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Interferon beta-1a in primary progressive MS: an exploratory, randomized, controlled trial
S M Leary1, D H Miller, V L Stevenson
1NMR Research Unit, Institute of Neurology, University College London, UK.
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 beta-1a 30 microg, 60 microg, 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- microg dose of interferon beta-1a was well tolerated, but the 60- microg dose caused severe flulike reactions and raised liver enzymes. No treatment effect was seen on the primary endpoint. Subjects on interferon beta-1a 30 microg had a lower rate of accumulation of T2 lesion load than controls (p = 0.025); subjects on 60 microg had a greater rate of ventricular enlargement than controls (p = 0.025).
Conclusions:
This study has demonstrated that interferon beta-1a 30 microg was well tolerated, identified useful outcome measures, but showed no efficacy on the primary outcome measure or on most of the secondary outcome measures.
Insights
Interferon beta-1a (IFN-β-1a) at 30 mcg was well tolerated in primary progressive multiple sclerosis (PPMS) patients but did not improve disability progression. The 60 mcg dose showed adverse effects.
Area of Science:
- Neurology
- Immunology
- Clinical Trials
Background:
- Primary progressive multiple sclerosis (PPMS) presents unique challenges.
- PPMS patients have historically been excluded from therapeutic trials.
- This study focuses on a randomized controlled trial specifically for PPMS.
Purpose of the Study:
- To evaluate the efficacy and safety of interferon beta-1a (IFN-β-1a) in patients with PPMS.
- To assess the impact of different doses of IFN-β-1a on disability progression and MRI outcomes.
- To identify relevant outcome measures for PPMS clinical trials.
Main Methods:
- A randomized, controlled trial involving 50 PPMS subjects.
- Intervention groups received weekly intramuscular IFN-β-1a (30 mcg or 60 mcg) or placebo for 2 years.
- Primary endpoint: time to sustained disability progression; secondary endpoints: neurological tests and MRI measures (lesion load, atrophy).
Main Results:
- The 30 mcg dose of IFN-β-1a was well tolerated; the 60 mcg dose led to severe side effects.
- No significant effect of IFN-β-1a on the primary endpoint of disability progression was observed.
- A reduced accumulation of T2 lesion load was noted with 30 mcg IFN-β-1a, but increased ventricular enlargement occurred with 60 mcg IFN-β-1a.
Conclusions:
- Interferon beta-1a at 30 mcg is safe for PPMS patients but lacks efficacy for the primary outcome.
- The study identified valuable outcome measures for future PPMS research.
- Higher doses of IFN-β-1a may have detrimental effects on brain volume in PPMS.
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