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Abstract
Background: Interferon β-1a (IFNβ-1a, Avonex) is efficacious in relapsing forms of MS. Studies of other IFNβ preparations in secondary progressive MS (SPMS) yielded conflicting results. This study was undertaken to determine whether IFNβ-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 IFNβ-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 IFNβ-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. IFNβ-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). IFNβ-1a was well tolerated by the majority of subjects. Neutralizing antibodies developed in 3.3% of IFNβ-1a–treated subjects.
Conclusions: IFNβ-1a demonstrated benefit on MSFC progression, relapses, quality of life, and MRI activity in SPMS.
- Received October 3, 2001.
- Accepted June 11, 2002.
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