METHOD OF USING CYTOKINE ASSAY TO DIAGNOSE, TREAT, AND EVALUATE INFLAMMATORY AND AUTOIMMUNE DISEASES

• US 20090325167A1
• Filed: 03/24/2009
• Published: 12/31/2009
• Est. Priority Date: 09/15/2003
• Status: Abandoned Application

• Current Assignee: Oklahoma Medical Research Foundation, The Board of Regents of the University of Colorado (University of Colorado System)
• Original Assignee: Oklahoma Medical Research Foundation, The Board of Regents of the University of Colorado (University of Colorado System)
• Inventors: Hensley, Kenneth, Alex, Philip J., Chappell, Cherie M., Centola, Michael B.
• Application Number:
  US12/410,394
• Publication Number:
  US 20090325167A1
• Time in Patent Office: Days
• US Class Current: 435/6.16
• CPC Class Codes: G01N 2800/104 Lupus erythematosus [SLE]
• CPC Class Codes: G01N 2800/24 Immunology or allergic disorders SLE G01N2800/104
• CPC Class Codes: G01N 2800/52 Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
• CPC Class Codes: 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
• CPC Class Codes: G01N 33/6863 Cytokines, i.e. immune system proteins modifying a biological response such as cell growth proliferation or differentiation, e.g. TNF, CNF, GM-CSF, lymphotoxin, MIF or their receptors

Abstract

The invention provides methods for diagnosing, treating, or evaluating inflammatory and autoimmune diseases by sampling peripheral blood, serum, plasma, tissue, cerebrospinal fluit, or other bodily fluids from a human subject having a suspected diagnosis. The sample is analyzed for the presence and amount of certain cytokines, which provides the diagnosis, prognosis or evaluation of therapeutic response.

Claims

1-80. -80. (canceled)

81. A method for aiding in the diagnosis of irritable bowel syndrome (IBS), said method comprising:

(a) obtaining a patient sample;

(b) measuring the level of a cytokine within the patient sample using an assay system or assay device;

(c) comparing the measured cytokine level of the patient sample with a pre-defined level of the cytokine found in normal or inflammatory states;

(d) determining if the patient has IBS based on the comparison in step (c); and

(e) reporting the determination to the patient or a clinician.

82. The method of claim 81, wherein the sample is a member selected from the group consisting of peripheral blood, serum, plasma, cerebrospinal fluid, tissue sample, skin, or other body fluid sample.

83. The method of claim 82, wherein the sample is serum.

84. The method of claim 81, wherein the cytokine is selected from the group consisting of TNF-α

, IFN-γ

, IL-1β

, IL-6, IL-7, GM-CSF, G-CSF, CCL2/MCP-1, and CXCL8/IL-8.

85. The method of claim 84, wherein the cytokine is IL-1β

.

86. The method of claim 81, wherein the assay system or assay device measures cytokine levels by cytokine expression.

87. The method of claim 86, wherein cytokine expression is measured using a member selected from the group consisting of PCR, competitive PCR, PCR-ELISA, a microarray, gene expression bead-based assays, and an in situ hybridization technique.

88. The method of claim 86, wherein cytokine expression is measured by immunohistochemistry.

89. The method of claim 86, wherein the cytokine levels are detected by a member selected from the group consisting of a visual means, chemiluminescence, a radiolabel, a fluorescent label, and electrical or thermal impulse signals.

90. The method of claim 86, wherein the cytokine levels are detected using a Southern blot or a Northern blot.

91. The method of claim 86, wherein the cytokine levels are detected using an ELISA.

92. A method for determining if a patient with irritable bowel syndrome (IBS) is predisposed to develop a severe inflammatory disease state, said method comprising:

(a) obtaining a patient sample;

(b) measuring the level of a cytokine within the patient sample using an assay system or assay device;

(c) comparing the measured cytokine level of the patient sample with a pre-defined level of the cytokine found in normal or inflammatory states;

(d) determining if said patient is predisposed to develop a severe inflammatory disease state; and

(e) reporting the determination to the patient or a clinician.

93. The method of claim 92, wherein the sample is a member selected from the group consisting of peripheral blood, serum, plasma, cerebrospinal fluid, tissue sample, skin, or other body fluid sample.

94. The method of claim 93, wherein the sample is serum.

95. The method of claim 92, wherein the cytokine is selected from the group consisting of TNF-α

, IFN-γ

, IL-1β

, IL-6, IL-7, GM-CSF, G-CSF, CCL2/MCP-1, and CXCL8/IL-8.

96. The method of claim 95, wherein the cytokine is IL-1β

.

97. The method of claim 92, wherein the assay system or assay device measures cytokine levels by cytokine expression.

98. The method of claim 97, wherein cytokine expression is measured using a member selected from the group consisting of PCR, competitive PCR, PCR-ELISA, a microarray, gene expression bead-based assays, and an in situ hybridization technique.

99. The method of claim 97, wherein cytokine expression is measured by immunohistochemistry.

100. The method of claim 97, wherein the cytokine levels are detected by a member selected from the group consisting of a visual means, chemiluminescence, a radiolabel, a fluorescent label, and electrical or thermal impulse signals.

101. The method of claim 97, wherein the cytokine levels are detected using a Southern blot or a Northern blot.

102. The method of claim 97, wherein the cytokine levels are detected using an ELISA.