Page 1 Page 2 Page 3 Page 4 Page 5 Page 6 Page 7 Page 8 Page 9 Page 10 Page 11 Page 12 Page 13 Page 14 Page 15 Page 16 Page 17 Page 18 Page 19 Page 20 Page 21 Page 22 Page 23 Page 24 Page 25 Page 26 Page 27 Page 28 Page 29 Page 30 Page 31 Page 32 Page 33 Page 34 Page 35 Page 36 Page 37 Page 38 Page 39 Page 40 Page 41 Page 42 Page 43 Page 44 Page 45 Page 46 Page 47 Page 48 Page 49 Page 50 Page 51 Page 52 Page 53 Page 54 Page 55 Page 56 Page 57 Page 58 Page 59 Page 60 Page 61 Page 62 Page 63 Page 64 Page 65 Page 66 Page 67 Page 6862 msfocusmagazine.org Medicine & Research The Thirteenth Kid on the Block – By Ellen Whipple, Pharm.D. In May, the FDAapproved Biogen’s Zinbryta (daclizumab), adding another disease- modifying therapy to the MS toolbox. It is administered subcutaneously as a 150 mg, once-monthly injection. Zinbryta – the thirteenth approved disease-modifying treatment for the relapsing forms of MS – is a humanized monoclonal antibody. Monoclonal antibodies are laboratory-created proteins that bind to specific substances in the body. According to Dr. BenThrower, medical director of the MS Institute at the Shepherd Center, Zinbryta has a very unique mechanism of action, affecting a molecule that plays a role in mediating the immune system. Dr.Thrower explained that “Zinbryta antagonizes a subunit of interleukin-2 (IL-2) on activated lymphocytes, thereby inhibiting CD25-IL-2 complex formation. This is important for patients with MS because abnormal CD25- IL-2 complexes are common in the disease.” The FDA approved Zinbryta based on data from the Phase III, DECIDE trial. Data from this trial were originally presented at the European Committee for Treatment and ResearchinMultipleSclerosis2015conference, and later published in the New England Journal of Medicine. The DECIDE trial was a two-to-three-year trial that evaluated whether Zinbryta would provide improved efficacy to Avonex (beta-interferon 1a, Biogen).The studyenrolled more than 1,800 patients with relapsing- remitting multiple sclerosis (RRMS). At week 96 of the trial, 73 percent of patients treated with Zinbryta were relapse-free compared to 59 percent of Avonex-treated patients. Zinbryta also significantly decreased the number of new or newly enlarging T2- hyperintense lesions, with a 54 percent reduction relative to Avonex at week 96. In addition, the risk of significant disease progression was less with Zinbryta compared with Avonex. The overall occurrence of adverse events was comparable across the Zinbryta and Avonex treatment groups. In patients treated with Zinbryta, there was an increased risk of developing serious infections, adverse skin effects (including some serious reactions), and elevated liver enzymes. Zinbryta contains a boxed warning regarding risk of liver problems and immune-mediated disorders (e.g., skin reactions, lymphadenopathy, non- infectious colitis). Because of these safety concerns, anyone prescribed Zinbryta is required to participate in a Risk Evaluation and Mitigation Strategy (REMS) program. The table on the next page summarizes the pertinent information regarding the Zinbryta REMS program. RX Update