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Assessing disability progression with the Multiple Sclerosis Functional CompositeMellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic, Cleveland, OH, USA rudickr{at}ccf.org
Department of Neurology, Vrije Universiteit Medical Centre, Amsterdam, The Netherlands
Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic, Cleveland, OH, USA
Center for Drug Evaluation and Research, United States Food and Drug Administration, Washington, DC, USA
Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Mount Sinai School of Medicine, New York, NY, USA
Hôpital Neurologique, Lyon, France
Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Mount Sinai School of Medicine, New York, NY, USA
St. Vincent’s University Hospital, Dublin, Ireland
St. Michael’s Hospital, Toronto, Ontario, Canada
Rochester Multiple Sclerosis Center, University of Rochester Medical Center, New York, NY, USA;
Department of Neurology, University of Pennsylvania School of Medicine, Philadelphia, PA, USA
Biogen Idec, Inc., Cambridge, Massachusetts, USA
Biogen Idec, Inc., Cambridge, Massachusetts, USA
Biogen Idec, Inc., Cambridge, Massachusetts, USA Background The initial Multiple Sclerosis Functional Composite (MSFC) proposal was a three-part composite of quantitative measures of ambulation, upper extremity function, and cognitive function expressed as a single composite Z-score. However, the clinical meaning of an MSFC Z-score change is not obvious. This study instead used MSFC component data to define a patient-specific disease progression event. Objective Evaluate a new method for analyzing disability progression using the MSFC. Methods
MSFC progression was defined as worsening from baseline on scores of at least one MSFC component by 20% (MSFC Progression-20) or 15% (MSFC Progression-15), sustained for Results Substantial numbers of patients met MSFC progression criteria, with MSFC Progression-15 being more sensitive than MSFC Progression-20, at both 1 and 2 years. MSFC Progression-20 and MSFC Progression-15 were related significantly to Expanded Disability Status Scale (EDSS) score change, relapse rate, and the SF-36 Physical Component Summary (PCS) score change. MSFC Progression-20 and MSFC Progression-15 at 1 year were predictive of EDSS progression at 2 years. Both MSFC progression end points demonstrated treatment effects in AFFIRM, and results were replicated in SENTINEL. Conclusion MSFC Progression-20 and MSFC Progression-15 are sensitive measures of disability progression; correlate with EDSS, relapse rates, and SF-36 PCS; and are capable of demonstrating therapeutic effects in randomized, controlled clinical studies.
Key Words: clinical end points • disability progression • multiple sclerosis • Multiple Sclerosis Functional Composite • natalizumab • relapsing-remitting
Multiple Sclerosis, Vol. 15, No. 8,
984-997 (2009) This article has been cited by other articles:
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3 months. Progression rates were determined using data from natalizumab clinical studies (Natalizumab Safety and Efficacy in Relapsing Remitting Multiple Sclerosis [AFFIRM] and Safety and Efficacy of Natalizumab in Combination With Interferon Beta-1a in Patients With Relapsing Remitting Multiple Sclerosis [SENTINEL]). Correlations between MSFC progression and other clinical measures were determined, as was sensitivity to treatment effects. 
