49 msfocusmagazine.org Rebif. Infusion-related reactionswere common with Ocrevus (reported in about 30 percent of patients). Serious infections were reported in 1.3 percent of the patients treated with Ocrevus and 2.9 percent of patients treated with Rebif. Neoplasms were reported in 0.5 percent patients treated with Ocrevus and 0.2 percent of patients treated with Rebif. In the ORATORIO study, more than 700 patients with PPMS were randomized to either Ocrevus orplacebo.Afterthreeyears, treatment with Ocrevus was associated with decreased progression of disability and deceased signs of disease activity in the brain compared with placebo. Infusion-related reactions, upper respiratory tract infections, and oral herpes simplex infections were more frequently reportedwithOcrevusthanplacebo.Neoplasms (an abnormal growth of tissue) were reported in 2.3 percent of patients treated with Ocrevus and in 0.8 percent of patients who were treated with placebo. Adverse Events The most commonly reported adverse events with Ocrevus in the Phase III clinical trial development programs were infusion reactions and upperrespiratorytract infections. These adverse events were generally mild to moderate in severity. Otheradverse events (specificallyinfections and malignancies) were also reported in the Phase III clinical trials. In these trials, treatment with Ocrevus increased the risk of upper respiratory tract infections, lower respiratory tract infections, skin infections, and herpes- related infections. It is important to note that Ocrevus was not associated with an increased risk of serious infections. One patient treated with Ocrevus in the Phase III clinical trial program also committed suicide. According to Dr. Thrower, while it is not possible to ascertain whether this event of suicide was related to treatment with Ocrevus, both patients and clinicians should be aware that the event occurred. In addition, one case of progressive multifocal leukoencephalopathy (PML) has been reported with Ocrevus. Because the patient had previously received treatmentwithTysabri® (natalizumab – Biogen), it is not clear what was the causative agent – Ocrevus, Tysabri, or both. Other Cautions: • Because of the increased risk of infection, Ocrevus should not be used by patients who are experiencing active Hepatitis B infections and should be avoided in patients having active infections until the infection has resolved. • Vaccinations with live-attenuated or live vaccines is also not recommended during treatment with Ocrevus and should be avoided until afterdiscontinuation of therapy until B-cell repletion occurs. • There also appeared to be an increased risk of breast cancer in the Ocrevus in the Phase III clinical trials. Because of this risk, patients should follow standard breast cancer screening protocols. Availability Ocrevus is currently available in the US. Patients can call 844-OCREVUS (844-627-3887) for more information on the drug. For patients who qualify, a patient assistance program is available.Call866-4ACCESS(866-422-2377)forinformationonthepatientassistanceprogram.