Abstract
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.
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No financial support was utilized in the study design, data gathering, analysis and writing of this manuscript.
Conflicts of interest
The MSBase Foundation acknowledges financial contributions to support the MSBase Registry from Biogen, Novartis, Merck, Roche and Sanofi Genzyme. NM has received compensation for consulting services from Actoverco Pharmaceuticals. RA received honoraria as a speaker and for serving on scientific advisory boards from Bayer, Biogen, GSK, Merck, Novartis, Roche and Sanofi-Genzyme. MT received travel grants from Novartis, Bayer-Schering, Merck and Teva; has participated in clinical trials by Sanofi Aventis, Roche and Novartis. CB received conference travel support from Biogen, Novartis, Bayer-Schering, Merck and Teva; has participated in clinical trials by Sanofi Aventis, Roche and Novartis. AA received personal fees and speaker honoraria from Teva, Merck, Biogen - Gen Pharma, Roche, Novartis, Bayer, Sanofi-Genzyme; received travel and registration grants from Merck, Biogen - Gen Pharma, Roche, Sanofi-Genzyme and Bayer. TK served on scientific advisory boards for BMS, Roche, Sanofi Genzyme, Novartis, Merck and Biogen, a steering committee for Brain Atrophy Initiative by Sanofi Genzyme, received conference travel support and/or speaker honoraria from WebMD Global, Novartis, Biogen, Sanofi-Genzyme, Teva, BioCSL and Merck and received research or educational event support from Biogen, Novartis, Genzyme, Roche, Celgene and Merck. SSH, CM, SO, VSH, BY, RT, RK, SH, AS, JI and TAH declare no conflicts of interest.
Ethics approval
This research was conducted in accordance with the World Medical Association Declaration of Helsinki and was approved by Melbourne Health Human Research Ethics Committee (2006.044) and local ethics committees in participating centers (unless exemption granted by the local regulations). MSBase is registered with WHO International Clinical Trials Registry Platform (ID ACTRN12605000455662). All participants have provided written or verbal consent to be registered in MSBase. Only pseudonymized non-identifiable data was utilized for the purpose of this study.
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The data analyzed in this study are the property of the individual contributing centers. They can be made available upon reasonable request for the purpose of replication of the analyses included in this study and at the discretion of the principal investigators.
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NM, SS, CM and TK designed, analyzed and drafted the manuscript. RA, SO, VS, MT, CB, BY, RT, RK, SH, AS, AA, JI, TAH revised the manuscript.All authors have read and approved the submitted manuscript.
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Moradi, N., Sharmin, S., Malpas, C. et al. Utilization of Multiple Sclerosis Therapies in the Middle East Over a Decade: 2009–2018. CNS Drugs 35, 1097–1106 (2021). https://doi.org/10.1007/s40263-021-00833-w
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DOI: https://doi.org/10.1007/s40263-021-00833-w