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.
These data suggested that Aubagio (14 mg) “significantly reduced [annualized relapse rate] versus placebo in the core period, regardless of prior treatment status,” the researchers wrote.
The annualized relapse rate remained low throughout the extension period of the trials — being 0.193 in treatment naïve patients, 0.284 in previously treated patients, and 0.272 in recently treated patients.
The rate of confirmed disability worsening (CDW) over 12 weeks also was similar across groups. At year five — the maximum time point at which each treatment subgroup had at least 10 patients — 12-week CDW rates for all groups varied between approximately 34% and 36%. Although this difference increased by years 12 and 13, with rates varying between 34% (in patients recently treated) and 53% (in treatment naïve patients), few patients remained available at these time points limiting the power of the analysis.
Expanded disability status scale (EDSS) scores remained stable across all groups and over the core and extension periods. When treatment with Aubagio began, average EDSS scores ranged from 2.48 in recently treated patients to 2.74 in previously treated ones. By year eight, these ranged from 2.58 in previously treated patients to 3.64 in the recently treated group.
Aubagio also maintained its established safety profile throughout the study, with no new or unexpected findings. More side effects occurred within the first four years, compared to later years, suggesting that they tend to occur relatively early and decline as treatment continues.
Treatment naïve patients were slightly less likely to permanently discontinue treatment due to side effects (15.2%), compared to previously treated (20.2%) and recently treated (19.6%) patients.
Overall, these findings support those of previous long-term safety and efficacy Aubagio studies.
“Across prior DMT subgroups, treatment with [Aubagio] 14 mg produced similar treatment effect on relapses, with stable disability, and no apparent effect on tolerability and safety,” the researchers concluded.
“These data may help to guide treatment decision making in the clinical setting, particularly in treatment-naive patients or those who do not respond to older first-line therapies,” they added.
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