Since the introduction of disease-modifying therapies for multiple sclerosis (MS), evidence from disease registries has shown how the therapies work in the real world and reduce the effect of MS on people’s lives, according to Daniel Kantor, MD, president of Kantor Neurology.
Since the introduction of disease-modifying therapies for multiple sclerosis (MS), evidence from disease registries has shown how the therapies work in the real world and reduce the effect of MS on people’s lives, according to Daniel Kantor, MD, president of Kantor Neurology.
Transcript
How has the introduction of disease-modifying therapies changed outcomes for patients with MS?
Prior to 1993, we had no disease-modifying therapies that were FDA approved for multiple sclerosis. In 1993 we saw our first medication come out, and what’s happened since that time is an explosion of medications, but also we’ve seen a vast reduction in the way that MS affects people’s lives.
The problem is that we weren’t smart enough back in the early 90s to really study MS carefully in the United States so that we could look at MS now and compare it to MS in the past. What that means is we don’t have an old registry in the United States that collected information about how people did before disease-modifying therapies, when that first generation of disease-modifying therapies came out, and now how we’ve done as more and more medications come out.
They’ve done a better job in Europe and other places globally. But in America we learn from our mistakes, and so we have launched what is now the largest registry in the United States collecting information on people with multiple sclerosis. With that registry, we’re able to look at how people do when they’re on one therapy, how they do when they switch to another therapy, what their reasons for switching are, what their safety concerns are. We collect information prospectively from both the patient as well as from the doctor.
We can do comparative safety studies; we can even do some comparative effectiveness studies. It can give us a better idea of how these medications work in the real world. In a controlled study, in a phase 3 study, we learn a lot about medications, and of course we learn whether the Food and Drug Administration is going to approve them or not, but we don’t know how those medicines work in the real world.
The value of a registry is that we obtain real-world evidence that lets us know how these medications work, not just in a small controlled study, but how they work in thousands of patients across the United States, and that gives us a better idea of how people with multiple sclerosis who don’t meet the strict inclusion and exclusion criteria of phase 3 studies, how those people actually do in the real world and how they do day to day.
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