# US 11,441,187 B2 · Methods of characterizing and treating hidradenitis suppurativa

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- Number: US 11,441,187 B2
- Document ID: US11441187B2
- Status: Granted
- Kind: B2
- Application number: 16/593,844
- Filed: 2019-10-04
- Published: 2020-04-09
- Granted: 2022-09-13
- Earliest claimed: 2018-10-04
- Assignees: The George Washington University
- Applicants: The George Washington University
- Inventors: Victoria Shanmugam; Derek Jones
- Web page: https://patentgrep.com/patent/US11441187B2

## CPC

- C12Q 1/6883: for diseases caused by alterations of genetic material
- A61K 31/00: Medicinal preparations containing organic active ingredients
- A61P 17/00: Drugs for dermatological disorders
- C12Q 1/6823: Release of bound markers
- C12Q 1/6825: Nucleic acid detection involving sensors
- G16H 50/30: for calculating health indices; for individual health risk assessment
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- C12Q 2600/112: Disease subtyping, staging or classification
- C12Q 2600/158: Expression markers
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## Abstract

Disclosures herein encompass methods of treating a subject with moderate to severe hidradenitis suppurativa (HS) encompassing the determination of differential gene expression to characterize HS severity followed by administration of a treatment specific for the stage of HS severity characterized in the subject.

## Claims

### Claim 1

A method of treating a subject with moderate to severe hidradenitis suppurativa (HS), the method comprising:
a) determining a gene expression level of S100A8, S100A9, NFATC3, dermcidin, and IL-37 in a biological sample of a human subject;
b) characterizing HS severity by comparing the subject's gene expression levels of S100A8, S100A9, NFATC3, dermcidin, and IL-37 to a sample that does not have HS, wherein HS severity is characterized as moderate to severe when the expression level of at least S100A8, S100A9, and NFATC3, is increased in the subject compared to the sample that does not have HS, and
the expression level of dermcidin or IL-37 is decreased in the subject compared to the sample that does not have HS; and
c) administering an antibiotic, a retinoid, a steroid hormone, an anti-inflammatory, or a combination thereof to a subject characterized as having moderate to severe HS.

### Claim 2 (depends on 1)

The method of claim 1, wherein the method of characterizing HS severity further comprises characterizing as moderate to severe when the expression level of at least three genes selected from the group consisting of S100A8, S100A9, NFATC3, BTK, CD247, HLA-DMA, or HLS-DMB, is increased in the subject compared to the sample that does not have HS, and
the expression level of dermcidin and IL-37 is decreased in the subject compared to the sample that does not have HS.

### Claim 3 (depends on 1)

The method of claim 1, the subject characterized as having moderate to severe HS is administered an anti-inflammatory.

### Claim 4 (depends on 3)

The method of claim 3, wherein the anti-inflammatory is a tumor necrosis factor inhibitor, an interleukin-1 inhibitor, a Janus kinase (JAK) inhibitor, an interleukin-17 inhibitor, an interleukin-23 inhibitor, a Complement component 5a (C5a) inhibitor, or a combination thereof.

### Claim 5 (depends on 1)

The method of claim 1, wherein at least one symptom of moderate to severe HS is ameliorated after administering an antibiotic, a retinoid, a steroid hormone, an anti-inflammatory, or a combination thereof the subject characterized with moderate to severe HS.

### Claim 6 (depends on 1)

The method of claim 1, wherein the Dermatology Quality of Life Index (DQLI) score is decreased after administering an antibiotic, a retinoid, a steroid hormone, an anti-inflammatory, or a combination thereof the subject characterized with moderate to severe HS.

### Claim 7 (depends on 1)

The method of claim 1, wherein abscess and inflammatory nodule count (AN count) is decreased after administering an antibiotic, a retinoid, a steroid hormone, an anti-inflammatory, or a combination thereof the subject characterized with moderate to severe HS.

### Claim 8 (depends on 1)

The method of claim 1, wherein the severity of HS does not progress after administering an antibiotic, a retinoid, a steroid hormone, an anti-inflammatory, or a combination thereof the subject characterized with moderate to severe HS.

