Guideline for multiple sclerosis treatment in Brazil: Consensus from the Neuroimmunology Scientific Department of the Brazilian Academy of Neurology

Comini-Frota, Elizabeth Regina; Vasconcelos, Cláudia C. F.; Mendes, Maria Fernanda; ,

doi:10.1590/0004-282X20160185

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Guidelines • Arq. Neuro-Psiquiatr. 75 (1) • Jan 2017 • https://doi.org/10.1590/0004-282X20160185 copy

Guideline for multiple sclerosis treatment in Brazil: Consensus from the Neuroimmunology Scientific Department of the Brazilian Academy of Neurology

Orientações para tratamento da esclerose múltipla no Brasil: Consenso do Departamento Científico de Neuroimunologia da Academia Brasileira de Neurologia

Authorship SCIMAGO INSTITUTIONS RANKINGS

ABSTRACT

Multiple sclerosis has become an ever-increasing challenge to neurologists. With the release of the latest medications on the market, Brazilian neurologists feel divided between following their patients’ evolution in accordance with the strict rules established by the Brazilian Ministry of Health regarding drug distribution, or following disease progression and worsening in accordance with the evidence in the literature. Therefore, a systematic review of the main published treatment guidelines was conducted and an escalating therapy proposed for guiding multiple sclerosis patient treatment in Brazil.

Keywords:
multiple sclerosis; Consensus; treatment

Drug	Date of pivotal trial	Patients (n)	Controls(n)	Time from disease onset to medication(years)	Preview relapses per year	EDSS	ARR placebo group	ARR treated group	RRR relapses (%)	RRR gadolinium enhanced lesions (%)	RRR T2 lesions (%)	N of paitents after 2 years (%)	Safety
Interferon beta 1 B	1993	115	112	4.7	3.3	2.9	1.27	0.84	34	43	63	76.0	Skin lesions / elevated hepatic enzymes
Interferon beta 1A Sc 44 mcg	1938	184	187	6.4	3	2.6	1.28	0.62	32	88	78	75.0	Skin lesions elevated hepatic enzymes
Interferon beta 1 AIM 30 mcg	1996	158	143	6.6	1.2	2.4	0.82	0.67	19	52	33	90.0	Increased hepatic enzymes
Glatiramer Acetate	1995	126	125	7.3	2.9	2.8	0.84	0.59	29	33	31	84.8	Lipodystrophies allergies
Mitoxantrone	2002	129	66	9.3	1.42	4.64	0.85	0.39	66			79.2	Heart failure/ leukemia
Natalizumab	2006	627	315	6	1.5	2.3	0.73	0.23	68	92	85	90.1	LEMP
Fingolimod	2010	429	418	6.9	1	2.3	0.4	0.18	55	82	76	77.0	Lymphopenia/infeccions diseases/AV block/ Macular edema
Dymethyl	2012	410	403	5.1	1.3	2.36	0.36	0.17	53	90	83	84.0	Lymphopenia/PML
Fumarate	2012	410	403	5.1	1.3	2.36	0.36	0.17	53	90	83	84.0	Lymphopenia/PML
Alemtuzumab	2012	386	164	1.7	2	2	0.67	0.18	67	94	83	93.7	Tireoidopathies
Alemtuzumab	2012	386	164	1.7	2	2	0.67	0.18	67	94	83	93.7	Infections
Teriflunomide	2012	362	369	8.2	1.4	2.71	0.5	0.32	32	80	77	73.4	Alopecia
Teriflunomide	2012	362	369	8.2	1.4	2.71	0.5	0.32	32	80	77	73.4	Elevated hepatic enzymes

