The Study
The New England Journal of Medicine has published results from two phase III clinical trials; DEFINE (Determination of the Efficacy and Safety of Oral Fumarate in Relapsing-Remitting MS) and CONFIRM (Comparator and an Oral Fumarate in Relapsing-Remitting Multiple Sclerosis) for BG-12 capsules in people living with relapsing-remitting MS.
The DEFINE trial involved over 1,200 participants and was designed to determine if BG-12 would be able to decrease the number of people experiencing relapses compared to that of a placebo, while also noting factors of safety and tolerability. The secondary outcomes included progression of disability, frequency of relapses and disease activity as detected by MRI.
CONFIRM trial involved over 1,400 participants and aimed to determine if BG-12 would be able to decrease the average annual rate of MS relapse at two years. Secondary objectives included disability progression, assessing effects on the proportion of people who experienced relapses, as well as disease activity as identified by MRI. Safety and tolerability were also considered.
The Findings
Within the DEFINE trial, a significant reduction in the number of participants who experienced relapses at two years, compared to the placebo group was identified. Secondary objectives were also met, which included reductions in the annualized relapse rate and reduction in risk of confirmed progression of disability as detected by EDSS (Expanded Disability Status Scale, a standard scale used to measure disability progression).
Within the CONFIRM trial, the average amount of MS relapses that occurred in one year reduced compared to the placebo. Significant reductions were also observed within the secondary objectives which involved a decrease in disease activity as seen on MRI as well as a fewer number of patients experiencing relapses in the BG-12 group compared to the placebo. Disability progression however, was not reduced significantly in the BG-12 groups compared to placebo.
What do these study findings mean to Canadians living with MS?
BG-12 must be approved by government regulatory bodies such as the U.S. Food and Drug Administration and Health Canada before it becomes available for treatment. The MS Society of Canada will provide updates on continued trials and/or the status of the treatment’s approval should a Health Canada approval be sought through an application to the Common Drug Review or Conseil du Médicament (Québec). Biogen Idec submitted an application to the U.S. Food and Drug Administration for approval to market oral BG-12 (dimethyl fumarate) for the treatment of relapsing-remitting MS earlier this year. Those who have questions about this therapy are encouraged to speak to their physician to discuss treatment options.