Brazilian Consensus for the Treatment of Multiple Sclerosis: Brazilian Academy of Neurology and Brazilian Committee on Treatment and Research in Multiple Sclerosis

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Abstract

ABSTRACT The expanding therapeutic arsenal in multiple sclerosis (MS) has allowed for more effective and personalized treatment, but the choice and management of disease-modifying therapies (DMTs) is becoming increasingly complex. In this context, experts from the Brazilian Committee on Treatment and Research in Multiple Sclerosis and the Neuroimmunology Scientific Department of the Brazilian Academy of Neurology have convened to establish this Brazilian Consensus for the Treatment of MS, based on their understanding that neurologists should be able to prescribe MS DMTs according to what is better for each patient, based on up-to-date evidence and practice. We herein propose practical recommendations for the treatment of MS, with the main focus on the choice and management of DMTs, as well as present a review of the scientific rationale supporting therapeutic strategies in MS.

Translated abstract

RESUMO O crescent arsenal terapêutico na esclerose múltipla (EM) tem permitido tratamentos mais efetivos e personalizados, mas a escolha e o manejo das terapias modificadoras da doença (TMDs) tem se tornado cada vez mais complexos. Neste contexto, especialistas do Comitê Brasileiro de Tratamento e Pesquisa em Esclerose Múltipla e do Departamento Científico de Neuroimunologia da Academia Brasileira de Neurologia reuniram-se para estabelecer este Consenso Brasileiro para o Tratamento da EM, baseados no entendimento de que neurologistas devem ter a possibilidade de prescrever TMDs para EM de acordo com o que é melhor para cada paciente, com base em evidências e práticas atualizadas. Por meio deste documento, propomos recomendações práticas para o tratamento da EM, com foco principal na escolha e no manejo das TMDs, e revisamos os argumentos que embasam as estratégias de tratamento na EM.

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Most cited references 84

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Alemtuzumab versus interferon beta 1a as first-line treatment for patients with relapsing-remitting multiple sclerosis: a randomised controlled phase 3 trial.

Jeffrey A Cohen, Alasdair J Coles, Douglas L Arnold … (2012)

The anti-CD52 monoclonal antibody alemtuzumab reduced disease activity in a phase 2 trial of previously untreated patients with relapsing-remitting multiple sclerosis. We aimed to assess efficacy and safety of first-line alemtuzumab compared with interferon beta 1a in a phase 3 trial. In our 2 year, rater-masked, randomised controlled phase 3 trial, we enrolled adults aged 18-50 years with previously untreated relapsing-remitting multiple sclerosis. Eligible participants were randomly allocated in a 2:1 ratio by an interactive voice response system, stratified by site, to receive intravenous alemtuzumab 12 mg per day or subcutaneous interferon beta 1a 44 μg. Interferon beta 1a was given three-times per week and alemtuzumab was given once per day for 5 days at baseline and once per day for 3 days at 12 months. Coprimary endpoints were relapse rate and time to 6 month sustained accumulation of disability in all patients who received at least one dose of study drug. This study is registered with ClinicalTrials.gov, number NCT00530348. 187 (96%) of 195 patients randomly allocated interferon beta 1a and 376 (97%) of 386 patients randomly allocated alemtuzumab were included in the primary analyses. 75 (40%) patients in the interferon beta 1a group relapsed (122 events) compared with 82 (22%) patients in the alemtuzumab group (119 events; rate ratio 0·45 [95% CI 0·32-0·63]; p<0.0001), corresponding to a 54·9% improvement with alemtuzumab. Based on Kaplan-Meier estimates, 59% of patients in the interferon beta 1a group were relapse-free at 2 years compared with 78% of patients in the alemtuzumab group (p<0·0001). 20 (11%) of patients in the interferon beta 1a group had sustained accumulation of disability compared with 30 (8%) in the alemtuzumab group (hazard ratio 0·70 [95% CI 0·40-1·23]; p=0·22). 338 (90%) of patients in the alemtuzumab group had infusion-associated reactions; 12 (3%) of which were regarded as serious. Infections, predominantly of mild or moderate severity, occurred in 253 (67%) patients treated with alemtuzumab versus 85 (45%) patients treated with interferon beta 1a. 62 (16%) patients treated with alemtuzumab had herpes infections (predominantly cutaneous) compared with three (2%) patients treated with interferon beta 1a. By 24 months, 68 (18%) patients in the alemtuzumab group had thyroid-associated adverse events compared with 12 (6%) in the interferon beta 1a group, and three (1%) had immune thrombocytopenia compared with none in the interferon beta 1a group. Two patients in the alemtuzumab group developed thyroid papillary carcinoma. Alemtuzumab's consistent safety profile and benefit in terms of reductions of relapse support its use for patients with previously untreated relapsing-remitting multiple sclerosis; however, benefit in terms of disability endpoints noted in previous trials was not observed here. Genzyme (Sanofi) and Bayer Schering Pharma. Copyright © 2012 Elsevier Ltd. All rights reserved.

