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Abstract
Background: Patients with primary progressive MS have atypical clinical and MRI characteristics and have been excluded from most therapeutic trials. The authors report a randomized, controlled trial restricted to primary progressive MS.
Methods: Fifty subjects were randomized to weekly IM interferon β-1a 30 μg, 60 μg, or placebo for 2 years. The primary endpoint was time to sustained progression in disability. Secondary outcomes included the timed 10-meter walk, nine-hole peg test, and on MRI, T2 and T1 brain lesion loads and brain and spinal cord atrophy.
Results: The 30-μg dose of interferon β-1a was well tolerated, but the 60-μg dose caused severe flulike reactions and raised liver enzymes. No treatment effect was seen on the primary endpoint. Subjects on interferon β-1a 30 μg had a lower rate of accumulation of T2 lesion load than controls (p = 0.025); subjects on 60 μg had a greater rate of ventricular enlargement than controls (p = 0.025).
Conclusions: This study has demonstrated that interferon β-1a 30 μg was well tolerated, identified useful outcome measures, but showed no efficacy on the primary outcome measure or on most of the secondary outcome measures.
- Received April 18, 2002.
- Accepted August 29, 2002.
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