Latin American algorithm for treatment of relapsing-remitting multiple sclerosis using disease-modifying agents

Abstract

Objective: It is estimated that circa 50,000 individuals have relapsing-remitting multiple sclerosis in Latin America. European and NorthAmerican algorithms for the treatment of multiple sclerosis do not foresee our regional difficulties and the access of patients to treatment. Methods:The Latin American Multiple Sclerosis Forum is an independent and supra-institutional group of experts that has assessed the latest scientific evidence regarding efficacy and safety of disease-modifying treatments. Accesses to treatment and pharmacovigilance programs for each of the eight countries represented at the Forum were also analyzed. Results: A specific set of guidelines based upon evidence-based recommendations was designed for Latin America. Future perspectives of multiple sclerosis treatment were also discussed. Conclusions: The present paper translated an effort from representatives of eight countries discussing a matter that cannot be adapted to our region directly from purely European and North-American guidelines for treatment.Key words: multiple sclerosis, treatment, Latin America. RESUMOObjetivo: Estima-se que haja aproximadamente 50.000 pessoas com a forma remitente-recorrente da esclerose múltipla na América Latina. Os algoritmos de tratamento norte-americanos e europeus não levam em consideração nossas peculiaridades regionais, nem a dificuldade no acesso ao tratamento por parte dos pacientes. Métodos: O Fórum Latino-americano de Esclerose Múltipla é um grupo de especialistas independente e suprainstitucional, que avaliou as mais recentes evidências científicas sobre a eficácia e a segurança das drogas modificadoras do curso da doença. Foram avaliados também o acesso ao tratamento e os programas de farmacovigilância de cada

Natalizumab adverse events are rare in patients with multiple sclerosis

“…With natalizumab in particular, the main concern is opportunistic infection by the JC virus, which gives rise to a condition of severe PML 1,6,10 . Some countries have specific pharmacovigilance protocols for reporting on PML and other side effects with natalizumab 3 , but Brazil is not one of them. In Brazil, adverse events are reported directly to the national agency for pharmacovigilance (ANVISA).…”

“…However, the adverse events relating to patients using this drug are still being learned. The more restricted recommendations on the use of natalizumab 3,4 are giving space to more flexible indications of the drug 5 .…”

“…The study was independent of all pharmaceutical companies, academia, private or governmental institutions. Patients who had received immunosuppressive drugs in the past were only included in the natalizumab protocol if at least six months had elapsed since the end of immunosuppressive drug administration, in accordance with current Brazilian and international recommendations 3,4 . Retrospective data from medical records were collected and forwarded to a central database.…”

“…In Brazil, as in other countries, natalizumab has been recommended for use when both glatiramer acetate and interferon beta have failed to control the relapses and severe disease activity in RRMS 3,4 . Guidelines from the Brazilian Academy of Neurology now indicate that natalizumab can be used as first line therapy or after failure of one immunomodulatory drug 5 .…”

Access and barriers to MS care in Latin America

“…The foundation in 1999 of the Latin American Committee for Treatment and Research in MS (LACTRIMS) created a continental organism that has gradually become the most significant stimulus for clinical education and epidemiologic studies in the region, 34 development of therapeutic guidelines, 35–39 and the most effective regional advocate for patients. 40 MS care is complex and expensive.…”