VALBENAZINE IMPROVES PHYSICAL, SOCIAL, AND EMOTIONAL IMPACTS ON THE TARDIVE DYSKINESIA IMPACT SCALE (TDIS): POST HOC ANALYSES OF KINECT-PRO™ DATA
Author(s)
Eduardo Dunayevich, MD1, M. Mercedes Perez-Rodriguez, MD, PhD2, Robert Farber, PhD1, Ashok Parameswaran, MD1, Michelle Turner, MS3, Morgan Bron, MS, PharmD1, Ericha Franey, PhD1, Donna Sparta, MS1, Sara Gao, MS1, Justin Nedzesky, MS, PharmD1, Susan D. Mathias, MPH3, Christoph U. Correll, MD4;
1Neurocrine Biosciences, Inc., San Diego, CA, USA, 2Icahn School of Medicine at Mount Sinai, New York, NY, USA, 3Health Outcomes Solutions, Palm Beach Gardens, FL, USA, 4The Zucker Hillside Hospital, Glen Oaks, NY, USA
1Neurocrine Biosciences, Inc., San Diego, CA, USA, 2Icahn School of Medicine at Mount Sinai, New York, NY, USA, 3Health Outcomes Solutions, Palm Beach Gardens, FL, USA, 4The Zucker Hillside Hospital, Glen Oaks, NY, USA
OBJECTIVES: The Tardive Dyskinesia Impact Scale (TDIS) is the only patient-reported outcome (PRO) measure specifically developed and psychometrically validated to measure the physical, social, and emotional impacts of tardive dyskinesia (TD). This post hoc analysis of the KINECT-PRO™ study explored responses to TDIS items to understand the pattern of physical, social, and emotional improvements with valbenazine.
METHODS: Participants received 24 weeks of open-label valbenazine treatment (40, 60, or 80 mg, once-daily). The TDIS includes 11 items organized into 6 conceptual scales that assess impact: Mouth/Throat Function (3 items); Dexterity, Mobility, and Emotional (2 items each); Pain and Social (1 item each). Each item assesses TD impacts over the last 7 days and is scored from 0 (no impact) to 4 (most impact). Mean percent changes from baseline for each TDIS item were analyzed descriptively at Week 24.
RESULTS: In 54 participants with available data at baseline, mean (SD) baseline scores in each TDIS conceptual scale were: Emotional (embarrassed 2.19 [1.36], self-conscious 2.09 [1.29]); Social (unwanted attention 1.85 [1.31]); Mouth/Throat Function (mouth noises 1.54 [1.27], speaking 1.15 [1.09], swallowing 0.59 [0.98]); Pain (experienced pain 1.20 [1.22]); Dexterity (writing 1.24 [1.20], gripping objects 0.91 [1.07]); Mobility (balance 0.94 [0.98], walking 0.63 [0.81]). In 45 participants with available data, mean percent changes from baseline at Week 24 indicated a score decrease (improvement) in all 11 TDIS items, ranging from -46.2% (losing balance) to -67.4% (mouth noises). Other items with >60% improvement were difficulty speaking (-63.3%), experienced pain (-61.9%), felt embarrassed (-61.5%), and felt self-conscious (-61.4%).
CONCLUSIONS: Items in the Emotional, Social, Mouth/Throat Function, and Pain scales were among the most impacted at baseline. However, substantial improvements were observed across all TDIS items at Week 24. These findings suggest utility of the TDIS for evaluating treatment-related changes in the physical, social, and emotional impacts of TD.
METHODS: Participants received 24 weeks of open-label valbenazine treatment (40, 60, or 80 mg, once-daily). The TDIS includes 11 items organized into 6 conceptual scales that assess impact: Mouth/Throat Function (3 items); Dexterity, Mobility, and Emotional (2 items each); Pain and Social (1 item each). Each item assesses TD impacts over the last 7 days and is scored from 0 (no impact) to 4 (most impact). Mean percent changes from baseline for each TDIS item were analyzed descriptively at Week 24.
RESULTS: In 54 participants with available data at baseline, mean (SD) baseline scores in each TDIS conceptual scale were: Emotional (embarrassed 2.19 [1.36], self-conscious 2.09 [1.29]); Social (unwanted attention 1.85 [1.31]); Mouth/Throat Function (mouth noises 1.54 [1.27], speaking 1.15 [1.09], swallowing 0.59 [0.98]); Pain (experienced pain 1.20 [1.22]); Dexterity (writing 1.24 [1.20], gripping objects 0.91 [1.07]); Mobility (balance 0.94 [0.98], walking 0.63 [0.81]). In 45 participants with available data, mean percent changes from baseline at Week 24 indicated a score decrease (improvement) in all 11 TDIS items, ranging from -46.2% (losing balance) to -67.4% (mouth noises). Other items with >60% improvement were difficulty speaking (-63.3%), experienced pain (-61.9%), felt embarrassed (-61.5%), and felt self-conscious (-61.4%).
CONCLUSIONS: Items in the Emotional, Social, Mouth/Throat Function, and Pain scales were among the most impacted at baseline. However, substantial improvements were observed across all TDIS items at Week 24. These findings suggest utility of the TDIS for evaluating treatment-related changes in the physical, social, and emotional impacts of TD.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
PCR90
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, SDC: Neurological Disorders