Announcer:
You’re listening to NeuroFrontiers on ReachMD, and this episode is sponsored by Teva Pharmaceuticals. Here’s your host, Ashley Baker.
Ms. Baker:
This is NeuroFrontiers on ReachMD, and I'm psychiatric nurse practitioner Ashley Baker. Joining me to discuss a study she presented at the 2024 Psych Congress Elevate Meeting that assessed the impacts of tardive dyskinesia is Dr. Stacy Finkbeiner, who is the U.S. Medical Director at Teva Pharmaceuticals. Dr. Finkbeiner, welcome to the program.
Dr. Finkbeiner:
Thank you so much. It's a pleasure to be here.
Ms. Baker:
To start us off, Dr. Finkbeiner, can you give us some background information on what led you to conduct this study?
Dr. Finkbeiner:
Yeah, absolutely. TD is actually a really interesting disease state from a historical perspective, so I think it's important to talk through that to really understand why we felt the need to do this study. So TD was first recognized around the 1960s after what we now call first-generation antipsychotics started being used. And as most people know, it's this presentation of irregular movements. And later on, newer generation antipsychotics that we now call second-generation or atypical antipsychotics were introduced a couple decades later in the 1990s. And when those were introduced, it was really with the promise that they didn't cause TD. And certainly, all of the marketing kind of focused on that piece. So a lot of the research that we have was either from those early stages in the 1960s, 1970s, maybe into the 80s. And then there was this large block of time where people really stopped thinking about TD and worrying about it because they thought it wasn't occurring anymore with these newer antipsychotics; people stopped being educated on it, and so there's really a huge gap in research until more relatively recently, in the last 7 to 10 years, when newer treatments started to come into the picture. And that really kind of reinvigorated some of the interest in understanding more about TD.
And even with this renewed interest in TD, most of the focus was still very much on the severity of the movements. And very few people were really talking about how those movements impact individuals. And that's because it's a movement disorder, so people are looking at the movements, and a lot of clinicians really considered it to be more of a cosmetic condition and not as important as the underlying psychiatric health of the individual. So what that means is that we really haven't had a lot of research into the quality of life aspect of TD for our patients. And what does that look like? What are the different ways in which TD can affect individuals? To what extent? And so these were really all of the questions that we felt really needed to be answered.
Ms. Baker:
Now as I understand it, the overall objective was to assess the multidimensional impacts of tardive dyskinesia on patients' lives. So how did you go about achieving that goal?
Dr. Finkbeiner:
Yeah, so we wanted to set this up as an observational study so that we can really follow what happens in real life. And we wanted it to be a large enough study to capture the wide variety of experiences of those living with TD and would also reflect the different sites of care where people typically go for their mental health support. We know that clinical trials often are a little bit more constrained settings; they don't necessarily always have the true diversity of patients that are participating, and so we felt a real-world study would kind of overcome some of these.
So to that goal, we really landed on trying to enroll 600 TD patients into this study, which, to our knowledge, would make it the largest TD study known to date, and substantially larger than any of the studies that have previously been done. And so certainly, that's quite a challenge in and of itself, to set up such a large study and to really try to have it in a variety of clinics around the U.S., so that it really does represent all the different types of patient experiences. But in this case, we also had the added challenge that, as I was describing, there really wasn't a lot known about the impact of TD. And what that meant is that there really weren't tools to assess the impact of TD, and so we really had to start from the ground up in really developing the tools that could actually measure this to help us better understand that.
So today we're really talking about that clinician tool that was developed. And so for that one, the way that we approached this was we brought together a panel of experts. Those included individuals in the psychiatry space, the neurology space, physical therapists, as well as those that have experience specifically in developing scales, to try and put together a tool that could be used to measure the impact and with that patient-to-patient variability that I was talking about.
So the tool that they created is really intended to help any clinician who interacts with someone with TD to really easily be able to assess the impact that the condition has on their quality of life. And the way that they did that is they thought through what are the common ways in which TD affects individuals? And they classified them into four domains of life that can potentially be affected by TD. So those include the physical domain, social, psychological, and then one that's really focused on work or education, or for those that maybe aren't in the workforce anymore, any sort of recreational or volunteer activity that really brings purpose and meaning to someone's life. And for each of those domains, the clinician is then asked to assess all the information that's available to them from the patient, caregiver, or even other providers, and take into account the level at which the movements interfere in daily life, cause distress to the individual, and how frequently either of those are occurring in order to rate the level of impact. And they're asked to do that on a score from 0 to 3, where 0 means no impact and 3 means severe impact.
