The disclosure relates to methods and assay that assists in the diagnosis of autoimmune and chronic inflammatory disorders such as systemic lupus erythematosus and rheumatoid arthritis by analyzing drug-responsiveness of an interferon signal in a hematological sample (e.g., blood) obtained from a human subject. The assay involves comparing the interferon signal in a control aliquot of the sample with the same interferon sample in an aliquot that has been exposed to a therapeutic modality (e.g., combined with a drug) that is known to be efficacious to treat the disorder. A significant difference between the interferon signals of the control and treated aliquots that corresponds to a characteristic interferon signature for the disorder indicates that the subject is afflicted with, or is likely to develop, the disorder.

Provided herein, in some embodiments, are methods of using certain cereblon-associated proteins, such as Aiolos, Ikaros, interferon (IFN), and IFN pathway proteins, casein kinase 1, alpha 1 (CSNK1A1), and ZFP9, as biomarkers for use in predicting and monitoring clinical sensitivity and therapeutic response to certain compounds in patients having various diseases and disorders, such as cancers (e.g., diffuse large B-cell lymphoma (DLBCL), multiple myeloma (MM), myelodysplasia syndromes (MDS) and acute myeloid leukemia (AML)) and IFN-associated disorders. Also provided herein, in certain embodiments, are methods of determining the efficacy of an immunomodulatory compound.

The present disclosure relates to the identification and use of biomarkers (e.g., analytes, analyte profiles, or markers (e.g., gene expression and/or protein expression profiles)) with clinical relevance to cytokine release syndrome (CRS).

Compositions of peptide fragments of preproinsulin for the treatment of type 1 diabetes and methods for selecting one or more peptide fragments of preproinsulin suitable for subject-specific immunomodulatory therapy for type 1 diabetes. The one or more peptides may be selected based on an autoimmune phenotype for the subject, which may be characterized by a stimulation assay and/or the based on a genotype for one or more genes related to type 1 diabetes.

The methods and apparatus of the present invention allow the evaluation of inflammation of the esophagus. Measurements may be utilized, for example, to diagnose a disease of the esophagus, to monitor inflammation of the esophagus, or to access the treatment of a disease of the esophagus. In one embodiment, the invention comprises a method for measuring esophageal inflammation comprising deploying a device into the esophagus of a subject, removing the device after a predetermined period of time, analyzing the device for a diagnostic indicator of esophageal inflammation and evaluating the diagnostic indicator to diagnose esophageal inflammation.

The invention provides methods, kits and reagents for diagnosing fibromyalgia (FM) in an individual by determining whether the levels of one or more cytokines in the individual are altered, as compared to control levels. The altered level(s) or patterns of expression of the cytokines measured in the affected individual compared to the level from the control is predictive/indicative of FM in the individual.

Provided are immunomodulatory pharmaceutical and non-pharmaceutical compositions that include alpha-synuclein and at least one preselected antigen, such as at least one preselected peptide antigen or immunogen. Also provided are methods for modulating immune activity toward at least one preselected antigen in an at least substantially antigen-specific manner that include administering such a composition to a human patient or to a non-human mammalian subject. Still further provided are enhanced assay methods for quantifying antigen-specific cellular responses, such as cytokine release, to preselected antigens.

A method for the early detection of head and neck cancer is provided. The method includes obtaining a saliva sample from a subject, determining the expression level of Desmoglien 3 (DSG3) in the saliva sample, and detecting head and neck cancer by the expression level of DSG3.

This document provides methods and materials involved in treating autoimmune conditions. For example, methods and materials for using either (a) one or more tumor necrosis factor alpha (TNF-) inhibitors or (b) one or more Janus kinase (JAK) inhibitors to treat autoimmune conditions such as rheumatoid arthritis are provided.

The invention provides compositions and methods of predicting a subject's risk of developing age-related macular degeneration (AMD) and methods of treating, delaying, or preventing the development and progression of AMD.