TY - JOUR
T1 - Disability progression in a clinical trial of relapsing-remitting multiple sclerosis eight-year follow-up
AU - Rudick, Richard A.
AU - Lee, Jar Chi
AU - Cutter, Gary R.
AU - Miller, Deborah M.
AU - Bourdette, Dennis
AU - Weinstock-Guttman, Bianca
AU - Hyde, Robert
AU - Zhang, Hao
AU - You, Xiaojun
PY - 2010/11
Y1 - 2010/11
N2 - 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.
AB - 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.
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U2 - 10.1001/archneurol.2010.150
DO - 10.1001/archneurol.2010.150
M3 - Article
C2 - 20625068
AN - SCOPUS:77954891546
SN - 0003-9942
VL - 67
SP - 1329
EP - 1335
JO - Archives of Neurology
JF - Archives of Neurology
IS - 11
ER -