Natalizumab adverse events are rare in patients with multiple sclerosis

Author:

Fragoso Yára Dadalti1,Alves-Leon Soniza Vieira2,Arruda Walter Oleschko3,Carvalho Margarete de Jesus4,Comini-Frota Elizabeth Regina5,Corrêa Éber Castro6,Ferreira Maria Lucia Brito7,Gama Paulo Diniz da8,Gomes Sidney9,Gonçalves Marcus Vinicius Magno10,Kaimen-Maciel Damacio Ramón11,Mendes Maria Fernanda12,Morales Rogerio Rizo13,Muniz Andre14,Salgado Pedro Rippel15,Ruocco Heloisa Helena16,Albuquerque Livia Brito Bezerra de7,Brooks Joseph Bruno Bidin1,Fêzer Letícia2,Georgetto Sergio11,Lopes Josiane11,Malfetano Fabíola Rachid2,Meira Isabella D'Andrea2,Oliveira Celso Luis Silva1,Oliveira Francisco Tomaz Meneses de9,Safanelli Fabiana10,Satomi Massaco15

Affiliation:

1. Universidade Metropolitana de Santos (UNIMES), Brazil

2. Universidade Federal do Rio de Janeiro (UFRJ), Brazil

3. Universidade Federal do Paraná (UFPR), Brazil

4. Faculdade de Medicina do ABC (FMABC), Brazil

5. Universidade Federal de Minas Gerais (UFMG), Brazil

6. CLINEN, Neurologia e Endocrionologia, Brazil

7. Hospital da Restauração, Brazil

8. Pontifícia Universidade Católica de São Paulo (PUC-SP), Brazil

9. Hospital Beneficência Portuguesa de São Paulo; Hospital Paulistano, Brazil

10. Universidade da Região de Joinville (UNIVILLE), Brazil

11. Universidade Estadual de Londrina (UEL), Brazil

12. Faculdade de Ciências Médicas da Santa Casa de São Paulo (FCMSCSP), Brazil

13. Universidade Federal de Uberlândia (UFU), Brazil

14. Hospital São Rafael de Salvador, Brazil

15. Universidade Federal de Mato Grosso do Sul (UFMS), Brazil

16. Centro de Atendimento de Esclerose Múltipla, Brazil

Abstract

ObjectiveTo assess the prevalence and the profile of adverse events (AE) of natalizumab in patients with multiple sclerosis (MS).MethodsData collection from neurologists attending to patients with MS at specialized units in Brazil.ResultsData from 103 patients attending the infusion centers of 16 MS units in 9 Brazilian states were included in the study. The total number of infusions was 1,042. Seventy-nine patients (76.7%) did not present any AE. Twenty-four patients (23.3%) presented only mild AE. There were three major AE, including two deaths. These three occurrences, although not necessarily being drug-related, must be taken into consideration.ConclusionThe profile of AEs for natalizumab shows that 97% of patients have none or only mild AE. However, still due to safety worries, the use of this medication should be restricted to MS units under the care of specialized neurologists.

Publisher

FapUNIFESP (SciELO)

Subject

Neurology,Clinical Neurology

Reference20 articles.

1. Natalizumab for relapsing remitting multiple sclerosis;Pucci E;Cochrane Database Syst Rev,2011

2. Defining the clinical course of multiple sclerosis: results of an international survey. National Multiple Sclerosis Society (USA) Advisory Committee on Clinical Trials of New Agents in Multiple Sclerosis;Lublin FD;Neurology,1996

3. Latin American algorithm for treatment of relapsing-remitting multiple sclerosis using disease-modifying agents;Finkelsztejn A;Arq Neuropsiquiatr,2012

4. Anticorpos monoclonais em esclerose múltipla;Melges LDD;Recomendações esclerose múltipla

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