Efficacy and tolerability of natalizumab in relapsing-remitting multiple sclerosis patients: a post-marketing observational study

被引:42
|
作者
Sangalli, F. [1 ]
Moiola, L. [1 ]
Bucello, S. [1 ]
Annovazzi, P. [2 ]
Rizzo, A. [2 ]
Radaelli, M. [1 ]
Vitello, G. [3 ]
Grimaldi, L. M. E. [3 ]
Ghezzi, A. [2 ]
Martinelli, V. [1 ]
Comi, G. [1 ]
机构
[1] IRCCS H San Raffaele, INSPE, Dept Neurol, I-20132 Milan, Italy
[2] Ctr Studi SM, Gallarate, VA, Italy
[3] Osped Giglio HSR, Cefalu, PA, Italy
关键词
Multiple sclerosis; Natalizumab; Efficacy; Safety;
D O I
10.1007/s10072-010-0344-z
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
To evaluate the efficacy and safety of natalizumab in patients with active relapsing remitting multiple sclerosis (MS). We included 285 MS patients receiving natalizumab. Clinical, neuroradiological and safety data were registered every 6 months. Neutralizing antibodies (NABs) were tested after 6 months of treatment. After 1 year, the annualized relapse rate decreased to 0.26, with a significant reduction compared to the previous year (2.13). At 24 months the proportion of "relapse free" patients was 78% while that of "MRI free" patients was 69%. Considering clinical and MRI cumulative activity, "disease free" patients were 63% at 24 months. A total of 18 patients showed NABs positivity. We reported 34 cases of treatment interruptions. In conclusion, our data confirm the remarkable efficacy of natalizumab in a group of patients with higher disease activity than that of pivotal studies.
引用
收藏
页码:S299 / S302
页数:4
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