Authors	Type of study	Publication date	MS clinical forms studied	Studied drugs	Type of studies reviewed	Disease or drugs aspects reviewed
Fredmann et al.¹⁹19. Freedman MS, Comi G, De Stefano N, Barkhof F, Polman CH, Uitdehaag BM et al. Moving toward earlier treatment of multiple sclerosis: findings from a decade of clinical trials and implications for clinical practice. Mult Scler Relat Disord. 2014;3(2):147-55. doi:10.1016/j.msard.2013.07.001 https://doi.org/10.1016/j.msard.2013.07....	Sistematic review	2013	CIS	IFN 1A SC, IFN 1A IM, IFN 1B. GA	Clinical trials	Start treatment
Castro-Borrero et al.²²22. Castro-Borrero W, Graves D, Frohman TC, Flores AB, Hardeman P, Logan D et al. Current and emerging therapies in multiple sclerosis: a systematic review. Ther Adv Neurol Disorder. 2012;5(4):205-20. doi:10.1177/1756285612450936 https://doi.org/10.1177/1756285612450936...	Sistematic review	2012	CIS, MSRR	IFN 1A SC, IFN 1A IM, IFN 1B. GA, MTX, NTZ, FNG	Pivotal trials	Efficacy of each drug
Nicholas et al.²⁹29. Nicholas R, Straube S, Schmidli H, Pfeiffer S, Friede T. Time-patterns of annualized relapse rates in randomized placebo-controlled clinical trials in relapsing multiple sclerosis: a systematic review and meta-analysis. Mult Scler. 2012;18(9):1290-6. doi:10.1177/1352458511435715 https://doi.org/10.1177/1352458511435715...	Sistematic review	2012	MSRR	Lenercept, CDB, aciclovir, AZA, HIgGIV, MTX, GA, NTZ, RTX	Clinical trials	ARR in first and second year follow-up
Freedmann et al.²⁰20. Freedman MS, Selchen D, Arnold DL, Prat A, Banwell B, Yeung M et al. Treatment optimization in MS: canadian MS Working Group updated recommendations. Can J Neurol Sci. 2013;40(3):307-23. doi:10.1017/S0317167100014244 https://doi.org/10.1017/S031716710001424...	Guideline	2013	CIS, MSRR, MSPP, MSSP	IFN, GA, NTZ, FNG, MTX, Aza, CDB, CFM, RTX, DCZ, OCZ	Clinical trials	Relapses, MRI, Cognition, Treatment iniciation, switching, progression
Dôrr²⁵25. Dörr J, Paul F. The transition from first-line to second-line therapy in multiple sclerosis. Curr Treat Options Neurol. 2015;17(6):354. doi:10.1007/s11940-015-0354-5 https://doi.org/10.1007/s11940-015-0354-...	Guideline	2015	CIS, MSRR	IFN 1A SC, IFN 1A IM, IFN 1B. GA, TRF, FNG, NTZ, DMF, MTX, ALZ, AZA	Sumary of reasosn to swith treatment: intra-class and escalating	Response or tolerability, safety, or adherence issues
Broadley et al.¹⁵15. Broadley SA, Barnett MH, Boggild M, Brew BJ, Butzkueven H, Heard R et al. Therapeutic approaches to disease modifying therapy for multiple sclerosis in adults: an Australian and New Zealand perspective: part 2 new and emerging therapies and their efficacy. J Clin Neurosci. 2014;;21(11):1847-56. doi:10.1016/j.jocn.2014.01.018 https://doi.org/10.1016/j.jocn.2014.01.0...	Revision and guideline	2015	CIS, MSRR, MSPP, MSSP	TRF, DMF, ALZ, LQN, DCZ, RTX, AHSCT	Clinical trials	ARR, Relapses, disability, new gad lesions, new T2 lesions, brain atrophy
