A 12-month, Open Label, Multicenter Pilot Study Evaluating Fingolimod Treatment in terms of Patient Satisfaction in Relapsing Remitting Multiple Sclerosis Patients - FINE Trial

Abstract

INTRODUCTIONMultiple sclerosis (MS) is a chronic immune-mediated disease of the central nervous system (CNS). Its primary characteristics are inflammation and damage to myelin sheaths, oligodendrocytes, axons, and neurons, and it mostly affects young adults. According to global estimates of the Multiple Sclerosis Foundation, more than 2 million people are affected by MS (1,2). Koch-Henriksen and Sørensen performed a large meta-regression analysis from the literature to investigate worldwide changes in demographic patterns of MS incidence and prevalence (2). The prevalence of the disease is higher among Caucasians and the female to male ratio of 2:1 has risen to 4:1 over recent years (3). Its etiology remains obscure; however, MS is believed to be caused through an intricate relationship between infectious agents and genetic and environmental aspects.Multiple sclerosis presents in four forms; the most frequently seen is relapsing-remitting MS (RRMS), which is diagnosed in 85% of patients with MS at onset. RRMS is characterized by more neuroinflammation than neurodegeneration; relapses and the generation of new lesions, which are visible with magnetic resonance imaging (MRI), particularly with contrast-enhancing T1-weighted lesions in particular; and worsening symptoms, followed by periods of stability. Over time, residual disabilities accumulate leading to permanent disability, and approximately 50% of people with untreated RRMS show transition to secondary progressive MS within a decade of the initial diagnosis, which is distinguished by its more extensive neurodegeneration, compared with inflammation (4). The remaining two presentations are primary progressive MS, which has no clear relapses or remissions and is diagnosed in approximately 10% of patients at onset, and progressive-relapsing MS, which affects 5% of patients. Introduction: To assess satisfaction and quality of life in patients with relapsing-remitting multiple sclerosis (RRMS) who were receiving fingolimod (0.5 mg/day) for 12 months as a second-line treatment after switching from injectable agents.