Fred D Lublin1, Stacey S Cofield2, Gary R Cutter2, Tarah Gustafson3, Stephen Krieger3, Ponnada A Narayana4, Flavia Nelson5, Amber R Salter6, Jerry S Wolinsky5. 1. Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Department of Neurology & Friedman Brain Institute, Icahn School of Medicine at Mount Sinai, 5 East 98th Street, New York, NY, United States. Electronic address: fred.lublin@mssm.edu. 2. Department of Biostatistics, The University of Alabama at Birmingham, Birmingham, AL, United States. 3. Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Department of Neurology & Friedman Brain Institute, Icahn School of Medicine at Mount Sinai, 5 East 98th Street, New York, NY, United States. 4. McGovern Medical School, Department of Diagnostic and Interventional Imaging, University of Texas Health Science Center at Houston, Houston, TX, United States. 5. McGovern Medical School, Department of Neurology, University of Texas Health Science Center at Houston, Houston, TX, United States. 6. Department of Biostatistics, Washington University School of Medicine, St. Louis, MO, United States.
Abstract
BACKGROUND: To report the long-term results of the blinded extension phase of the randomized, controlled study of the combined use of interferon beta-1a (IFN) 30μg IM weekly and glatiramer acetate (GA) 20mg daily compared to each agent alone in relapsing-remitting multiple sclerosis (RRMS). METHODS:1008 RRMS patients were followed on protocol until the last participant enrolled completed 3 years, allowing some subjects to be followed for up to 7 years. The primary endpoint was reduction in annualized relapse rate. Secondary outcomes included time to confirmed disability, Multiple Sclerosis Functional Composite (MSFC) score and MRI metrics. RESULTS: Similar to the core study, combination IFN + GA was not superior to the better of the single agents (GA) in risk of relapse. Both the combination therapy and GA were significantly better than IFN in reducing the risk of relapse. The combination was not better than either agent alone in lessening confirmed EDSS worsening or change in MSFC. Also similar to the core result, the combination was superior to either agent alone in reducing new lesion activity, but the 3 year MRI result did not presage a clinical benefit over the extended observation interval. CONCLUSION:Combining GA &; IFN did not produce a significant clinical benefit over the entire study duration. The earlier effect on reducing MRI activity did not result in a later clinical advantage. The combination showed a sustained advantage in reducing disease activity free status.
RCT Entities:
BACKGROUND: To report the long-term results of the blinded extension phase of the randomized, controlled study of the combined use of interferon beta-1a (IFN) 30μg IM weekly and glatiramer acetate (GA) 20mg daily compared to each agent alone in relapsing-remitting multiple sclerosis (RRMS). METHODS: 1008 RRMS patients were followed on protocol until the last participant enrolled completed 3 years, allowing some subjects to be followed for up to 7 years. The primary endpoint was reduction in annualized relapse rate. Secondary outcomes included time to confirmed disability, Multiple Sclerosis Functional Composite (MSFC) score and MRI metrics. RESULTS: Similar to the core study, combination IFN + GA was not superior to the better of the single agents (GA) in risk of relapse. Both the combination therapy and GA were significantly better than IFN in reducing the risk of relapse. The combination was not better than either agent alone in lessening confirmed EDSS worsening or change in MSFC. Also similar to the core result, the combination was superior to either agent alone in reducing new lesion activity, but the 3 year MRI result did not presage a clinical benefit over the extended observation interval. CONCLUSION: Combining GA & IFN did not produce a significant clinical benefit over the entire study duration. The earlier effect on reducing MRI activity did not result in a later clinical advantage. The combination showed a sustained advantage in reducing disease activity free status.
Authors: Minal J Bhanushali; Tarah Gustafson; Steve Powell; Robin A Conwit; Jerry S Wolinsky; Gary R Cutter; Fred D Lublin; Stacey S Cofield Journal: Clin Trials Date: 2014-04 Impact factor: 2.486
Authors: J W Lindsey; T F Scott; S G Lynch; S S Cofield; F Nelson; R Conwit; T Gustafson; G R Cutter; J S Wolinsky; F D Lublin Journal: Mult Scler Relat Disord Date: 2012-02-23 Impact factor: 4.339
Authors: J S Wolinsky; P A Narayana; J H Noseworthy; F D Lublin; J N Whitaker; A Linde; P Gjörstrup; H C Sullivan Journal: Neurology Date: 2000-05-09 Impact factor: 9.910
Authors: Fred D Lublin; Stacey S Cofield; Gary R Cutter; Robin Conwit; Ponnada A Narayana; Flavia Nelson; Amber R Salter; Tarah Gustafson; Jerry S Wolinsky Journal: Ann Neurol Date: 2013-03-11 Impact factor: 10.422
Authors: Jerry S Wolinsky; Ponnada A Narayana; Flavia Nelson; Sushmita Datta; Paul O'Connor; Christian Confavreux; Giancarlo Comi; Ludwig Kappos; Tomas P Olsson; Philippe Truffinet; Lin Wang; Aaron Miller; Mark S Freedman Journal: Mult Scler Date: 2013-02-27 Impact factor: 6.312