Rituximab in relapsing-remitting multiple sclerosis: A 72-week, open-label, phase I trial

被引:420
作者
Bar-Or, Amit [1 ,2 ]
Calabresi, Peter A. J. [3 ]
Arnlod, Douglas [4 ]
Markowitz, Clyde [5 ]
Shafer, Stuart [6 ]
Kasper, Lloyd H. [7 ]
Waubant, Ernmanuelle [8 ]
Gazda, Suzanne [9 ]
Fox, Robert J. [10 ]
Panzara, Michael [11 ]
Sarkar, Neena [12 ]
Agarwal, Sunil [12 ]
Smith, Craig H. [12 ]
机构
[1] McGill Univ, Montreal Neurol Inst, Expt Therapeut Program, Montreal, PQ H3A 2B4, Canada
[2] McGill Univ, Neuroimmunol Unit, Montreal, PQ H3A 2B4, Canada
[3] Johns Hopkins Univ Hosp, Dept Neurol, Baltimore, MD 21287 USA
[4] NeuroRx Res, Montreal, PQ, Canada
[5] Hosp Univ Penn, Philadelphia, PA 19104 USA
[6] Vero Neurol, Vero Beach, FL USA
[7] Dartmouth Med Sch, Lebanon, NH USA
[8] Univ Calif San Francisco, Dept Neurol, San Francisco, CA 94143 USA
[9] Integra Clin Res, San Antonio, TX USA
[10] Cleveland Clin, Mellen Ctr Multiple Sclerosis, Cleveland, OH 44106 USA
[11] Biogen Idec, Cambridge, MA USA
[12] Genentech Inc, San Francisco, CA 94080 USA
关键词
D O I
10.1002/ana.21363
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
We evaluated the safety, tolerability, pharmacodynamics, and activity of B-cell depletion with rituximab in patients with relapsing-remitting multiple sclerosis, receiving two courses of rituximab 6 months apart, and followed for a total of 72 weeks. No serious adverse events were noted; events were limited to mild-to-moderate infusion-associated events, which tended to decrease with subsequent infusions. Infections were also mild or moderate, and none led to withdrawal. Fewer new gadolinium-enhancing or T2 lesions were seen starting from week 4 and through week 72. An apparent reduction in relapses was also observed over the 72 weeks compared with the year before therapy.
引用
收藏
页码:395 / 400
页数:6
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