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Published in: Neurology and Therapy 1/2019

Open Access 01-06-2019 | Multiple Sclerosis | Commentary

An Overview of High-Efficacy Drugs for Multiple Sclerosis: Gulf Region Expert Opinion

Authors: Raed Alroughani, Jihad Said Inshasi, Dirk Deleu, Jasem Al-Hashel, Mustafa Shakra, Osama Robin Elalamy, Ahmed Osman Shatila, Abdullah Al-Asmi, Isa Al Sharoqi, Beatriz Garcia Canibano, Amir Boshra

Published in: Neurology and Therapy | Issue 1/2019

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Abstract

This article discusses the opinions of the multiple sclerosis (MS) experts in the Gulf region on the use of high-efficacy disease-modifying drugs (DMDs; natalizumab, fingolimod, alemtuzumab, cladribine tablets, and ocrelizumab) in clinical practice. The experts reviewed the current literature including pivotal clinical trials and meta-analyses for high-efficacy DMDs, supplemented by the expert opinions on the usage of these DMDs in clinical practice. Several criteria were discussed by the panel based on different efficacy, safety, and convenience attributes. The panel concluded that all the DMDs available for the treatment of MS have benefits and risks, which should be considered while discussing the treatment plan with the patient. It is important to have a personalized approach based on the risk-benefit assessment for each case. Common considerations while choosing treatments include effectiveness, side effects/safety, and convenience/route of administration.
Funding: Merck Serono Middle East FZ LTD.
Footnotes
1
Cladribine described across the article refers to the oral formulation, Cladribine tablets.
 
