WEDNESDAY, Sept. 19 (HealthDay News) -- For patients with relapsing-remitting multiple sclerosis, treatment with oral BG-12 (dimethyl fumarate) is associated with a reduction in the annualized relapse rate comparable to that found with glatiramer acetate and significantly better than that found with placebo, according to two studies published in the Sept. 20 issue of the New England Journal of Medicine.
Robert J. Fox, M.D., from the Cleveland Clinic, and colleagues conducted a phase 3 study to examine the efficacy and safety of oral BG-12 at 240 mg two or three times daily, compared with placebo and glatiramer acetate. At two years, the researchers found that the annualized relapse rate was significantly lower with BG-12 two or three times a day (relative reduction, 44 and 51 percent, respectively), and with glatiramer acetate (relative reduction, 29 percent), versus placebo. BG-12 at both doses and glatiramer acetate correlated with significant reductions in the number of new or enlarging T2-weighted hyperintense lesions or T1-weighted hypointense lesions.
Ralf Gold, M.D., from the St. Josef-Hospital/Ruhr-University Bochum in Germany, and colleagues conducted a phase 3 placebo-controlled study to compare oral BG-12 twice daily or three times daily with placebo. The researchers found that a significantly lower proportion of patients had a relapse in the BG-12 groups (relative reduction, 53 and 48 percent, respectively) compared with placebo. There was also a significant risk reduction in the proportion with confirmed progression of disability and in the number of gadolinium-enhancing lesions and new or enlarging T2-weighted hyperintense lesions with BG-12 treatment.
"Further exploration of the mechanism of action of BG-12 may help to guide future clinical studies," Gold and colleagues write.
Several authors from the Fox study disclosed financial ties to pharmaceutical companies, including Biogen Idec, which funded both studies.
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