RESUMO
BACKGROUND: Natalizumab has been recommended for the treatment of relapsing-remitting multiple sclerosis (RRMS) in patients with insufficient response to interferon-beta/glatiramer acetate (DMT) or aggressive MS. The pivotal trials were not conducted to investigate natalizumab monotherapy in this patient population. METHOD: Retrospective, multicenter study in Germany and Switzerland. Five major MS centers reported all RRMS patients who initiated natalizumab >or=12 months prior to study conduction. RESULTS: Ninety-seven RRMS patients were included [69% female, mean age 36.5 years, mean Expanded Disability Status Scale (EDSS) 3.4; 93.8% were pre-treated with DMT], mean treatment duration with natalizumab was 19.3 +/- 6.1 months. We found a reduction of the annualized relapse rate from 2.3 to 0.2, 80.4% were relapse free with natalizumab. EDSS improved in 12.4% and 89.7% were progression free (change of >or= 1 EDSS point). Eighty-six per cent of patients with highly active disease (>or= 2 relapses in the year and >or= 1 Gadolinium (Gd)+ lesion at study entry, n = 20) remained relapse free. The mean number of Gd enhancing lesions was reduced to 0.1 (0.8 at baseline). Discontinuation rate was 8.2% (4.1% for antibody-positivity). CONCLUSION: Natalizumab is effective after insufficient response to other DMT and also in patients with high disease activity.
Assuntos
Anticorpos Monoclonais/administração & dosagem , Sistema Nervoso Central/efeitos dos fármacos , Resistência a Medicamentos/imunologia , Fatores Imunológicos/administração & dosagem , Esclerose Múltipla Recidivante-Remitente/tratamento farmacológico , Adulto , Anticorpos Monoclonais/efeitos adversos , Anticorpos Monoclonais Humanizados , Sistema Nervoso Central/imunologia , Sistema Nervoso Central/patologia , Meios de Contraste , Avaliação da Deficiência , Feminino , Gadolínio , Alemanha , Acetato de Glatiramer , Humanos , Fatores Imunológicos/efeitos adversos , Fatores Imunológicos/uso terapêutico , Imunossupressores/uso terapêutico , Interferon beta/uso terapêutico , Imageamento por Ressonância Magnética , Masculino , Pessoa de Meia-Idade , Esclerose Múltipla Recidivante-Remitente/imunologia , Esclerose Múltipla Recidivante-Remitente/patologia , Natalizumab , Avaliação de Resultados em Cuidados de Saúde , Peptídeos/uso terapêutico , Estudos Retrospectivos , Prevenção Secundária , Índice de Gravidade de Doença , Falha de Tratamento , Adulto JovemRESUMO
BACKGROUND: Natalizumab has been recommended for the treatment of patients with relapsing remitting multiple sclerosis with insufficient response to interferon-beta (IFN-beta) or glatiramer acetate (GA). METHOD: Prospective, observational study. RESULTS: We found a reduction of the annualized relapse rate from 2.1 under IFN-beta or GA to 0.2 one year after switching to natalizumab. There were 94% fewer gadolinium enhancing lesions with natalizumab. CONCLUSION: Natalizumab reduced short term clinical and MRI activity in second line therapy and efficacy is comparable to first line therapy as demonstrated in the pivotal trials.
Assuntos
Anticorpos Monoclonais/uso terapêutico , Esclerose Múltipla Recidivante-Remitente/tratamento farmacológico , Fármacos Neuroprotetores/uso terapêutico , Adulto , Anticorpos Monoclonais/efeitos adversos , Anticorpos Monoclonais Humanizados , Encéfalo/patologia , Progressão da Doença , Feminino , Gadolínio , Acetato de Glatiramer , Humanos , Fatores Imunológicos/uso terapêutico , Interferon beta/uso terapêutico , Imageamento por Ressonância Magnética , Masculino , Esclerose Múltipla Recidivante-Remitente/patologia , Natalizumab , Fármacos Neuroprotetores/efeitos adversos , Peptídeos/uso terapêutico , Projetos Piloto , Recidiva , Resultado do TratamentoRESUMO
BACKGROUND: Prevalence rates of headache in multiple sclerosis (MS) patients varied widely in recent studies. This study aimed to investigate the 1 year prevalence of headache in MS compared with the general population. METHODS: Population-based case-control study in Germany. RESULTS: We included 491 patients with definite MS (68% female, mean age 45.3 years, 63.7% relapsing remitting MS, mean Expanded Disability Status Scale (EDSS) 3.2, 106 treated with interferon-beta, 53 with glatiramer acetate, 271 untreated) and 447 age and gender matched controls. Headache was diagnosed with a validated questionnaire according to the International Headache Society Criteria. Headache prevalence was 56.2% (tension type headache 37.2%, migraine 24.6%). Headache prevalence rates did not differ from controls. Headache was not associated with disability or treatment. Trigeminal neuralgia was found in 6.3% of MS cases. CONCLUSION: Results suggest that headache in MS patients reflects comorbidity in most conditions.