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

Amit Bar-Or; Peter A.J. Calabresi; Douglas Arnlod; Clyde Markowitz; Stuart Shafer; Lloyd H. Kasper; Emmanuelle Waubant; Suzanne Gazda; Robert J. Fox; Michael Panzara; Neena Sarkar; Sunil Agarwal; Craig H. Smith

doi:10.1002/ana.21363

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

Amit Bar-Or, Peter A.J. Calabresi, Douglas Arnlod, Clyde Markowitz, Stuart Shafer, Lloyd H. Kasper, Emmanuelle Waubant, Suzanne Gazda, Robert J. Fox, Michael Panzara, Neena Sarkar, Sunil Agarwal, Craig H. Smith

School of Medicine

Research output: Contribution to journal › Article › peer-review

353 Scopus citations

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.

Original language	English (US)
Pages (from-to)	395-400
Number of pages	6
Journal	Annals of neurology
Volume	63
Issue number	3
DOIs	https://doi.org/10.1002/ana.21363
State	Published - Mar 1 2008

ASJC Scopus subject areas

Neurology
Clinical Neurology

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10.1002/ana.21363

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

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.",

author = "Amit Bar-Or and Calabresi, {Peter A.J.} and Douglas Arnlod and Clyde Markowitz and Stuart Shafer and Kasper, {Lloyd H.} and Emmanuelle Waubant and Suzanne Gazda and Fox, {Robert J.} and Michael Panzara and Neena Sarkar and Sunil Agarwal and Smith, {Craig H.}",

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AU - Calabresi, Peter A.J.

AU - Arnlod, Douglas

AU - Markowitz, Clyde

AU - Shafer, Stuart

AU - Kasper, Lloyd H.

AU - Waubant, Emmanuelle

AU - Gazda, Suzanne

AU - Fox, Robert J.

AU - Panzara, Michael

AU - Sarkar, Neena

AU - Agarwal, Sunil

AU - Smith, Craig H.

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

Abstract

ASJC Scopus subject areas

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