Gajofatto-Benedetti et al.¹1. Gajofatto A, Benedetti MD. Treatment strategies for multiple sclerosis: when to start, when to change, when to stop? World J Clin Cases. 2015;3(7):545-55. doi:10.12998/wjcc.v3.i7.545 https://doi.org/10.12998/wjcc.v3.i7.545...	Revision	2015	CIS, MSRR	IFN, GA, DMF, TRF, NTZ, FNG, ALZ, MTX, Pegy-IFN, AZA	Clinical trials	ARR reduction, tolerability and safety issues
La Mantia et al.²³23. La Mantia L, Di Pietrantonj C, Rovaris M, Rigon G, Frau S, Berardo F et al. Interferons-beta versus glatiramer acetate for relapsing-remitting multiple sclerosis. Cochrane Database Syst Rev. 2014;7:CD009333. doi:10.1002/14651858.CD009333.pub2 https://doi.org/10.1002/14651858.CD00933...	Systematic review	2014	CIS, MSRR, MSPP, MSSP	IFN 1A SC, IFN 1A IM, IFN 1B. GA	Clinical trials	Efficacy on relapses, MRI
Fillippini et al.²⁶26. Filippini G, Del Giovane C, Vacchi L, D'Amico R, Di Pietrantonj C, Beecher D. Immunomodulators and immunosuppressants for multiple sclerosis: a network meta-analysis. Cochran Datab Syst Rev. 2013;6:CD008933˙. doi:10.1002/14651858.CD008933.pub2 https://doi.org/10.1002/14651858.CD00893...	Systematic review	2014	MSRR, MSSP, MSPR	IFN 1A SC, IFN 1A IM, IFN 1B. GA, NTZ, CFX, AZA, MTT, HIgGIV	Clinical trials	Relapses at 24 months of follow-up
Tulmann et al.²⁷27. Tullman MJ. A review of current and emerging therapeutic strategies in multiple sclerosis. Am J Manag Care. 2013;19(2 Suppl):S21-7.	Review	2014	MSRR, MSSP	IFN 1A SC, IFN 1A IM, IFN 1B. GA, TRF, FNG, NTZ, DMF, MTX, ALZ, DCZ OCZ, LQN	Clinical trials and reviews	Efficacy and adverse events
Wingerchuck et al.²⁴24. Wingerchuk DM, Carter JL Multiple sclerosis: current and emerging disease-modifying therapies and treatment strategies. Mayo Clin Proc. 2014;89(2):225-40. doi:10.1016/j.mayocp.2013.11.002 https://doi.org/10.1016/j.mayocp.2013.11...	Review	2015	MSRR	IFN 1A SC, IFN 1A IM, IFN 1B. GA, TRF, FNG, NTZ, DMF, ALZ	Clinical trials and systematic reviews	Risk-benefit profiles, monotherapy, escalating and induction therapies
Damal et al.³⁰30. Damal K, Stoker E, Foley JF. Optimizing therapeutics in the management of patients with multiple sclerosis: a review of drug efficacy, dosing, and mechanisms of action. Biologics. 2013;7:247-58. doi:10.2147/BTT.S53007 https://doi.org/10.2147/BTT.S53007...	Review	2013	MSRR	IFN 1A SC, IFN 1A IM, IFN 1B. GA, NTZ, FNG, TRF, DMF	Clinical trials	Mecanism of action and safety
Weber et al.³¹31. Weber MS, Menge T, Lehmann-Horn K, Kronsbein HC, Zettl U, Sellner J et al. Current treatment strategies for multiple sclerosis: efficacy versus neurological adverse effects. Curr Pharm Des. 2012;18(2):209-19. doi:10.2174/138161212799040501 https://doi.org/10.2174/1381612127990405...	Review	2012	CIS, MSRR, MSPP, MSSP	IFN, GA TRF, MTX, CDB, NTZ, LQN, RTX	Clinical trials	Risk benefit profiles

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[1] Correspondence: Elizabeth Regina Comini-Frota; Universidade José do Rosário Vellano (UNIFENAS-BH), Rua Líbano 66 Belo Horizonte, MG, Brazil, CEP 31710-030. E-mail: elizabeth.frota@unifenas.br, elizcomini@gmail.com.