Prior treatment with disease-modifying therapies (DMTs) does not affect the long-term benefits of Aubagio (teriflunomide) in treating relapsing forms of multiple sclerosis (MS), according to a review study.
The study, “Prior treatment status: impact on the efficacy and safety of teriflunomide in multiple sclerosis,” was published in the journal BMC Neurology.
Breakthrough disease activity, poor tolerability, or a failure to adhere to injectable DMTs may require patients to switch to another therapy. Few studies, however, have examined how prior treatment affects this change.
An international team of researchers asked how prior DMT use affected the long-term safety and effectiveness of Aubagio, an once-daily approved oral medication for relapsing MS marketed by Sanofi Genzyme.
The team analyzed data from six clinical trials: a Phase 2 trial and its extension (NCT01487096 and NCT00228163, respectively), the Phase 3 TEMSO trial and its extension (NCT00134563 and NCT00803049), the Phase 3 TOWER trial (NCT00751881), and the Phase 3 TENERE trial (NCT00883337).
Patients were categorized as “treatment naïve,” “previously treated,” or “recently treated” based on their past DMT use.
Treatment naïve patients either had never used DMTs, or they discontinued treatment more than two years before being randomized in a trial; previously treated patients had discontinued DMT use from six months to two years prior; while recently treated patients had discontinued DMT use within six months before entering a trial.
During the core trial period, the annualized relapse rate (the average number of relapses per year) in patients receiving Aubagio 14 mg fell by 34% among treatment naïve (from 0.536 to 0.353) and in the previously treated group (from 0.834 to 0.548), and by 41% among recently treated patients (from 0.821 to 0.484), compared to a placebo.
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