All About Multiple Sclerosis

More MS news articles for June 2003

Benefit of interferon ß-1a on MSFC progression in secondary progressive MS

http://www.neurology.org/cgi/content/abstract/59/5/679

Neurology 2002;59:679-687
J. A. Cohen, MD, G. R. Cutter, PhD, J. S. Fischer, PhD, A. D. Goodman, MD, F. R. Heidenreich, MD, M. F. Kooijmans, MD, PhD, A. W. Sandrock, MD, PhD, R. A. Rudick, MD, J. H. Simon, MD, PhD, N. A. Simonian, MD, E. C. Tsao, PhD and J. N. Whitaker, MD for the IMPACT Investigators*
Deceased.
From the Mellen Center for Multiple Sclerosis Treatment and Research, Department of Neurology (Drs. Cohen, Fischer, and Rudick), Cleveland Clinic Foundation, OH; Center for Research Methodology and Biometrics (Dr. Cutter), AMC Cancer Center, Lakewood, CO; Department of Neurology (Dr. Goodman), University of Rochester, NY; Department of Neurology (Dr. Heidenreich), Hannover Medical School, Germany; Biogen, Inc. (Drs. Kooijmans, Sandrock, Simonian, and Tsao), Cambridge, MA; Department of Radiology (Dr. Simon), University of Colorado, Denver; and Department of Neurology (Dr. Whitaker), University of Alabama at Birmingham.

Background:

Interferon ß-1a (IFNß-1a, Avonex) is efficacious in relapsing forms of MS.

Studies of other IFNß preparations in secondary progressive MS (SPMS) yielded conflicting results.

This study was undertaken to determine whether IFNß-1a slowed disease progression in SP-MS.

Methods:

A total of 436 subjects with SPMS and Expanded Disability Status Scale (EDSS) score 3.5 to 6.5 were randomized to receive IFNß-1a (60 µg) or placebo by weekly intramuscular injection for 2 years.

The primary outcome measure, used for the first time in a large-scale MS trial, was baseline to month 24 change in the MS Functional Composite (MSFC), comprising quantitative tests of ambulation (Timed 25-Foot Walk), arm function (Nine-Hole Peg Test [9HPT]), and cognition (Paced Auditory Serial Addition Test [PASAT]).

Results:

Median MSFC Z-score change was reduced 40.4% in IFNß-1a subjects (-0.096 vs -0.161 in placebo subjects, p = 0.033), an effect driven mainly by the 9HPT and PASAT.

There was no discernible benefit on the EDSS, which in this range principally reflects walking ability.

IFNß-1a subjects had 33% fewer relapses (p = 0.008).

There was significant benefit on eight of 11 MS Quality of Life Inventory subscales.

New or enlarging T2-hyperintense brain MRI lesions and gadolinium-enhancing lesions were reduced at months 12 and 24 (both p < 0.001).

IFNß-1a was well tolerated by the majority of subjects.

Neutralizing antibodies developed in 3.3% of IFNß-1a–treated subjects.

Conclusions:

IFNß-1a demonstrated benefit on MSFC progression, relapses, quality of life, and MRI activity in SPMS.

© 2002 American Academy of Neurology