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 of identifying a subgroup of patients suffering from diffuse cutaneous systemic sclerosis (dcSSc) which subgroup of patients benefits from a treatment with at least one sGC stimulator and/or sGC activator in a higher degree than patients not belonging to this subgroup.

The present invention in general relates to the field of antibody profiling in spondyloarthritis. In particular, the inventors found that antibody levels against selected peptides are raised in spondylarthritis patients, and herein provide a diagnostic method and kit comprising such peptides for use in the diagnosis of spondyloarthritis.

A system and method for the detection of autoantibodies in saliva is described. In particular, the system is suitable for detecting an autoantibody in a subject, wherein the presence of the autoantibody is indicative of the presence or increased risk of development of an autoimmune disease or disorder.

A method can be used for detecting, in a sample, an autoantibody binding to a polypeptide having the sequence SEQ ID NO: 1, SEQ ID NO: 11 or SEQ ID NO: 24. A carrier containing said polypeptide and an autoantibody binding to said polypeptide are useful. The autoantibody may be used for the diagnosis of a disease, and a method can be used for isolating an autoantibody binding to said polypeptide. The polypeptide and a kit containing said polypeptide are useful, and can be used for the manufacture of a kit or medical device. A method involves contacting a medical or diagnostic device containing said polypeptide with a buffered solution containing an antibody binding specifically to said polypeptide. A sample containing said autoantibody as a positive control and a diluted sample containing said autoantibody are useful.

The present invention includes a method and kit of determining that a patient negative for anti- Ro autoantibodies has Sjögren’s syndrome (SS) without performing a lip biopsy comprising: obtaining a liquid biological sample from the patient suspected of having SS; determining that the patient is negative for anti-Ro autoantibodies; and detecting autoantibodies to 1, 2, 3, 4, 5, 6, 7, 8, or 9 proteins selected from: CCDC155, DDB1, MUM1L1, NFU1, RPS29, SOX5, TCP10, ZNF655, or RPAP3, which indicate(s) that the patient has SS. Also, a lack of certain autoantibodies such as KCNAB1, KCNAB2, or as listed in Table 1, Table 2, or Table 3, and FIGS. 11 or 16 in Ro neg cases may be used to detect SS.

Described herein is the finding that patients with Sjögren's syndrome exhibit a statistically significant increase in expression of BMP6 in the salivary gland, relative to healthy control subjects. Also described herein is the finding that overexpression of BMP6 in the salivary glands of mice results in an increase in electrical potential across the salivary gland. Thus, provided herein are methods of diagnosing a subject as having Sjögren's syndrome, or at risk for developing Sjögren's syndrome, by measuring the level of BMP6 expression in a salivary gland of a subject, measuring electrical potential in a salivary gland of a subject, or both. Also provided herein are methods of treating a subject with Sjögren's syndrome by administering an agent that inhibits expression of BMP6 expression or activity. Also described herein is the use of XIST and MECP2 as diagnostic and therapeutic targets for male Sjögren's syndrome patients.

The application relates to a method for diagnosis of an autoimmune disease, comprising the step of determining the presence or absence of antibodies directed against CSa-receptor in a sample of the subject to be diagnosed, wherein the presence of antibodies directed against CSa-receptor is indicative of an autoimmune disease in said subject. Furthermore, the application relates to kits comprising C5a-receptor or an immunogenic fragment thereof and the use of CSa-receptor.

This invention is directed to methods and compositions for diagnosis, prognosis and for determining methods of treatment. The physiological status of a cell present in a sample (e.g. clinical sample) can be used in diagnosis or prognosis of a condition (e.g. Chronic Lymphocytic Leukemia), in patient selection for therapy, to monitor treatment and to modify or optimize therapeutic regimens.

Methods of treating patients and evaluating patients for disease stage and/or severity are disclosed.