,700
Patent Claims:	1. A method of treating a population of patients having an autoimmune disease with infliximab, the method comprising providing a first population of patients having an autoimmune disease; excluding only patients having an HLA profile comprising HLA-B*39:01 from the first population of patients; treating the population of patients not excluded from the first population with infliximab; and treating the excluded patients with an autoimmune disease therapy that is not infliximab. 2. The method of claim 1, wherein the HLA profile is or has been obtained using a polymerase chain reaction (PCR)-based approach, a direct sequencing approach, a next generation (NGS) approach and/or a direct HLA typing test. 3. The method of claim 1, wherein the method comprises obtaining biological samples from the patients and performing a genetic assay to determine the presence or absence of allele HLA-B*39:01 in the biological samples. 4. The method of claim 3, comprising obtaining PCR-amplified genomic DNA samples of the biological samples from the patients, contacting under hybridizing conditions the genomic DNA with an oligonucleotide that specifically hybridizes to HLA-B*39:01, and detecting the presence or absence of HLA-B*39:01 in the samples. 5. The method of claim 1, wherein the infliximab is administered to a patient in the population at a dose of at least 5 mg/kg infliximab. 6. The method of claim 1, wherein the infliximab is administered to a patient in the population at a dose of about 5 mg/kg to about 10 mg/kg infliximab. 7. The method of claim 1, wherein the infliximab is administered to a patient in the population at a dose of about 5 mg/kg infliximab. 8. The method of claim 1, wherein the autoimmune disease is selected from the group consisting of Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis. 9. The method of claim 1, wherein the autoimmune disease therapy that is not infliximab is a TNF inhibitor. 10. The method of claim 1, wherein the autoimmune disease therapy that is not infliximab is selected from the group consisting of azathioprine, mercaptopurine, adalimumab, certolizumab, methotrexate, natalizumab, vedolizumab, ustekinumab, mesalamine, budesonide, hyoscyamine, celecoxib, hydroxychloroquin, etanercept, prednisone, cyclosporine, tocilizumab, meloxicam, leflunomide, sulfasalazine, abatacept, rituximab, golimumab, acitretin, secukinumab, apremilast, sarilumab, ixekizumab, and corticotropin.

Details for Patent 10,519,228

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	RITUXAN	rituximab	Injection	103705	11/26/1997		2038-05-08
Janssen Biotech, Inc.	REMICADE	infliximab	For Injection	103772	08/24/1998		2038-05-08
Immunex Corporation	ENBREL	etanercept	For Injection	103795	11/02/1998		2038-05-08
Immunex Corporation	ENBREL	etanercept	For Injection	103795	05/27/1999		2038-05-08
Immunex Corporation	ENBREL	etanercept	Injection	103795	09/27/2004		2038-05-08
Immunex Corporation	ENBREL	etanercept	Injection	103795	02/01/2007		2038-05-08