期刊
JOURNAL OF NEUROLOGY
卷 260, 期 5, 页码 1388-1395出版社
SPRINGER HEIDELBERG
DOI: 10.1007/s00415-012-6809-7
关键词
Multiple sclerosis; Natalizumab; Relapse; Disease activity; Disease-modifying therapy; Annualized relapse rate
资金
- Biogen Idec Inc.
- Elan Pharmaceuticals, Inc.
- Actelion
- Advancell
- Allozyne
- Bayer
- Bayhill
- Biogen Idec
- BioMarin
- CSL Behring
- Eli Lilly
- European Union
- GeNeuro
- Genmab
- Gianni Rubatto Foundation
- Glenmark
- Merck Serono
- MediciNova
- Mitsubishi Pharma
- Novartis
- Novartis Research Foundation
- Novonordisk
- Peptimmune
- Roche
- Roche Research Foundation
- Sanofi-Aventis
- Santhera
- Swiss MS Society
- Swiss National Research Foundation
- Teva
- UCB
- Wyeth
- Bayer Schering
- GlaxoSmithKline
- Almirall
- Bayer Schering Pharma
- Biogen Idec/Elan Corporation
- Novo Nordisk
In clinical practice natalizumab is typically used in patients who have experienced breakthrough disease during treatment with interferon beta (IFN beta) or glatiramer acetate. In these patients it is important to reduce disease activity as quickly as possible. In a phase II study, differences between natalizumab and placebo in MRI outcomes reflecting inflammatory activity were evident after the first infusion and maintained through a 6-month period, suggesting a rapid onset of natalizumab treatment effects. To explore how soon after natalizumab initiation clinical effects become apparent, annualized relapse rates per 3-month period and time to first relapse were analyzed in the phase III AFFIRM study (natalizumab vs. placebo) and in the multinational Tysabri(A (R)) Observational Program (TOP). In AFFIRM, natalizumab reduced the annualized relapse rate within 3 months of treatment initiation compared with placebo in the overall population (0.30 vs. 0.71; p < 0.0001) and in patients with highly active disease (0.30 vs. 0.94; p = 0.0039). The low annualized relapse rate was maintained throughout the 2-year study period, and the risk of relapse in AFFIRM patients treated with natalizumab was reduced [hazard ratio against placebo 0.42 (95 % CI 0.34-0.52); p < 0.0001]. Rapid reductions in annualized relapse rate also occurred in TOP (baseline 1.99 vs. 0-3 months 0.26; p < 0.0001). Natalizumab resulted in rapid, sustained reductions in disease activity in both AFFIRM and in clinical practice. This decrease in disease activity occurred within the first 3 months of treatment even in patients with more active disease.
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