48 msfocusmagazine.org Medicine & Research FDA Approves By Ellen Whipple, Pharm.D. As reported in our last issue, The U.S. Food and Drug Administration approved Ocrevus™ (ocrelizumab - Genentech) as a treatment for both relapsing-remitting and primary progressive multiple sclerosis in May of 2017. This article explores the research behind this approval and what you need to know about this new treatment option. Ocrevus is a milestone in MS – the first product approved as a treatment for PPMS. But Ocrevus is a “first” in another way as well. Dr. Ben Thrower, director of the Multiple Sclerosis Institute at Shepherd Center and senior medical advisor to MS Focus, said, “Ocrevus is a welcome addition to the MS armamentarium of disease-modifying therapies, as it is the first approved product that specifically targets B-cells.” Ocrevus is a humanized monoclonal antibody designed to selectively target CD20- positive B-cells, a type of immune cells that contributetodemyelinationandaxonaldamage. The Research The approval of Ocrevus was supported by data from three Phase III clinical trials. The OPERA I and OPERA II studies evaluated the use of Ocrevus in patients with RRMS. The ORATORIO study evaluated the use of Ocrevus in 700 patients with PPMS. In the OPERA-I and OPERA-II studies, more than 1,500 patients with RRMS were randomized to either Ocrevus or high-dose interferon beta-1a (Rebif® – EMD Serono). During the two-year study, Ocrevus was associated with improved efficacy compared with Rebif. Ocrevus decreased relapses by about 50 percent, slowed the worsening of disability, and reduced the number of enhancing lesions on MRI compared with RX Update Taking Ocrevus How do you take it? Ocrevus is administered by intravenous infusion every six months. The first dose is administered as two 300 mg infusions given two weeks apart. Subsequent doses are given as single 600 mg infusions. What are the side effects? Infusion reactions – such as dizziness, rash, hives, and sweating – are commonwith Ocrevus. To prevent these infusion reactions from occurring, pre-medications are given prior to the infusions. These pre-medications typically consist of corticosteroids, antihistamines, and acetaminophen. Because of the potential of infusion-related reactions, Thrower stressed that “patients should be monitored for at least one hour after the completion of the infusion and that infusions should be stopped and/or permanently discontinued in patients who experience serious infusion reactions.”