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Eight-Year Follow-up

Richard A. Rudick, MD; Jar-Chi Lee, MS; Gary R. Cutter, PhD; Deborah M. Miller, PhD; Dennis Bourdette, MD; Bianca Weinstock-Guttman, MD; Robert Hyde, PhD; Hao Zhang, PhD; Xiaojun You, PhD

Arch Neurol. Published online July 12, 2010. doi:10.1001/archneurol.2010.150

Objective  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.

Design  Retrospective analysis of the Multiple Sclerosis Collaborative Research Group study data.

Setting  The intramuscular interferon beta-1a pivotal trial was a double-blind, placebo-controlled phase 3 study.

Participants  Patients with relapsing-remitting multiple sclerosis who received at least 2 years of treatment and completed an EDSS evaluation 8 years postrandomization.

Intervention  Thirty micrograms of intramuscular interferon beta-1a or placebo once weekly during the 2-year clinical trial.

Main Outcome Measures  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.

Results  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.

Conclusion  In this phase 3 clinical trial of intramuscular interferon beta-1a, compared with effects of treatment, baseline EDSS score, and number of relapses during the study, worsening of 1 point or more on EDSS from baseline lasting 6 months was the strongest predictor of clinically significant disability 8 years after randomization into the clinical trial.

Author Affiliations: Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic, Cleveland, Ohio (Drs Rudick and Miller; and Ms Lee); Department of Biostatistics, University of Alabama at Birmingham, Birmingham (Dr Cutter); Oregon Health & Science University, Portland (Dr Bourdette); William C. Baird Multiple Sclerosis Center, Buffalo, New York (Dr Weinstock-Guttman); and Biogen Idec Inc, Cambridge, Massachusetts (Drs Hyde, Zhang, and You).

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