Systemic Lupus Erythematosus is marked by altered immune regulation linked to waxing and waning clinical disease. Embodiments described herein identify sets of biomarkers/mediators and their use for informing and/or predicting a future SLE disease activity event such as an impending SLE flare or SLE-related organ inflammation. Such an approach can be beneficial in the management of lupus.

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 invention provides a method for determining a systemic lupus erythematosus-associated disease state in a subject comprising the steps of (a) providing a sample to be tested; and (b) measuring the presence and/or amount in the test sample of one or more biomarker(s) selected from the group defined in Table A, wherein the presence and/or amount in the test sample of the one or more biomarker(s) selected from the group defined in Table A is indicative of a systemic Lupus-associated disease state. The invention also provides an array and a kit suitable for use in the methods of the invention.

Provided herein are methods of using compounds and compositions for treating, managing, and/or preventing systemic lupus erythematosus (SLE). Pharmaceutical compositions and dosing regimens for use in the methods are also provided herein.

The invention relates to a method for detecting and measuring the presence of mono-nucleosomes and oligo-nucleosomes and nucleosomes that contain particular histone variants and the use of such measurements for the detection and diagnosis of disease. The invention also relates to a method of identifying histone variant biomarkers for the detection and diagnosis of disease and to biomarkers identified by said method.

The disclosure relates to antibodies specific to FcRn, formulations comprising the same, use of each in therapy, processes for expressing and optionally formulating said antibody, DNA encoding the antibodies and hosts comprising said DNA.

The invention provides a method for determining a systemic lupus erythematosus-associated disease state in a subject comprising the steps of (a) providing a sample to be tested; and (b) measuring the presence and/or amount in the test sample of one or more biomarker(s) selected from the group defined in Table A, wherein the presence and/or amount in the test sample of the one or more biomarker(s) selected from the group defined in Table A is indicative of a systemic lupus. The invention also provides an array and a kit suitable for use in the methods of the invention.

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 provides methods of diagnosing and monitoring systemic lupus erythematosus.

Methods and reagents for diagnosing, prognosing, and treating systemic lupus erythematosus (SLE) are disclosed, involving calculating an SLE risk score for a subject based on a level of each of an erythrocyte C4d (EC4d) marker, a B-cell C4d (BC4d) marker, anti-nuclear antibodies (ANA), and optional rule-out markers.