Objective: Currently, direct comparative evidence or head-to-head data between BG-12 (dimethyl fumarate) and other disease-modifying treatments (DMTs) is limited. This study is a systematic review and data synthesis of published randomized clinical trials comparing the efficacy and safety of existing DMTs to BG-12 for Relapsing-Remitting Multiple Sclerosis (RRMS).
Methods: A systematic review was conducted by searching MEDLINE, EMBASE, and the Cochrane Library for English-language publications from 1 January 1960 to 15 November 2012. Clinicaltrials.gov, metaRegister of Controlled Trials, and conference proceedings from relevant annual symposia were also hand searched. Two independent reviewers collected and extracted data, with discrepancies reconciled by a third reviewer. Included studies were randomized controlled trials (RCTs) of DMTs (interferon [IFN] beta-1a, IFN beta-1b, glatiramer acetate [GA], BG-12, fingolimod, natalizumab, and teriflunomide) in adults with RRMS. Mixed treatment comparisons were conducted to derive the relative effect size for the included treatments. Annualized relapse rate (ARR), disability progression, and safety outcomes were assessed.
Results: BG-12 240 mg twice a day (BID) significantly reduces ARR compared to placebo (Rate Ratio: 0.529 [95% CI: 0.451 – 0.620]), IFNs (0.76 [95% CI: 0.639 – 0.904]), GA (0.795 [95% CI: 0.668 – 0.947]), and teriflunomide 7 mg and 14 mg (0.769 [95% CI: 0.610 – 0.970] and 0.775 [95% CI: 0.614 – 0.979]), and does not show a significant difference when compared to fingolimod. Only natalizumab was significantly superior to BG-12 in reducing ARR. BG-12 also demonstrated favorable results for disability and safety outcomes.
Based on indirect comparison, BG-12 offers an effective oral treatment option for patients with RRMS with an overall promising efficacy and safety profile compared to currently approved DMTs. Key limitations of the systematic review were the large heterogeneity in patients enrolled, and the variability in the definition of outcomes in included trials.
This study suggests that BG12 is as good as fingolimod and better than aubagio, interferons and copaxone. Well the efficacy over the latter three is well accepted but you would really need to do head to head in claims of superiority of the newer DMT. I have seen similar analysis show that cladribine and fingolimod and natalizumab have similar efficacy, so it is always difficult when comparing studies, however what can be compared is ease of use and side-effect profiles.
CoI None ProfG multiple