Rituximab in relapsing-remitting multiple sclerosis: a 72-week, open-label, phase I trial - PubMed (original) (raw)

Clinical Trial

. 2008 Mar;63(3):395-400.

doi: 10.1002/ana.21363.

Peter A J Calabresi, Douglas Arnold, Clyde Markowitz, Stuart Shafer, Lloyd H Kasper, Emmanuelle Waubant, Suzanne Gazda, Robert J Fox, Michael Panzara, Neena Sarkar, Sunil Agarwal, Craig H Smith

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Clinical Trial

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

Amit Bar-Or et al. Ann Neurol. 2008 Mar.

Erratum in

Abstract

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.

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