13 years of consistent results
In two 2-year clinical studies, over 1500 adults with relapsing multiple sclerosis (MS) took a medication called dimethyl fumarate (DMF). Once the body processes VUMERITY® (diroximel fumarate), it takes the same active form as DMF. This is how VUMERITY was approved by the FDA.
For up to 13 years, researchers observed people who had participated in the two original 2-year DMF studies to understand its effectiveness and safety. This is the longest DMF study so far.
For up to
13
years
DMF was shown to be effective, and no new safety concerns were reported.
How was DMF studied?
Understanding the study design
- The two original 2-year clinical studies were extended to look at long-term efficacy and safety of DMF in people with relapsing MS
- They studied people who continuously took DMF and people who took placebo before taking DMF
- 2079 people completed the two original 2-year studies of DMF*
- Of those people, 1736 enrolled in the long-term study, including newly diagnosed people. 759 completed the study†
People left the long-term study at various points in their DMF treatment journey.
On average, people took DMF for over 8 years.
*They took 240 mg of DMF twice a day, 3 times a day, or placebo for the first 2 years.
†They took 240 mg of DMF twice a day for years 3-10.
Limitations to keep in mind
- There are some limitations to keep in mind for long-term studies. These limitations may include:
- People who stop treatment by choice
- People who withdrew from the study due to side effects or reasons related to the study
- No control group to compare results to
- In this study, some people withdrew over time or stopped taking DMF due to side effects. These findings are only relevant to those who stayed in the study (which is a small part of the initial study group)
What were the results of the long-term study?
Relapses
were relapse-free
over 10 years
Relapses in people taking DMF stayed stable and low over 10 years. More people (436 out of 694) did not experience a relapse.
About 75% of people taking DMF (519 out of 694) were relapse-free within the first
2 years of treatment.
Disability progression
had no progression
over 10 years
More people who continuously took DMF (360 out of 501) had no disability progression for 10 years.
About 92% of people (632 out of 686) had no disability progression in the first 2 years of DMF treatment.
Results in newly diagnosed people were consistent
People who were newly diagnosed with relapsing MS took DMF as their first treatment.
Relapses
The relapse
rate was similar
to other people in the study.
Disability progression
81% had no progression at year 10
At year 10, 81% of newly diagnosed people with relapsing MS on DMF treatment (380 out of 470 people) had no disability progression.
Safety considerations
No new safety concerns were reported after up to
13 years of observation
- These safety results were similar to the two original 2-year clinical studies
- In people who took DMF for up to 13 years, the rate of serious infection remained low.‡ The rate did not change regardless of the white blood cell counts
- Most side effects were mild to moderate and the number of them did not increase over time
- The most serious side effects were MS relapse (14%) and fall (2%)
- The most common side effects were MS relapse (39%), common cold (26%), urinary tract infection (21%), flushing (19%), upper respiratory tract infection (16%), and headache (16%)
- Learn about the serious side effects and the most common side effects from the DMF clinical trials
‡1% of patients or less were affected per year.
Actor portrayal.
