|Timothy Vollmer, MD|
“Tecfidera represents the second oral treatment [the first being Gilenya] that is more effective than current first-line medications and has a good safety profile,” said Dr. Timothy Vollmer, Medical Director of the Rocky Mountain MS Center. “Side effects from Tecfidera were relatively mild and only lasted for a couple of weeks."
BG-12, an oral treatment for relapsing-remitting forms of multiple sclerosis, has received FDA approval and will be sold under the name Tecfidera. Manufactured by Biogen Idec, it becomes the third oral disease-modifying medication available to treat MS. Others include fingolimod (Gilenya) and teriflunomide (Aubagio).
Tecfidera has been clinically proven to reduce relapses and development of brain lesions, and appears to slow disability progression over time. It also has an encouraging safety profile and is well-tolerated by patients.
Tecfidera appears to have dual anti-inflammatory and neuroprotective effects, which may represent a new class in treatment for MS. It has been shown to activate the Nrf2 transcriptional pathway. This pathway is thought to defend against oxidative-stress induced neuronal death, protect the blood-brain barrier, and support maintenance of myelin integrity in the central nervous system—all key elements to treating MS.
Tecfidera has been used for many years in Europe and elsewhere to treat psoriasis. Phase III clinical trials of Tecfidera include the DEFINE and CONFIRM studies, which combined, enrolled more than 2,600 patients. For more detailed information about these studies CLICK HERE.
The most common side effects associated with Tecfidera were flushing and gastrointestinal (GI) events (i.e., diarrhea, nausea and abdominal pain) and occurred in up to 60% of patients but were generally mild and generally resolved with in a few weeks. In some patients, average lymphocyte counts decreased during the first year of treatment and then remained stable. The incidence of infections and serious infections was similar in Tecfidera-treated patients and those on placebo. Patients taking Tecfidera should have a complete blood count (CBC) before starting treatment and a follow-up CBC annually.