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Timothy L. Vollmer, MD
Department of Neurology
University of Colorado Health Sciences Center Professor

Co-Director of the RMMSC at Anschutz Medical Center

Medical Director-Rocky Mountain MS Center
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Multiple Sclerosis Institute
Center for Neurological Disorders

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Weill Medical College of Cornell University

Clinical Attending in Neurology,
New York-Presbyterian Hospital
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Department of Neurology
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From Vancouver, an Update on MS: VIDEO

Dr. Robert Fox and Dr. Stephen Krieger

Long-term Follow-up of Clinical Trials

Stephen Krieger, MD: Hello. I'm Dr Stephen Krieger, associate professor of neurology at the Icahn School of Medicine at Mount Sinai in New York. Today I'm at the American Academy of Neurology 2016 Annual Meeting in Vancouver with Dr Robert Fox, staff neurologist at the Mellen Center for Multiple Sclerosis at Cleveland Clinic. Welcome, Dr Fox.

Robert Fox, MD: It's great to be here with you.

Dr Krieger: Let's talk about the 2016 Annual Meeting, particularly around multiple sclerosis (MS). What do you think some of the exciting or emerging trends are in MS that we've seen here at the meeting?

Dr Fox: There were a couple different areas. One was long-term follow-up of many of our phase 3 and phase 4 clinical trials. Many of our therapies for relapsing MS are relatively new to people, and we only have a couple of years of experience with them when they come out on the market. It's important for us to get longer-term experience, and we are now getting more of that. Many of the drugs presented long-term data from 5, 7, even upwards of 11 years. Reassuringly, there was very good safety and there weren't many new safety problems that were identified in these long-term follow-ups.

Dr Krieger: For a long time, we've had our old-school injectable medicines and a cohort of new drugs. Now we're starting to see maturing data for all of them—the orals as well as some of the more recent infusion medicines—with extension data showing that the efficacy can be maintained in a great number of people when treated long-term. As you said, safety has to be looked at carefully. We've seen safety signals emerge in clinical practice during these past couple of years, including rare risks of progressive multifocal leukoencephalopathy (PML) with several of our medicines.

Dr Fox: That's true, and fortunately, although we have seen those new safety signals over the past several years, they've remained very rare. For example, PML with dimethyl fumarate and fingolimod remains in the 1:15,000 to 1:20,000 range. It's not zero, but it's certainly reassuring that these are very rare complications.

Risk Stratification

Dr Krieger: Another theme that we're starting to see is better ways of risk-stratifying our patients and better biomarkers in general, like the JC antibody. We'll see more of that to be sure in the coming years, but allowing us to pick medicines better for our patients and ensure their safety in the long term is where I think the MS field is going.

Dr Fox: Yes, we are learning a little bit more about risk stratification. Intriguing data regarding natalizumab and PML suggest that weight is a risk factor; lighter-weight patients who might receive a higher total dose of the drug or dose per kilogram may be at a little bit of an increased risk for PML. It used to be said that you can't be too rich or too skinny, but it may be that you can be too skinny with this drug.

Dr Krieger: It's true. Why are the rates of PML higher in Europe than they are in the United States? Body weight may play a role.

Dr Fox: The more we learn about risk stratification, we can identify patients who are at increased risk and who should consider alternative therapies, and identify those who are at lower risk and who can be more comfortable continuing therapies longer-term. That will really help us guide patients toward the right therapy.

Story Source: The above story is based on materials provided by MEDSCAPE
Note: Materials may be edited for content and length


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