Aubagio (teriflunomide), taken as a 14 mg tablet once a day, shows long-term safety and efficacy in patients with relapsing forms of multiple sclerosis (MS), according to results of the Phase 3 TOWER extension study.
Treatment was generally well tolerated by the 751 patients using Aubagio for a median of 4.2 years, and up to 6.3 years, in this extension trial, with side effects remaining consistent with those reported in earlier studies, and long-term disease stabilization evident, its researchers reported.
These results are in the study “Long-term safety and efficacy of teriflunomide in patients with relapsing multiple sclerosis: Results from the TOWER extension study,” published in the journal Multiple Sclerosis and Related Disorders.
Aubagio, an approved MS therapy marketed by Sanofi Genzyme, proved to be safe and effective in treating relapsing forms of MS, including relapsing-remitting MS (RRMS), in the Phase 3 TOWER trial (NCT00751881) as well as in several other trials.
For lifelong conditions such as MS, however, therapies must remain effective and tolerable for patients over long periods of time.
An international team of researchers assessed the long-term safety and efficacy outcomes from the extension study of the TOWER clinical trial.
TOWER’s core study had randomly assigned patients, all of whom had at least one relapse in the previous year, to a placebo (253 patients), or to treatment with Aubagio at 7 mg (265 people) or at 14 mg (233 patients) for at least 48 weeks. Depending on the time of their enrollment, participants received treatment for a maximum of 152 weeks (almost three years).
Those who completed the core study were invited to join its open label extension, where all were given Aubagio at 14 mg daily.
In total, 751 patients moved into the extension study, whose main goal was to establish the “long-term safety and tolerability” of Aubagio at the 14 mg dose.
Other study endpoints included confirmed disability worsening over a 12-week period (12-week CDW), as measured on the expanded disability status scale (EDSS). Another goal was tracking patients’ relapse rates.
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