Teriflunomide versus subcutaneous interferon beta-1a in patients with relapsing multiple sclerosis: a randomised, controlled phase 3 trial.
Mult Scler
; 20(6): 705-16, 2014 May.
Article
em En
| MEDLINE
| ID: mdl-24126064
ABSTRACT
BACKGROUND:
In previous studies, teriflunomide significantly reduced the annualised relapse rate (ARR) and disability progression.OBJECTIVE:
This phase 3, rater-blinded study (NCT00883337) compared teriflunomide with interferon-beta-1a (IFNß-1a).METHODS:
Patients with relapsing multiple sclerosis were randomised (111) to oral teriflunomide 7-or 14 mg, or subcutaneous IFNß-1a 44 µg. The primary composite endpoint was time to failure, defined as first occurrence of confirmed relapse or permanent treatment discontinuation for any cause. Secondary endpoints included ARR, Fatigue Impact Scale (FIS) and Treatment Satisfaction Questionnaire for Medication (TSQM). The study was completed 48 weeks after the last patient was randomised.RESULTS:
Some 324 patients were randomised (IFNß-1a 104; teriflunomide 7 mg 109; teriflunomide 14 mg 111). No difference in time to failure was observed. There was no difference in ARR between teriflunomide 14 mg and IFNß-1a, but ARR was significantly higher with teriflunomide 7 mg. FIS scores indicated more frequent fatigue with IFNß-1a, though differences were only significant with teriflunomide 7 mg. TSQM scores were significantly higher with teriflunomide. There were no unexpected safety findings.CONCLUSION:
Effects on time to failure were comparable between teriflunomide and IFNß-1a. There was no difference between teriflunomide 14 mg and IFNß-1a on ARR, though ARR was higher with teriflunomide 7 mg. The teriflunomide safety profile was consistent with previous studies.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Toluidinas
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Crotonatos
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Adjuvantes Imunológicos
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Interferon beta
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Esclerose Múltipla Recidivante-Remitente
Tipo de estudo:
Clinical_trials
Limite:
Adult
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Aged
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Female
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Humans
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Male
/
Middle aged
Idioma:
En
Revista:
Mult Scler
Assunto da revista:
NEUROLOGIA
Ano de publicação:
2014
Tipo de documento:
Article
País de afiliação:
França