(#50) Patients Taking Once-Daily Valbenazine Report Improved Quality of Life/Functionality and Experience Remission of Tardive Dyskinesia Symptoms With Once-Daily Valbenazine: Findings From KINECT-PRO™

Abstract: Once-daily valbenazine is approved for tardive dyskinesia (TD), a persistent movement disorder associated with physical, social, and emotional impacts. KINECT-PRO™ (NCT05859698) is the first and only study to assess and report the effects of an approved TD medication (valbenazine) on quality of life (QoL) and functionality using multiple validated patient-reported outcomes (PROs): the Tardive Dyskinesia Impact Scale (TDIS), the only psychometrically validated PRO developed for TD; the Sheehan Disability Scale (SDS); and EuroQoL Group's EQ Visual Analog Scale (EQ-VAS). Participants were required to have mild-to-severe TD movements (per Abnormal Involuntary Movement Scale [AIMS] item 8) and awareness of their TD with mild-to-severe associated distress (per AIMS item 10). Mean PRO scores at baseline indicated QoL/functional impacts in study participants, including those with mild TD symptoms per clinician assessment (i.e., AIMS item 8 score of 2). After 24 weeks of treatment with valbenazine (40, 60, or 80 mg, once-daily), mean changes from baseline in the PROs (primary endpoints) indicated robust and clinically meaningful improvements in QoL/functionality: TDIS (-8.0), SDS Work/School (-1.2), SDS Social/Leisure (-2.3), SDS Family/Home (-1.6), EQ-VAS (+13.1); n=45 except SDS Work/School (n=10). The mean change in AIMS total score (sum of items 1-7) was -6.8; 57.8% (26/45) met the stringent threshold for symptomatic remission, defined as a score ≤1 ("none" or "minimal") on all AIMS items 1-7. Valbenazine is the only VMAT2 inhibitor with robust datasets that provide evidence for improvements in QoL/functioning and symptomatic remission of TD regardless of primary psychiatric condition or movement severity.

Short Description: Once-daily valbenazine is approved for tardive dyskinesia (TD), a persistent movement disorder associated with physical, social, and emotional impacts. KINECT-PRO™ is the first and only clinical trial to assess the effects of a TD medication (valbenazine) on quality of life (QoL) and functionality using multiple validated patient-reported outcomes (PROs). Over 24 weeks of valbenazine treatment, robust and continued improvements were observed in all PROs, including in participants with mild TD movement severity per clinician assessment.

Name of Sponsoring Organization(s): Neurocrine Biosciences, Inc.