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

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

Research output: Contribution to journalArticle

50 Citations (Scopus)

Abstract

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. Amultivariate 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.

Original languageEnglish (US)
Pages (from-to)1329-1335
Number of pages7
JournalArchives of Neurology
Volume67
Issue number11
DOIs
StatePublished - Nov 2010

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Relapsing-Remitting Multiple Sclerosis
Clinical Trials
Random Allocation
Logistic Models
Placebos
Phase III Clinical Trials
Multiple Sclerosis
Therapeutics
Outcome Assessment (Health Care)
Recurrence
Research
Interferon beta-1a
Progression
Predictors

ASJC Scopus subject areas

  • Clinical Neurology

Cite this

Rudick, R. A., Lee, J. C., Cutter, G. R., Miller, D. M., Bourdette, D., Weinstock-Guttman, B., ... You, X. (2010). Disability progression in a clinical trial of relapsing-remitting multiple sclerosis eight-year follow-up. Archives of Neurology, 67(11), 1329-1335. https://doi.org/10.1001/archneurol.2010.150

Disability progression in a clinical trial of relapsing-remitting multiple sclerosis eight-year follow-up. / Rudick, Richard A.; Lee, Jar Chi; Cutter, Gary R.; Miller, Deborah M.; Bourdette, Dennis; Weinstock-Guttman, Bianca; Hyde, Robert; Zhang, Hao; You, Xiaojun.

In: Archives of Neurology, Vol. 67, No. 11, 11.2010, p. 1329-1335.

Research output: Contribution to journalArticle

Rudick, RA, Lee, JC, Cutter, GR, Miller, DM, Bourdette, D, Weinstock-Guttman, B, Hyde, R, Zhang, H & You, X 2010, 'Disability progression in a clinical trial of relapsing-remitting multiple sclerosis eight-year follow-up', Archives of Neurology, vol. 67, no. 11, pp. 1329-1335. https://doi.org/10.1001/archneurol.2010.150
Rudick, Richard A. ; Lee, Jar Chi ; Cutter, Gary R. ; Miller, Deborah M. ; Bourdette, Dennis ; Weinstock-Guttman, Bianca ; Hyde, Robert ; Zhang, Hao ; You, Xiaojun. / Disability progression in a clinical trial of relapsing-remitting multiple sclerosis eight-year follow-up. In: Archives of Neurology. 2010 ; Vol. 67, No. 11. pp. 1329-1335.
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