Abstract: This invention related to methods and assays for screening for, identifying, and predicting the severity and clinical manifestations of systemic lupus erythematosus (SLE). Specifically, this invention provides various biomarkers for the prediction of flares of the disease both in number and severity, as well as clinical manifestations of the disease, and methods of using these biomarkers to correctly subclassify patients with this disease, and prescribe appropriate treatment. The invention also provides for biomarkers of lupus disease activity, i.e., flares, as well as biomarkers for the prediction of future flares, and methods of using these biomarkers. The invention also provides, in these biomarkers, targets and methods for drug development and basic research for SLE.

Abstract: The present invention relates to methods for identifying patients that will respond to treatment with anti-TNF-therapy, i.e., anti-TNF responder patients. In particular, the present invention relates to determining response to an inhibitor of tumor necrosis factor (TNF) in a patient with a chronic inflammatory disease by determining the activity of type I interferon in the patient. The invention further relates to quantification of type I interferon as a measure of predicting responsiveness to anti-TNF therapy in patients with a chronic inflammatory disease such as rheumatoid arthritis (RA), psoriatic arthritis, ankylosing spondylitis, juvenile chronic arthritis, lupus, Crohn's disease, as well as for cardiovascular disease.

Abstract: This invention related to methods and assays for screening for, identifying, and predicting the severity and clinical manifestations of systemic lupus erythematosus (SLE). Specifically, this invention provides various biomarkers for the prediction of flares of the disease both in number and severity, as well as clinical manifestations of the disease, and methods of using these biomarkers to correctly subclassify patients with this disease, and prescribe appropriate treatment. The invention also provides for biomarkers of lupus disease activity, i.e., flares, as well as biomarkers for the prediction of future flares, and methods of using these biomarkers. The invention also provides, in these biomarkers, targets and methods for drug development and basic research for SLE.

Abstract: The present invention relates to methods for identifying patients that will respond to treatment with anti-TNF-therapy, i.e., anti-TNF responder patients. In particular, the present invention relates to determining response to an inhibitor of tumor necrosis factor (TNF) in a patient with a chronic inflammatory disease by determining the activity of type I interferon in the patient. The invention further relates to quantification of type I interferon as a measure of predicting responsiveness to anti-TNF therapy in patients with a chronic inflammatory disease such as rheumatoid arthritis (RA), psoriatic arthritis, ankylosing spondylitis, juvenile chronic arthritis, lupus, Crohn's disease, as well as for cardiovascular disease.

Abstract: The invention provides novel methods for determining susceptibility for, diagnosing, and/or treating complex diseases such as autoimmune diseases, Alzheimer's disease, and schizophrenia. The novel methods are based upon the finding that the positioning of long interspersed nuclear elements (LINEs) in the genome can play an important role in the induction and progression of complex diseases. Specifically, the distance and interaction between a LINE such as the L1 element and a susceptibility gene associated with a complex diseases can provide information about the risk for the complex disease, and also provide novel targets for therapy.

Abstract: Four unique transcripts have been isolated from the &bgr; chain of the T cell receptor in T cells in the synovial tissue of a patient with rheumatoid arthritis. Two of these transcripts were isolated from fresh synovial tissue and two were isolated from a T cell line derived from the synovial tissue. The sequences of the four transcripts are highly homologous, with a conserved amino acid sequence of IGQ_N in the highly diverse V-D junction. The &agr; chain and the antigenic specificity of the T cell line derived transcripts has also been characterized.

Abstract: The present invention provides diagnostic methods for determining the severity of disease or disease activity in patients suffering from autoimmune, inflammatory, malignant, vascular, or viral diseases, which involves measuring the level of CD40 ligand (CD40L) in the patient's serum or other body fluid.

Abstract: Four unique transcripts have been isolated from the .beta. chain of the T cell receptor in T cells in the synovial tissue of a patient with rheumatoid arthritis. Two of these transcripts were isolated from fresh synovial tissue and two were isolated from a T cell line derived from the synovial tissue. The sequences of the four transcripts are highly homologous, with a conserved amino acid sequence of IGQ.sub.-- N in the highly diverse V-D junction. The .alpha. chain and the antigenic specificity of the T cell line derived transcripts has also been characterized.

Abstract: Antibodies to specific subsets of T cells can be obtained by incubating a polyclonal population of T cells with a microbial superantigen, and injecting of the incubated T cells into a host animal. Antibodies obtained by this method and methods of use thereof are also provided.

Abstract: This invention relates to a method of obtaining antibodies specific to a population of T-lymphocytes (T cells) restricted by V.beta. gene usage. The invention also relates to the antibodies obtained and to methods of using them. According to the invention, T cells are incubated with an effective amount of a superantigen under conditions and for a time sufficient to allow division and growth of T-cells reactive to the superantigen. The incubated T-cells are injected into a mammal, and thereafter serum containing antibodies specific to the incubated and injected T-cells is removed from the mammal.