Multiple Sclerosis: A Global Concern with Multiple Challenges in an Era of Advanced Therapeutic Complex Molecules and Biological Medicines.

Victor Rivera

doi:10.3390/biomedicines6040112

Abstract

Multiple sclerosis (MS) has become a common neurological disorder involving populations previously considered to be infrequently affected. Genetic dissemination from high- to low-risk groups is a determining influence interacting with environmental and epigenetic factors, mostly unidentified. Disease modifying therapies (DMT) are effective in treating relapsing MS in variable degrees; one agent is approved for primary progressive disease, and several are in development. In the era of high-efficacy medications, complex molecules, and monoclonal antibodies (MAB), including anti-VLA4 (natalizumab), anti-CD52 (alemtuzumab), and anti-CD20 (ocrelizumab), obtaining NEDA (no evidence of disease activity) becomes an elusive accomplishment in areas of the world where access to MS therapies and care are generally limited. Countries’ income and access to public MS care appear to be a shared socioeconomic challenge. This disparity is also notable in the utilization of diagnostic tools to adhere to the proposed elements of the McDonald Criteria. The impact of follow-on medications (“generics”); injectable non-biological complex drugs (NBCD), oral sphingosine-1-phosphate receptor modulators, and biosimilars (interferon 1-a and 1-b), utilized in many areas of the world, is disconcerting considering these products generally lack data documenting their efficacy and safety. Potential strategies addressing these concerns are discussed from an international point of view.

Highlights

Multiple sclerosis (MS) is an inflammatory and demyelinating disease that manifests pathologically and clinically after the disruption of the dynamic equilibrium of brain plasticity enables the development of a chronic process affecting the central nervous system (CNS)
During the last part of the 20th century and the first decades of the current epoch, epidemiologic studies have shown a notable increase in prevalence in Latin American countries [14], including Mexico [15], and the Middle East [16], while frequencies remain elevated in North America and some European countries
The criteria aim to increase sensitivity without affecting specificity, reducing the possibility of misdiagnosis, and adding novel aspects in its structure, like the inclusion of symptomatic and asymptomatic lesions, as well as cortical signals detected by magnetic resonance imaging (MRI), to comply with the concepts of lesions disseminated in space (DIS)

Summary

Introduction

Multiple sclerosis (MS) is an inflammatory and demyelinating disease that manifests pathologically and clinically after the disruption of the dynamic equilibrium of brain plasticity enables the development of a chronic process affecting the central nervous system (CNS). The impact of follow-on “generic” and biosimilar medications in some areas of the world deserves discussion in view of the lack of data substantiating their efficacy and safety profiles These preoccupations are enhanced in many areas of the world where limited capabilities exist affecting their local licensing agencies in their ability to provide an objective, analytical, and educated approval process for complex therapeutic molecules. This commentary addresses the concerns derived from the expanding global presence of MS, the unexpected consequences of the socioeconomic burden to MS communities, and the impact exerted in the different aspects of the disease, from adequate application of the elements of the current diagnostic criteria to access to care.

The Global Emergence of MS

Ubiquitous Application of MS Diagnostic Criteria

Global MS Care Disparities

Impact of Follow-On Therapeutic Molecules and Biosimilar Medications

Findings

Conclusions