Poster
160
(#160) Valbenazine Improves Physical, Social, and Emotional Impacts on the Tardive Dyskinesia Impact Scale (TDIS): Post Hoc Analyses of KINECT-PRO Data
Psych Congress 2025
Abstract: Introduction: The Tardive Dyskinesia Impact Scale (TDIS) is the only psychometrically validated patient-reported outcome (PRO) that measures the physical, social, and emotional impacts of tardive dyskinesia (TD). To better understand the effects of valbenazine on TD impacts, TDIS data from the KINECT-PRO study were analyzed post hoc.
Methods: Study participants received 24 weeks of open-label treatment with valbenazine (40, 60, or 80 mg, once-daily). The TDIS includes 11 items organized into 6 scales: Mouth/Throat Function (3 items), Dexterity (2 items), Mobility (2 items), Emotional (2 items), Pain (1 item), and Social (1 item). Item scores range from 0 (no impact) to 4 (most impact). For each TDIS item, mean changes from baseline (CFBs) were analyzed at all post-baseline visits.
Results: At baseline, the highest mean item scores were: embarrassed (2.19), self-conscious (2.09) [Emotional scale]; unwanted attention (1.85) [Social scale]; and mouth noises (1.54) [Mouth/Throat Function scale]. Improvements with valbenazine were observed in all 11 TDIS items, generally increasing over time from Week 4 (first post-baseline visit) through Week 24 (end of treatment). At Week 24, mean CFBs in the most impacted items at baseline were: embarrassed (-1.31), felt self-conscious (-1.24), mouth noises (-0.93), and unwanted attention
(-0.89).
Conclusions: Sustained improvements were observed in all 11 TDIS items, with Emotional, Social, and Mouth/Throat Function items being among the most impacted at baseline and also most improved at Week 24. These results support the use of TDIS to evaluate the effects of treatment on the physical, social, and emotional impacts of TD.
Short Description: The Tardive Dyskinesia Impact Scale (TDIS) is the only psychometrically validated patient-reported outcome (PRO) for tardive dyskinesia (TD). It was one of 3 primary PRO endpoints in KINECT-PRO, which aimed to assess TD impacts, functional impairment, and health-related quality of life in a comprehensive way. Post hoc analyses of TDIS data from KINECT-PRO demonstrated improvements in the physical, social, and emotional impacts of TD in participants who received 24 weeks of once-daily valbenazine treatment.
Name of Sponsoring Organization(s): Neurocrine Biosciences, Inc.
Methods: Study participants received 24 weeks of open-label treatment with valbenazine (40, 60, or 80 mg, once-daily). The TDIS includes 11 items organized into 6 scales: Mouth/Throat Function (3 items), Dexterity (2 items), Mobility (2 items), Emotional (2 items), Pain (1 item), and Social (1 item). Item scores range from 0 (no impact) to 4 (most impact). For each TDIS item, mean changes from baseline (CFBs) were analyzed at all post-baseline visits.
Results: At baseline, the highest mean item scores were: embarrassed (2.19), self-conscious (2.09) [Emotional scale]; unwanted attention (1.85) [Social scale]; and mouth noises (1.54) [Mouth/Throat Function scale]. Improvements with valbenazine were observed in all 11 TDIS items, generally increasing over time from Week 4 (first post-baseline visit) through Week 24 (end of treatment). At Week 24, mean CFBs in the most impacted items at baseline were: embarrassed (-1.31), felt self-conscious (-1.24), mouth noises (-0.93), and unwanted attention
(-0.89).
Conclusions: Sustained improvements were observed in all 11 TDIS items, with Emotional, Social, and Mouth/Throat Function items being among the most impacted at baseline and also most improved at Week 24. These results support the use of TDIS to evaluate the effects of treatment on the physical, social, and emotional impacts of TD.
Short Description: The Tardive Dyskinesia Impact Scale (TDIS) is the only psychometrically validated patient-reported outcome (PRO) for tardive dyskinesia (TD). It was one of 3 primary PRO endpoints in KINECT-PRO, which aimed to assess TD impacts, functional impairment, and health-related quality of life in a comprehensive way. Post hoc analyses of TDIS data from KINECT-PRO demonstrated improvements in the physical, social, and emotional impacts of TD in participants who received 24 weeks of once-daily valbenazine treatment.
Name of Sponsoring Organization(s): Neurocrine Biosciences, Inc.
