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II. Tecfidera vs. Placebo vs. Open-label Comparator
III. Is Tecfidera Right for You?
Tecfidera (dimethyl fumarate) is effective at treating relapsing forms of multiple sclerosis (MS) in adults, including relapsing-remitting MS (RRMS), clinically isolated syndrome (CIS) and active secondary progressive MS (SPMS).
As outlined by the U.S. National Library of Medicine, the efficacy and safety of Tecfidera has been proven in two large-scale clinical studies. [1]
Tecfidera vs. Placebo for RRMS
Study 1 was a randomized, double-blind, placebo-controlled trial in 1,234 patients with RRMS. The study took place over the course of two years.
In the trial, 410 patients were given Tecfidera 240mg twice per day, 416 patients were given Tecfidera 240mg three times per day and 408 patients were given a placebo.
Patients had a median age of 39 years and a median baseline Expanded Disability Status Scale (EDSS) score of 2 (on a scale of one to 10). The median time since diagnosis was four years.
By the end of the study, Tecfidera was observed to have had a statistically significant effect on all endpoints, including:
- The proportion of patients who had relapsed.
- Annualized relapse rate (ARR).
- Time to 12-week confirmed disability progression (defined as at least a one-point increase from baseline EDSS score).
The Tecfidera 240 mg three times daily dose showed no additional benefit over the Tecfidera 240 mg twice-daily dose. As such, all results are based on the twice-daily dose.
The proportion of patients with disability progression was 16.4 percent for those taking Tecfidera. By contrast, the proportion of patients with disability progression was 27.1 percent for those taking a placebo.
The ARR for patients taking Tecfidera was 0.172, while the ARR for those taking a placebo was 0.364.
Patients taking Tecfidera also had significantly fewer brain lesions after two years than those taking a placebo. [1]
Tecfidera vs. Placebo vs. Open-Label Comparator
Study 2 was a multicenter, randomized, double-blind, placebo-controlled trial that examined the same endpoints as Study 1.
The main difference was that in Study 2, one group of 350 patients took an open-label comparator (in other words, a medication similar to Tecfidera that patients were aware was not Tecfidera). Of the rest of the patients, 359 were given Tecfidera 240mg twice per day, 345 were given Tecfidera 240mg three times per day and 363 were given a placebo.
Patients had a median age of 37 years and a baseline EDSS score of 2.5. The median time since diagnosis was three years.
The final results compared the efficacy of Tecfidera to that of a placebo. As in Study 1, the Tecfidera 240mg three times daily dose showed no additional benefit over the Tecfidera 240mg twice-daily dose. As such, all results are based on the twice-daily dose.
The proportion of patients with disability progression was 13 percent for patients taking Tecfidera versus 17 percent for those taking a placebo.
The ARR for patients taking Tecfidera was 0.224, while the ARR for those taking a placebo was 0.401.
Patients taking Tecfidera once again had significantly fewer brain lesions after two years than those taking a placebo. [1]
Is Tecfidera Right for You?
Just as with all medications, you need to talk to your doctor to find out if Tecfidera is right for you.
According to the Tecfidera website, patients should not take Tecfidera if they have ever had an allergic reaction (i.e. hives, welts or difficulty breathing) to Tecfidera or any of its ingredients.
Be sure to tell your doctor if you have or have ever had:
- Low white blood cell count
- An infection
- Any other medical conditions
Also tell your doctor if you are:
- Pregnant or planning to become pregnant
- Breastfeeding or planning to breastfeed
- Taking prescription or over-the-counter medications, vitamins or supplements [2]
If your doctor does determine that Tecfidera is right for you, you can save on your prescription by purchasing it from a trustworthy online pharmacy or pharmacy referral service like My Drug Center. Visit our blog on Tecfidera to learn more today.
DISCLAIMER: The information in the article is not meant to be used for treatment or diagnosis. It is designed for general awareness and for information purposes only. Always consult a medical professional for your specific healthcare needs.