Tecfidera ( BG-12 ) is an oral twice daily treatment for relapsing forms of multiple sclerosis. In the DEFINE trial, Tecfidera dropped relapses by 53% and reduced the likelihood of disability worsening by 38% compared to placebo. The impact was robust on MRI with 90% less new contrast activity. New or enlarging T2 areas on MRI were reduced by 85%. In the CONFIRM Trial, the twice a day dose of Tecfidera lowered relapses by 44% compared to placebo. In a comparison group of patients in the trial, Copaxone reduced relapses by 29%. The difference between Tecfidera and Copaxone was not a statistically significant difference but trial was not set-up to prove a difference between the two treatments.. Tecfidera is an oral formulation of dimethyl fumurate, which has been demonstrated to reduce inflammation and protect cells in experimental research. Dimethyl fumarate is a component of the drug Fumaderm, used to treat psoriasis in Germany.
The starting dose is 120 mg twice a day for 7 days and then 240 mg twice a day. Earlier trials with only once a day dose did not have a significant impact on relapses so the medication must be taken twice a day. Flushing can occur in 40% of patients which tends to resolve over one month. Flushing can be reduced by taking Tecfidera with food and aspirin 30 minutes prior to dosing. Nausea, vomiting, diarrhea and/or abdominal pain can also occur in about a third of patients which generally also resolve after the first month, if occur. Medications can be taken to help reduce these gastrointestinal symptoms so contact your healthcare provider. Managing these side effects is important for a successful start. Tecfidera can lower lymphocytes, a type of white blood cell. No increased risk of serious infections were seen in the clinical trials, but potential risk of serious infection exists. A baseline complete blood count within 6 months should be preformed before starting treatment. Approximately 3% of patients can continuously very lymphocytes (type of white blood cell) in their blood. Liver blood test elevations can occur. Adequate contraception is required to prevent the potential risk of fetal harm.