# US 12,601,738 B2 · Method and means for diagnosis of spondyloarthritis

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- Number: US 12,601,738 B2
- Document ID: US12601738B2
- Status: Granted
- Kind: B2
- Application number: 17/761,527
- Filed: 2020-09-18
- Published: 2022-11-17
- Granted: 2026-04-14
- Earliest claimed: 2019-09-18
- Assignees: Universiteit Hasselt; Katholieke Universiteit Leuven
- Applicants: Universiteit Hasselt; Katholieke Universiteit Leuven, K.U. Leuven R&D
- Inventors: Patrick Vandormael; Veerle Somers; Kurt De Vlam; Dana Quaden
- Web page: https://patentgrep.com/patent/US12601738B2

## 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 7/00: Peptides having 5 to 20 amino acids in a fully defined sequence; Derivatives thereof
- C07K 16/18: against material from animals or humans
- G01N 33/6887: {from muscle, cartilage or connective tissue}
- C07K 2317/34: Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
- G01N 2800/10: Musculoskeletal or connective tissue disorders
- G01N 2800/101: Diffuse connective tissue disease, e.g. Sjögren, Wegener's granulomatosis
- 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

The present invention in general relates to the field of antibody profiling in spondyloarthritis. In particular, the inventors found that antibody levels against selected peptides are raised in spondylarthritis patients, and herein provide a diagnostic method and kit comprising such peptides for use in the diagnosis of spondyloarthritis.

## Claims

### Claim 1

An in vitro method comprising:
detecting the presence or quantity of autoantibodies in a sample of a subject wherein the autoantibodies bind to a polypeptide comprising the full-length of SEQ ID No: 8;
wherein the subject is a human subject suspected of having spondyloarthritis or wherein the human subject has spondyloarthritis, and
wherein the sample is a blood serum sample or blood plasma sample.

### Claim 2 (depends on 1)

The in vitro method according to claim 1, further comprising detecting the presence or quantity of autoantibodies in the sample of the subject wherein the autoantibodies bind to a second polypeptide comprising the full length of a sequence selected from the list comprising SEQ ID No: 1, SEQ ID No: 2, SEQ ID No: 3, SEQ ID No: 4, SEQ ID No: 5, SEQ ID No: 6, SEQ ID No: 7, SEQ ID No: 9.

### Claim 3 (depends on 1)

The in vitro method according to claim 1, further comprising detecting the presence or quantity of autoantibodies in the sample of the subject wherein the autoantibodies bind to one or more additional polypeptides comprising the full length of a sequence selected from SEQ ID No. 1 and SEQ ID No. 4.

### Claim 4 (depends on 1)

The in vitro method according to claim 1, further comprising:
detecting the presence or quantity of autoantibodies in the sample, wherein the autoantibodies bind to polypeptides comprising the full length sequence of SEQ ID No: 1 and SEQ ID No: 4.

### Claim 5 (depends on 1)

The in vitro method of claim 1, wherein the presence or quantity of autoantibodies that bind to a polypeptide comprising a full-length sequence of SEQ ID NO: 11 are detected.