In separate 2-year clinical studies, TECFIDERA was tested against a placebo, or "fake" pill—a standard way to measure if a drug works as expected.
Cut RELAPSES IN HALF
DelayPROGRESSION OFPHYSICAL DISABILITY
SlowDEVELOPMENTOF BRAIN LESIONS
Cut relapses in half*
*In a 2-year study, TECFIDERA reduced risk of relapse by 49% compared with placebo. See more below.
Delay progression of physical disability
Slow development of brain lesions
Relapses, also called flare-ups or exacerbations, can be disruptive. Reducing the risk of relapses should be one of the goals of treatment.
Although no relapsing MS medication completely gets rid of relapses, TECFIDERA cut them in half when compared with placebo.
In a 2-year study, 27% of people taking TECFIDERA had a relapse, compared with 46% taking placebo.
TECFIDERA CUT THE RISK OF RELAPSES IN HALF
In another 2-year study, 29% of people taking TECFIDERA had a relapse, compared with 41% taking placebo.
In a 2-year study, TECFIDERA cut the number of relapses by 44% compared with placebo.
TECFIDERA CUT THE NUMBER OF RELAPSES BY NEARLY HALF
In another 2-year study, TECFIDERA cut the number of relapses by 53% compared with placebo.
When you have relapsing MS, you know how important it is to stay as active and mobile as you possibly can.
In a 2-year clinical study, TECFIDERA was shown to delay the progression of physical disability, which is an important goal of treatment.
People taking TECFIDERA were 38% less likely to experience physical disability progression compared with those taking placebo
8 out of 10 people taking TECFIDERA had no disability progression compared with 7 out of 10 people taking placebo.
The link between brain lesions and the progression of MS has not been confirmed. However, brain lesions can happen without you feeling them, and may be a sign that the disease is active. Lesions revealed on an MRI scan may help your healthcare provider determine how well your treatment is working. Talking to your healthcare provider about the results of your MRI could help with the management of your relapsing MS.
To understand the impact of TECFIDERA on brain lesions, researchers looked at lesions using 3 different MRI techniques to determine the age and stage of the lesions. Based on all 3 measures, people taking TECFIDERA had fewer lesions compared with those taking placebo.
(Average number of Gd+ lesions at 2 years)
Gd+ lesions: Inflamed brain tissue that is attacked and considered “active.” These lesions disappear when inflammation decreases.
90% fewer Gd+ lesions for TECFIDERA
(Average number of new or newly enlarging T2 lesions over 2 years)
T2 lesions: Scars that indicate the long-term impact of MS on the brain. They can either be new lesions or old lesions that develop again.
85% fewer T2 lesions for TECFIDERA
(Average number of new T1 lesions over 2 years)
T1 lesions: Nerve cells in the brain that can’t be repaired, which can mean a loss of function.
72% fewer T1 lesions for TECFIDERA
After the 2 main clinical studies for TECFIDERA were over, researchers did a separate analysis that combined results from the 2 studies. These people had been newly diagnosed with relapsing MS within a year of entering the trial, and had never been on a disease modifying therapy for MS before.
This analysis was not planned as part of the original 2 studies, so the data may not be as reliable. These findings are not included in the full Prescribing Information for TECFIDERA. Additional studies may be needed to confirm these findings, and to determine if the changes were due to TECFIDERA.
After 2 years, in a separate analysis, newly diagnosed people taking TECFIDERA were:
to have a relapse
to have physical disability progression
compared with people taking placebo.
221 newly diagnosed people took TECFIDERA, 223 newly diagnosed people took placebo
(21% of people taking TECFIDERA had a relapse vs 42% taking placebo; and 7% of people taking TECFIDERA experienced physical disability progression vs 23% of people taking placebo)
The most common side effects in people taking TECFIDERA included flushing, a cold, headache, diarrhea, nausea, and stomach pain (compared with people taking placebo).
It is not known exactly how TECFIDERA works in the body, but researchers have discovered information about what it does inside the cells.
During inflammation, the body produces toxins that can cause oxidative stress on the cells. When this stress builds up, it can damage or even destroy healthy cells in different parts of the body, including the central nervous system (CNS).
One way the body reacts to oxidative stress is through a pathway called Nrf2, short for nuclear factor (erythroid-derived 2)-like 2. This pathway is an important part of a complex communication system involved in the body's response to oxidative stress.
Researchers have learned that dimethyl fumarate leads to activation of the Nrf2 pathway in our cells. Much about how TECFIDERA works in the body remains unknown, but talking with your doctor can help you learn more about your treatment options.
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