Assays and methods for diagnosing and treating autoimmune diseases. Particularly, the invention provides methods for differential diagnosis of specific autoimmune diseases, including autoimmune rheumatic disorders.

The present invention relates to methods for detecting whether a subject suffers from an autoimmune disease, such as, for example, antiphospholipid syndrome (APS), by detecting antiphospholipid antibodies (aPL) in a sample using a novel target, the lysobisphosphatidic acid (LBPA) bound to the endothelial protein C receptor (EPCR) or an LBPA-binding fragment thereof. Furthermore, the present invention relates to methods for identifying an inhibitor of endothelial protein C receptor (EPCR) function in autoimmune disease, preferably without a side effect on EPCR regulatory function in coagulation, and a method for producing a pharmaceutical composition comprising the steps of identifying a potential inhibitor, and suitably formulating said potential inhibitor into a pharmaceutical composition. Moreover, the present invention relates to said inhibitor as identified or said pharmaceutical composition for use in the prevention and/or treatment of an autoimmune disease, such as, for example, an antiphospholipid syndrome, in a subject. Furthermore, the present invention relates to a method for treating and/or preventing an autoimmune disease, such as, for example, antiphospholipid syndrome, in a subject.

The present invention relates to a method aiding in the assessment of rheumatoid arthritis (“RA”). The method is used in assessing RA in vitro. It is practiced by analyzing biochemical markers, comprising measuring the concentration of anti-CCP and anti-PIK3CD and correlating the concentrations determined to the absence or presence of RA. The invention also relates to the use of a marker panel comprising anti-CCP and anti-PIK3CD in the diagnosis of RA and it teaches a kit for performing the method of the invention. Further the invention relates to the use of a marker panel comprising anti-CCP and anti-PIK3CD to differentiate RA from other autoimmune diseases, preferably osteoarthritis (OA).

Described are glutathione adducts of fatty aldehydes (FALD-GSH) and methods useful in the detection of FALD-GSH in the identification of pathologies associated with leukocyte-mediated disease conditions, including eosinophil and neutrophil activation. Thus, the present disclosure provides methods of diagnosing a subject as having or being at risk of developing a leukocyte-mediated disease (LMD) comprising (a) detecting the level of glutathione adducts of 2-halofatty aldehydes (FALD-GSH) in a sample; (b) comparing the amount of FALD-GSH with a control or standard reflective of diseased and/or healthy levels of FALD-GSH; and (c) diagnosing the subject as having or being at risk of developing LMD if the level of FALD-GSH in the sample is higher than the control or standard.

This document provides methods and materials involved in assessing mammals (e.g., humans) for arthritis. For example, methods and materials for assessing a mammal's gut microbial diversity to identify the mammal as having arthritis (e.g., rheumatoid arthritis) are provided. This document also provides methods and materials involved in treating arthritis.

Described herein are methods for treating rheumatoid arthritis by determining whether a subject having rheumatoid arthritis will respond to an anti-TNF-alpha therapy based on the number of innate and adaptive immune cells in a sample from the subject prior to treatment.

Aspects of the application relate to methods and systems for obtaining information regarding multiple amino acids in a polypeptide based on binding interactions between the polypeptide and one or more amino acid recognizers. Kinetic signature information may be obtained from a series of signal pulses indicative of a series of binding events between one or more amino acid recognizers and an amino acid of a polypeptide (e.g., a terminal amino acid, an internal amino acid). The kinetic signature information (e.g., pulse duration, interpulse duration, recognition segment (RS) duration, intersegment duration) may be used to determine one or more chemical characteristics (e.g., identity, modification) of multiple amino acids of the polypeptide.

The present invention relates to an in vitro method for evaluating the prognosis of an autoimmune or chronic inflammatory disease in an individual, comprising the following steps: a) determining (i) the level of an anti-IL-17 autoantibody and/or (ii) the level of an [IL-17/anti-IL-17 autoantibody] complex in a biological sample of the individual, and b) comparing the level of autoantibody and/or of complex determined in step a) with a reference value, the comparison being indicative of the prognosis of an autoimmune or chronic inflammatory disease in said individual.

This disclosure provides methods and compositions for detecting Tph cells and/or reducing the number (or frequency) and/or activity of such cells in order to provide therapeutic benefit to a subject having or at risk of developing an autoantibody-associated condition such as an autoantibody-associated autoimmune disease.

A method, device, computer program and related immunoassay are disclosed for assessing the efficacy of a statin selected from, for example, selected from RvT1 (7,13,20-trihydroxy-8,10,14,16Z,18-docosapentaenoic acid), RvT2 (7,12,13-trihydroxy-8,10,14,16Z,19Z-docosapentaenoic acid), RvT3 (7,8,13-trihydroxy-9,11,14,16Z,19Z-docosapentaenoic acid) and RvT4 (7,13-dihydroxy-8,10,14,16Z,19Z-docosapentaenoic acid), for use in the treatment of an inflammatory condition in an individual patient, which comprises measuring the levels of at least one 13-series resolvin in biological samples obtained from the patient before and after administration of the statin, wherein an increase in the level of the resolvin after administration of the statin is indicative of efficacy of the statin. Also disclosed is a method of storing a biological sample to preserve lipid mediators in the sample comprising placing the sample in an organic solvent and storing the sample at a temperature of ≤−75° C.