Journal
NEUROLOGY
Volume 78, Issue 23, Pages 1877-1885Publisher
LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1212/WNL.0b013e318258f7d4
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Funding
- sanofi-aventis
- Genzyme
- Biogen Idec
- Genzyme Corporation
- Novartis
- Merck Serono
- Teva Pharma
- UCB Pharma
- Bayer Schering
- LFB
- Serono Symposia International Foundation
- Merck Serono International
- Biogen Dompe
- Teva Pharmaceutical Industries Ltd.
- Actelion
- Advancell
- Allozyne
- BaroFold
- Bayer Health Care Pharmaceuticals
- Bayer Schering Pharma
- Bayhill
- BioMarin
- CSL Behring
- Elan
- Genmab
- Genmark
- GeNeuro SA
- GlaxoSmithKline
- Lilly
- MediciNova
- Novo Nordisk
- Peptimmune
- Santhera
- Roche
- Teva
- UCB
- Wyeth
- Swiss MS Society
- Swiss National Research Foundation
- European Union
- Gianni Rubatto Research Foundation
- Novartis Research Foundation
- Roche Research Foundation
- Acorda Therapeutics
- Genentech
- Teva Neuroscience
- Daiichi-Sankyo
- EMD Serono
- ONO
- Bayer
- BioMS
- Cognosci
- Warburg Pincus
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Objective: To evaluate teriflunomide as add-on therapy to ongoing stable-dosed interferon-beta (IFN beta) in patients with relapsing forms of multiple sclerosis (RMS). Methods: A total of 118 patients with RMS were randomly assigned 1: 1: 1 to receive oral placebo or teriflunomide, 7 or 14 mg, once daily for 24 weeks; 86 patients entered the 24-week extension. The primary objective was to evaluate safety; secondary objectives were to evaluate the effects of treatment on disease activity assessed by MRI and relapse rate. Results: Teriflunomide was well tolerated with a low and similar incidence of treatment-emergent adverse events (TEAEs) across the 3 groups; TEAEs led to treatment discontinuation of 4.9%, 8.1%, and 7.9% of patients in the placebo, 7-mg, and 14-mg groups, respectively. The number of gadolinium-enhancing T1 (T1-Gd) lesions was reduced in both teriflunomide groups, with relative risk reductions (RRRs) of 84.6% (p = 0.0005) and 82.8% (p < 0.0001) for 7 and 14 mg, respectively, compared with IFN beta alone at 48 weeks. T1-Gd lesion volume was also reduced in the 7-mg group (RRR 72.1%, p = 0.1104) and 14-mg group (RRR 70.6%, p = 0.0154). A trend toward dose-dependent reduction in annualized relapse rate was also noted (RRRs 32.6% [p = 0.4355] and 57.9% [p = 0.1005] for 7 and 14 mg, respectively). Conclusion: Teriflunomide as add-on therapy to IFN beta had acceptable safety and tolerability and reduced MRI disease activity compared with IFN beta alone. Classification of evidence: This study provides Class II evidence that teriflunomide, 7 and 14 mg, added to IFN beta, is safe. The T1-Gd lesion burden was significantly reduced with both teriflunomide doses. Neurology (R) 2012;78:1877-1885
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