Background

The multiple sclerosis (MS) landscape has changed over the past two decades across the world and in the Middle East. The Middle East is an ethnically diverse region located between 12° and 42° of latitude and 35° and 54° of longitude and varying altitudes. The magnitude of the shifts observed in the epidemiology and management of MS differ in each region and from country to country.

Objectives

The aim of this study was to provide a clinicodemographic overview of the cohorts of patients contributed to MSBase, a large international MS registry, in the Middle East and describe disease-modifying treatment (DMT) utilization in the different countries within the region. Understanding the differences between these cohorts is integral to interpretation of the studies conducted using registry data and provides insight into clinical practice in these cohorts.

Methods

The MSBase registry was searched for patients with MS or clinically isolated syndrome from the Middle Eastern countries with data captured between 2009 and 2018. In 2-year epochs, and with special focus on the most recent epoch (2017–2018), we explored the demographic, clinical characteristics and treatment exposures of the studied cohorts and reported the results using standard descriptive statistics.

Results

Over the 10-year study period, 13,356 patients from 17 centers in 8 Middle Eastern countries fulfilled the inclusion criteria. The represented countries were Egypt, Iran, Kuwait, Lebanon, Oman, Saudi Arabia, Turkey and the United Arab Emirates. Overall, the represented cohort was young (median 36 years, quartiles 29–45) and captured relatively early after the onset of MS (median disease duration < 10 years, quartiles 3–12). The relapsing-remitting phenotype was the most prevalent phenotype in all countries (73–97%) and the highest proportion of progressive MS was reported in Saudi Arabia (12%). Median Expanded Disability Status Scale (EDSS) ranged from 0 to 3, depicting a mildly disabled cohort, with the exception of Saudi Arabia where the median EDSS was 4 (quartiles 1.5–6.5). The median relapse frequency was highest in Lebanon (median 1.03, 95% CI 0.94–1.16) followed by Egypt (median 1.02, 95% CI 0.89–1.24) and lowest in Saudi Arabia (median 0.70, 95% CI 0.58–0.95) and Kuwait (median 0.75, 95% CI 0.71–0.80). The treatment landscape greatly varied between different countries. Platform injectable therapies were mostly utilized in Egypt, Iran and Turkey (86%, 79% and 53%, respectively), while oral therapies and monoclonal antibodies were more commonly used in Kuwait, Lebanon and the United Arab Emirates (87.2%, 67.3% and 58.7%, respectively).

Conclusion

Patients in the Middle East enrolled in a large multinational registry are representative of the general MS population. The spectrum of therapies used in the individual countries, however, is highly variable. Further studies that include rural and non-academic practices are needed to enhance our understanding of the MS cohorts in the Middle East.

中文翻译：

---

十年来中东多发性硬化症疗法的使用情况：2009-2018

背景

在过去的二十年里，多发性硬化症 (MS) 的格局在世界各地和中东发生了变化。中东是一个种族多样化的地区，位于纬度 12° 和 42° 以及经度 35° 和 54° 之间，海拔各不相同。在 MS 的流行病学和管理中观察到的变化幅度在每个地区和国家之间都不同。

目标

本研究的目的是提供中东地区大型国际 MS 登记处 MSBase 患者队列的临床人口学概况，并描述该地区不同国家的疾病缓解治疗 (DMT) 使用情况。了解这些队列之间的差异对于解释使用注册数据进行的研究是不可或缺的，并有助于深入了解这些队列的临床实践。

方法

MSBase 登记处搜索了来自中东国家的 MS 或临床孤立综合征患者，收集了 2009 年至 2018 年间的数据。在 2 年的时期，特别关注最近时期（2017-2018 年），我们探索了研究队列的人口统计学、临床特征和治疗暴露，并使用标准描述性统计报告结果。

结果

在 10 年的研究期间，来自 8 个中东国家的 17 个中心的 13,356 名患者符合纳入标准。代表国家是埃及、伊朗、科威特、黎巴嫩、阿曼、沙特阿拉伯、土耳其和阿拉伯联合酋长国。总体而言，所代表的队列很年轻（中位 36 岁，四分位数 29-45）并且在 MS 发作后相对较早地被捕获（中位疾病持续时间 < 10 年，四分位数 3-12）。复发缓解表型是所有国家中最普遍的表型（73-97%），沙特阿拉伯报告的进展性 MS 比例最高（12%）。中位扩展残疾状态量表 (EDSS) 范围从 0 到 3，描绘了一个轻度残疾队列，但沙特阿拉伯除外，其中 EDSS 中位数为 4（四分位数 1.5-6.5）。黎巴嫩的中位复发频率最高（中位 1.03，95% CI 0.94–1.16）其次是埃及（中位数 1.02, 95% CI 0.89–1.24），沙特阿拉伯最低（中位数 0.70, 95% CI 0.58–0.95）和科威特（中位数 0.75, 95% CI 0.71–0.80） . 不同国家的治疗情况差异很大。平台注射疗法主要用于埃及、伊朗和土耳其（分别为 86%、79% 和 53%），而口服疗法和单克隆抗体更常用于科威特、黎巴嫩和阿拉伯联合酋长国（87.2%、67.3%）和 58.7%，分别）。

结论

参加大型跨国注册的中东患者代表了一般 MS 人群。然而，各个国家使用的治疗范围差异很大。需要包括农村和非学术实践在内的进一步研究，以增强我们对中东 MS 队列的理解。