BG 12, Part 1
One of the most exciting disease modifying medications on the horizon in the treatment of MS is currently known as BG-12. It is made by Biogen, the same company that makes Avonex and Tysabri. This is the first oral medication from this company and it is hoped that this medication will be a competitor to the first oral medication approved for MS, Gilyena. The medication is also known as dimethyl fumarate and has been used for years to treat psoriasis, primarily in Germany. The results of two major trials were released in 2011. These were what are known as phase III trials, meaning these are the final steps the medication must take before it is submitted to the Food and Drug Administration (FDA) for approval.
In the first of these, known as the DEFINE trial, BG-12 was compared to a placebo. The trial enrolled 1,237 patients, 18 to 55 years of age, at 198 sites in 28 countries. Subjects had to have active disease to be enrolled in the study as well as an EDSS less than 5.0, meaning that people with significant disability were not enrolled in the study. As with all such studies, the DEFINE trial was a randomized, double-blinded study, meaning that none of the study subjects or investigators knew who was getting the active medication and who was getting the placebo. The main goal of the trial was to evaluate the effect on relapses at the end of a two-year period. The medication was studied in two dosing regimens, a twice-daily and a three times daily regimen. The medication was effective in reducing relapses compared to placebo, and the medication also reduced disease activity on the MRI as well as reduced the progression of disability as measured by the EDSS.
The second main trial was known as the CONFIRM study. It also was a large trial, enrolling 1430 subjects with relapsing MS. In this study, lasting also two years, patients were assigned to one of four groups: BG-12 three times per day, BG-12 two times per day, Copaxone, or placebo. Again, the primary outcome measure was a reduction in the relapse rate. Compared to placebo, the higher dose of BG-12 was found to reduce relapses 51%, the lower dose reduced relapses 44%, and Copaxone reduced relapses by 29%. BG-12 also reduced disease activity on the MRI. The study was unable to show that BG-12 reduced disability progression compared to placebo, but this might have been a result of the trial lasting two years, which is rather short in duration of MS. Also, for an unclear reason, the placebo group in the study had relatively mild disease, making it difficult to show that BG-12 reduced disability.