Ocrelizumab: A Review in Multiple Sclerosis

Abstract

Ocrelizumab (Ocrevus^®) is a humanized anti-CD20 monoclonal antibody approved for the treatment of adults with relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS). In the two identically designed, 96-week OPERA I and II trials in patients with RMS, ocrelizumab significantly reduced annualized relapse rates versus interferon β-1a. In the ≥ 120-week ORATORIO trial in patients with PPMS, ocrelizumab significantly reduced the risk of ≥ 12-week confirmed disability progression relative to placebo. These primary endpoint results were supported by a number of secondary outcomes, including disease activity in the brain assessed by magnetic resonance imaging. Ocrelizumab was generally well tolerated in these studies, with infusion-related reactions and infections being the most common adverse events, which were mostly mild to moderate in severity. In summary, ocrelizumab is a novel high-efficacy disease-modifying therapy for RMS that is more effective than interferon β-1a and also a valuable new treatment option for delaying progression in early PPMS. It offers a convenient once every 6 months treatment regimen, with no need for routine monitoring.