Poster
152
(#152) Once-Daily Valbenazine Improves the Impacts and Symptoms of Tardive Dyskinesia Regardless of Psychiatric Diagnosis: Results From the Phase 4 KINECT-PRO Study
Psych Congress 2025
Abstract: Introduction: Once-daily valbenazine is approved for the treatment of tardive dyskinesia (TD). KINECT-PRO is the first clinical trial of an approved TD medication to assess and report TD impacts, functional impairment, and health-related quality of life (HRQoL) using multiple validated patient-reported outcomes (PROs).
Methods: KINECT-PRO included: 4-wk treatment with valbenazine 40 mg; 12-wk continuation with 40 mg or increase to 60 or 80 mg; 8-wk stable dosing with 40, 60, or 80 mg. Participants had mild-to-severe TD severity and mild-to-severe associated distress. Changes from baseline (CFBs) at Wk24 for 3 PROs were designated as primary endpoints: Tardive Dyskinesia Impact Scale (TDIS, psychometrically validated to measure TD impacts); Sheehan Disability Scale (SDS); and EuroQoL Group's EQ Visual Analog Scale (EQ-VAS). The mean CFB at Wk24 in AIMS total score (secondary endpoint) was also analyzed. Outcomes were analyzed in the overall study population, by psychiatric diagnosis (schizophrenia/schizoaffective disorder [SCHZ] or major depressive disorder/bipolar disorder [MOOD]), and by TD severity (mild or moderate/severe).
Results: Of 59 enrolled participants (SCHZ [n=27], MOOD [n=32], TD-moderate/severe [n=35], TD-mild [n=24]), 76.3% had Wk24 data. Mean CFBs at Wk24 for the PRO primary endpoints and AIMS secondary endpoint were: TDIS (-8.0, -5.8, -9.7 [overall, SCHZ, MOOD]; SDS (social life/leisure activities (-2.3, -1.6, -2.9) and family life/home responsibilities (-1.6, -0.7, -2.3); EQ-VAS (+13.1, +8.3, +17.0); AIMS (-6.8, -5.8, -7.6). Both TD severity subgroups had similar improvements.
Conclusions: Robust improvements in TD impacts, functional impairment, and HRQoL were observed with once-daily valbenazine, regardless of psychiatric diagnosis or TD severity.
Short Description: Once-daily valbenazine is approved for the treatment of tardive dyskinesia (TD) and Huntington's disease chorea. KINECT-PRO is the first clinical trial to assess and report the effects of an approved TD medication in a comprehensive way. It was designed to include 3 patient-reported outcomes (PROs) as primary endpoints and subgroups categorized by psychiatric diagnosis or TD severity. This 24-week study demonstrated robust improvements in TD impacts and TD symptoms, both overall and in all subgroups.
Name of Sponsoring Organization(s): Neurocrine Biosciences, Inc.
Methods: KINECT-PRO included: 4-wk treatment with valbenazine 40 mg; 12-wk continuation with 40 mg or increase to 60 or 80 mg; 8-wk stable dosing with 40, 60, or 80 mg. Participants had mild-to-severe TD severity and mild-to-severe associated distress. Changes from baseline (CFBs) at Wk24 for 3 PROs were designated as primary endpoints: Tardive Dyskinesia Impact Scale (TDIS, psychometrically validated to measure TD impacts); Sheehan Disability Scale (SDS); and EuroQoL Group's EQ Visual Analog Scale (EQ-VAS). The mean CFB at Wk24 in AIMS total score (secondary endpoint) was also analyzed. Outcomes were analyzed in the overall study population, by psychiatric diagnosis (schizophrenia/schizoaffective disorder [SCHZ] or major depressive disorder/bipolar disorder [MOOD]), and by TD severity (mild or moderate/severe).
Results: Of 59 enrolled participants (SCHZ [n=27], MOOD [n=32], TD-moderate/severe [n=35], TD-mild [n=24]), 76.3% had Wk24 data. Mean CFBs at Wk24 for the PRO primary endpoints and AIMS secondary endpoint were: TDIS (-8.0, -5.8, -9.7 [overall, SCHZ, MOOD]; SDS (social life/leisure activities (-2.3, -1.6, -2.9) and family life/home responsibilities (-1.6, -0.7, -2.3); EQ-VAS (+13.1, +8.3, +17.0); AIMS (-6.8, -5.8, -7.6). Both TD severity subgroups had similar improvements.
Conclusions: Robust improvements in TD impacts, functional impairment, and HRQoL were observed with once-daily valbenazine, regardless of psychiatric diagnosis or TD severity.
Short Description: Once-daily valbenazine is approved for the treatment of tardive dyskinesia (TD) and Huntington's disease chorea. KINECT-PRO is the first clinical trial to assess and report the effects of an approved TD medication in a comprehensive way. It was designed to include 3 patient-reported outcomes (PROs) as primary endpoints and subgroups categorized by psychiatric diagnosis or TD severity. This 24-week study demonstrated robust improvements in TD impacts and TD symptoms, both overall and in all subgroups.
Name of Sponsoring Organization(s): Neurocrine Biosciences, Inc.
