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Dr. Obeidat:
Hello. This is CME on ReachMD. I am Dr. Ahmed Obeidat. Joining me today is Dr. Mark Freedman.
Mark, what do you tell us about managing MS in special populations?
Dr. Freedman:
This is a great question because all our information comes from clinical trials. So what do you with those people? And what we’ve learned is really coming from some of the long-term safety data that was reading out after the drug was released, and people collected this in these special populations. And it's important to highlight that these particular populations have, perhaps, risks that the groups that were in the clinical studies never had, and so we don't know what some of the treatment effects will be. So we have to tread with a little bit of caution. That’s especially true, of course, in the pediatric group where very few studies have ever been done. There’s only been a couple of drugs that were actually properly tested in the pediatric population, but most of the other drugs are actually used. And we get this data from safety information as it comes out to us.
Same thing is true for some of the comorbidities which we know, and some of them that we don't know may be putting patients at higher risk for problems. But we also don't know about the efficacy of the drugs. We know that they’re very efficacious in that group in the 20s, 30s, and 40s, but there's a thought that as the patient ages, there's immunosenescence and other factors that come into play that maybe the drugs aren't as effective, and so why put the patients at risk? These are the things that come out of the questions of the use of these medications that we have today in the special groups.
Dr. Obeidat:
Yeah. So great points. There are several unmet needs. You identified unmet needs in the pediatric population; you identified unmet needs in people who are older with MS. The drugs are tested in mostly younger populations, and then when they become approved and people are using them, we are using them, I’m using them, and people are older than the populations studied. So are they effective? Are they safe in that population? This is where there’s a big need for many of these studies to actually be conducted.
How about people with advanced MS? People who maybe are not able to walk or are using a walker to walk. They’re mostly excluded from studies, and that's something that, you know, this population exists, and they ask us for treatment. We think about treatment for them, and what your thoughts on this population?
Dr. Freedman:
This is why a lot of insurers will actually stop paying for the medication once either the patient reaches a certain age or a certain disability level. And this is a problem because, just because they can't walk, they have problems with their eyes, they have problem with their hands, the disease could still advance, and we have to fight like crazy to try to get medications for them but we don’t know if they actually work. And nobody's going to do a clinical study in an EDSS of 7 and 8, although some of these have been tried. It’s just been too difficult to get patients for them. So there’s a lot of unknowns in these groups of people.
We need a study that could probably address some of this, no?
Dr. Obeidat:
Yeah, yeah, yeah, yeah, exactly. And people are trying. There is one study called the Chariot-MS clinical trial. They’re trying to study the medication cladribine in people with advanced MS and focusing on hand function. And that's one of the things that you mentioned is people, even though they cannot walk, they still need to use their hands. They still need to see, right? So why to exclude people from being on a treatment? So there are some efforts to try to study, but definitely there are very few efforts. Very limited. You can count them on fingers, right? Versus all the trials kind of excluding this population just for maybe the ease of analysis. Right? One of the things is, because what outcome you're going to look at is EDSS and the EDSS in people in a wheelchair is not going to change much. And that's what it comes from.
That's really, really great discussions. It’s a brief discussion, but it's a really great discussion and I learned a lot from it. And I hope we gave the audience something to think about. And thanks for tuning in.
Dr. Freedman:
Thank you, Ahmed.
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