Natalizumab adverse events are rare in patients with multiple sclerosis;Eventos adversos por natalizumabe são raros em pacientes com esclerose múltipla

Arquivos de Neuro-Psiquiatria

Volumn 71, Issue 3, 2013, Pages 137-141

  Fragoso, Yára Dadalti ^a   Alves Leon, Soniza Vieira ^b   Arruda, Walter Oleschko ^c   Carvalho, Margarete de Jesus ^d   Comini Frota, Elizabeth Regina ^e   Corrêa, Éber Castro ^f   Ferreira, Maria Lucia Brito ^g   da Gama, Paulo Diniz ^h   Gomes, Sidney ⁱ   Gonçalves, Marcus Vinicius Magno ^j   Kaimen Maciel, Damacio Ramön ^k   Mendes, Maria Fernanda ^d   Morales, Rogerio Rizo ^l   Muniz, Andre ^m   Salgado, Pedro Rippel ⁿ   Ruocco, Heloisa Helena ^o   de Albuquerque, Livia Brito Bezerra ^g   Brooks, Joseph Bruno Bidin ^a   Fêzer, Letícia ^b   Georgetto, Sergio ^k   Lopes, Josiane ^k   Malfetano, Fabíola Rachid ^b   Meira, Isabella D'Andrea ^b   Oliveira, Celso Luis Silva ^a   de Oliveira, Francisco Tomaz Meneses ⁱ   Safanelli, Fabiana ^j   Satomi, Massaco ⁿ   more..

^a UNIVERSIDADE METROPOLITANA DE SANTOS   (Brazil)

^b FEDERAL UNIVERSITY OF RIO DE JANEIRO   (Brazil)

^c FEDERAL UNIVERSITY OF PARANÁ   (Brazil)

^d Universidade Federal de Minas Gerais ^*

^e FEDERAL UNIVERSITY OF MINAS GERAIS   (Brazil)

^f CLINEN   (Brazil)

^g HOSPITAL DA RESTAURAÇÃO   (Brazil)

^h PONTIFÍCIA UNIVERSIDADE CATÓLICA DE SÃO PAULO   (Brazil)

ⁱ HOSPITAL BENEFICÊNCIA PORTUGUESA DE SÃO PAULO   (Brazil)

^j UNIVERSITY OF JOINVILLE REGION   (Brazil)

^k STATE UNIVERSITY OF LONDRINA   (Brazil)

^l FEDERAL UNIVERSITY OF UBERLÂNDIA   (Brazil)

^m HOSPITAL SÃO RAFAEL   (Brazil)

ⁿ FEDERAL UNIVERSITY OF MATO GROSSO DO SUL   (Brazil)

^o Centro de Atendimento de Esclerose Múltipla   (Brazil)

more..

Author keywords

Adverse events; Antibodies; Monoclonal; Multiple sclerosis; Natalizumab

Indexed keywords

ANTIFUNGAL AGENT; DEXAMETHASONE; NATALIZUMAB; PREDNISONE;

ACUTE RESPIRATORY FAILURE; ADOLESCENT; ADULT; ARTICLE; ASTHENIA; BLURRED VISION; BRAZIL; DEATH; DISEASE ACTIVITY; DIZZINESS; FATIGUE; FEMALE; FEVER; HEADACHE; HEALTH CARE PERSONNEL; HEART ARREST; HEART INFARCTION; HICCUP; HUMAN; HYPERTENSION; INFECTION; MAJOR CLINICAL STUDY; MALE; MEDICAL RECORD; MULTIPLE SCLEROSIS; MUSCLE SPASM; MYCOSIS; NAUSEA AND VOMITING; NUCLEAR MAGNETIC RESONANCE IMAGING; PAIN; PARESTHESIA; PREVALENCE; RELAPSE; RESPIRATORY TRACT INFECTION; RETROSPECTIVE STUDY; SEPTICEMIA; SIDE EFFECT; SKIN MANIFESTATION; SKIN PRURITUS; SKIN REDNESS; SPASTICITY; TUBERCULOSIS; URINARY TRACT INFECTION;

