Claims for Patent: 10,533,049

Summary for Patent: 10,533,049

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:	16/406,698
Patent Claims:	1. A method for treating an autoimmune disease in a subject in need thereof, comprising first determining that the subject has an HLA profile that does not include an HLA-B*39:01 allele, then administering infliximab to the subject. 2. The method of claim 1, comprising: (i) obtaining a biological sample from the subject; (ii) detecting whether the HLA-B*39:01 allele is present in said biological sample; (iii) determining that the subject does not have the HLA-B*39:01 allele, based on detecting the absence of said HLA alleles in step (ii); and then (iv) administering a therapeutically effective amount of infliximab to the subject. 3. The method of claim 2, wherein the therapeutically effective amount is at least 5 mg/kg infliximab. 4. The method of claim 2, wherein the therapeutically effective amount is about 5 mg/kg to about 10 mg/kg infliximab. 5. The method of claim 2, wherein the therapeutically effective amount is about 5 mg/kg infliximab. 6. 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. 7. The method of claim 1, wherein the method comprises obtaining a biological sample from the subject and performing a genetic assay to determine the absence of allele HLA-B*39:01. 8. The method of claim 7, further comprising obtaining a PCR-amplified genomic DNA sample of the biological sample from the subject, contacting under hybridizing conditions the genomic DNA with an oligonucleotide that specifically hybridizes to HLA-B*39:01, and detecting the absence of HLA-B*39:01 in the sample. 9. A method for treating an autoimmune disease in a subject in need thereof, wherein the method comprises determining that the subject does not have HLA-B*39:01 by obtaining or having obtained the HLA profile of the subject and then administering infliximab to the subject.

Details for Patent 10,533,049

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Janssen Biotech, Inc.	REMICADE	infliximab	For Injection	103772	08/24/1998		2038-05-08