Rituximab in relapsing-remitting multiple sclerosis: a 72-week, open-label, phase I trial.
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.
Bar-Or
Amit
A
Montreal Neurological Institute, McGill University, Montreal, Quebec, Canada. amit.bar-or@mcgill.ca
Calabresi
Peter A J
PA
Arnold
Douglas
D
Arnlod
Douglas
D
Markowitz
Clyde
C
Shafer
Stuart
S
Kasper
Lloyd H
LH
Waubant
Emmanuelle
E
Gazda
Suzanne
S
Fox
Robert J
RJ
Panzara
Michael
M
Sarkar
Neena
N
Agarwal
Sunil
S
Smith
Craig H
CH
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
D000911:Antibodies, Monoclonal; D058846:Antibodies, Monoclonal, Murine-Derived; D000069283:Rituximab