From the NEJM Journal Watch, March 30, 2017:
FDA Approves Ocrelizumab for Severe MS
By Kelly Young
Edited by Susan Sadoughi, MD, and Richard Saitz, MD, MPH, FACP, DFASAM
The FDA has approved the injectable monoclonal antibody ocrelizumab (Ocrevus) to treat primary progressive multiple sclerosis (PPMS) and relapsing MS in adults. The treatment depletes B cells via binding by CD20.
In two recent trials of nearly 1700 patients with relapsing MS, patients randomized to ocrelizumab had a 47% reduction in relapse rate, a 40% reduction in worsening disability, and over a 95% reduction in new lesions after 3 months compared with those given high-dose interferon.
In a recent PPMS trial, 33% of patients given ocrelizumab had worsening disability at 3 months, versus 39% in the placebo group.
Ocrelizumab is associated with infusion-related reactions, which can include laryngeal or pharyngeal edema, hypotension, and tachycardia. The treatment may increase risk for cancers, specifically breast cancer, but the most common side effects were respiratory tract and skin infections. In addition, patients with active infections should delay treatment, given a higher rate of infections seen with ocrelizumab in clinical trials. Lastly, vaccination with live or live attenuated vaccines is not advised during treatment.
The drug's list price will be $65,000 a year, the New York Times reports.