Treatment of relapsing-remitting multiple sclerosis (RRMS) patients with Tecfidera (dimethyl fumarate) is associated with fewer new brain lesions at two years, lower relapse rates, increased time to first relapse, and reduced treatment discontinuation than with Aubagio (teriflunomide), according to a nationwide study from France and a real-world, population-based study from Denmark.
The data were presented at the 34th congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), which took place Oct. 10-12, in Berlin, Germany.
Both Sanofi Genzyme’s Aubagio and Biogen’s Tecfidera are first-line therapies for patients with RRMS. However, no study to date has compared their effectiveness. These two studies aimed to address this gap.
The French study, “Comparative efficacy of teriflunomide versus dimethyl-fumarate on clinical and MRI outcomes: a two years French multicenter observational study,” was presented by CRTI, France. It compared the two medications on clinical and MRI outcomes in patients with RRMS from 34 MS centers included in the French prospective national group of MS patients, OFSEP.
A total of 1,770 RRMS patients, 713 on Aubagio and 1,057 on Tecfidera, were included in the study. Age range was 18 to 65 years, and the Expanded Disability Status Scale (EDSS) score was between 0 (no disability) and 5.5 (disability severe enough to impair daily activities). All participants underwent a brain magnetic resonance imaging (MRI) scan within six months before treatment start.
Four parameters were analyzed at one and two years following therapy initiation: The proportion of patients with one or more relapses after treatment initiation; proportion of patients with at least one new T2 brain lesion on MRI; patients with an increased (worse) EDSS score, and; reasons for treatment discontinuation.
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After accounting for potential confounders (variables), the results showed that treatment with either Aubagio or Tecfidera led to a similar proportion of patients with at least one relapse (21.6% versus 20.2% after one year, 30.4% versus 29.5% at the second year), and similar EDSS score progression (27.4% versus 27.1% at year one, 41.6% versus 40.6% at year two, respectively).
However, the proportion of patients with one or more MRI lesions was significantly lower with Tecfidera (60.8%) than with Aubagio (72.2%) after two years of treatment. Also, fewer patients on Tecfidera (8.5%) reported lack of treatment effectiveness at two years than those on Aubagio (14.5%).
Based on the results, Laplaud concluded: “On this large study, we found no difference in terms of risk of relapse or EDSS progression at one and two years between the two treatments,” and “no significant difference at one year in terms of lesion increase” or “treatment withdrawal due to lack of efficacy.”
However, at two years, “a significant difference in favor of Tecfidera for the risk of T2 lesion” was seen, Laplaud noted, plus a significant difference “in favor of Tecfidera for treatment withdrawal due to lack of efficacy.”
In turn, the Danish study, “Comparative effectiveness of teriflunomide and dimethyl fumarate in relapsing remitting multiple sclerosis. A Danish nationwide cohort study,” aimed to compare treatment effectiveness and discontinuation in a real-world setting. The data were presented by The Danish Multiple Sclerosis Center in Denmark.
The study used data from the nationwide, population-based Danish Multiple Sclerosis Registry (DMSR). A total of 1,696 patients were included in the study — 1,178 on Aubagio and 518 on Tecfidera. Mean follow-up period was 2 years.
The team assessed the adjusted annualized relapse rate (ARR) (the number of confirmed relapses per year), relapse rate ratios, time to first relapse, time to six months confirmed EDSS worsening, and incidence of treatment discontinuation.
Results showed lower mean ARR in Tecfidera- than in Aubagio-treated patients — 0.11 versus 0.19. Treatment with Tecfidera showed increased time to first relapse, but no difference in confirmed EDSS worsening compared to Aubagio.
The data also revealed that treatment discontinuation due to elevated disease activity was seen in 22.1% of patients in the Aubagio group, and 10.2% of those receiving Tecfidera. Discontinuation due to adverse events was 17.4% for Aubagio and 16.2% for Tecfidera.
Based on the results, Buron concluded: “the patient group treated with Tecfidera had a lower annualized relapse rate, a lower risk of first relapse, and a lower incidence of discontinuation due to disease breakthrough when compared with the Aubagio-group.” No differences in EDSS worsening were seen.
Of note, several of the studies’ authors received consulting fees, speaker fees, research support, honoraria, travel grants and/or were members of scientific advisory boards of Biogen and/or Sanofi Genzyme. Two of the authors of the Danish study were involved in clinical trials sponsored by the two companies.