Method for diagnosing and treating fibromyalgia

Abstract

The invention provides methods, kits and reagents for diagnosing fibromyalgia (FM) in an individual by determining whether the levels of one or more cytokines in the individual are altered, as compared to control levels. The altered level(s) or patterns of expression of the cytokines measured in the affected individual compared to the level from the control is predictive/indicative of FM in the

1 - 54 . (canceled) 
     
     
         55 . A method for diagnosing fibromyalgia (FM) in an individual comprising:
 (a) stimulating a peripheral blood mononuclear cell (PBMC) sample obtained from the individual with one or more mitogens,   (b) determining the protein expression levels in the PBMC sample of at least four cytokines selected from the group consisting of IL5, IL6, IL8, IL 10, IFN-γ, MCP-1, MIP-α and MIP-β at the protein level by an antibody bead-based capture assay, wherein the bead-based capture assay comprises beads derivatized with antibodies specific to the at least four cytokines,   (c) comparing the detected levels of protein expression to the expression of the at least four cytokines in a control sample,   (d) diagnosing the individual with FM if the at least four cytokines have an altered expression in the PBMC sample, as compared to the expression levels of the at least four cytokines in the control sample.   
     
     
         56 . The method of  claim 55 , wherein determining the protein expression levels in the PBMC sample comprises determining the protein expression levels of at least five cytokines selected from the group consisting of IL5, IL6, IL8, IL 10, IFN-γ, MCP-1, MIP-α and MIP-β. 
     
     
         57 . The method of  claim 55 , wherein determining the protein expression levels in the PBMC sample comprises determining the protein expression levels of at least six cytokines selected from the group consisting of IL5, IL6, IL8, IL 10, IFN-γ, MCP-1, MIP-α and MIP-β. 
     
     
         58 . The method of  claim 55 , wherein determining the protein expression levels in the PBMC sample comprises determining the protein expression levels of at least seven cytokines selected from the group consisting of IL5, IL6, IL8, IL 10, IFN-γ, MCP-1, MIP-α and MIP-β. 
     
     
         59 . The method of  claim 55 , wherein determining the protein expression levels in the PBMC sample comprises determining the protein expression levels of IL5, IL6, IL8, IL 10, IFN-γ, MCP-1, MIP-α and MIP-β. 
     
     
         60 . The method of  claim 55 , wherein the at least four cytokines are IL6, IL8, MIP-α and MIP-β. 
     
     
         61 . The method of  claim 55 , wherein the one or more mitogens comprises a T-cell mitogen. 
     
     
         62 . The method of  claim 55 , wherein the one or more mitogens is selected from the group consisting of lipopolysaccharide (LPS), phytohemagglutinin (PHA), phorbol ester, phorbol myristate acetate (PMA), PMA with ionomycin, pokeweed mitogen (PWM) and concavalin A (Con-A). 
     
     
         63 . The method of  claim 55 , wherein the altered expression is characterized by an increase or decrease in expression of the at least four cytokines by at least about 1.5 times, at least about 2 times, at least about 2.5 times, at least about 3 times, at least about 4 times or at least about 5 times. 
     
     
         64 . The method of  claim 55 , wherein the bead-based assay is a fluorescence-based assay. 
     
     
         65 . The method of  claim 55 , wherein the bead-based capture assay is an enzyme-linked immunoassay (ELISA) assay. 
     
     
         66 . The method of  claim 55 , wherein the beads derivatized with antibodies specific to the at least four cytokines are magnetic beads. 
     
     
         67 . The method of  claim 56 , wherein the at least five cytokines comprise IL6, IL8, MIP-α and MIP-β and one or more cytokines selected from IL5, IL10, IFN-γ and MCP-1. 
     
     
         68 . The method of  claim 56 , wherein the one or more mitogens comprises a T-cell mitogen. 
     
     
         69 . The method of  claim 56 , wherein the one or more mitogens is selected from the group consisting of lipopolysaccharide (LPS), phytohemagglutinin (PHA), phorbol ester, phorbol myristate acetate (PMA), PMA with ionomycin, pokeweed mitogen (PWM) and concavalin A (Con-A). 
     
     
         70 . The method of  claim 56 , wherein the bead-based capture assay is an enzyme-linked immunoassay (ELISA) assay. 
     
     
         71 . The method of  claim 57 , wherein the at least six cytokines comprise IL6, IL8, MIP-α and MIP-β and two or more cytokines selected from IL5, IL10, IFN-γ and MCP-1. 
     
     
         72 . The method of  claim 57 , wherein the one or more mitogens comprises a T-cell mitogen. 
     
     
         73 . The method of  claim 57 , wherein the one or more mitogens is selected from the group consisting of lipopolysaccharide (LPS), phytohemagglutinin (PHA), phorbol ester, phorbol myristate acetate (PMA), PMA with ionomycin, pokeweed mitogen (PWM) and concavalin A (Con-A). 
     
     
         74 . The method of  claim 57 , wherein the bead-based capture assay is an enzyme-linked immunoassay (ELISA) assay. 
     
     
         75 . The method of  claim 58 , wherein the at least seven cytokines comprise IL6, IL8, MIP-α and MIP-β and three or more cytokines selected from IL5, IL10, IFN-γ and MCP-1. 
     
     
         76 . The method of  claim 58 , wherein the one or more mitogens comprises a T-cell mitogen. 
     
     
         77 . The method of  claim 58 , wherein the one or more mitogens is selected from the group consisting of lipopolysaccharide (LPS), phytohemagglutinin (PHA), phorbol ester, phorbol myristate acetate (PMA), PMA with ionomycin, pokeweed mitogen (PWM) and concavalin A (Con-A). 
     
     
         78 . The method of  claim 58 , wherein the bead-based capture assay is an enzyme-linked immunoassay (ELISA) assay.