Genentech announce positive results from two Phase 3 studies evaluating ocrelizumab compared with Rebif (interferon beta-1a) in patients with relapsing multiple sclerosis (MS).

OPERA I and OPERA II are randomized, double-blind, double-dummy, global multi-center studies evaluating the efficacy and safety of ocrelizumab compared with interferon beta-1a in people with relapsing forms of MS. Both studies enrolled a total of 1,656 people with relapsing forms of MS (eg, relapsing-remitting MS and secondary-progressive MS with relapses). The primary endpoint of the OPERA studies was annualized protocol-defined relapse rate (ARR) at two years (96 weeks).

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Treatment with ocrelizumab significantly reduced the annualized relapse rate (ARR) over a two-year period compared with interferon beta-1a, the primary endpoint in both studies. Ocrelizumab also significantly reduced the progression of clinical disability compared with interferon beta-1a, as measured by the Expanded Disability Status Scale (EDSS).

Ocrelizumab is an investigational, humanized monoclonal antibody designed to selectively target CD20-positive B cells by binding to CD20 cell surface proteins expressed on certain B cells, but not on stem cells or plasma cells.

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