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Teriflunomide added to interferon-β in relapsing multiple sclerosis: a randomized phase II trial
M S Freedman1, J S Wolinsky, B Wamil
1University of Ottawa, Ottawa, Canada. mfreedman@toh.on.ca
Neurology
|May 25, 2012
Summary
Teriflunomide added to interferon-beta (IFNβ) demonstrated acceptable safety and reduced MRI-detected disease activity in patients with relapsing multiple sclerosis (RMS). This add-on therapy showed significant reductions in T1-gadolinium-enhancing lesions compared to IFNβ alone.
Area of Science:
- Neuroimmunology
- Clinical Neurology
- Pharmacology
Background:
- Relapsing forms of multiple sclerosis (RMS) are characterized by inflammatory lesions in the central nervous system.
- Interferon-beta (IFNβ) is a common disease-modifying therapy for RMS, but additional treatments are often needed.
- Teriflunomide is an oral immunomodulatory drug approved for RMS treatment.
Purpose of the Study:
- To evaluate the safety and efficacy of teriflunomide as an add-on therapy to stable interferon-beta (IFNβ) in patients with RMS.
- To assess the impact of teriflunomide on MRI-measured disease activity and relapse rates.
Main Methods:
- A randomized, double-blind, placebo-controlled trial involving 118 patients with RMS.
- Patients received oral placebo, teriflunomide 7 mg, or teriflunomide 14 mg once daily for 24 weeks, with an extension period.
- Primary endpoint was safety; secondary endpoints included MRI lesion counts and relapse rates.
Main Results:
- Teriflunomide was well-tolerated with a low incidence of treatment-emergent adverse events, similar across groups.
- Both 7 mg and 14 mg of teriflunomide significantly reduced T1-gadolinium-enhancing lesions compared to IFNβ alone at 48 weeks (RRRs of 84.6% and 82.8%, respectively).
- A trend towards dose-dependent reduction in annualized relapse rate was observed with teriflunomide add-on therapy.
Conclusions:
- Teriflunomide is a safe and well-tolerated add-on therapy to interferon-beta for patients with RMS.
- Add-on teriflunomide significantly reduces MRI-assessed disease activity, specifically T1-gadolinium-enhancing lesions.
- These findings support the use of teriflunomide in combination with IFNβ for managing RMS.
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