Disability progression in a clinical trial of relapsing-remitting multiple sclerosis: eight-year follow-up

Archives of Neurology
Richard A RudickXiaojun You

Abstract

To investigate the value of Expanded Disability Status Scale (EDSS) worsening sustained for at least 6 months and other parameters as predictors for disability status. Retrospective analysis of the Multiple Sclerosis Collaborative Research Group study data. The intramuscular interferon beta-1a pivotal trial was a double-blind, placebo-controlled phase 3 study. Patients with relapsing-remitting multiple sclerosis who received at least 2 years of treatment and completed an EDSS evaluation 8 years postrandomization. Thirty micrograms of intramuscular interferon beta-1a or placebo once weekly during the 2-year clinical trial. Positive predictive values for 6-month sustained progression during 2 years were calculated to determine the ability to predict disability status at 8 years. A multivariate logistic regression model was used to assess the relationship between predictors and EDSS milestones at follow-up. Forty-five patients had sustained 6-month EDSS progression during the clinical trial and 115 did not. Progression during the trial was the strongest predictor of reaching EDSS milestones at the follow-up visit, 8 years after randomization. Other independent predictors were treatment arm assignment and baseline EDSS score. In th...Continue Reading

Citations

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