Multiple Sclerosis is a chronic neurological disease that causes damage to the myelin (the fatty substance that surrounds nerve fibers) in the central nervous system, resulting in a disrupted flow of information within the brain and between the brain and body.
There are currently approximately 1 million people in the U.S. with MS who will experience some level of disability, and there is no cure.
We do not know the cause of this unpredictable disease. However, it is thought to be the result of genetic, environmental, and infectious factors that cause the body’s own immune system to attack the central nervous system and cause neurological damage.
It is undeniable that this disease can be devastating, and there is still a lot of work to be done to find a cure and help those living with MS.
Thankfully, researchers are working hard to make progress, and this CHIMES clinical trial is focused on making significant progress for minority populations battling MS.
During the past decades, this destructive disease was thought only to affect a particular population — namely Caucasian people of Northern European descent. Within that population, women were at a much higher risk.
However, more recently, experts are learning more about this condition, its impact, and perhaps more importantly, how it affects patients.
One of the most important discoveries made in recent years has been the extent to which this condition affects minority communities, especially African American and Latino populations, and research suggests that the disease progresses more aggressively among these groups.
The good news is that experts and neurologists are learning more about this disease every day, and those discoveries are getting us closer to effective treatments and, hopefully, one day, a cure.
According to Dr. Lilyana Amezcua, Associate Professor of Neurology at the University of Southern California Keck School of Medicine, there’s new hope for MS patients.
Although disease is never a good thing, “this is a really good time to have MS,” she explains. With several effective treatments available and innovative research ongoing to support advances in medicine and prevention, things are looking up for people impacted by Multiple Sclerosis.
CHIMES — which stands for Characterization of ocrelizumab In Minorities with Multiple Sclerosis — is a first-of-its-kind clinical trial exclusively focused on minorities living with multiple sclerosis, specifically Black and Latino populations. And this work is more important than ever.
Even though this disease tends to take a more severe course and progresses faster in African Americans and Latinos with MS, minorities are vastly underrepresented in most clinical trials.
We sat down with Dr. Amezcua to learn more about what MS is, how it works, who is at risk, and her inspiring work on the CHIMES study, which is dedicated to learning more about how experts can meet the needs of self-identified Hispanic/Latino-Americans living with multiple sclerosis (MS).
Can you give us a quick explanation of what Multiple Sclerosis is and how this disease progresses and causes disability?
In simple form, Multiple Sclerosis (MS) is an immune-mediated disease that affects the brain, spinal cord, and eyes, and where the covering, what we call myelin, or the nerve fibers underlying the myelin, get destroyed.
Over time, with the development of these scars — and that’s why we call it Multiple Sclerosis, meaning multiple scars across the central nervous system — one can develop disability such as difficulty walking, sensory changes, vision changes, blindness, bladder fatigue, and a wide range of issues including mental health issues.
Commonly MS starts right around when you’re trying to get to be who you are; in young adulthood, between 20-40 years old is the most common time. And you do see a female predominance. Males do get it, but females get it at a much higher rate, at a 3 to 1 ratio.
Unfortunately, we don’t know the cause, but we do know that multiple environmental triggers can basically cause the disease to develop, but you do have to have a genetic predisposition.
We call it immune-mediated because, with MS, your body develops active cells that are basically contributing to the destruction of myelin and nerve fibers.
Recently, we are learning that this disease does, in fact, affect minorities, and it seems to progress more aggressively among minority populations, including African Americans and Hispanics. Why do you think this is the case?
That is correct; we’ve understood for 100 years or so that the most common background to get MS is white, Northern European descent. And in fact, when we look at the world distribution of MS, you still see the northern latitude is where a lot of white Northern European descent resides, and so these areas are where you see the heaviest prevalence of cases.
But over the years, we’ve seen changes, particularly here in the United States. A study about seven years ago looked at the incidence rates and the number of new cases by race and ethnicity in the US. They looked at African Americans, Hispanics, Asians, and whites, and they calculated how many new patients were coming up.
What they found, which was astonishing, was that African Americans were almost twice as likely as whites to develop MS, and they were growing at a higher rate. And this was a new concept that was displacing what we previously thought — that African Americans were at half the risk of getting MS.
So that prompted experts to want to understand better why we are now seeing MS in minorities, or maybe it has been there, and we just have not looked at it carefully enough. And you have to understand that regarding the number of MS cases in the US, the prevalence, we have very little understanding of that. We were just able to calculate that there are close to 1 million people living with MS here in the United States, and there are likely more because we just don’t have the correct registries for it.
