Tecfidera for Multiple Sclerosis, What the Studies Say
Less than one year ago, Tecfidera (dimethyl fumarate) was approved by the Food and Drug Administration (FDA) for treatment of relapsing remitting multiple sclerosis (MS), which is the most common form of this neurodegenerative disease. As with all drugs, postmarketing studies and reviews are performed after drug approval, and anyone who is considering or already taking Tecfidera should follow the findings of the research to keep up with the latest developments.
Tecfidera is one of three oral medications for MS that is known as a disease-modifying drug. The other two are Aubagio (teriflunomide, approved 2012) and Gilenya (fingolimod, approved 2010).
The drug appears to work by reducing inflammation and the ability of the immune system cells to reach and damage the central nervous system and thus the nerve cells. All three drugs are expensive, ranging in price from about $45,000 to $60,000 per year, with Tecfidera costing about $55,000.
Here is a brief overview of what has been discovered about Tecfidera and what is in the pipeline concerning this drug. MSers are encouraged to do their own research and to talk to their healthcare providers about any questions or concerns as well as seek out the experiences of others who are using the drug.
Studies of Tecfidera
In one of the most recently published reports (December 2013), the authors pointed out the following:
- “No head-to-head trials have been conducted.” This is important to know because it means no one has determined how Tecfidera compares with other MS drugs on the market. All the researchers had to show was that Tecfidera worked better than nothing (placebo).
- The safety and efficacy of the drug were confirmed in 2 phase III trials, which showed that taking dimethyl fumarate twice a day reduced the proportion of individuals with relapses at 2 years by 34 to 49 percent and the yearly relapse rate by 44 to 53 percent
- Severe flushing and gastrointestinal symptoms caused 3 and 4 percent of patients in the studies, respectively, to drop out of the trials.
Barbara Glesser, MD, professor of neurology and clinical director of the University of California Los Angeles Multiple Sclerosis Program, noted that the other two oral MS drugs have demonstrated somewhat similar rates. Gilenya reduces relapse rates by about 54 percent and Aubagio lowers the rates by around 30 percent, both when compared with placebo.
One question of special concern to women and men of childbearing age is the effect of any drug on pregnancy and the child. A new review (December 2013) looked at what is known about the safety of using Tecfidera and the other two oral MS drugs.
So far, limited information gathered from animal studies indicates that Tecfidera and the other two drugs pose a potential increased risk of early miscarriage, birth defects, and impaired growth. Currently there is a clinical trial underway that is investigating pregnancy outcomes in women exposed to Tecfidera right before conception or during pregnancy. The trial is actively recruiting as of this date, and outcomes are not expected until 2020.
Other precautions concerning Tecfidera
Use of Tecfidera may increase your risk of developing an infection because the drug can lower your lymphocytes (white blood cells) count. Therefore your doctor will want to check your lymphocyte levels before you start treatment and then at least once a year.
The reported occurrences of side effects associated with Tecfidera are as follows:
Abdominal pain, 18%
These adverse effects tend to decrease over time, according to scientists.
The above represents some of the latest information published about Tecfidera from researchers, but what do the real experts—Msers—have to say? What has been your experience with Tecfidera for MS?
Also read: Alcohol use and MS
Balance problems, MS, and yoga
Lu E et al. A review of safety-related pregnancy data surrounding the oral disease-modifying drugs for multiple sclerosis. CNS Drugs 2013 Dec 17
Venci JV, Gandhi MA. Dimethyl fumarate (tecfidera): a new oral agent for multiple sclerosis. Annals of Pharmacotherapy 2013 Dec; 47(12): 1697-702