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.
RCT Entities:
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.
Authors: Thomas F Scott; Troy Desai; Chris Hackett; Edward J Gettings; Teresa Hentosz; Wisam Elmalik; Carol J Schramke Journal: Int J MS Care Date: 2019-12-05
Authors: Shekoufeh Nikfar; Abbas Kebriaeezadeh; Rassoul Dinarvand; Mohammad Abdollahi; Mohammad-Ali Sahraian; David Henry; Ali Akbari Sari Journal: Daru Date: 2013-06-22 Impact factor: 3.117
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