Multiple sclerosis is a notoriously complex and difficult neurological disorder to treat, given that it is caused by the patient’s own immune system attacking his or her nervous system, and can manifest in a wide variety of symptoms.
Despite the complexity of auto-immune disorders such as MS, Dr. Michael Racke of The Ohio State University Wexner Medical Center, one of the nation’s leading researchers specializing in treating patients with MS, has been engaged in a study surrounding a new treatment for patients with MS. Racke shared with HealthScene Ohio some information surrounding his current research.
HealthScene Ohio: In brief, how does MS affect the lives of patients who have it?
Dr. Michael Racke: MS is the second most common cause of neurologic disability in young adults in the U.S. after trauma. It can basically affect everything your brain and spinal cord do-- from the motor and sensory function to vision, coordination, and bowel and bladder function. MS can also cause significant fatigue and affect cognitive ability. It used to be that, when someone was diagnosed with MS, that meant they were going to lose about 40 percent of their lifetime earning potential. As treatments have improved, so has the outlook for these patients and their families.
HSO: From a research standpoint, what are the challenges faced with trying to find a treatment for MS?
MR: As with most neurologic illnesses, the brain and spinal cord do not recover well from injury. While the MS field has made a lot of progress in preventing further damage to the brain and spinal cord, we still have a long way to go in helping the nervous system repair itself. To put it another way, we are doing a much better job in keeping younger MS patients from acquiring a disability, whereas we have do not have a treatment to offer the MS patient who has been in a wheelchair for years to get out of that wheelchair.
HSO: What kinds of treatment options are currently out there?
MR: Some treatments, such as interferon-beta and glatiramer acetate, have been around for over 20 years. They offer a safe, injectable way to treat MS. There are now oral therapies – such as fingolimod, dimethyl fumarate, and teriflunomide – which offer convenience, a little better efficacy, but also some risk. Finally, there are infusions, such as natalizumab, alemtuzumab, ocrelizumab, and daclizumab. These agents offer even greater efficacy, but they each have some risks associated with them. Most of the risks are associated with effects on inhibiting the immune response.
HSO: You recently presented at the Consortium of Multiple Sclerosis Centers in New Orleans, where you talked about a new treatment involving stem cell transplants. Will there be more trials in the future?
MR: I presented the rationale for why we should consider autologous hematopoietic stem cell transplants (AHSCT) for MS, including the five-year results of the HALT-MS trial and the plans for the BEAT MS trial, which will be comparing AHSCT to best available therapy for patients with aggressive multiple sclerosis. I will be the overall protocol chair for the BEAT MS trial, and I am very excited to see the potential for this type of treatment for patients with MS.
HSO: In addition to trials, are there any advances in the approved treatments for MS?
MR: Ocrelizumab is the most recent of the approved infusions for multiple sclerosis. Ocrelizumab is a strong anti-inflammatory agent that dramatically reduces relapses and, in primary progressive MS, slows disease progression. One way neurologists evaluate MS treatments is to assess the level of NEDA for a particular time frame. NEDA stands for “No Evidence of Disease Activity” and typically means the patient has not had any relapses, disability progression or new lesions on the brain. In one recent study of ocrelizumab, about 50 percent of MS patients experienced NEDA during the two years of the clinical trial.
HSO: You mentioned that OSU Wexner Medical Center is the main site for studying the effects of ocrelizumab on the immune response in patients with MS. Why is it important to study the immune response of MS patients?
MR: I would say one of the main reasons is to understand what about the treatment produces its efficacy and what can we learn to make the medication safer. For example, one of the major issues with natalizumab is that it can result in a disease called progressive multifocal leukoencephalopathy, or PML, a disease that had never been seen in MS patients before and used to be seen only in AIDS patients or patients on immunosuppression due to cancer chemotherapy or immunosuppression after organ transplantation. If a patient is on natalizumab, when is it safe to switch to them to another treatment if they indicate an increased risk for developing PML? I would also say that we are learning about markers to indicate whether our treatment is really effective in reducing damage to the brain, which might help us to decide to keep someone on treatment early in the course of treatment.
HSO: How does ocrelizumab compare to other possible treatments for MS?
MR: For the FDA-approved treatments, ocrelizumab has the highest evidence of NEDA at two years at 48 percent, followed by 39 percent in the trial for alemtuzumab and 37 percent NEDA in the trial for natalizumab. On the other hand, the most recent trials to use AHSCT in MS had around 70 percent NEDA after five years, which makes this treatment a very exciting potential treatment for patients with MS.
HSO: If ocrelizumab is found to be an effective treatment for MS, what could that mean for MS patients?
MR: I suspect that as other treatments are approved, we may actually see competition help to lower the cost for these medications, which would help with accessibility and affordability of these agents for patients with MS.
Emily Real is a contributing writer. Feedback welcome at feedback@cityscenemediagroup.com.
About the Expert
Neurologist Dr. Michael Racke is one of the nation’s leading researchers specializing in treating patients with multiple sclerosis. In addition to his efforts in treating multiple sclerosis, Dr. Racke also serves on the executive committee of the Consortium of Multiple Sclerosis Centers as well as on the Research Programs Advisory Committee of the National Multiple Sclerosis Society. In June, Dr. Racke presented research at the national meeting of the Consortium of Multiple Sclerosis Centers in New Orleans. Dr. Racke earned his MD at the University of Medicine and Dentistry at New Jersey Medical School and completed his residency at Emory University Hospital.