EID: 84875719322     PISSN: 0004282X     EISSN: 16784227     Source Type: Journal    
DOI: 10.1590/S0004-282X2013000300002     Document Type: Article

References (20)

1. Pucci E, Giuliani G, Solari A, et al. Natalizumab for relapsing remitting multiple sclerosis. Cochrane Database Syst Rev 2011; 10: CD007621.
2. Lublin FD, Reingold SC. 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. Neurology 1996;46:907-911.
3. Finkelsztejn A, Gabbai AA, Fragoso YD, et al. Latin American algorithm for treatment of relapsing-remitting multiple sclerosis using diseasemodifying agents. Arq Neuropsiquiatr 2012;70:799-806.
4. Ministério da Saúde do Brasil, Imprensa Nacional, Brasília, DF. ° 184 - Diário Oficial da União 24 Sep 10 - p. 679 - section 1 number 493, 23rd Sept 2010.
5. Melges LDD, Alvarenga MP, Pimentel MLV. Anticorpos monoclonais em esclerose múltipla. In: Machado S, et al. Recomendações esclerose múltipla. São Paulo, Omnifarma, 2012:53-59.
6. Bloomgren G, Richman S, Hotermans C, et al. Risk of natalizumabassociated progressive multifocal leukoencephalopathy. N Engl J Med 2012;366:1870-1880.
7. Hellwig K, Schimrigk S, Fischer M, et al. Allergic and nonallergic delayed infusion reactions during natalizumab therapy. Arch Neurol 2008;65:656-658.
8. Casanova Estruch B. Safety profile and practical considerations of monoclonal antibody treatment. Neurologia 2011 [Epub ahead of print] PMID 2159627.
9. Singh JA, Wells GA, Christensen R, et al. Adverse effects of biologics: a network meta-analysis and Cochrane overview. Cochrane Database Syst Rev 2011;2:CD008794.
10. Goodin DS, Cohen BA, O'Connor P, Kappos L, Stevens JC. Assessment: the use of natalizumab (Tysabri) for the treatment of multiple sclerosis (an evidence-based review): report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology 2008;71:766-773.
11. Namey M, Halper J, O'leary S, Beavin J, Bishop C. Best practices in multiple sclerosis: infusion reactions versus hypersensitivity associated with biologic therapies. J Infus Nurs 2010;33:98-111.
12. Barbaud A, Granel F, Waton J, Poreaux C. How to manage hypersensitivity reactions to biological agents? Eur J Dermatol 2011;21:667-674.
13. Rudick RA, Panzara MA. Natalizumab for the treatment of relapsing multiple sclerosis. Biologics 2008;2:189-199.
14. Gutwinski S, Erbe S, Münch C, Janke O, Müller U, Haas J. Severe cutaneous Candida infection during natalizumab therapy in multiple sclerosis. Neurology 2010;74:512-523.
15. Stallmach A, Hagel S, Bruns T. Adverse effects of biologics used for treating IBD. Best Pract Res Clin Gastroenterol 2010;24:167-182.
16. Cohen M, Rocher F, Brunschwig C, Lebrun C. Recurrent pericarditis due to natalizumab treatment. Neurology 2009;72:1616-1617.
17. Sylvestre MP, Huszti E, Hanley JA. Do OSCAR winners live longer than less successful peers? A reanalysis of the evidence. Ann Intern Med 2006;145:36-363.
18. Suissa S. Immortal time bias in pharmaco-epidemiology. Am J Epidemiol 2008;167:492-499.
19. Maclure M, Fireman B, Nelson JC, et al. When should case-only designs be used for safety monitoring of medical products? Pharmacoepidemiol Drug Saf 2012;21(Suppl 1):S50-S61.
20. Rudick RA, Miller D, Hass S, et al. Health-related quality of life in multiple sclerosis: effects of natalizumab. Ann Neurol 2007;62:335-346.