Ms. Baker:
With all of this in mind, let's turn to the results. What were the key findings?
Dr. Finkbeiner:
So in terms of the key results from this interim analysis, what we're looking at is really the assessment of impact from the clinician perspective using this newly developed scale. And what we're seeing is that when the clinician rates the impact of TD, a large percentage of the individuals, ranging from 80 to 90-some percent, experience some level of impact in some aspect of their life. So for each of these domains, a fair portion, even though the majority of the individuals are actually of more mild severity of the movements, are actually experiencing some level, whether that's mild, moderate, or severe. And then if you focus on more of the individuals that are experiencing moderate to severe impact, we see that ranges from 53 to 70 percent based on the individual domains.
Now the Global Impact Score is a way for clinicians to get kind of a quick snapshot of whether an individual is experiencing the impact of TD, so that they can then decide to have a conversation with the patient. And what we see here is that 98 percent of the individuals in our study for this interim analysis are experiencing some level of impact in some domain, so whether that's mild, moderate, or severe. And then if you hone in on the moderate to severe impact, that's still 83 percent of the individuals that are actually experiencing that high level of impact.
Ms. Baker:
For those just tuning in, you're listening to NeuroFrontiers on ReachMD. I'm psychiatric nurse practitioner Ashley Baker, and I'm speaking with Dr. Stacy Finkbeiner about her study that examined the multidimensional impacts of tardive dyskinesia.
Now, Dr. Finkbeiner, if we take a step back from the study and look at the larger picture here, can you tell us about the role quality-of-life measures play in the treatment of tardive dyskinesia?
Dr. Finkbeiner:
Yeah, I think one of the key things that we're hoping to accomplish with all the work that we're doing is really focusing on the importance of clinicians having conversations with their patients of all the different ways in which TD can affect their life. And what we know historically has been the case is that even if clinicians were talking to their patients about the impact of TD, sometimes they might just say, “Are the movements bothering you?” And the patient might say no. And that sometimes is often a function that the patient doesn't even know that the things that they're experiencing as a frustration or disturbance in their life are even necessarily related to tardive dyskinesia. But I think having quality measures can really help clinicians create some structure and some examples of questions that they can ask the patients to really dig into it further so that the patient is able to really articulate what their true experience is. And that can really inform a more positive and productive conversation between the clinician and the patient to really help the clinician understand what are the different ways in which the individual might be experiencing impact of their TD and to facilitate that conversation around whether treatment is needed.
Ms. Baker:
And before we close, how can the findings from your study influence our approach to managing patients with tardive dyskinesia?
Dr. Finkbeiner:
I think that's a great question, and that was something that the developers of the Impact Scale that was utilized in this study were really very mindful of. They didn't want to create something that sits on a shelf and nobody uses. So the idea here is, it's a tool, people can use it if they find that the structure helps inform their questions, and if they don't pull it out again, that's fine. But what it really does is it creates an opportunity for discussion, and it creates those examples so people can be more mindful of what types of questions or things to observe for those individuals that have TD. You know, the idea was that this could be utilized by anyone who's really interfacing with that patient at some point during the clinical visit. It could also be from a caregiver perspective, or if the front staff or a nurse, a physical therapist, even dentists or other therapists that are dealing with the patient observe something, it's a way to create some framework to provide that feedback to the treating clinician, who then has a much more informed picture of what challenges the individual might be experiencing.
Ms. Baker:
As those final comments bring us to the end of today's program, I want to thank my guest, Dr. Stacy Finkbeiner, for joining me to share the key findings from her study on the impacts of tardive dyskinesia. Dr. Finkbeiner, it was great having you on the program.
Dr. Finkbeiner:
Thank you so much for the opportunity. I really appreciate being able to talk about my research.
Announcer:
You've been listening to NeuroFrontiers, and this episode was sponsored by Teva Pharmaceuticals. To access this and other episodes in our series, visit NeuroFrontiers on ReachMD.com, where you can Be Part of the Knowledge. Thanks for listening!