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Oral teriflunomide for patients with relapsing multiple sclerosis (TOWER): a randomised, double-blind, placebo-controlled, phase 3 trial.

Christian Confavreux, Paul O’Connor, Giancarlo Comi … (2014)

Teriflunomide is an oral disease-modifying therapy approved for treatment of relapsing or relapsing-remitting multiple sclerosis. We aimed to provide further evidence for the safety and efficacy of teriflunomide in patients with relapsing multiple sclerosis.

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ECTRIMS/EAN guideline on the pharmacological treatment of people with multiple sclerosis

X Montalban, R. Gold, A Thompson … (2018)

Multiple sclerosis (MS) is a complex disease of the central nervous system. As new drugs are becoming available, knowledge on diagnosis and treatment must continuously evolve. There is therefore a need for a reference tool compiling current data on benefit and safety, to aid professionals in treatment decisions and use of resources across Europe. The European Committee of Treatment and Research in Multiple Sclerosis (ECTRIMS) and the European Academy of Neurology (EAN) have joined forces to meet this need. The objective was to develop an evidence-based clinical practice guideline for the pharmacological treatment of people with MS to guide healthcare professionals in the decision-making process.

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Contributors

Vanessa Daccach Marques: Role: ND

Giordani Rodrigues dos Passos: Role: ND

Maria Fernanda Mendes: Role: ND

Dagoberto Callegaro: Role: ND

Marco Aurélio Lana-Peixoto: Role: ND

Elizabeth Regina Comini-Frota: Role: ND

Cláudia Cristina Ferreira Vasconcelos: Role: ND

Douglas Kazutoshi Sato: Role: ND

Maria Lúcia Brito Ferreira: Role: ND

Mônica Koncke Fiuza Parolin: Role: ND

Alfredo Damasceno: Role: ND

Anderson Kuntz Grzesiuk: Role: ND

André Muniz: Role: ND

André Palma da Cunha Matta: Role: ND

Bianca Etelvina Santos de Oliveira: Role: ND

Carlos Bernardo Tauil: Role: ND

Damacio Ramón Kaimen Maciel: Role: ND

Denise Sisteroli Diniz: Role: ND

Eber Castro Corrêa: Role: ND

Fernando Coronetti: Role: ND

Frederico M. H. Jorge: Role: ND

Henry Koiti Sato: Role: ND

Marcus Vinícius Magno Gonçalves: Role: ND

Nise Alessandra de C. Sousa: Role: ND

Osvaldo J. M. Nascimento: Role: ND

Paulo Diniz da Gama: Role: ND

Renan Domingues: Role: ND

Renata Faria Simm: Role: ND

Rodrigo Barbosa Thomaz: Role: ND

Rogério de Rizo Morales: Role: ND

Ronaldo Maciel Dias: Role: ND

Samira dos Apóstolos-Pereira: Role: ND

Suzana Costa Nunes Machado: Role: ND

Thiago de Faria Junqueira: Role: ND

Jefferson Becker: Role: ND

Journal

Journal ID (publisher-id): anp

Title: Arquivos de Neuro-Psiquiatria

Abbreviated Title: Arq. Neuro-Psiquiatr.

