CONFIRM
Dimethyl fumarate
CONFIRM showed that oral dimethyl fumarate reduced relapses and MRI activity versus placebo while including glatiramer acetate as an active reference.
- Phase
- Phase III
- Population
- Relapsing-remitting multiple sclerosis (RRMS)
- Controlled period
- Jun 2007 — Aug 2011
What was compared
Dimethyl fumarate 240 mg twice daily
Orally twice daily
n=359Placebo
Matching oral capsules
n=363Additional randomized arms
Dimethyl fumarate 240 mg three times daily
Orally three times dailyn=345Glatiramer acetate
20 mg subcutaneously once daily; active referencen=350Primary endpoint
Annualized relapse rate
2 years
Primary endpoint results
Annualized relapse rate
Relapses per participant-year
44% and 51% lower with dimethyl fumarate; 29% lower with glatiramer acetate.
Selected secondary outcomes
Reductions versus placebo were not statistically significant.
Both dimethyl fumarate regimens and glatiramer acetate improved key MRI outcomes.
Study population
- Randomized
- 1,417 randomized
- Age
- Mean 37.3 years; eligible 18–55
- Sex
- 993 women (70%)
- Disability
- EDSS 0–5.0
- Disease definition
- Relapsing-remitting multiple sclerosis
Who entered the trial
Key inclusion criteria
- Defined based on McDonald criteria 2005
- Relapsing-remitting clinical course
- Baseline EDSS 0–5.0
Key exclusion criteria
- Other chronic immune disease or malignancy
- Clinically important urologic, pulmonary, or gastrointestinal disease
- Pregnancy or breastfeeding
Safety signal
- Flushing and gastrointestinal events were more frequent with dimethyl fumarate.
- Lymphocyte counts decreased with dimethyl fumarate; injection-related events were more frequent with glatiramer acetate.
Why it mattered
CONFIRM supplied a second large pivotal data set for dimethyl fumarate and contextualized its effect alongside a familiar active reference.
Important limitation
The study was not designed or powered to establish superiority or noninferiority between dimethyl fumarate and glatiramer acetate.