Long-term impact of interferon beta-1b in patients with CIS: 8-year follow-up of BENEFIT.
J Neurol Neurosurg Psychiatry
; 85(11): 1183-9, 2014 Nov.
Article
em En
| MEDLINE
| ID: mdl-24218527
ABSTRACT
OBJECTIVE:
To examine the long-term impact of early treatment initiation of interferon beta-1b (IFNB1b, Betaferon/Betaseron) in patients with a first event suggestive of multiple sclerosis (MS).METHODS:
In the original placebo-controlled phase of BENEFIT, patients were randomised to IFNB1b 250 µg or placebo subcutaneously every other day. After 2 years or diagnosis of clinically definite MS (CDMS), all patients were offered open-label IFNB1b treatment for a maximum duration of 5 years. Thereafter, patients were enrolled in an observational extension study for up to 8.7 years.RESULTS:
Of the initial 468 patients, 284 (60.7%; IFNB1b 178 (61.0% of the original arm), placebo 106 (60.2% of original arm)) were enrolled in the extension study. 94.2% of patients were receiving IFNB1b. Patients originally randomised to IFNB1b had a reduced risk of developing CDMS by 32.2% over the 8-year observation period (HR 0.678; 95% CI 0.525 to 0.875; p=0.0030), a longer median time to CDMS by 1345 days (95% CI 389 to 2301), and a lower annualised relapse rate (0.196 (95% CI 0.176 to 0.218) versus 0.255 (95% CI 0.226 to 0.287), p=0.0012), with differences mainly emerging in the first year of the study. Cognitive outcomes remained higher in the early treated patients. EDSS remained low over time with a median of 1.5 in both arms.CONCLUSIONS:
These 8-year results provide further evidence supporting early initiation of treatment with IFNB1b in patients with a first event suggestive of MS.Palavras-chave
Texto completo:
1
Bases de dados:
MEDLINE
Assunto principal:
Interferon beta
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Esclerose Múltipla
Tipo de estudo:
Clinical_trials
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Observational_studies
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Prognostic_studies
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Risk_factors_studies
Limite:
Adult
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Female
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Humans
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Male
Idioma:
En
Revista:
J Neurol Neurosurg Psychiatry
Ano de publicação:
2014
Tipo de documento:
Article
País de afiliação:
França