### Claim 9 (depends on 1)

The method of claim 1, wherein the method characterizing HS severity comprises:
a) obtaining a biological sample of a human subject;
b) determining the gene expression level of S100A8, S100A9, NFATC3, dermcidin, and IL-37 in the biological sample by contacting the biological sample with a bead,
wherein the bead comprises at least one oligonucleotide sequence complementary to S100A8, S100A9, NFATC3, dermcidin, and IL-37;
c) detecting binding between S100A8, S100A9, NFATC3, dermcidin, and IL-37 in the biological sample to the bead comprising at least one oligonucleotide sequence complementary to S100A8, S100A9, NFATC3, dermcidin, and IL-37, wherein detection of a bound oligonucleotide is measured using a fluorescent label; and
d) characterizing HS severity as moderate to severe when the expression level of at least S100A8, S100A9, and NFATC3 is increased in the subject compared to the sample that does not have HS.

### Claim 10

A method of treating a subject with moderate to severe hidradenitis suppurativa (HS), the method comprising:
a) determining gene expression level of S100A8, S100A9, NFATC3, dermcidin, and IL-37 in a biological sample of a human subject;
b) characterizing HS severity by comparing the subject's gene expression levels of S100A8, S100A9, NFATC3, dermcidin, and IL-37 to a sample that does not have HS,
wherein HS severity is characterized as moderate to severe when the expression level of NFATC3 is increased at least 1.5-fold, the expression level of S100A8 is increased at least 2-fold and the expression level of S100A9 is increased at least 2-fold in the subject compared to the sample that does not have HS, and the expression level of dermcidin is decreased at least 3-fold and the expression level of IL-37 is decreased at least 2-fold in the subject compared to the sample that does not have HS; and
c) administering an antibiotic, a retinoid, a steroid hormone, an anti-inflammatory, or a combination thereof to a subject characterized as having moderate to severe HS.

### Claim 11 (depends on 10)

The method of claim 10, the subject characterized as having moderate to severe HS is administered an anti-inflammatory.

### Claim 12 (depends on 11)

The method of claim 11, wherein the anti-inflammatory is a tumor necrosis factor inhibitor, an interleukin-1 inhibitor, a Janus kinase (JAK) inhibitor, an interleukin-17 inhibitor, an interleukin-23 inhibitor, a Complement component 5a (C5a) inhibitor, or a combination thereof.

### Claim 13 (depends on 10)

The method of claim 10, wherein at least one symptom of moderate to severe HS is ameliorated after administering an antibiotic, a retinoid, a steroid hormone, an anti-inflammatory, or a combination thereof the subject characterized with moderate to severe HS.

### Claim 14 (depends on 10)

The method of claim 10, wherein the Dermatology Quality of Life Index (DQLI) score is decreased after administering an antibiotic, a retinoid, a steroid hormone, an anti-inflammatory, or a combination thereof the subject characterized with moderate to severe HS.

### Claim 15 (depends on 10)

The method of claim 10, wherein abscess and inflammatory nodule count (AN count) is decreased after administering an antibiotic, a retinoid, a steroid hormone, an anti-inflammatory, or a combination thereof the subject characterized with moderate to severe HS.

### Claim 16 (depends on 10)

The method of claim 10, wherein the severity of HS does not progress after administering an antibiotic, a retinoid, a steroid hormone, an anti-inflammatory, or a combination thereof the subject characterized with moderate to severe HS.

### Claim 17 (depends on 10)

The method of claim 10, wherein the method of characterizing HS severity comprises:
a) obtaining a biological sample of a human subject;
b) determining the gene expression level of S100A8, S100A9, NFATC3, dermcidin, and IL-37 in the biological sample by contacting the biological sample with a bead,
wherein the bead comprises at least one oligonucleotide sequence complementary to S100A8, S100A9, NFATC3, dermcidin, and IL-37;
c) detecting binding between S100A8, S100A9, NFATC3, dermcidin, and IL-37 in the biological sample to the bead comprising at least one oligonucleotide sequence complementary to S100A8, S100A9, NFATC3, dermcidin, and IL-37, wherein detection of a bound oligonucleotide is measured using a fluorescent label; and
d) characterizing HS severity as moderate to severe when the expression level of S100A8, S100A9, and NFATC3 is increased in the subject compared to the sample that does not have HS.

### Claim 18 (depends on 17)

The method of claim 17, wherein the method of characterizing HS severity further comprises characterizing HS severity as moderate to severe when the expression level of BTK, CD247, HLA-DMA, or HLS-DMB, is increased in the subject compared to the sample that does not have HS.