Abstract: The invention relates to a method for assessing the efficacy of an immunotherapy comprising administration of GAD to a patient, comprising the following steps: measuring at least one of GADA IgG subclass distribution; GADA levels; distribution of cytokines secreted from lymphocytes; and lymphocyte proliferation in presence of GAD or CD3/CD28 beads; in a first blood, plasma or serum sample obtained from said patient at a first point in time and in a second blood, plasma or serum sample obtained from said patient at a later point in time; and comparing the so obtained measurements. The invention also relates to novel administration regimens of GAD in treatment or prevention of type 1 diabetes, that may include administration by injection into a lymph node, oral administration of vitamin D and/or an assessment of efficacy according to the above methodology followed by an adjustment of dosage and/or administration route based on said assessment.

Abstract: The present invention relates to methods and formulations for GAD-vaccination to evoke a systemic effect rather that a GAD-specific effect. The present invention may therefore be used in the treatment of disease in humans not bearing on a GAD-specific effect. The invention includes a method to treat an autoimmune disease or disorder by administering at least one sequestered autoantigen in a prime and boost regimen for sensitization purposes followed by a boost for treatment purposes. This may be done upon diagnosis. Examples of sequestered autoantigens include: GAD65, GAD67, Pro-Insulin, Basic Myelin Protein, MOG and Chondrotoin II. The present invention relates to medications and methods for treatment of autoimmune disease within six months from diagnosis.