Multiple Sclerosis in Special Populations of the Middle East North Africa Region

General introduction

Multiple sclerosis (MS) is a chronic autoimmune disease affecting the central nervous system (CNS) and characterized mainly by demyelination and neuronal loss. It predominantly affects patients aged 20 to 40 years [1]. The pathogenesis of MS is defined as a cascade of pathobiological events ranging from the inflammation of the white and grey matter due to immune cell infiltration to the breakdown of the blood-brain barrier (BBB) and formation of demyelinating lesions. Following the BBB breakdown, activated T cells, antibodies against myelin, and activated microglia which may release free radicals, nitric oxide, and proteases contribute to the tissue damage [2]. According to the third edition of Atlas of MS, the global estimate of MS has increased from 2.3 million in 2009 to 2.87 million people living with MS in 2020 [3]. Several factors are likely to play an important role in explaining this increase, including the 60% improvements in MS diagnosis, 56% improvements in treatment and support, and 53% improvements in counting methods nationally and globally [4]. According to this edition the prevalence of MS varies considerably around the world in which the European region, mainly San Marino and Germany, got the highest number of people with MS (337 per 100,000 and 303 per 100,000 respectively), followed by the United States of America (USA) (288 per 100 Findings,000). In contrast, the Eastern Mediterranean, South-East Asia, Africa, and the Western Pacific had estimated a prevalence below 40 per 100,000 [4]. This implies that the Middle East North Africa (MENA) region falls in the low-to-moderate MS prevalence zone. However, this prevalence tends to increase consistent with the global rising prevalence of the disease [5]. The exact etiology of MS is unknown; however, several factors are involved in its pathogenesis including the immune, environmental, and the genetic associations [1]. Clinically, MS can cause a wide range of disabling symptoms that may affect any part of the body. Sensory loss, muscle cramps, dysarthria, nystagmus, optic neuritis, trigeminal neuralgia, facial myokymia, diplopia, fatigue, pain, cognitive difficulties, depression, bladder, bowel, and sexual dysfunction are all common symptoms of MS which can vary among patients, and even can fluctuate within one patient over time [6]. Moreover, according to the clinical course, MS can be classified into two main phenotypes: Relapsing-Remitting MS (RRMS), and Progressive MS (PMS) [7]. It is important to know that there is no cure for MS, that’s why the treatment focuses mainly on accelerating recovery from acute exacerbations, slowing down the progression of disease and managing the symptoms [8]. When the patient faces an acute attack, corticosteroids (CSTs) administration is the standard first line treatment to improve the rate of recovery as it has a rapid effect in reducing brain and spinal cord inflammation. High dose of methylprednisolone is the treatment of choice either administered orally or intravenously as both routes of administration reduce disease progression within the first five weeks of treatment. Slowing down the progression of the disease requires the administration of disease-modifying therapy (DMT). The first line treatment in this case differs when the patient has RRMS, SPMS, or PPMS [9].

General Problem

What are the different aspects of multiple sclerosis in the special populations of the MENA region?

General Objective

To assess epidemiological, clinical and treatment aspects of multiple sclerosis in special populations of the MENA region including elderly, pediatrics, pregnant women, and people using “off-label” therapies such as rituximab.

Specific Objectives

• Study #1: To determine the epidemiology, clinical characteristics, and treatment patterns of MS in children in the MENA region
• Study #2: To compare the real-world efficacy and safety of Disease-Modifying therapies in the treatment of pediatric MS in the MENA region
• Study #3: To assess the efficacy and safety of off-label rituximab in a large cohort of Middle Eastern MS patients
• Study #4: To determine the epidemiology, clinical characteristics, and treatment patterns of MS in elderly patients in the MENA region
• Study #5: To evaluate the effectiveness and safety of high-efficacy DMTs in pregnant MS patients in the MENA region

Data collection

Data of the 5 studies will be collected from the prospectively collected data of patients from the Middle East and North Africa Committee for treatment and research in MS (MENACTRIMS) registry and other local database registries from different MENA countries including, but not limited to the United Arab of Emirates, Lebanon, Kuwait, Tunisia, Egypt, and Oman.

Studies design

All the 5 studies are retrospective cohort studies based on prospectively collected data from the MENACTRIMS registry and other MENA countries registries.

Mots clés : multiple sclerosis, Middle East North Africa (MENA), disease-modifying therapy, elderly. pediatrics, pregnancy, rituximab