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

Autoria SCIMAGO INSTITUTIONS RANKINGS

RESUMO

A esclerose múltipla vem se tornando um desafio crescente para os neurologistas. Com o lançamento de novos medicamentos no mercado, os neurologistas brasileiros se encontram divididos entre, apesar da evolução dos seus pacientes, seguir as regras restritas estabelecidas pelo Ministério da Saúde para distribuição de medicamentos, ou ao contrário, considerar a progressão e piora da doença, em concordância com as evidências da literatura. Devido a este impasse foi realizada uma revisão sistemática sobre as principais orientações de tratamento publicadas e foi proposto um escalonamento terapêutico para orientar o tratamento dos pacientes com esclerose múltipla no Brasil.

Palavras-chave: esclerose múltipla; Consenso; tratamento

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.¹⁹	Sistematic review	2013	CIS	IFN 1A SC, IFN 1A IM, IFN 1B. GA	Clinical trials	Start treatment
Castro-Borrero et al.²²	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.²⁹	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.²⁰	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
Dôrr²⁵	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.¹⁵	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.¹	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.²³	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.²⁶	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.²⁷	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.²⁴	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.³⁰	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.³¹	Review	2012	CIS, MSRR, MSPP, MSSP	IFN, GA TRF, MTX, CDB, NTZ, LQN, RTX	Clinical trials	Risk benefit profiles

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E-mail: revista.arquivos@abneuro.org

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[TFN1] ARR: annualized relapse rate; RRR: relative risk reduction; PML: Progressive Multifocal Leucoencephalopathy, AV: atrial-ventricular.