This study reports the effects of BG-12 on measures of health-related quality of life (HRQoL) over two years of treatment in the Phase III DEFINE study population. BG-12 (dimethyl fumarate) is an oral compound approved for the treatment of RRMS in the US. It is thought to exert anti-inflammatory effects through the activation of the nuclear factor E2-related factor 2 pathway.
The DEFINE trial demonstrated a reduction in annualised relapse rate at two years by 53% with BG-12 BID and 48% with BG-12 TID, as well as a significant beneficial effect on disease activity as measured by MRI. In total 1,237 subjects were included in the DEFINE trial. HRQoL was assessed by the Short Form-36 (SF-36), global assessment of well-being visual analog scale and EuroQol-5D. The HRQoL impairment was highest in people with greater disability scores and in those who had a relapse. Changes in SF-36 physical component summary scores significantly favoured BG-12 over placebo. This demonstrates the beneficial effects of BG-12 on HRQoL measures, coupled to the previously demonstrated clinical efficacy.
Authors: Kappos L, Gold R
Source: Mult Scler. 2013 Oct 22. [Epub ahead of print]
Read the abstract