Biomarkers for Systemic Lupus Erythematosus Disease, and Intensity and Flare

Abstract

The present invention involves the identification of biomarkers that are predictive of impeding systemic lupus erythematosus (SLE) disease flare. Methods for treating patients so identified are also provided.

1 - 30 . (canceled) 
     
     
         31 . A kit comprising:
 (a) one or more reagents for assessing the expression of at least four chemokines or adhesion molecules ;   (b) one or more reagents for assessing the expression of at least two TNFR superfamily member molecules;   (c) one or more reagents for assessing the expression of at least two regulatory mediator molecules;   (d) one or more reagents for assessing the expression of at least two SLE mediator molecules; and   (e) one or more reagents for assessing anti-nuclear antibody (ANA) testing and/or anti-extractable nuclear antigen (anti-ENA) in a biological sample.   
     
     
         32 . The kit of  claim 31 , wherein said chemokines or adhesion molecules are selected from the group consisting of C-C motif chemokine ligand 2 (CCL2)/monocyte chemoattractant protein-1 (MCP-1), C-C motif chemokine ligand 3 (CCL3)/macrophage inflammatory protein-1 alpha (MIP-1α), C-X-C motif chemokine ligand 10 (CXCL10)/IFN-gamma-inducible protein 10 (IP-10), C-X-C motif chemokine ligand 9 (CXCL9)/monokine induced by interferon-gamma (MIG), C-C motif chemokine ligand 4 (CCL4)/macrophage inflammatory protein-1 beta (MIP-1β), Intercellular Adhesion Molecule 1 (ICAM-1), monocyte-specific chemokine 3 (CCL7/MCP-3), vascular cell adhesion molecule-1 (VCAM-1), and interleukin-8 (CXCL8/IL-8) . 
     
     
         33 . The kit of  claim 31 , wherein said TNFR superfamily member molecules are selected from the group consisting of tumor necrosis factor receptor I (TNFRI), tumor necrosis factor receptor II (TNFRII), tumor necrosis factor-related apoptosis-inducing ligand (TRAIL), B-lymphocyte stimulator (BLyS), Fas, nerve growth factor-β (NGF-β), and tumor necrosis factor-α (TNF-α) . 
     
     
         34 . The kit of  claim 31 , wherein said regulatory mediator molecules are selected from the group consisting of transforming growth factor beta (TGF-β), interleukin-1 receptor antagonist (IL-1RA), and interleukin-10 (IL-10) . 
     
     
         35 . The kit of  claim 31 , wherein said reagents are beads attached to binding ligands for each of said biomarkers. 
     
     
         36 . The kit of  claim 31 , wherein said SLE mediator molecules are stem cell factor (SCF) and Resistin. 
     
     
         37 . The kit of  claim 31 , further comprising:
 (f) one or more reagents for assessing the expression of one or more innate cytokines;   (g) one or more reagents for assessing the expression of one or more Th1 cytokines;   (h) one or more reagents for assessing the expression of one or more Th2 cytokines; and/or   (i) one or more reagents for assessing the expression of one or more Th17 cytokines.   
     
     
         38 . The kit of  claim 37 , wherein
 the one or more innate cytokines are selected from the group consisting of interferon-alpha (IFN-α), interleukin-15 (IL-15), interleukin-7 (IL-7), interleukin-1α (IL-1α), and interleukin-1β (IL-1β);   the one or more Th1 cytokines are selected from the group consisting of interferon-gamma (IFN-γ), interleukin-12p70 (IL-12p70), interleukin-2 (IL-2), and interleukin-2R α  (IL-2R α );   the one or more Th2 cytokines are selected from the group consisting of interleukin-4 (IL-4) and interleukin-13 (IL-13); and   the one or more Th17 cytokines are selected from the group consisting of interleukin-17A (IL-17A), interleukin-6 (IL-6), interleukin-21 (IL-21), and interleukin-23 (IL-23).   
     
     
         39 . The kit of  claim 31 , wherein the kit comprises:
 one or more reagents for assessing the expression of CCL2/MCP-1, CCL3/MIP-1α, CXCL10/IP-10, and CXCL9/MIG;   one or more reagents for assessing the expression of TNFRI and TNFRII;   one or more reagents for assessing the expression of TGF-β and IL-1 RA; and   one or more reagents for assessing the expression of SCF.   
     
     
         40 . The kit of  claim 39 , further comprising:
 one or more reagents for assessing the expression IL-7, IL-1α, or IL-1β;   one or more reagents for assessing the expression of IFN-γ, IL-12p70, IL-2 or IL-2Rα;   one or more reagents for assessing the expression IL-13 or IL-4; and/or   one or more reagents for assessing the expression IL-17A, IL-6, IL-21, and IL-23.   
     
     
         41 . The kit of  claim 31 , further comprising buffers, diluents, filters, and/or package inserts with instructions.