A randomized controlled trial of recombinant interferon beta-1a in XXXX . Italian Amyotrophic Lateral Sclerosis Study Group.

@entity2655 @entity1 @entity204 @entity683
OBJECTIVE: To evaluate the efficacy of recombinant interferon beta (IFNbeta)-1a in the treatment of @entity2655 . BACKGROUND: It has been proposed that IFNs affect the progression of @entity2655 by interfering with putative immune mechanisms involved in the pathogenesis of the disease. METHODS: @entity1 (n = 61) 40 to 70 years of age with a 6- to 24-month history of confirmed @entity2655 with mild to moderate disability received IFNbeta-1a, 12 mIU (n = 31), or placebo (n = 30) subcutaneously three times a week for 6 months and were followed up for an additional 6 months. @entity1 were assessed after 4, 12, 24, 36, and 48 weeks. Medical Research Council scale, Norris scale, and bulbar scores as well as forced vital capacity were used to assess disability. Selected electrophysiologic measures (latency, amplitude, and duration of the compound muscle action potential) were also used. RESULTS: Twenty @entity1 randomized to IFNbeta-1a and 17 @entity1 given placebo completed the study. A total of 16 @entity1 receiving IFNbeta-1a became non-self-supporting compared with 16 on placebo (52% versus 53%). There were no significant differences between the two treatment groups for any of the measures of disease progression and disability. @entity204 were reported in six @entity1 treated with IFNbeta-1a and four @entity1 on placebo. Adverse events were reported more frequently with IFNbeta-1a (77% of @entity1 ) compared with placebo (57%), with @entity683 -like symptoms and local erythema being the commonest complaints. CONCLUSIONS: This pilot study suggests that IFNbeta-1a is not effective in the treatment of @entity2655 .
