Transcript
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Dr. Moody:
Hello, I'm Dr. Melissa Moody, and with me today is Dr. Tracy Hicks. Today we'll review presented clinical data from recent congresses and talk about the implications to practice.
Tracy, can you tell us about the post hoc analysis from KINECT-PRO?
Dr. Hicks:
So KINECT-PRO, which is patient-reported outcomes, PRO, is the first clinical trial to assess and report the effects of an improved TD medication, valbenazine, on quality of life using multiple validated patient-reported outcomes, or PROs.
So there are three important points to consider. So the first point: patients with tardive dyskinesia reported improved quality-of-life scores and met TD remission criteria with once-daily valbenazine in KINECT-PRO regardless of TD movement severity at baseline.
At week 24, mean change from baseline indicated improvements across all outcomes. So overall, 57.8%, or 26 out of 45 of participants, met the AIMS remission threshold at week 24. The PRO and AIMS improvements were observed in both psychiatric-diagnosis subgroups.
Second point: valbenazine improves physical, social, and emotional impacts on the TDIS scale. The objective of this post hoc analysis was to provide more detailed insights into the impact of TD by focusing on change in individual items from the TDIS, the only PRO specifically developed and psychometrically validated to measure the physical and socio-emotional impacts of TD.
Awareness of dyskinetic movements with mild-to-moderate associated distress, AIMS Item 10, with the results being the mean TDIS item scores at baseline showed impact across all conceptual scales, with the largest impacts in emotional, social, and mouth/throat function scales. The percentage changes from baseline indicated that the participants experienced substantial improvements across all 11 TDIS items.
So these data, in conjunction with the substantial improvements found in the primary PRO, or patient-reported outcome, endpoints, and secondary AIMS endpoints, show valbenazine to be the first VMAT inhibitor to demonstrate robust improvements in quality of life, functionality, and TD improvement in patients with TD.
Our third and final point: real-world use of deutetrabenazine reduces tardive dyskinesia severity and improves quality of life. The IMPACT-TD registry is an ongoing phase 4 study including 611 adults with an AIMS score of greater than 2 or greater than or equal to 1 item on the AIMS and probable TD, or alternatively, who were receiving VMAT2 inhibitor therapy for TD at enrollment. Participants newly treated with deutetrabenazine for TD had meaningful reductions in abnormal movement severity similar to those seen in the pivotal randomized controlled trials.
So the KINECT-PRO reminds us to individualize treatment by looking beyond movement severity alone and considering how TD affects a patient's daily functioning, emotional well-being, and overall quality of life. The TDIS also gives us a more patient-centered view of TD by helping us identify how symptoms affect social, emotional, and physical functioning, which can guide more person-centered treatment decisions.
Dr. Moody:
Wow, Tracy, that was such great information.
Do you think that that information is going to change the way that you approach your treatment clinically for your patients?
Dr. Hicks:
Absolutely, Melissa. I'm a believer in person-centered care, and I think having these findings, the KINECT-PRO information, helps us to hear the patient's point of view and know how to individualize patient care.
Dr. Moody:
Thank you so much for that. I think we're out of time. This has been a great discussion. Thank you for listening.
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