Methods and compositions for diagnosing multiple sclerosis (“MS”) in an individual or the predisposition or risk of MS, and for the prediction of the response to treatment of MS in an individual. More particularly, methods and compounds for the use of clinical, neuroradiological, genetic, biological and/or immunological markers as prognostic indicators, diagnostic markers, or predictors of response to MS therapy.

Methods and systems to characterize multiple sclerosis (MS) in a subject, e.g., in a subject having a progressive form of MS are disclosed.

The methods disclosed herein include diagnosing a patient with MS, selecting a patient for further testing for MS, should the patient show elevated level of human IgG relative to an appropriate control. The methods also include differentiating subtypes of MS. The methods also include evaluating the efficacy of an MS drug or course of drug treatments, and/or treating MS. The methods include determining whether patients have elevated levels of IgG3-IgG1 immune complexes (which can include glycosylated IgG antibodies) in both blood and CSF. Methods also include diagnosing patients with primary-progressive MS (PPMS) and secondary-progressive MS (SPMS) where patients have higher levels of IgG3-IgG1 complexes in both CSF and blood, and reduced levels of albumin compared to patients with relapsing-remitting MS (RRMS). The methods optionally include treating the sample to dissociate immune and/or protein complexes, contacting the sample with a reagent that binds specifically to a human IgG or other protein, comparing the results to an appropriate control, and determining whether the patient has an altered level of IgG or other protein consistent with MS.

Methods of selecting a subject for treatment of amyotrophic lateral sclerosis (ALS) and methods of treatment for subjects having ALS or at risk of developing ALS are provided. The method of selecting subjects for treatment includes obtaining a biological sample from the subject, where the sample is obtained from the subject's gastrointestinal tract or skeletal muscle. The method further includes measuring a biomarker in the subject's sample and selecting the subject for treatment of ALS when the biomarker measurement in the subject's sample is lower or higher relative to a control measurement.

Provided are methods and kits for early determination of disease outcome and prognosis of Multiple Sclerosis (MS) patients and for adjustment of suitable treatment.

Contemplated compositions and methods are directed to prevent and/or treat various autoimmune diseases that are typically associated with glycan dysregulation, and especially autoimmune demyelinating diseases. Further especially contemplated aspects include animal models and systems for screening compounds to treat and/or prevent such diseases.

The present disclosure relates to the use of a soluble CD52 glycoprotein in treating diseases regulated by effector T-cells, for example sepsis or multiple sclerosis. The present disclosure also relates to diagnostic methods based on the detection of CD52 expression levels in a subject.

The present invention refers to a method of predicting response of a human subject to Interferon beta, (IFN-β), wherein the subject is suffering from Multiple Sclerosis (MS), and wherein the method comprises using, as an indicator, the percentage of CD5+ CD19+ CD45+ B cells over the total count of lymphocytes (CD45+ cells) in a biological sample originating from the human subject and the percentage of CD8+ CD45+ perforin+ T cells over the total count of lymphocytes (CD45+ cells) in a biological sample originating from the human subject, wherein if the percentage of CD5+ CD19+ CD45+ B cells over the total count of lymphocytes (CD45+ cells) is lower than or equal to 3% and/orthe percentage of CD8+ CD45+ perforin+ T cells over the total count of lymphocytes (CD45+ cells) is greater than or equal to 1%, is indicative of response.

The present disclosure provides for the diagnosis and prediction of neuromyelitis optica (NMO) in subject. It also provides for treatment of multiple sclerosis (MS) in a subject. Thus, in accordance with the present disclosure, there is provided a method for treating a subject having neuromyelitis optica (NMO) comprising administering to said subject an inhibitor of B-cell activating factor (BAFF) and/or an inhibitor or proliferating inducing ligand (APRIL).

The invention is directed to methods of promoting myelin formation in central nervous system (CNS) tissue in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of interleukin-4 induced gene 1 (IL4-i1) protein. The invention is also directed to methods of monitoring the progression of conditions marked by an impairment of myelin formation in the CNS comprising assessing the levels or activity of IL4-i1 in activated macrophages obtained from the subject.