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 3 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.

CONCLUSIONS

KINECT-PRO is the first study of its kind, and valbenazine is the only VMAT2 inhibitor to demonstrate QoL/functional improvements in patients with TD across multiple validated PROs.