Roche and Biogen Idec announced that the experimental monoclonal antibody ocrelizumab, given intravenously, significantly reduced disease activity as measured by MRI (magnetic resonance imaging) scans in a phase II study of 220 people with relapsing-remitting MS. The results were announced in a December 4 press release. Data analysis is ongoing and the companies expect to provide a full report at an upcoming medical meeting. Since this is a phase 2 study, additional research will be needed to further determine this drug's safety and benefits.
Details
Ocrelizumab binds to a molecule (CD20) on the surface of B cells and depletes them from the circulation. B cells are immune cells that make antibodies and may play a role in the immune attack on brain and spinal cord tissues in multiple sclerosis. The drug is a humanized version of rituximab, a mouse antibody to CD20 that has previously shown benefit in people with relapsing-remitting MS.
In the aspects of this phase II study reported in the press release, participants were randomly assigned to receive one of two treatment regimens and observed for 24 weeks, with plans for observing them for up to 96 weeks. Participants received repeated intravenous infusions of one of three different dose regimens of ocrelizumab or inactive placebo) or intramuscular injections (Avonex®, interferon beta-1a, Biogen Idec).
The main objective of this study was to determine whether ocrelizumab was effective in reducing MS disease activity compared with placebo, as observed on MRI at 12, 16, 20, and 24 weeks. The press release reports that ocrelizumab "showed a strong effect with a highly statistically significant reduction" in signs of disease activity. The companies are continuing to analyze the data, and plan to provide a full report at an upcoming medical meeting, including the results of secondary endpoints - which include relapse rate and the appearance of new disease activity - and safety information. Since this was a phase 2 study, additional research will be needed to further determine this drug's safety and benefits.
With information from the National MS Society (USA)
National Research and Programs
Offert en français.
Disclaimer
The Multiple Sclerosis Society of Canada is an independent, voluntary health
agency and does not approve, endorse or recommend any specific product or therapy,
but provides information to assist individuals in making their own decisions.