Publisher: Academia Brasileira de Neurologia - ABNEURO (São Paulo, SP, Brazil )

ISSN (Print): 0004-282X

ISSN (Electronic): 1678-4227

Publication date (Print and electronic): August 2018

Volume: 76

Issue: 8

Pages: 539-554

Affiliations

[23] Sorocaba São Paulo orgnamePontifícia Universidade Católica de São Paulo Brazil

[15] Brasília Distrito Federal orgnameUniversidade Católica de Brasília Brazil

[31] Salvador Bahia orgnameEscola Bahiana de Medicina e Saúde Pública Brazil

[9] Campinas São Paulo orgnameUniversidade Estadual de Campinas Brazil

[19] São Paulo orgnameUniversidade Estadual Paulista Brazil

[7] Recife PE orgnameHospital da Restauração Brasil

[6] Rio de Janeiro Rio de Janeiro orgnameUniversidade Federal do Estado do Rio de Janeiro Brazil

[2] Porto Alegre Rio Grande do Sul orgnamePontifícia Universidade Católica do Rio Grande do Sul Brazil

[13] João Pessoa PB orgnameFundação Centro Integrado de Apoio ao Portador de Deficiência Brazil

[17] Goiânia Goiás orgnameUniversidade Federal de Goiás orgdiv1Faculdade de Medicina Brazil

[20] Curitiba PR orgnameInstituto de Neurologia de Curitiba Brasil

[18] Brasília DF orgnameClínica de Neurologia e Endocrinologia Brasil

[28] Uberlândia Minas Gerais orgnameUniversidade Federal de Uberlândia Brazil

[5] Belo Horizonte Minas Gerais orgnameUniversidade José do Rosário Vellano Brazil

[1] Ribeirão Preto orgnameUniversidade de São Paulo orgdiv1Faculdade de Medicina de Ribeirão Preto orgdiv2Hospital das Clínicas de Ribeirão Preto Brazil

[27] São Paulo São Paulo orgnameHospital Israelita Albert Einstein Brazil

[12] Niterói Rio de Janeiro orgnameUniversidade Federal Fluminense Brazil

[24] São Paulo SP orgnameSenne Líquor Diagnóstico Brasil

[21] Joinville orgnameUniversidade da Região de Joinville Brazil

[8] Curitiba PR orgnameClínica Gonçalves Dias Brasil

[26] Campinas SP orgnameFaculdade São Leopoldo Mandic Brasil

[4] Belo Horizonte Minas Gerais orgnameUniversidade Federal de Minas Gerais orgdiv1Centro de Investigação em Esclerose Múltipla de Minas Gerais Brazil

[25] São Paulo SP orgnameHospital Cruz Azul Brasil

[14] Brasília Distrito Federal orgnameUniversidade de Brasília Brazil

[29] Brasília DF orgnameHospital de Base do Distrito Federal Brasil

[11] Salvador BA orgnameHospital São Rafael Brasil

[22] Manaus Amazonas orgnameUniversidade Federal do Amazonas orgdiv1Hospital Universitário Getúlio Vargas Brazil

[30] Florianópolis SC orgnameImperial Hospital de Caridade Brasil

[10] Cuiabá MT orgnameClínica Privada Brasil

[16] Londrina PR orgnameSanta Casa de Misericórdia de Londrina Brasil

[3] São Paulo São Paulo orgnameUniversidade de São Paulo orgdiv1Faculdade de Medicina orgdiv2Hospital das Clínicas Brazil

Article

Publisher ID: S0004-282X2018000800539

DOI: 10.1590/0004-282x20180078

PubMed ID: 30231128

SO-VID: b53e49d5-1675-46ab-ad74-00e9bb7f26b3

License:

This work is licensed under a Creative Commons Attribution 4.0 International License.

History

Date received : 17 March 2018

Date accepted : 16 May 2018

Page count

Figures: 0, Tables: 0, Equations: 0, References: 125, Pages: 16

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SciELO Brazil

Keywords: esclerose múltipla,consenso,multiple sclerosis,drug therapy,consensus,tratamento farmacológico

Data availability:

Keywords: esclerose múltipla, consenso, multiple sclerosis, drug therapy, consensus, tratamento farmacológico

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SciELO Brazil

Most cited references 84

Alemtuzumab versus interferon beta 1a as first-line treatment for patients with relapsing-remitting multiple sclerosis: a randomised controlled phase 3 trial.

Oral teriflunomide for patients with relapsing multiple sclerosis (TOWER): a randomised, double-blind, placebo-controlled, phase 3 trial.

ECTRIMS/EAN guideline on the pharmacological treatment of people with multiple sclerosis

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