Why do we know so little about how MS uniquely impacts people of color and other minorities?
As far as why we think we see more cases in minority populations, we don’t really know. There are several possible reasons — likely because these populations have not been studied in terms of MS.
We did a review in 2014 looking at the MS literature in terms of race and ethnicity, and we found that only 1 percent was dedicated to minorities or cohorts that are non-white. So that tells you that we just know little. Now, the other reason is that we have a problem with participation.
Nevertheless, we now are seeing some changes. And it’s important to understand MS by looking at different groups because African Americans and Hispanics do progress more aggressively compared to what we typically know of whites with Multiple Sclerosis.
So, we need to understand better why, what are those factors? Are they environmental? Are they genetic? Or are they really just related to social deterrence of health? Do these minority populations have access to a neurologist? Do they have access to the treatment they need, which can be quite expensive? We’re talking about drugs that are on average $65,000 a year or more. And even health literacy — Hispanics and African Americans know well what diabetes and high blood pressure might be. Still, diseases like MS, if it has not been in that population, then it’s less likely for them to know about MS or know what symptoms to look for.
In different groups, symptoms are perceived differently. In some populations, sensory issues might be totally looked over. And we do see differences in their presentation of symptoms in different ethnic groups.
One of the things we do see is that Hispanics, for example, they present with MS at a much younger age compared to whites, and they are more likely to present with visual loss or inflammation of the optic nerve. And we’ve done huge studies where we’ve looked at the issue of presentation and the issue of what may be behind those differences in presentation, which may be genetic.
African Americans are more likely to have a lot more rapid progression of what we call brain atrophy or loss of tissue of the brain. So, there are differences that we need to try to address and learn what the drivers are behind those differences. We need to consider if there are other issues we’ve been missing in the past. What we’ve seen is telling us that perhaps there are differences in recovery, so is it a recovery issue? Or is it biological? Or are there other issues that are outside of biology and are social – did they start treatment as early as a white individual with the same presentation? It’s about the access and utilization of care.
Tell us about the CHIMES study. In the simplest terms, what is the purpose of this study, and where are you now in terms of the trial’s current phase and findings to date?
One important fact is that despite MS now having over 20 treatments to choose from to treat your MS, minorities were vastly underrepresented in clinical trials.
We’re able to see that within all of these treatments, including the drug we are looking at in CHIME, the average representation of minorities in those studies was less than 10 percent. So, our current management of MS has been based on data that works for whites primarily.
CHIMES represents a really unique clinical trial where we are trying to better understand the current efficacy that we know of and the safety of one of the B cell depleting drugs that we have, which is ocrelizumab, both in African Americans and Hispanics with relapsed MS.
What is different about this clinical trial is that it is unique by design in that it has integrated various stakeholders. So when we’re developing a proposal or a protocol or a clinical trial, you typically have the input of scientific experts and sponsors. In this case, it also included advocacy groups for Multiple Sclerosis and patients with the background of African American or Hispanic.
The goal is for patients to give input in terms of what has been contributing to low minority participation and what we can do with this clinical trial to make sure that we are meeting our patients’ needs. So, we don’t want just to investigate the safety and efficacy of ocrelizumab; we also want to better understand their understanding of MS, their quality of life, and, importantly, the biology — so what exactly is happening on a biological level?
There was some observational data to support that these minority groups may need to have much more effective therapies, more highly effective treatment. We will be looking at their cellular immunity and genetic components of the disease. And of course, the most important is to promote greater access to treatment and enhance the quality of care through clinical research.
How do you hope this CHIMES clinical trial could change the course of this disease, particularly among the Latino and black communities?
This is a complex disease that requires special care. We know that minorities are 30-40 percent less likely to have a neurologist. And with this disease, you need a neurologist to care for MS.
Our study provides focused disease insights to provide better-tailored care to self-identified African American and Hispanic/Latino-Americans people with MS. We’re also minimizing the possible socioeconomic barrier that we see with African American and Latino populations because this CHIMES study is actually providing an already FDA-approved drug to them for free through the trial.
The trial is enrolling currently. There are multiple sites throughout the US. If an individual is interested, all they have to do is contact us. We will connect with their provider to get what we need from their medical records and get them screened appropriately for the clinical trial. Because this is an already approved drug out in the market, this trial is a 12-month trial, and patients can go into a second-year extension.
We hope to get results 12 months from now and have some preliminary data to work with.
This is the time, if ever, to have MS because there is good treatment.
It is important to note that timing is everything. The earlier you start treatment, the more hopeful the outcome will be. Timing, treatment, and care are all really important.