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Health See other Health Articles Title: New Data, New Drugs, and...a Vitamin for MS? Medscape... A Promising Phase 3 Bruce Cree, MD, PhD, MCR: Hello. I'm Bruce Cree, associate professor of clinical neurology from the University of California, San Francisco. With me is Stephen Krieger, associate professor of neurology at the Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai in New York. Today we will be discussing multiple sclerosis (MS) highlights from the 67th Annual American Academy of Neurology meeting in Washington, DC. What do you find interesting at this meeting? Stephen Krieger, MD: This was a great meeting. We heard a lot of results from research in MS that will be important for us over the coming years. For example, we heard the daclizumab clinical trial results.[1] This was a phase 3 trial, a direct comparison with weekly intramuscular interferon injection. Dr Cree: What did the trial show? Dr Krieger: Daclizumab is a new candidate medicine for MS, with a new mechanism of action. It was superior to interferon in preventing relapses, preventing MRI lesions, and even preventing the accumulation of disability. It was positive on all three of those metrics. Dr Cree: How long was the trial? Dr Krieger: This was a 2-year primary core endpoint trial, a decent-length, robust, phase 3 trial. Dr Cree: What does daclizumab do? What is its supposed mechanism of action? Dr Krieger: We are still learning. It's a monoclonal antibody, given monthly by subcutaneous injection. Daclizumab is a modulator of CD25, which works on interleukin receptors and seems to modulate the immune system through that mechanism. Dr Cree: It has some interesting properties because it seems to induce a type of natural killer cell, the NK56 (bright) cell, which has suppressor activity. Do you think it might work as a biomarker for a therapeutic response? Dr Krieger: That would be something we don't yet have. If we look at these CD56 (bright) cells and gauge whether the mechanism is having the desired biological effect, it could give us the ability to know whether a drug is working or will work without waiting to see in a given patient. Dr Cree: Daclizumab isn't yet approved, and we have heard some of the efficacy data. Were any safety signals associated with this? These days, many MS products have potential risk/benefit considerations that are somewhat different from the days when we started working in MS, when we had only the interferons and glatiramer acetate that were so safe. What are the safety characteristics of daclizumab? Is there anything that we should be looking out for? Dr Krieger: Yes. This is a new mechanism of action, and with anything that works on the immune system in a novel way, we need to take a step back and look at some of the other consequences. Liver function test abnormalities are going to be important here. There were a significant number of elevated liver function tests, including those that crossed Hy's law. Neurologists will have to review Hy's law if this drug is approved. Liver function test abnormalities were twice as common as we have seen with interferon, so we have to monitor those levels. 1 of 3 Next Page Post Comment Private Reply Ignore Thread
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