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Delayed-release dimethyl fumarate and disability assessed by the Multiple Sclerosis Functional Composite: Integrated
Gavin Giovannoni1, Ralf Gold2, Ludwig Kappos3
1Queen Mary University London, UK.
Abstract:
The effect of delayed-release dimethyl fumarate (DMF; also known as gastro-resistant DMF) on the Multiple Sclerosis Functional Composite (MSFC) was assessed using integrated Phase 3 DEFINE and CONFIRM data. Patients treated with DMF (n = 769) demonstrated significant superiority on the MSFC, and each component, compared with placebo (n = 771) over two years: mean change for DMF vs placebo was 0.054 vs -0.053 on MSFC; -0.088 vs -0.286 on Timed 25-Foot Walk, 0.047 vs 0.003 on 9-Hole Peg Test and 0.178 vs 0.123 on Paced Auditory Serial Addition Test. DMF was an efficacious treatment for patients with MS.
Insights
Delayed-release dimethyl fumarate (DMF) significantly improved the Multiple Sclerosis Functional Composite (MSFC) and its components in patients with multiple sclerosis over two years compared to placebo.
Area of Science:
- Neurology
- Clinical Trials
- Pharmacology
Background:
- Multiple Sclerosis (MS) is a chronic neurological disease.
- Assessing functional composite scores is crucial for evaluating MS treatments.
- Dimethyl fumarate (DMF) is an established therapy for MS.
Purpose of the Study:
- To evaluate the efficacy of delayed-release dimethyl fumarate (DMF) on the Multiple Sclerosis Functional Composite (MSFC) in patients with MS.
- To analyze the impact of DMF on individual components of the MSFC.
Main Methods:
- Utilized integrated data from Phase 3 DEFINE and CONFIRM clinical trials.
- Compared outcomes between patients treated with DMF (n=769) and placebo (n=771) over a two-year period.
- Assessed changes in MSFC total score and its subtests: Timed 25-Foot Walk, 9-Hole Peg Test, and Paced Auditory Serial Addition Test.
Main Results:
- Patients receiving DMF showed statistically significant superiority on the MSFC compared to placebo (mean change: 0.054 vs -0.053).
- Significant improvements were observed in DMF-treated patients across all MSFC components: Timed 25-Foot Walk (-0.088 vs -0.286), 9-Hole Peg Test (0.047 vs 0.003), and Paced Auditory Serial Addition Test (0.178 vs 0.123).
Conclusions:
- Delayed-release dimethyl fumarate (DMF) is an efficacious treatment for patients with multiple sclerosis.
- DMF demonstrates a positive effect on functional outcomes as measured by the MSFC.
