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From the Mellen Center for Multiple Sclerosis Treatment and Research, Departments of Neurology (Drs. Rudick and Miller) and Biomedical Engineering (Dr. Fisher), Cleveland Clinic Foundation, OH; Center for Research Methodology and Biometrics (Dr. Cutter and M. Baier), AMC Cancer Center, Lakewood, CO; Department of Neurology (Dr. Dougherty), Walter Reed Army Medical Center, Washington, DC; Department of Neurology (Dr. Weinstock–Guttman), Buffalo General Hospital, NY; Department of Neurology (Dr. Mass), Oregon Health Sciences Center, Portland; and Biogen, Inc. (Dr. Simonian), Cambridge, MA.
Address correspondence and reprint requests to Dr. Richard A. Rudick, Mellen Center, Area U100, Cleveland Clinic Foundation 9500 Euclid Avenue, Cleveland, OH 44195; e-mail: rudickr{at}ccf.org
OBJECTIVE: To determine whether the MS Functional Composite (MSFC) can predict future disease progression in patients with relapsing remitting MS (RR-MS).
BACKGROUND: The MSFC was recommended by the Clinical Outcomes Assessment Task Force of the National MS Society as a new clinical outcome measure for clinical trials. The MSFC, which contains a test of walking speed, arm dexterity, and cognitive function, is expressed as a single score on a continuous scale. It was thought to offer improved reliability and responsiveness compared with traditional clinical MS outcome measures. The predictive value of MSFC scores in RR-MS has not been determined.
METHODS: The authors conducted a follow-up study of patients with RR-MS who participated in a phase III study of interferon ß-1a (AVONEX) to determine the predictive value of MSFC scores. MSFC scores were constructed from data obtained during the phase III trial. Patients were evaluated by neurologic and MRI examinations after an average interval of 8.1 years from the start of the clinical trial. The relationships between MSFC scores during the clinical trial and follow-up status were determined.
RESULTS: MSFC scores from the phase III clinical trial strongly predicted clinical and MRI status at the follow-up visit. Baseline MSFC scores, and change in MSFC score over 2 years correlated with both disability status and the severity of whole brain atrophy at follow-up. There were also significant correlations between MSFC scores during the clinical trial and patient-reported quality of life at follow-up. The correlation with whole brain atrophy at follow-up was stronger for baseline MSFC than for baseline EDSS.
CONCLUSION: MSFC scores in patients with RR-MS predict the level of disability and extent of brain atrophy 6 to 8 years later. MSFC scores may prove useful to assign prognosis, monitor patients during early stages of MS, and to assess treatment effects.
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