期刊
MULTIPLE SCLEROSIS JOURNAL
卷 18, 期 9, 页码 1278-1289出版社
SAGE PUBLICATIONS LTD
DOI: 10.1177/1352458512436594
关键词
Multiple sclerosis; teriflunomide; oral therapy; long-term treatment; clinical trials
资金
- sanofi-aventis
- Biogen Idec
- Genzyme Corporation
- Novartis
- Merck Serono
- Teva Pharma
- UCB Pharma
- Bayer Schering
- LFB
- Canadian Institute of Health Research and Multiple Sclerosis Society of Canada
- Genzyme
- Teva
- Actelion
- Bayer
- BioMS
- Cognosci
- Daiichi Sankyo
- EMD Serono
- Genentech
- Genmab
- Roche
- Teva Neurosciences
- Warburg Pincus
Background: Teriflunomide, an oral disease-modifying therapy in development for patients with relapsing forms of multiple sclerosis (RMS), was well tolerated and effective in reducing magnetic resonance imaging (MRI) lesions in 179 RMS patients in a phase 2 36-week, placebo-controlled study. Methods: A total of 147 patients who completed the core study entered an open-label extension. Teriflunomide patients continued their assigned dose, and placebo patients were re-allocated to teriflunomide, 7 mg/day or 14 mg/day. An interim analysis was performed at a cut-off on January 8 2010. Results: The mean and median duration of study treatment, including both the core and extension phase, from baseline to the interim cut-off, was 5.6 years (standard deviation: 2.7 years) and 7.1 years (range: 0.05-8.5 years), respectively. Of 147 patients, 62 (42.2%) discontinued (19% due to treatment-emergent adverse events (TEAEs)). The most common TEAEs were mild infections, fatigue, sensory disturbances and diarrhoea. No serious opportunistic infections occurred, with no discontinuations due to infection. Asymptomatic alanine aminotransferase increases (<= 3x upper limit of normal (ULN)) were common (7 mg, 64.2%; 14 mg, 62.1%); increases >3xULN were similar across groups (7 mg, 12.3%; 14 mg, 12.1%). Mild decreases in neutrophil counts occurred; none led to discontinuation. The incidence of malignancies was comparable to that of the general population, and cases were not reminiscent of those observed in immunocompromised patients. Annualised relapse rates remained low, minimal disability progression was observed, with a dose-dependent benefit with teriflunomide 14 mg for several MRI parameters. Conclusion: Teriflunomide had a favourable safety profile for up to 8.5 years.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据