The relation between peripheral levels of CD19+ B cells with the inflammatory activity and the prognosis of multiple sclerosis: a pilot cohort study in patients with multiple sclerosis from Girona

Abstract

TITLE: The relation between peripheral levels of CD19+ b cells with the inflammatory activity and the prognosis of multiple sclerosis. A pilot cohort study in patients with multiple sclerosis from Girona. BACKGROUND: Multiple sclerosis (MS) is a chronic autoimmune inflammatory disease of the central nervous system. Globally, it is the first cause of non-traumatic neurological disability in young adults having a great impact in the health system. Although it has been thoroughly investigated, its pathogenesis remains unclear. Recent studies have shown that besides T cells, B cells are also involved in the pathological pathways of the disease. This new finding has led to new fields of investigation as new drugs are being developed and new biomarkers of diagnosis, treatment and prognosis have been proposed. OBJECTIVE: The purpose of this study is to determine whether the levels of CD19+ B cells in peripheral blood of patients who have just been diagnosed with Multiple Sclerosis (MS) are related to the inflammatory activity and prognosis of the disease. DESIGN: The selected study design is a pilot ambispective cohort study. METHOD: Peripheral blood samples from almost 200 patients involved in the BioEM study carried out in the Unitat de Neuroimmunologia i Esclerosi Multiple (UNIEM), will be analysed to determine the levels of CD19+ B cells at the onset of the disease. Then, a minimum follow-up period of 4 years is required to assess the evolution of the disease which will be evaluated measuring the inflammatory activity and the neurological disability. The first one will be assessed using the information from the basal lumbar puncture and the reports from the annual brain MRI and the latter will be described using the Kurtzke EDSS. When all the data is compiled, CD19 levels will be compared with the presence or absence of Gadolinium enhancing lesions; presence or absence of new or enlarged T2 lesions; OCGB index and OCMB in CSF; all of them surrogate markers of inflammatory activity. Plus, the levels will be compared to the presence or absence of progression of the neurological disability