VUMERITY & clinical trials
To understand the benefits and risks of treating with VUMERITY® (diroximel fumarate), it's important to know how it was first studied. In clinical trials, a medication called dimethyl fumarate (DMF) was tested in people with relapsing-remitting MS. DMF was studied in two 2-year clinical trials with over 1500 adults with relapsing MS. Once it's processed in the body, VUMERITY takes the same active form as DMF, resulting in similar safety and efficacy. VUMERITY was approved based on the data in the DMF clinical trials.
*Groups of people switching from an interferon were also studied. The results of that subgroup were similar to those people who switched from GA to VUMERITY.
What was studied
How the study† was designed and analyzed
- The study looked at safety and efficacy in 166 people who had been on GA before switching to VUMERITY
- Researchers studied patients after they stopped taking GA. This was to assess their relapsing MS status before starting VUMERITY. They looked at relapses, disability progression, and active brain lesions
- People took 231 mg (1 pill) of VUMERITY twice a day for the first week. Then they took 462 mg (2 pills) twice a day after that
†This study was a post hoc analysis, meaning that what was studied was not part of the original planned anaylsis.
Limitations to keep in mind
- This study does not compare GA to VUMERITY
- Several things varied from person to person:
- The amount of time since people in the study were diagnosed with relapsing MS
- The amount of time that people treated their relapsing MS with a medication
- The amount of time between stopping their prior relapsing MS treatment and starting VUMERITY. This length of time was determined by their doctor and is not mentioned in the study
Safety considerations
Safety and side effects
- No new safety concerns were identified with up to 2 years of treatment in patients who switched from GA to VUMERITY
- The most serious side effects were allergic reactions, PML, herpes zoster infections (shingles), other serious infections, decreased white blood cell count, liver problems, and serious gastrointestinal problems
- 12% (20 of 166 people) experienced at least 1 serious adverse event
- Learn about the serious side effects from the DMF clinical trials
- The most common side effects were flushing (32.5%), MS relapse (23.5%), upper respiratory tract infection (15.1%), and diarrhea (15.1%)
- Learn about the most common side effects from the DMF clinical trials
- 19 of 166 people discontinued treatment due to side effects; however, no one who had been on GA and switched to VUMERITY stopped taking VUMERITY due to stomach issues
Efficacy
After 2 years of treatment, most people who had previously been on GA and switched to VUMERITY had:
Relapse Rate
annual relapse
rate reduction
VUMERITY reduced the annual relapse rate by 74%‡
The annual relapse rate up to 2 years after starting VUMERITY was 0.15.
were relapse free
About 78% of people (130 out of 166 people taking VUMERITY) were estimated to be relapse-free.
‡In the 12 months prior to starting treatment with VUMERITY their annual relapse rate was 0.58. Up to two years after starting VUMERITY their annual relapse rate was 0.15.
Disability Progression
had no progression
About 85% of people (141 out of 166 people taking VUMERITY) were estimated to have no confirmed disability progression after switching from GA to VUMERITY.
Active (Gd+) Lesions
had no active lesions
96% of people (95 out of 99 taking VUMERITY) who switched from GA had no active (Gd+) lesions.§
§Gd+ lesion data is available for 99 of the 166 patients had been on GA and switched to VUMERITY.
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