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Rev Neurol (Paris). 1999;155 Suppl 2:S13-9.

[Interferon beta-1a (Avonex TM): clinical and MRI impacts].

[Article in French]

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1
Clinique Neurologique, CHU de Lille.

Abstract

This article presents critical aspects of the pivotal phase III study that led to approval of interferon beta-1a (Avonex) as treatment for relapsing-remitting multiple sclerosis (MS). An update on data from the pivotal study or other open studies, further demonstrating the practical clinical impact of Avonex, are also presented. The purpose of the pivotal study was to determine whether Avonex could slow the progressive irreversible neurological disability of relapsing-MS. 301 patients were randomised into a double-blind placebo-controlled, multicentric trial of Avonex. Avonex 6.0 MUI (30 micrograms) was administered by intramuscular injection weekly. The primary outcome variable was time to sustained physical disability at 6 months progression of at least 1.0 point on the EDSS. Avonex produced a significant delay in time to sustained EDSS progression (p = 0.02). The Kaplan-Meier estimate of the proportion of patients progressing by the end of 104 weeks was 34.9 p. 100 in the placebo group and 21.9 p. 100 in the Avonex treated group, representing a 37 p. 100 reduction in the risk of accumulating disability. Further analysis showed that the clinical efficacy related to disability did not depend on the definition of disability progression. Significantly fewer Avonex recipients progressed to EDSS milestones of 4.0 or 6.0. The exacerbation frequency was decreased by 32 p. 100 in the Avonex group. Patients treated with Avonex had also a significantly lower number and volume of gadolinium-enhanced lesions on MRI. There was no major adverse events related to treatment. Injection site reactions were rare and no reports of skin necrosis have been recorded. There was no significant and clinically relevant biological disturbances due to Avonex.

PMID:
10367320
[Indexed for MEDLINE]
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