# US 5,700,641 A · Diagnostic method, test kit, drug and therapeutic treatment for autoimmune diseases

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- Number: US 5,700,641 A
- Document ID: US5700641A
- Status: Granted
- Kind: A
- Application number: 08/396,238
- Filed: 1995-03-01
- Granted: 1997-12-23
- Earliest claimed: 1995-03-01
- Inventors: Eeva-Marjatta Salonen
- Web page: https://patentgrep.com/patent/US5700641A

## CPC

- G01N 33/6854: {Immunoglobulins}
- C12Q 1/6804: Nucleic acid analysis using immunogens (immunoassay G01N33/53)
- C12Q 1/6883: for diseases caused by alterations of genetic material
- 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}
- G01N 2800/102: Arthritis; Rheumatoid arthritis, i.e. inflammation of peripheral joints
- G01N 2800/104: Lupus erythematosus [SLE]
- G01N 2800/24: Immunology or allergic disorders
- 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)
- 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

## Abstract

Synthesized telomeric sequences bind to and can be used for detecting anti-DNA antibodies in serum. Autoimmune diseases such as Lupus Erythematosus, Rheumatoid Arthritis, and Scleroderma, can be detected by detecting an elevated level of anti-DNA antibodies using telomeric sequences. Test kits for such detection are provided including immobilized telomeric sequences capable of binding anti-DNA antibodies. Pharmaceutical compositions for inhibiting or reducing the activity of anti-DNA antibodies contain an effective amount of telomeric sequences effective in inhibiting the antibodies specific to the patient treated.

## Claims

### Claim 1

A method for detecting anti-DNA-antibodies in a sample by contacting said sample with a telomeric sequence of DNA selected from the group consisting of a single stranded telomere, a complementary strand thereto, a double stranded teleomere, and a part or a repeat or a combination of any of the foregoing, to provide binding of said antibodies to said telomeric sequence of DNA, and detecting said binding of said antibodies to said telomeric sequence.

### Claim 2 (depends on 1)

The method according to claim 1, wherein the telomeric sequence is selected from the group consisting of the human telomere strand 5'-TTAGGG-3', the complementary strand thereto, a double stranded human telomere, a functional part of any of said strands, a repeat of any of said strands and a combination of any of the foregoing.

### Claim 3 (depends on 2)

The method according to claim 2, wherein said repeat of said telomere strand is selected from the group consisting of
5'-TTAGGG TTAGGG TTAGGG TTAGGG TTAGGG-3' (SEQ ID NO:1)
5'-CCCTAA CCCTAA CCCTAA CCCTAA CCCTAA-3' (SEQ ID NO:2), and
a duplex thereof.

### Claim 4 (depends on 1)

The method according to claim 1 said sample is mammalian serum.

### Claim 5

The method according 4, wherein the serum is human serum.

### Claim 6

A diagnostic method for detecting autoimmune diseases in mammals by contacting a serum sample from said mammal with telomeric sequence of DNA which is specific to said mammal and which is selected from the group consisting of a single stranded telomere, a complementary strand thereto, a double stranded telomere, a part or a repeat or a combination of any of the foregoing, to detect an elevated level of autoantibodies present in said mammals above a normal level of autoantibodies.

### Claim 7 (depends on 6)

The diagnostic method of claim 6 wherein said autoimmune disease is selected from the group consisting of Lupus Erythematosus, Rheumatoid Arthritis and Scleroderma.

### Claim 8 (depends on 7)

The diagnostic method of claim 7 wherein said autoimmune disease is Systemic Lupus Erythematosus (SLE).

### Claim 9 (depends on 6)

The diagnostic method according to claim 6, wherein said telomeric sequence is selected from the group consisting of the human telomere strand 5'-TTAGGG-3', the complementary strand thereto, a double stranded human telomere, a functional part of any of said strands, a repeat of any of said strands and a combination of any of the foregoing.

### Claim 10 (depends on 9)

The diagnostic method according to claim 9, wherein said repeat of said telomere strand is selected from the group consisting of
5'-TTAGGG TTAGGG TTAGGG TTAGGG TTAGGG-3' (SEQ ID NO:1)
5'-CCCTAA CCCTAA CCCTAA CCCTAA CCCTAA-3' (SEQ ID NO:2), and
a duplex thereof.

