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New treatment for secondary progressive multiple sclerosis on horizon

U-M leads worldwide MS clinical trial

Multiple sclerosis (MS) is a major autoimmune disease that causes inflammation of the insulating
membranes (myelin) that surround the nerves within the central nervous system. MS onset is generally at the prime of life, between ages of 15 and 45. More than 500,000 people in the U.S. have MS, and there are 10,000 new cases every year. The University of Michigan Health System is actively involved in finding newer, better treatments for MS—and its related diseases.xray blog

As a physician and researcher in the area of multiple sclerosis (MS), I am often asked if there are new treatments and medications on the horizon. Thanks to years of research, the answer is yes, and I’m pleased to say that the University of Michigan is a major leader in some of the most important issues surrounding MS today. We’re trying to find the links between MS and other autoimmune diseases. We’re also conducting a new clinical trial and mechanistic study that may uncover a new treatment for secondary progressive MS. Approximately 85% of patients with newly diagnosed MS have relapsing-remitting MS . About 10-15 years after diagnosis, 50% of these patients will develop secondary-progressive MS , which is associated with significant disability. Finding a new treatment for this large group of people will make a significant impact on people’s lives. We’ve recently been given the tools to combat a disease that is a leading disabler of young adults.

Basic and clinical research

Early in 2014, U-M received two Autoimmunity Centers of Excellence (ACE) Awards: one for clinical and one for basic research. The Autoimmunity Centers of Excellence (ACE) is sponsored by the National Institute of Allergy and Infectious Diseases, a branch of National Institutes of Health. The ACE awards are given out every five years and we are the only institution in the U.S. to be awarded both. The ACE program enables collaborative basic and clinical research across scientific disciplines to identify effective treatments for autoimmune diseases. ACE enhances the interactions between scientists and clinicians to speed up the translation of research findings into medical applications. This is a huge opportunity for the departments of Neurology and Rheumatology and the graduate programs in Immunology and Neuroscience to collaborate with other top researchers on the most crucial questions concerning autoimmune disease.

U-M ACE Clinical Trial

The U-M Clinical ACE links experienced researchers in MS, scleroderma, diabetes, rheumatoid arthritis and autoimmune thyroid diseases, who are exploring the related yet distinct mechanisms of target organ damage in these conditions. A huge project like this could unlock the secret to why these diseases happen—and how we can stop them or even reverse their damage.

The main ACE Award Clinical project is a clinical translational research study called “Mechanistic Studies of Phase III Trial with BAF312 (Siponimod) in Secondary Progressive Multiple Sclerosis.” The parent study, EXPAND (EXploring the efficacy and safety of siponimod in PAtients with secoNDary progressive multiple sclerosis), is a Phase III clinical trial sponsored by Novartis Pharmaceuticals involving more than 300 centers around the world. It is the largest secondary progressive MS trial that has ever been conducted and will include nearly 1,600 subjects worldwide. Phase III trials confirm a drug’s effectiveness and safety before it is available to the public. Utilizing the EXPAND clinical trial, our study is the first in-depth neurological study of its kind for MS and involves a unique collaboration among 19 US academic centers, Novartis and the National Institutes of Health.

Since 2010, we have seen a number of treatment breakthroughs with the oral drugs fingolimod, teriflunomide and dimethyl fumarate, and the potassium channel blocker dalfampridine, which improves nerve conduction. While all of these medications may work for early relapsing remitting MS, they do not mask everyone’s symptoms entirely nor do they work on progression. We’re hoping that siponimod (BAF312) will be the answer to a lot of questions surrounding progressive MS disease course—the mechanics, if you will, of the disease. Even if therapy doesn’t work–and I hope that it does–we will learn how to do progressive MS trials and which biomarkers work, so future trials will know what outcome measures to use.It may even unlock the answers to similar mysteries with other, linked autoimmune diseases.

Managing the symptoms of MS

In addition to treatments specific to MS, we must also remember that we now have much better ways of managing the symptoms of MS. We have medications for fatigue, depression, spasticity, bladder and bowel problems, sexual dysfunction, pain and cognitive impairment. These have all come about as the result of research—and through the generosity of patients who are willing to participate in clinical trials.

The Complete Team

Here at the University of Michigan Health System, we often talk about our team—the physicians, scientists, nurses and health professionals—who come to work every day hoping to make the lives of our patients and families better. We also never forget about the other members of our team: Our patients who have generously done their part to further science.

We’re doing research for our patients, but we couldn’t do it without them.

Take the next step:

Learn more about the NIH ACE study here.

Find a U-M Health System specialist in MS.

Learn about Dr. Mao-Draayer’s work here.

Contact research coordinator Courtney Graft at (734) 763-2211 or Catherine Dowling (734) 764-8971

yang boilerYang Mao-Draayer, M.D., Ph.D., is associate professor, Neurology, and director of neuroscience research in the Autoimmunity Center of Excellence Multiple Sclerosis Center/Holtom-Garrett Neuroimmunology Program. She completed medical school at the Capital Institute of Medicine in Beijing, China, and received her doctoral degree from the University of Iowa. She also completed a residency in neurology and a fellowship in multiple sclerosis/neuroimmunology at the University of Vermont College of Medicine. She joined the U-M Multiple Sclerosis Program at U-M in 2012. A specialist in MS and other central nervous system inflammatory diseases, she is the director of the EXPAND clinical trial mechanistic study and designed the NIH ACE clinical protocol AMS04 with David A. Fox, MD, professor of Internal Medicine and chair of Rheumatology and the overall PI of the ACE.

 

HS_150x150_BLOG.fwThe University of Michigan Health System’s Multiple Sclerosis Center, part of the University of Michigan’s Department of Neurology, has highly skilled specialists with the experience to handle the most complex multiple sclerosis cases. Our center is accredited as a Center for Excellence by the National Multiple Sclerosis Society. Working closely with a multidisciplinary team of experts, we effectively treat all issues that can play a part in multiple sclerosis. For more information, go to: http://www.uofmhealth.org/medical-services/brain-neurological-conditions/multiple-sclerosis