Safety and efficacy of ofatumumab in relapsing-remitting MS: A phase 2 study
Treatment, therapies and management:
Ofatumumab is a human CD20 monoclonal antibody, which binds to CD20 on B lymphocytes and induces B-cell depletion through complement-dependent cytotoxicity.
This randomised, double-blinded, placebo-controlled trial included 38 patients with RRMS. It looked at the safety and efficacy of ofatumumab.
Patients received two ofatumumab infusions (100mg, 300mg or 700mg), or placebo 2 weeks apart. Overall ofatumumab resulted in a significant reduction in B cells, as measured by CD19+ expression. Also, new brain MRI lesion activity was suppressed in the first 24 weeks after ofatumumab, in all doses administered.
There were no unexpected safety concerns with ofatumumab and overall it was well tolerated in patients with RRMS. Positive effects were also demonstrated on the MRI data. This study provides Class II evidence that ofatumumab does not increase the number of serious adverse events.
Sorensen PS, Lisby S
: Neurology. 2014 Jan 22. [Epub ahead of print]
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