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VBCN - July 2015 Volume 2, No 2 - Multiple Sclerosis
Rosemary Frei, MSc

Indianapolis, IN—A recent analysis of current evidence indicates that physicians can switch patients with relapsing-remitting multiple sclerosis (RRMS) from other disease-modifying therapies (DMTs) to teriflunomide (Aubagio) without worrying about a drop in efficacy or serious adverse events.

Mark S. Freedman, MD, MSc, FAAN, Professor of Medicine (Neurology), University of Ottawa, Ontario, and colleagues performed a post hoc analysis of data from recent clinical trials of the drug, including the TEMSO and TOWER studies and the TENERE extension study. The results were presented at the 2015 Consortium of Multiple Sclerosis Centers annual meeting.

The 237 patients in the open-label extension of TENERE received teriflunomide 14 mg daily; of these, 59 patients switched from interferon beta-1a (Avenox, Rebif). In TENERE, patients were randomized to 7 mg or 14 mg of teriflunomide or to 44 µg of subcutaneous interferon beta-1a daily. In TEMSO and TOWER, patients were randomized to 7 mg or 14 mg of teriflunomide or to placebo daily. TEMSO and TOWER had a washout period before starting treatment with teriflu­nomide in patients who had received other treatments.

The baseline RRMS characteristics of patients in the pooled TEMSO and TOWER studies and the TENERE extension study were roughly the same. However, the average disease duration in TEMSO/TOWER in patients who had ≥2 previous DMTs was 10.26 years versus 7.70 to 9.67 years in patients who had received fewer previous DMTs.

The adjusted annualized relapse rate was significantly lower with 14 mg of teriflunomide daily than with placebo in TEMSO/TOWER patients who were treatment-naïve before study entry or had received 1 previous DMT. The relapse rate was also significantly lower with 7 mg daily of teriflunomide versus placebo in TEMSO/TOWER in patients who had not received previous DMTs (P <.001).

The probability of disability progression was also significantly lower in patients in the pooled TEMSO and TOWER who had received 1 previous DMT and then 14 mg of teriflunomide than among those who received placebo (P <.05).

Dr Freedman and colleagues reported that the safety profile for 7 mg and 14 mg of teriflunomide in TEMSO and TOWER was “consistent and manageable,” and that in the TENERE extension study, the “incidence and nature of adverse events…were similar in all groups and consistent with previous studies.” They added that there were no new or “unexpected” adverse events from switching to teriflunomide.

Lana Zhovtis Ryerson, MD, Assistant Professor of Neurology, NYU Langone Multiple Sclerosis Comprehensive Care Center, NY, told Value-Based Care in Neurology that despite the weaknesses inherent in post hoc analyses, these results may be clinically meaningful.

“It is important to understand what the bottom line is and not to overstate the results,” Dr Zhovtis Ryerson commented. “For patients with more active disease, teriflunomide may be more useful than placebo. I do not think we can assume teriflunomide can be used as an escalation therapy; meaning, ‘Oh, someone has failed 2 drugs, let’s put them on teriflunomide. They will do better.’ That is not what this shows at all. It is simply a comparison with placebo.”

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Last modified: August 5, 2015
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