Poster
158
(#158) Once-Daily Valbenazine Improves the Impacts of Tardive Dyskinesia (TD) in Patients Who Met a Threshold for TD Remission: Post Hoc Analyses of Patient-Reported Outcomes From KINECT-PRO
Psych Congress 2025
Abstract: Introduction: Once-daily valbenazine is approved for the treatment of tardive dyskinesia (TD). KINECT-PRO is the first study of an approved TD medication to assess TD impacts, functional impairment, and health-related quality of life (HRQoL) using multiple validated patient-reported outcomes (PROs). This post-hoc analysis examined PROs in participants meeting a TD remission threshold.
Methods: Participants with mild-to-severe TD severity and awareness with mild-to-severe associated distress (per Abnormal Involuntary Movement Scale [AIMS] items 8 and 10 at baseline) received open-label valbenazine (40, 60, or 80 mg) for 24 weeks. Adapted from Schooler-Kane criteria, TD remission was defined as scoring ≤1 ("minimal" or "none") in all AIMS body regions (items 1-7) at Wk24. In participants meeting this threshold, changes from baseline (CFBs) were analyzed post hoc in 3 validated PROs: Tardive Dyskinesia Impact Scale (TDIS, the only psychometrically validated PRO for measuring TD impacts), Sheehan Disability Scale (SDS, measuring impairment), and EuroQoL Group's EQ Visual Analog Scale (EQ-VAS, measuring HRQoL).
Results: Of 45 participants with available Wk24 data, 26 (57.8%) met the remission threshold. In these 26 participants, mean baseline PRO scores were: TDIS (15.5), SDS social (5.1) and family/home responsibilities (4.1); EQ-VAS (61.8). CFBs indicated increasing improvements from Wk4 (first post-baseline visit) through Wk24. Mean CFBs at Wk24 indicated robust improvements: TDIS (-10.9); SDS social (-3.2) and family/home responsibilities (-2.4); EQ-VAS (+19.3).
Conclusions: Among participants meeting a TD remission threshold after 24 weeks of once-daily valbenazine, PROs indicated continued improvements in TD impacts, functional impairment, and HRQoL, with robust improvements by Wk24.
Short Description: KINECT-PRO is the first clinical trial to specifically assess and report the effects of a VMAT2 inhibitor (valbenazine) on the impacts of TD using multiple validated patient-reported outcomes (PROs). This post-hoc analysis evaluated PROs in participants who met a threshold for TD remission at Week 24, defined as a score ≤1 on all 7 body region items of the Abnormal Involuntary Movement Scale. In these participants, robust PRO improvements were observed at Week 24.
Name of Sponsoring Organization(s): Neurocrine Biosciences, Inc.
Methods: Participants with mild-to-severe TD severity and awareness with mild-to-severe associated distress (per Abnormal Involuntary Movement Scale [AIMS] items 8 and 10 at baseline) received open-label valbenazine (40, 60, or 80 mg) for 24 weeks. Adapted from Schooler-Kane criteria, TD remission was defined as scoring ≤1 ("minimal" or "none") in all AIMS body regions (items 1-7) at Wk24. In participants meeting this threshold, changes from baseline (CFBs) were analyzed post hoc in 3 validated PROs: Tardive Dyskinesia Impact Scale (TDIS, the only psychometrically validated PRO for measuring TD impacts), Sheehan Disability Scale (SDS, measuring impairment), and EuroQoL Group's EQ Visual Analog Scale (EQ-VAS, measuring HRQoL).
Results: Of 45 participants with available Wk24 data, 26 (57.8%) met the remission threshold. In these 26 participants, mean baseline PRO scores were: TDIS (15.5), SDS social (5.1) and family/home responsibilities (4.1); EQ-VAS (61.8). CFBs indicated increasing improvements from Wk4 (first post-baseline visit) through Wk24. Mean CFBs at Wk24 indicated robust improvements: TDIS (-10.9); SDS social (-3.2) and family/home responsibilities (-2.4); EQ-VAS (+19.3).
Conclusions: Among participants meeting a TD remission threshold after 24 weeks of once-daily valbenazine, PROs indicated continued improvements in TD impacts, functional impairment, and HRQoL, with robust improvements by Wk24.
Short Description: KINECT-PRO is the first clinical trial to specifically assess and report the effects of a VMAT2 inhibitor (valbenazine) on the impacts of TD using multiple validated patient-reported outcomes (PROs). This post-hoc analysis evaluated PROs in participants who met a threshold for TD remission at Week 24, defined as a score ≤1 on all 7 body region items of the Abnormal Involuntary Movement Scale. In these participants, robust PRO improvements were observed at Week 24.
Name of Sponsoring Organization(s): Neurocrine Biosciences, Inc.
