Tecfidera (BG-12)

The medicine I take. Take home message: Possibly twice as effective as Copaxone with a long safety record for treatment of psoriasis in Germany. Approved as frontline treatment in the US, Canada and the UK/Europe. Short version: The mechanism of action is not well-studied, however it was originally used as a treatment for psoriasis back when they thought the disease was due to a vitamin deficiency. BG-12 is similar to a vitamin and is thought to help your antioxidant pathways (how cool is that!?). Which means it has low side effects and doesn’t suppress your overall immune system like Tysabri, leaving you vulnerable to opportunistic infections and cancer. It is an oral medicine, taken 2x daily. The most common side effects are intense flushing and digestive upset which usually resolve completely after a few months. A few cases of PML in patients with unusually suppressed lymphocytes have been reported and so periodic monitoring of your white blood cell counts are required. Look at these convincing graphs of it’s effectiveness rate (taken from Gold et al., 2012). Note it was never directly compared to Copaxone, however the individual effectiveness studies of both drugs indicate it is ~2x as effective.

Figure 1. Kaplan–Meier Plot of Primary and Secondary Clinical Outcomes.
Panel A shows the time to the first relapse that was confirmed by the independent neurologic evaluation committee and the proportion of patients with a confirmed relapse among patients in the group that received BG-12 twice daily, the group that received BG-12 thrice daily, and the placebo group. The P values and hazard ratios for a relapse with BG-12 as compared with placebo were calculated with the use of a Cox proportional hazards model, adjusted for baseline score (≤2.0 vs. >2.0) on the Expanded Disability Status Scale (EDSS, which ranges from 0 to 10, with higher scores indicating greater disability), age at baseline (<40 years vs. >= 40 years), region, and the number of relapses in the year before study entry. The estimated proportion of patients with a relapse at 2 years is a Kaplan-Meier estimate. Panel B shows the time to confirmed progression of disability in each of the three groups. The P values and hazard ratios for progression with BG-12 as compared with placebo were calculated with the use of a Cox proportional-hazards model, adjusted for baseline score on the EDSS, age at baseline, and region. The estimated proportion of patients with confirmed progression of disease at 2 years is a Kaplan-Meier estimate.

Phase 3 research article (Gold et al, 2012) can be found here (use your local University to obtain article for free): http://www.nejm.org/doi/pdf/10.1056/NEJMoa1114287

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