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Mult Scler ; 20(2): 234-42, 2014 Feb.
Article in English | MEDLINE | ID: mdl-23842212

ABSTRACT

BACKGROUND: Multiple sclerosis (MS) is characterised by inflammatory lesions of the central nervous system. Interferon beta-1b (IFNB-1b) has been shown to improve clinical and magnetic resonance imaging (MRI) measures for patients with MS. OBJECTIVE: To evaluate whether IFNB-1b in patients presenting with clinically isolated syndromes (CIS) prevented persisting T1 hypointensities on MRI (persistent black holes (PBHs)). METHODS: In the placebo-controlled phase, patients (n = 468) were initially randomised to IFNB-1b (n = 292) or placebo (n = 176) for two years or clinically definite MS (CDMS). In the open-label phase (n = 418), both groups were offered IFNB-1b for up to five years. Lesions were classified as PBHs if T1 hypointensity persisted throughout the last available scan (minimum time one year). RESULTS: A total of 435 patients were evaluable for analysis. The number of PBHs/patient was lower in the early rather than the delayed treatment arm during both phases (.42 vs .71, p = .0102 and .70 vs 1.17, p = .0121). Exploratory analyses identified baseline characteristics that affected rate of conversion. CONCLUSIONS: Although the rate of lesions that converted to PBH showed no significant differences between groups, the numbers of PBHs per patient out of new lesions was significantly lower in IFNB-1b patients compared to patients on placebo. TRIAL REGISTRATION NUMBER: NCT00544037.


Subject(s)
Central Nervous System/pathology , Demyelinating Diseases/drug therapy , Demyelinating Diseases/pathology , Immunosuppressive Agents/therapeutic use , Interferon-beta/therapeutic use , Adolescent , Adult , Double-Blind Method , Female , Humans , Interferon beta-1b , Male , Middle Aged , Young Adult
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