Genzyme recently announced results from magnetic resonance imaging (MRI) analysis of participants in the Phase III TEMSO clinical trial showing that Aubagio® (teriflunomide) was able to slow the loss of brain volume (or atrophy) versus a placebo over two years in patients with relapsing multiple sclerosis (RMS).
Brain volume loss (BVL) is widespread in multiple sclerosis (MS), and occurs throughout the disease course at a rate considerably greater than in the general population. In MS, brain volume correlates with and predicts future disability, making BVL a relevant measure of diffuse central nervous system (CNS) damage leading to clinical disease progression, as well as serving as a useful outcome in evaluating MS therapies.
TEMSO MRI data was analysed with SIENA (structural image evaluation using normalization of atrophy). SIENA is a fully automated method for finding temporal brain changes, taking as input two MRI images at different points in time, and giving as output a “change” image, along with a global estimate of percentage brain volume change.
Change in brain volume from baseline was measured in RMS patients who received treatment with Aubagio (14 mg or 7 mg) or a placebo. Results from studies with MS patients treated with Aubagio showed that the incidence of serious adverse events was analogous among patients treated with the drug and those treated with the placebo.
The analysis results will be presented this week, on October 10, at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), which is taking place in Barcelona, Spain.
The data that will be presented shows:
- By month 12, the average percent of brain volume reduction from baseline was 0.39, 0.40, and 0.61 for Aubagio 14 mg, 7 mg, and placebo, respectively. This variation was inferior for both Aubagio groups versus placebo: 14 mg by 36.9%; 7 mg by 34.4%.
- By month 24, the difference in brain atrophy reduction for Aubagio versus placebo was preserved. The average percent in brain volume reduction from baseline was 0.90, 0.94, and 1.29 for Aubagio 14 mg, 7 mg, and placebo, respectively. This variation was inferior for both Aubagio groups versus placebo: 14 mg by 30.6%; 7 mg by 27.6%.
“Control or prevention of brain atrophy is an important target for MS treatment,” said Prof. Dr. Ludwig Kappos, Neurology Chair, University Hospital Basel, Switzerland. “These data help provide further insight into teriflunomide’s potential effects in people with RMS.”
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“These results showing the reduction in brain atrophy over two years add to the growing body of data for Aubagio,” said Bill Sibold, Head of Genzyme’s Multiple Sclerosis business. “We remain committed to furthering the understanding of Aubagio and the potential benefits it could deliver to relapsing MS patients.”
Aubagio, a pyrimidine synthesis inhibitor, is an oral compound that inhibits the function of specific immune cells that have been implicated in MS. It is related to leflunomide, a drug used to treat rheumatoid arthritis. Aubagio can inhibit a key enzyme required by white blood cells (lymphocytes) – which in turn reduces the proliferation of T and B immune cells that are active in MS, and also inhibits the production of immune messenger chemicals by T cells.
Aubagio was approved by the U.S. Food and Drug Administration (FDA) in September 2012 for patients with relapsing forms of MS.