Efficacy of subcutaneous interferon ß-1a on MRI outcomes in a randomised controlled trial of patients with clinically isolated syndromes.
J Neurol Neurosurg Psychiatry
; 85(6): 647-53, 2014 Jun.
Article
em En
| MEDLINE
| ID: mdl-24292999
ABSTRACT
AIM:
The REbif FLEXible dosing in early MS (REFLEX) study compared several brain MRI outcomes in patients presenting with clinically isolated syndromes suggestive of multiple sclerosis and treated with two dose-frequencies of subcutaneous interferon (IFN) ß-1a or placebo.METHODS:
Patients were randomised (111) to IFN ß-1a, 44 µg subcutaneously three times a week or once a week, or placebo three times a week for up to 24 months. MRI scans were performed every 3 months, or every 6 months if the patient developed clinically definite multiple sclerosis. End points analysed included number of combined unique active lesions per patient per scan; numbers and volumes of new T2, T1 hypointense and gadolinium-enhancing (Gd+) lesions per patient per scan; and brain volume.RESULTS:
517 patients were randomised (intent-to-treat population subcutaneous IFN ß-1a three times a week, n=171; subcutaneous IFN ß-1a once a week, n=175; placebo, n=171). Combined unique active lesions were lower in patients treated with subcutaneous IFN ß-1a versus placebo (mean (SD) lesions per patient per scan three times a week 0.6 (1.15); once a week 1.23 (4.26); placebo 2.70 (5.23); reduction versus placebo three times a week 81%; once a week 63%; p<0.001) and with three times a week versus once a week (48% reduction; p=0.002). The mean numbers of new T2, T1 hypointense and Gd+ lesions were all significantly lower in the two active treatment arms compared with placebo (p≤0.004 for three times a week or once a week) and in the three times a week group compared with once a week (p≤0.012).CONCLUSIONS:
Both subcutaneous IFN ß-1a 44 µg regimens improved MRI outcomes versus placebo, with the three times a week regimen having a more pronounced effect than once a week dosing. TRIAL REGISTRATION clinicaltrial.gov identifier, NCT00404352.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Encéfalo
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Imageamento por Ressonância Magnética
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Adjuvantes Imunológicos
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Interferon beta
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Esclerose Múltipla
Tipo de estudo:
Clinical_trials
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Prognostic_studies
Limite:
Adult
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
J Neurol Neurosurg Psychiatry
Ano de publicação:
2014
Tipo de documento:
Article
País de afiliação:
Itália