Literature
6.
go back to reference Cheng Z, Zhang J, Liu H, Li Y, Zhao Y, Yang E. Central nervous system penetration for small molecule therapeutic agents does not increase in multiple sclerosis- and Alzheimer’s disease-related animal models despite reported blood-brain barrier disruption. Drug Metab Dispos. 2010;38:1355–61. https://doi.org/10.1124/dmd.110.033324.CrossRefPubMed Cheng Z, Zhang J, Liu H, Li Y, Zhao Y, Yang E. Central nervous system penetration for small molecule therapeutic agents does not increase in multiple sclerosis- and Alzheimer’s disease-related animal models despite reported blood-brain barrier disruption. Drug Metab Dispos. 2010;38:1355–61. https://​doi.​org/​10.​1124/​dmd.​110.​033324.CrossRefPubMed
8.
go back to reference Cohen JA, Barkhof F, Comi G, Hartung H-P, Khatri BO, Montalban X, Pelletier J, Capra R, Gallo P, Izquierdo G, Tiel-Wilck K, de Vera A, Jin J, Stites T, Wu S, Aradhye S, Kappos L. Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis. N Engl J Med. 2010;362:402–15. https://doi.org/10.1056/NEJMoa0907839.CrossRefPubMed Cohen JA, Barkhof F, Comi G, Hartung H-P, Khatri BO, Montalban X, Pelletier J, Capra R, Gallo P, Izquierdo G, Tiel-Wilck K, de Vera A, Jin J, Stites T, Wu S, Aradhye S, Kappos L. Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis. N Engl J Med. 2010;362:402–15. https://​doi.​org/​10.​1056/​NEJMoa0907839.CrossRefPubMed
9.
go back to reference Cohen JA, Coles AJ, Arnold DL, Confavreux C, Fox EJ, Hartung H-P, Havrdova E, Selmaj KW, Weiner HL, Fisher E, Brinar VV, Giovannoni G, Stojanovic M, Ertik BI, Lake SL, Margolin DH, Panzara MA, Compston DAS, CARE-MS I Investigators. Alemtuzumab versus interferon beta 1a as first-line treatment for patients with relapsing-remitting multiple sclerosis: a randomised controlled phase 3 trial. Lancet Lond Engl. 2012;380:1819–28. https://doi.org/10.1016/S0140-6736(12)61769-3.CrossRef Cohen JA, Coles AJ, Arnold DL, Confavreux C, Fox EJ, Hartung H-P, Havrdova E, Selmaj KW, Weiner HL, Fisher E, Brinar VV, Giovannoni G, Stojanovic M, Ertik BI, Lake SL, Margolin DH, Panzara MA, Compston DAS, CARE-MS I Investigators. Alemtuzumab versus interferon beta 1a as first-line treatment for patients with relapsing-remitting multiple sclerosis: a randomised controlled phase 3 trial. Lancet Lond Engl. 2012;380:1819–28. https://​doi.​org/​10.​1016/​S0140-6736(12)61769-3.CrossRef
10.
go back to reference Coles AJ, Twyman CL, Arnold DL, Cohen JA, Confavreux C, Fox EJ, Hartung H-P, Havrdova E, Selmaj KW, Weiner HL, Miller T, Fisher E, Sandbrink R, Lake SL, Margolin DH, Oyuela P, Panzara MA, Compston DAS. Alemtuzumab for patients with relapsing multiple sclerosis after disease-modifying therapy: a randomised controlled phase 3 trial. Lancet. 2012;380:1829–39. https://doi.org/10.1016/S0140-6736(12)61768-1.CrossRefPubMed Coles AJ, Twyman CL, Arnold DL, Cohen JA, Confavreux C, Fox EJ, Hartung H-P, Havrdova E, Selmaj KW, Weiner HL, Miller T, Fisher E, Sandbrink R, Lake SL, Margolin DH, Oyuela P, Panzara MA, Compston DAS. Alemtuzumab for patients with relapsing multiple sclerosis after disease-modifying therapy: a randomised controlled phase 3 trial. Lancet. 2012;380:1829–39. https://​doi.​org/​10.​1016/​S0140-6736(12)61768-1.CrossRefPubMed
17.
go back to reference Giovannoni G, Soelberg Sorensen P, Cook S, Rammohan K, Rieckmann P, Comi G, Dangond F, Adeniji AK, Vermersch P. Safety and efficacy of cladribine tablets in patients with relapsing-remitting multiple sclerosis: results from the randomized extension trial of the CLARITY study. Mult Scler Houndmills Basingstoke Engl. 2017. https://doi.org/10.1177/1352458517727603.CrossRef Giovannoni G, Soelberg Sorensen P, Cook S, Rammohan K, Rieckmann P, Comi G, Dangond F, Adeniji AK, Vermersch P. Safety and efficacy of cladribine tablets in patients with relapsing-remitting multiple sclerosis: results from the randomized extension trial of the CLARITY study. Mult Scler Houndmills Basingstoke Engl. 2017. https://​doi.​org/​10.​1177/​1352458517727603​.CrossRef
18.
go back to reference Giovannoni G, Soelberg Sorensen P, Cook S, Rammohan KW, Rieckmann P, Comi G, Dangond F, Hicking C, Vermersch P. Efficacy of cladribine tablets in high disease activity subgroups of patients with relapsing multiple sclerosis: a post hoc analysis of the CLARITY study. Mult Scler Houndmills Basingstoke Engl. 2018. https://doi.org/10.1177/1352458518771875.CrossRef Giovannoni G, Soelberg Sorensen P, Cook S, Rammohan KW, Rieckmann P, Comi G, Dangond F, Hicking C, Vermersch P. Efficacy of cladribine tablets in high disease activity subgroups of patients with relapsing multiple sclerosis: a post hoc analysis of the CLARITY study. Mult Scler Houndmills Basingstoke Engl. 2018. https://​doi.​org/​10.​1177/​1352458518771875​.CrossRef
