Como escolher o tratamento inicial na esclerose múltipla: uma abordagem baseada em casos

Apóstolos, Samira Luisa Pereira; Boaventura, Mateus; Mendes, Natalia Trombini; Teixeira, Larissa Silva; Campana, Igor Gusmão

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Arquivos de Neuro-Psiquiatria

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Sumário

INFLAMMATORY AND DEMYELINATING DISEASE • Arq. Neuro-Psiquiatr. 80 (5 Suppl 1) • Maio 2022 • https://doi.org/10.1590/0004-282X-ANP-2022-S128 copiar

Como escolher o tratamento inicial na esclerose múltipla: uma abordagem baseada em casos

Autoria SCIMAGO INSTITUTIONS RANKINGS

RESUMO

Antecedentes:

A imunoterapia mudou drasticamente a história natural da esclerose múltipla (EM), doença esta que era classicamente associada a grandes incapacidades. Sabe-se hoje que o controle precoce da atividade de doença é crucial para evitar incapacidade progressiva, e o uso de terapias de alta eficácia pode ser benéfico. Apesar disso, a segurança ainda é uma preocupação dos pacientes e médicos. A escolha da terapia modificadora da doença é um desafio na prática clínica e suas particularidades devem ser mais discutidas.

Objetivo

Discutir o estado da arte da seleção da terapia inicial para pacientes com EM remitente recorrente.

Métodos

Utilizamos uma abordagem baseada em casos clínicos, com discussão das diversas opções terapêuticas em diferentes contextos de EM.

Resultados:

Foram apresentados casos clínicos compatíveis com o uso das principais terapias para EM, divididas em moderada e alta eficácia. No grupo de moderada eficácia discutimos sobre os interferons, acetato de glatirâmer, teriflunomida e fumarato de dimetila enquanto que no de alta eficácia falamos sobre fingolimode, cladribina, natalizumabe, ocrelizumabe, alentuzumabe e ofatumumabe.

Conclusão

Os avanços no tratamento da EM são notáveis. Fortes evidências suportam que o uso de terapia de alta eficácia de forma precoce possa ser benéfica. No entanto, biomarcadores, fatores prognósticos clínicos e radiológicos, bem como questões individuais dos pacientes, devem ser valorizados e considerados para uma decisão de tratamento personalizado.

Palavras-chave:
Esclerose Múltipla; Terapêutica

	Administration route and dosage	ARR reduction†	Rates of sustained NEDA 3 (time)
Moderate efficacy
Interferon Beta	Injectable (IM or SC)	28-34%^18-20
IFNβ-1a	IM - 30ug weekly		14% in DECIDE study (96wk)
IFNβ-1a	SC - 22ug or 44ug 3x/week		**
IFNβ-1b	SC - 250ug every other day		27% in pooled data from OPERA I and OPERA II studies (96wk)
Peg IFNβ-1a	SC- 125ug every 2 weeks		37% in ADVANCE study (2yr)
Glatiramer Acetate	SC - 40mg 3x/week or 20mg once daily	29%²⁴	**
Dimethyl fumarate	Oral - 240mg twice daily	44-53%^35,36	27% in pooled data from CONFIRM and DEFINE studies (2yr)
Teriflunomide	Oral - 7mg or 14mg once daily	31-36%^28,29	23% in TEMSO study
High efficacy
Fingolimod	Oral - 0.5mg once daily	51-55%^42,43	31% in pooled data from FREEDOMS and FREEDOMS II studies (2yr)
Cladribine	Oral - 1.75mg/kg/year taken in 2 weeks. Repeat course after 12 months	58%⁵⁰	30% in CLARITY Extension study (2yr)
Ofatumumab	SC - 20mg monthly after initial load	50-60%⁶⁶	42% in pooled data from ASCLEPIOS I and II trials (2yr)
Natalizumab	IV - 300mg every 4 weeks	54-68%^51,52	37% in AFFIRM study (2yr)
Alemtuzumab	IV - 2 cycle, 12 months apart: 12mg/day for 5 days and 12mg/day for 3 days	55%⁵⁷	61% in CARE MS I Extension Study (3yr)
Ocrelizumab	IV - 600mg every 6 months	46-47%⁶³	48% in pooled data from OPERA I and OPERA II studies (96wk)

	Adverse effects	Risk of infections‡	Monitoring	Special population
Moderate efficacy
Interferon Beta	Headache, injection site reactions,flu-like symptoms, elevated liver enzymes, psychiatric symptoms	Not increased	CBC and liver enzymes every 6 months	Relatively safe during pregnancy and lactation. Can be used in children
Glatiramer Acetate	Injection site reactions, palpitation, dyspnea, anxiety	Not increased	Not needed	Relatively safe during pregnancy and breastfeeding
Dimethyl fumarate	Flushing, gastrointestinal symptoms, liver and renal toxicity	Not increased	CBC every 6 months	Limited data during pregnancy. Breastfeeding contraindicated
Teriflunomide	Headache, GI symptoms, hair thinning, liver enzymes increase	Not increased	Liver enzymes monthly for 6 months, then every 6 months	Potentially teratogenic. Accelerate drug elimination in case of accidental pregnancy
High efficacy
Fingolimod Cladribine	Headache, hypertension, macular edema, liver toxicity, bradyarrhythmia Headache, lymphopenia, nausea, malignancy	May be increased for herpes virus and respiratory infections Slightly increased risk of overall infection rate and serious infections AE	CBC and liver enzymes every 6 months. Fundoscopy before and 3-4 months after start CBC 2 and 6 months after each course, cancer screening according to age	Can be used in children older than 10yo. Not recommended during pregnancy and lactation Avoid pregnancy for 6 months after the last treatment course. Breastfeeding allowed after 7 days
Ocrelizumab	Infusion reactions, headache, malignancy risk potential	Increased risk of upper respiratory, UTI and herpes virus infections	CBC and liver enzymes annually	Avoid pregnancy for at least 6-12 months after treatment
Ofatumumab	Infections, injection site reactions, headache	Not increased	CBC and liver enzymes annually	Avoid pregnancy for at least 6-12 months after treatment
Natalizumab	Fatigue, allergic reactions, headache, PML	Not increased, except for JCV-PML cases	JCV/ PML screening every 3-6m, CBC and liver enzymes every 6 months	High risk of relapse if stopped, Consider maintenance of treatment until 32-36 weeks of pregnancy. Low absorption in breastfeeding
Alemtuzumab	Infusion reactions, infections, thyroid disorder and other autoimmune conditions (ITP, kidney disease)	Increased risk of overall infection rate, and serious infections AE.	CBC, renal function, urinalysis every month and TSH every 3 months until 2 years after last cycle; cancer screening annually	Possibility of pregnancy and breastfeeding after 4 months of last infusion. Monitor development of autoimmune diseases during pregnancy.

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[1] Correspondence:
Samira Luisa Pereira Apóstolos; Email: samira.apostolos.neuro@gmail.com.