Valbenazine Improves Quality of Life, Functionality, and Movement Severity in Patients With Tardive Dyskinesia: Findings From the KINECT-PRO™ Study

Background/Objective: Once-daily INGREZZA ® (valbenazine), a selective vesicular monoamine transporter 2 (VMAT2) inhibitor, is approved for tardive dyskinesia (TD) and Huntington's chorea.KINECT-PRO (NCT05859698) is currently the only study to assess the effects of a VMAT2 inhibitor (valbenazine) on quality of life (QoL) and functionality in patients with TD using multiple validated patient-reported outcomes (PROs).Methods: Adults with mild-to-severe TD movement severity (per Abnormal Involuntary Movement Scale [AIMS] item 8) and awareness of TD with mild-to-severe associated distress (per AIMS item 10) received open-label valbenazine (40, 60, or 80 mg) for 24 weeks.Primary endpoints included changes from baseline (CFBs) at Week 24 in three validated QoL/functionality PROs: Tardive Dyskinesia Impact Scale (TDIS), the only psychometrically validated PRO developed specifically for TD; Sheehan Disability Scale (SDS); and EuroQoL Group's EQ-Visual Analogue Scale (EQ-VAS).Secondary endpoints included CFB in AIMS total score.Results: Substantial and clinically meaningful improvements in patient-reported QoL/functionality and clinician-reported TD severity were observed throughout treatment with valbenazine in the overall study population and regardless of psychiatric diagnosis (mood disorders, psychotic disorders) or TD severity at baseline (mild, moderate/severe).At Week 24 (N=45), mean CFBs were: TDIS (-8.0); SDS Social/Leisure (-2.3); SDS Family/Home (-1.6);EQ-VAS (+13.1);AIMS (-6.8).Previously established minimal clinically important difference (MCID) thresholds for TD were exceeded for TDIS and AIMS.Safety and tolerability were consistent with valbenazine's known profile.