# US 2014/0193844 A1 · Biomarkers for Ankylosing Spondylitis

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- Number: US 2014/0193844 A1
- Document ID: US20140193844A1
- Status: Published application
- Kind: A1
- Application number: 14/233,342
- Filed: 2012-07-12
- Published: 2014-07-10
- Earliest claimed: 2011-07-19
- Assignees: University Health Network
- Inventors: Florence Wing Ling Tsui; Robert Davies Inman
- Web page: https://patentgrep.com/patent/US20140193844A1

## CPC

- G01N 33/564: for pre-existing immune complex or autoimmune disease {, i.e. systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, rheumatoid factors or complement components C1-C9}
- C07K 14/4713: {Autoimmune diseases, e.g. Insulin-dependent diabetes mellitus, multiple sclerosis, rheumathoid arthritis, systemic lupus erythematosus; Autoantigens}
- G01N 33/6893: {related to diseases not provided for elsewhere}
- G01N 2800/10: Musculoskeletal or connective tissue disorders
- G01N 2800/102: Arthritis; Rheumatoid arthritis, i.e. inflammation of peripheral joints
- G01N 2800/56: Staging of a disease; Further complications associated with the disease
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)
- C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00)

## Abstract

There is described herein methods and peptides for detecting autoantibodies to NOG and/or SOST in a patient sample in order to diagnose of prognosticate Ankylosing Spondylitis in the patient.

## Claims

### Claim 1

A method for diagnosing a subject with Ankylosing Spondylitis comprising:
a. providing a sample from the subject;
b. detecting a level of autoantibodies to at least one of NOG and SOST in the sample;
c. comparing the level of autoantibodies detected in b. to a level of autoantibodies in a control sample;
wherein a relatively higher level of autoantibodies in the subject sample compared to the control sample is indicative of Ankylosing Spondylitis in the subject.

### Claim 2

A method for prognosticating Ankylosing Spondylitis in a subject comprising:
a. providing a sample from the subject;
b. detecting a level of autoantibodies to at least one of NOG and SOST in the sample;
c. comparing the level of autoantibodies detected in b. to a level of autoantibodies in a control sample;
wherein a relatively higher level of autoantibodies in the subject sample compared to the control sample is at least one of (i) indicative of the likelihood of the subject to have progression in ankylosis and (ii) a predictor of severity of disease.

### Claim 3 (depends on 1)

The method of claim 1, wherein the level of autoantibodies in the sample compared to the control sample is 2-10× higher.

### Claim 4 (depends on 1)

The method of claim 1, wherein samples are one of serum, plasma and synovial fluid samples.

### Claim 5 (depends on 1)

The method of claim 1, wherein the autoantibodies are pre-complexed with antigen.

### Claim 6 (depends on 5)

The method of claim 5, wherein the autoantibody is in a NOG-IgG immune complex.

### Claim 7 (depends on 5)

The method of claim 5, wherein the autoantibody is in a SOST-IgG immune complex.

### Claim 8 (depends on 5)

The method of claim 5, wherein the autoantibody is in a NOG/SOST-IgG immune complex.

### Claim 9 (depends on 1)

The method of claim 1, wherein the level of autoantibodies to at least one of NOG and SOST in the sample is detected using at least one peptide capable of selectively binding to autoantibodies to at least one of NOG and SOST.

### Claim 10 (depends on 9)

The method of claim 9, wherein the peptide comprises conserved residues, the conserved residues being one of:
a. residues 5-18 of N54 (SEQ ID NO. 1) or conservative amino acid substitutions thereof;
b. residues 3, 4, 6, 8, 9, 11, 12, 13, 15 and 16 of CN54 (SEQ ID NO. 2), preferably residues 3-16, or conservative amino acid substitutions thereof;
c. residues 6-13 of N77 (SEQ ID NO. 3) or conservative amino acid substitutions thereof;
d. residues 7-14 CN76 (SEQ ID NO. 4) or conservative amino acid substitutions thereof; and
e. residues 3-7 and 9-12 of S146 (SEQ ID NO. 5), preferably residues 3-12, or conservative amino acid substitutions thereof.

### Claim 11 (depends on 10)

The method of claim 10, wherein the conserved residues are one of:
a. residues 5-18 of N54 (SEQ ID NO. 1);
b. residues 3, 4, 6, 8, 9, 11, 12, 13, 15 and 16 of CN54 (SEQ ID NO. 2), preferably residues 3-16;
c. residues 6-13 of N77 (SEQ ID NO. 3);
d. residues 7-14 CN76 (SEQ ID NO. 4); and
e. residues 3-7 and 9-12 of S146 (SEQ ID NO. 5), preferably residues 3-12.

### Claim 12 (depends on 9)

The method of claim 9, wherein the peptide is 6-30 amino acids in length.

### Claim 13 (depends on 9)

The method of claim 9, wherein the peptide is at least one of N54, CN54, N77, CN76 and S146.

### Claim 14

An isolated peptide comprising conserved residues, the conserved residues being one of:
a. residues 5-18 of N54 (SEQ ID NO. 1) or conservative amino acid substitutions thereof;
b. residues 3, 4, 6, 8, 9, 11, 12, 13, 15 and 16 of CN54 (SEQ ID NO. 2), preferably residues 3-16, or conservative amino acid substitutions thereof;
c. residues 6-13 of N77 (SEQ ID NO. 3 or conservative amino acid substitutions thereof);
d. residues 7-14 CN76 (SEQ ID NO. 4) or conservative amino acid substitutions thereof; and
e. residues 3-7 and 9-12 of S146 (SEQ ID NO. 5), preferably residues 3-12, or conservative amino acid substitutions thereof.

### Claim 15 (depends on 14)

The peptide of claim 14, wherein the conserved residues are one of:
a. residues 5-18 of N54 (SEQ ID NO. 1);
b. residues 3, 4, 6, 8, 9, 11, 12, 13, 15 and 16 of CN54 (SEQ ID NO. 2), preferably residues 3-16;
c. residues 6-13 of N77 (SEQ ID NO. 3);
d. residues 7-14 CN76 (SEQ ID NO. 4); and
e. residues 3-7 and 9-12 of S146 (SEQ ID NO. 5), preferably residues 3-12.

### Claim 16 (depends on 14)

The peptide of claim 14, wherein the peptide is 6-30 amino acids in length.

### Claim 17 (depends on 14)

The peptide of claim 14, wherein the peptide is one of N54, CN54, N77, CN77 and S146.

### Claim at position 18

-25. (canceled)