### Claim 11 (depends on 6)

The diagnostic method of claim 6, wherein the immunoglobulin (Ig) class of said autoantibodies is determined with the aid of anti-Ig-antibodies.

### Claim 12 (depends on 9)

The diagnostic method according to claim 9, wherein the existence of SLE in a human patient is detected by contacting a sample of said patient's serum with an immobilized human telomeric sequence to bind autoantibodies present in said serum to said immobilized telomeric sequence and detecting an elevated level of bound IgG class autoantibodies among said bound autoantibodies.

### Claim 13 (depends on 9)

The diagnostic method according to claim 9, wherein the existence of SLE in a human patient is detected by contacting a sample of said patient's serum with an immobilized human telomeric sequence to bind autoantibodies present in said serum to said immobilized telomeric sequence and detecting an elevated level of bound IgM class autoantibodies among said bound autoantibodies.

### Claim 14

A test kit for the diagnosis of autoimmune disease in mammals, said test kit including a telomeric sequence of DNA selected from the group consisting of a single stranded telomere, a complementary strand thereto, a double stranded telomere, a part or a repeat or a combination of any of the foregoing, capable of binding autoantibodies present in said serum, wherein said telomeric sequence is immobilized on a solid support and
a label capable of indicating the binding of said autoantibody to said telomeric sequence.

### Claim 15 (depends on 14)

The test kit according to claim 14 wherein said telomeric sequence is selected from the group consisting of the human telomere strand 5'-TTAGGG-3', the complementary strand thereto, a double stranded human telomere, a functional part of any of said strands, a repeat of any of said strands and a combination of any of the foregoing.

### Claim 16 (depends on 15)

The test kit according to claim 15, wherein said repeat of said telomere strand is selected from the group consisting of
5'-TTAGGG TTAGGG TTAGGG TTAGGG TTAGGG-3' (SEQ ID NO:1)
5'-CCCTAA CCCTAA CCCTAA CCCTAA CCCTAA-3' (SEQ ID NO:2), and
a duplex thereof.

### Claim 17 (depends on 14)

The test kit according to claim 14, wherein said kit further comprises a labeled telomeric sequence.

### Claim 18 (depends on 14)

The test kit according to claim 14 wherein said label is selected from the group consisting of a radio label, an enzyme label, a fluorochrome label, a dye, a sol, biotin, and a luminescent label.

### Claim 19 (depends on 14)

The test kit according to claim 14, wherein the label is provided as one or more labeled anti-Ig-antibodies selected from the group consisting of anti-IgG, anti-IgM, anti-IgA, anti-IgD, and anti-IgE.

### Claim 20 (depends on 19)

The test kit according to claim 19 wherein said anti-Ig antibody is anti-IgG or anti-IgM.

### Claim 21

A test kit for the diagnosis of autoimmune disease in mammals, said test kit including a telomeric sequence of DNA selected from the group consisting of a dingle stranded telomere, a complementary strand thereto, a double stranded telomere, a part or a repeat or a combination of any of the foregoing, capable of binding autoantibodies present in said serum; and
an amount of one or more labelled anti-Ig-antibodies selected from the group consisting of anti-IgG, anti-IgM, anti-IgA, anti-IgD and anti-IgE.

### Claim 22 (depends on 21)

The test kit according to claim 21, wherein said telomeric sequence is immobilized on a solid support.

### Claim 23 (depends on 21)

The test kit according to claim 21 wherein said telomeric sequence is selected from the group consisting of the human telomere strand 5'-TTAGGG-3', the complementary strand thereto, a double stranded human telomere, a functional part of any of said strands, a repeat of any of said strands, and a combination of any of the foregoing.

### Claim 24 (depends on 23)

The test kit according to claim 23 wherein said repeat of said telomere strand is selected from the group consisting of
5'-TTAGGG TTAGGG TTAGGG TTAGGG TTAGGG-3' SEQ ID NO:1
5'-CCCTAA CCCTAA CCCTAA CCCTAA CCCTAA-3' SEQ ID NO:2 and
a duplex thereof.

### Claim 25 (depends on 21)

The test kit according to claim 21 wherein said label is selected from the group consisting of a radio label, an enzyme label, a fluorochromic label, a dye, a sol, biotin, and a luminescent label.

### Claim 26 (depends on 21)

The test kit according to claim 21 wherein said anti-Ig-antibody is anti-IgG or anti-IgM.