20.
go back to reference Hauser SL, Bar-Or A, Comi G, Giovannoni G, Hartung H-P, Hemmer B, Lublin F, Montalban X, Rammohan KW, Selmaj K, Traboulsee A, Wolinsky JS, Arnold DL, Klingelschmitt G, Masterman D, Fontoura P, Belachew S, Chin P, Mairon N, Garren H, Kappos L. Ocrelizumab versus interferon beta-1a in relapsing multiple sclerosis. N Engl J Med. 2017;376:221–34. https://doi.org/10.1056/NEJMoa1601277.CrossRefPubMed Hauser SL, Bar-Or A, Comi G, Giovannoni G, Hartung H-P, Hemmer B, Lublin F, Montalban X, Rammohan KW, Selmaj K, Traboulsee A, Wolinsky JS, Arnold DL, Klingelschmitt G, Masterman D, Fontoura P, Belachew S, Chin P, Mairon N, Garren H, Kappos L. Ocrelizumab versus interferon beta-1a in relapsing multiple sclerosis. N Engl J Med. 2017;376:221–34. https://​doi.​org/​10.​1056/​NEJMoa1601277.CrossRefPubMed
21.
go back to reference Havrdová E, Arnold DL, Bar-Or A, Comi G, Hartung H-P, Kappos L, Lublin F, Selmaj K, Traboulsee A, Belachew S, Bennett I, Buffels R, Garren H, Han J, Julian L, Napieralski J, Hauser SL, Giovannoni G. No evidence of disease activity (NEDA) analysis by epochs in patients with relapsing multiple sclerosis treated with ocrelizumab vs interferon beta-1a. Mult Scler J Exp Transl Clin. 2018. https://doi.org/10.1177/2055217318760642.CrossRefPubMedPubMedCentral Havrdová E, Arnold DL, Bar-Or A, Comi G, Hartung H-P, Kappos L, Lublin F, Selmaj K, Traboulsee A, Belachew S, Bennett I, Buffels R, Garren H, Han J, Julian L, Napieralski J, Hauser SL, Giovannoni G. No evidence of disease activity (NEDA) analysis by epochs in patients with relapsing multiple sclerosis treated with ocrelizumab vs interferon beta-1a. Mult Scler J Exp Transl Clin. 2018. https://​doi.​org/​10.​1177/​2055217318760642​.CrossRefPubMedPubMedCentral
27.
go back to reference Lemtrada PI. Genzyme Corporation, MA, USA. Food and Drug Administration; 2018. Lemtrada PI. Genzyme Corporation, MA, USA. Food and Drug Administration; 2018.
29.
go back to reference Markowitz CE. Multiple sclerosis update. Am J Manag Care. 2013;19:s294–300.PubMed Markowitz CE. Multiple sclerosis update. Am J Manag Care. 2013;19:s294–300.PubMed
33.
go back to reference Miller DH, Soon D, Fernando KT, MacManus DG, Barker GJ, Yousry TA, Fisher E, O’Connor PW, Phillips JT, Polman CH, Kappos L, Hutchinson M, Havrdova E, Lublin FD, Giovannoni G, Wajgt A, Rudick R, Lynn F, Panzara MA, Sandrock AW, Investigators AFFIRM. MRI outcomes in a placebo-controlled trial of natalizumab in relapsing MS. Neurology. 2007;68:1390–401. https://doi.org/10.1212/01.wnl.0000260064.77700.fd.CrossRefPubMed Miller DH, Soon D, Fernando KT, MacManus DG, Barker GJ, Yousry TA, Fisher E, O’Connor PW, Phillips JT, Polman CH, Kappos L, Hutchinson M, Havrdova E, Lublin FD, Giovannoni G, Wajgt A, Rudick R, Lynn F, Panzara MA, Sandrock AW, Investigators AFFIRM. MRI outcomes in a placebo-controlled trial of natalizumab in relapsing MS. Neurology. 2007;68:1390–401. https://​doi.​org/​10.​1212/​01.​wnl.​0000260064.​77700.​fd.CrossRefPubMed
34.
go back to reference Moss B, Utigard E, Baldassari L, Cohen J, Ontaneda D. Real-world experience with ocrelizumab (P6.356). Neurology. 2018;90:P6.356. Moss B, Utigard E, Baldassari L, Cohen J, Ontaneda D. Real-world experience with ocrelizumab (P6.356). Neurology. 2018;90:P6.356.
35.
go back to reference NICE Pathways. Disease-modifying therapies for multiple sclerosis. 2018. NICE Pathways. Disease-modifying therapies for multiple sclerosis. 2018.
39.
go back to reference Polman CH, O’Connor PW, Havrdova E, Hutchinson M, Kappos L, Miller DH, Phillips JT, Lublin FD, Giovannoni G, Wajgt A, Toal M, Lynn F, Panzara MA, Sandrock AW. A randomized, placebo-controlled trial of natalizumab for relapsing multiple sclerosis. N Engl J Med. 2006;354:899–910. https://doi.org/10.1056/NEJMoa044397.CrossRefPubMed Polman CH, O’Connor PW, Havrdova E, Hutchinson M, Kappos L, Miller DH, Phillips JT, Lublin FD, Giovannoni G, Wajgt A, Toal M, Lynn F, Panzara MA, Sandrock AW. A randomized, placebo-controlled trial of natalizumab for relapsing multiple sclerosis. N Engl J Med. 2006;354:899–910. https://​doi.​org/​10.​1056/​NEJMoa044397.CrossRefPubMed
Metadata
Title
An Overview of High-Efficacy Drugs for Multiple Sclerosis: Gulf Region Expert Opinion
Authors
Raed Alroughani
Jihad Said Inshasi
Dirk Deleu
Jasem Al-Hashel
Mustafa Shakra
Osama Robin Elalamy
Ahmed Osman Shatila
Abdullah Al-Asmi
Isa Al Sharoqi
Beatriz Garcia Canibano
Amir Boshra
Publication date
01-06-2019
Publisher
Springer Healthcare
Published in
Neurology and Therapy / Issue 1/2019
Print ISSN: 2193-8253
Electronic ISSN: 2193-6536
DOI
https://doi.org/10.1007/s40120-019-0129-0

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