Dr. Miravalle, could you please describe the approach and purpose of the Tysabri study?
The Brain Volume study is for people with MS who have been taking Tysabri for at least 2 years. With this study we will measure both clinical and MRI outcomes. In terms of clinical outcomes, we will measure patient reported outcomes (PRO’s) which include questionnaires related to quality of life questionnaires, fatigue, functional capacity, as well as physical exams. In addition, we will do MRIs of the brain to measure patient’s brain volume.
We will compare the patients’ outcomes with outcomes of healthy controls – people without MS, who are same ages and gender distribution as MS patients. We will evaluate two aspects: a) whether there is any significant change in brain atrophy over a period of two years and b) how the rate of brain atrophy in patients on highly effective MS medication compares to the normal aging process in people without MS.
This is the first time that an MS study is looking at comparisons between MS patients and healthy controls. We are trying to understand whether or not the brain atrophy rate in patients who have MS that is controlled and who are receiving highly effective medications normalizes to the brain atrophy rate in the normal aging process. Brain atrophy is a condition in which cells in the brain are lost, or the connections between them are damaged, resulting in decreased brain volume.
How will this research add to what we already know about MS and brain atrophy?
There is a big gap in our understanding of whether if you can control the disease and brain atrophy with highly effective therapies. We don’t know whether the rate of brain atrophy in line with what we expect from normal aging, or if there is still increased brain atrophy despite the use of highly effective treatments. That will be the key question: Can we confidently say that if we actively control the disease process through highly effective medications, the rate of brain volume change in MS patients is equal to someone without MS and normal aging process?
In the progression of MS research, why does this study important?
We are trying to understand what interventions will maximize brain health. The key outcome in MRIs is that one of the stronger negative predictive values for MRIs for future disability is brain atrophy. If patients are losing brain volume, we know that is going to impact their disability over time, their quality of life and their overall brain health. Therefore, having an understanding of how you can positively impact brain atrophy rate is key.
What are the benefits of the medication as a longitudinal assessment of brain atrophy? The fact that enrolled patients have been taking Tysabri for two years allows us to understand that whatever finding you have, you can assume that it’s due to treatment with Tysabri.
What would you say to someone who is thinking about participating in the study and why is their participation important?
We have a unique opportunity to understand how patients’ brain volume is changing over time. And the techniques that we’ll be using in the MRI’s are techniques that are not available in standard of care MRI’s, and insurance will not cover. So if you don’t have these MRI’s conducted in the context of research, you might not have access to that information.
This research will contribute to our understanding of the disease process. The patients will also become the population that will be the ideal outcome in terms of treatment. So if we can show patients that their disease is controlled with DMTs, lifestyle modifications, with exercise, and with activities that actually will maximize lifelong brain health, that will become a new model of care in which every patient should aim to get to that level. With this unique population of patients, we hope to demonstrate demonstrate that with a combination of highly effective drug therapies and other lifestyle strategies, you can maximize your brain health.
If you are interested in participating in this study, please contact Eric Engbretson with the RMMSC at Anschutz Medical Campus to find out if you qualify. Eric’s contact information is below:
Professional Research Assistant
University of Colorado Denver