Claims for Patent: 10,519,227

Summary for Patent: 10,519,227

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:	16/406,695
Patent Claims:	1. A method of treating a condition in a subject in need of infliximab therapy, comprising: identifying the subject as not having a genetic variation comprising the HLA-B*39:01 allele; and administering a therapeutically effective amount of infliximab to the subject, wherein the subject has a decreased risk of drug-induced liver injury (DILI), wherein the subject's decreased risk of DILI is associated with an absence of the genetic variation. 2. The method of claim 1, wherein the condition is selected from the group consisting of Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis. 3. The method of claim 1, wherein the subject is identified as not having the genetic variation based on the results of a genetic assay, wherein the genetic assay comprises one or more of a polymerase chain reaction (PCR)-based approach, a direct sequencing approach, a next generation (NGS) approach and/or a direct HLA typing test. 4. The method of claim 1, wherein the subject is identified as not having the genetic variation based on the results of a genetic assay, wherein the genetic assay comprises 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 presence or absence of HLA-B*39:01 in the sample. 5. The method of claim 1, wherein the method comprises obtaining a biological sample from the subject and performing a genetic assay on the biological sample. 6. The method of claim 1, wherein the therapeutically effective amount is at least 5 mg/kg infliximab. 7. The method of claim 1, wherein the therapeutically effective amount is about 5 mg/kg to about 10 mg/kg infliximab. 8. The method of claim 1, wherein the therapeutically effective amount is about 5 mg/kg infliximab.

Details for Patent 10,519,227

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