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Neurology 2001;57:2191-2197
© 2001 American Academy of Neurology
Articles

Clinical–MRI correlations in a European trial of interferon beta-1b in secondary progressive MS

P. D. Molyneux, MD, G. J. Barker, PhD, F. Barkhof, MD, K. Beckmann, MSc, F. Dahlke, MD, M. Filippi, MD, M. Ghazi, D. Hahn, MD, D. MacManus, DCR, C. Polman, MD, C. Pozzilli, MD, L. Kappos, MD, A. J. Thompson, FRCP, K. Wagner, MD, T. Yousry, MD and D. H. Miller, FRCP for the European Study Group on Interferon Beta-1b in Secondary Progressive MS*

From the NMR Research Unit (Drs. Molyneux, Barker, MacManus, Miller, and Thompson), Institute of Neurology, London, UK; MRI Centre for MS Research and Radiology (Drs. Barkhof and Polman), Academic Hospital of the Vrije Universiteit, Amsterdam, the Netherlands; Schering AG (Drs. Beckmann, Dahlke, Ghazi, and Wagner), Berlin, Germany; Neuroimaging Research Unit (Dr. Filippi), Scientific Institute Ospedale Raffaele, Milan, Italy; Institute fur Rontgendiagnostik der Bayer (Dr. Hahn). Julius-Maximillians-Universität, Würzburg, Germany; Neurologische Poliklinik (Dr. Kappos), Universitatsspital Basel, Switzerland; Universita Degli Studi di Roma "La Sapienza" (Dr. Pozzilli), Rome, Italy; and Institut fur Radiologische Diagnostik Neuroradiologie der Ludwig-Maximillians-Universitat (Dr. Yousry), Munich, Germany.

Address correspondence and reprint requests to Dr. D.H. Miller, NMR Research Group, Institute of Neurology, University College London, Queen Square, London WC1N 3BG, UK; e-mail: d.miller{at}ion.ucl.ac.uk

Background: The recently completed placebo-controlled multicenter randomized trial of interferon beta-1b (Betaferon) in 718 patients with secondary progressive MS shows significant delay of disease progression and reduction of relapse rate. This study provides an opportunity to assess the level of relationship between clinical and MRI outcomes in this cohort of patients with secondary progressive MS.

Methods: Brain T2-weighted lesion volume was measured annually in all available patients, with visual analysis to identify any new or enlarging (active) T2 lesions at each annual time point. A subgroup of 125 patients had monthly gadolinium-enhanced, T1-weighted imaging at months 0 to 6 and 18 to 24. Relapses were documented and expanded disability status scale (EDSS) was measured every 3 months.

Results: For the annual MRI outcomes, a significant but modest correlation was identified between the change in T2 lesion volume from baseline to the final scan and the corresponding change from baseline in EDSS (r = 0.17, p < 0.0001). There were significant correlations between the cumulative number of active T2 lesions and 1) change in EDSS (r = 0.18, p < 0.0001) and 2) relapse rate (r = 0.24, p < 0.0001). In the subgroup of 125 patients undergoing monthly imaging, MRI lesion activity was correlated with relapse rate over months 0 to 24 (r = 0.24, p = 0.006) but not with change in EDSS.

Conclusions: These results confirm that the clinical–MRI relationships previously identified in relapsing-remitting MS still are apparent in the secondary progressive phase of the disease and support the use of MRI as a relevant outcome measure. In view of the relatively modest nature of the correlations, it seems unwise to rely on such MRI measures alone as primary efficacy variables in secondary progressive MS trials.




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