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.
authors.affiliation: Montreal Neurological Institute, McGill University, Montreal, Quebec, Canada. amit.bar-or@mcgill.ca
authors.forename: Amit
authors.initials: A
authors.lastname: Bar-Or
authors.forename: Peter A J
authors.initials: PA
authors.lastname: Calabresi
authors.forename: Douglas
authors.initials: D
authors.lastname: Arnold
authors.forename: Douglas
authors.initials: D
authors.lastname: Arnlod
authors.forename: Clyde
authors.initials: C
authors.lastname: Markowitz
authors.forename: Stuart
authors.initials: S
authors.lastname: Shafer
authors.forename: Lloyd H
authors.initials: LH
authors.lastname: Kasper
authors.forename: Emmanuelle
authors.initials: E
authors.lastname: Waubant
authors.forename: Suzanne
authors.initials: S
authors.lastname: Gazda
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Fox
authors.forename: Michael
authors.initials: M
authors.lastname: Panzara
authors.forename: Neena
authors.initials: N
authors.lastname: Sarkar
authors.forename: Sunil
authors.initials: S
authors.lastname: Agarwal
authors.forename: Craig H
authors.initials: CH
authors.lastname: Smith
mesh_terms: D000328:Adult; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D058846:Antibodies, Monoclonal, Murine-Derived; D001402:B-Lymphocytes / Q000473:pathology; D005260:Female; D006801:Humans; D008212:Lymphocyte Depletion; D008279:Magnetic Resonance Imaging / Q000379:methods; D008297:Male; D008875:Middle Aged; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy* / Q000276:immunology / Q000473:pathology; D000069283:Rituximab; D013997:Time Factors
chemical_list: D000911:Antibodies, Monoclonal; D058846:Antibodies, Monoclonal, Murine-Derived; D000069283:Rituximab