Objective: To evaluate the effects of once-daily valbenazine (VBZ) on the impacts of tardive dyskinesia (TD) using multiple patient-reported outcomes (PROs), including the psychometrically validated Tardive Dyskinesia Impact Scale (TDIS), along with clinician-rated assessments for TD severity such as the Abnormal Involuntary Movement Scale (AIMS).

Background: VBZ is approved for the treatment of TD and Huntington’s disease chorea. TD is known to have negative impacts on physical, social, and emotional functioning, even for patients with mild severity, but research is limited on how vesicular monoamine transporter 2 (VMAT2) inhibitors can improve patient-reported functional outcomes.

Method: This open-label study included screening (4 wks), initial treatment with VBZ 40 mg (4 wks), continuation with 40 mg or increase to 60 or 80 mg (12 wks), stable dosing with 40, 60, or 80 mg (8 wks), and safety follow-up (2 wks). Participants had at least mild TD severity (per AIMS item 8) and mild or worse associated distress from their dyskinetic movements (per AIMS item 10). PROs included the TDIS, Sheehan Disability Scale (SDS), and EuroQoL’s EQ-5D-5L visual analog scale (EQ-VAS) for health state. Mean changes from baseline for the PROs and AIMS total score (sum of items 1-7) were analyzed by TD severity (“mild” or “mod/sev” [moderate/severe] per AIMS item 8) and in the overall population.

Results: Of 59 enrolled participants (mild TD [n=24], mod/sev TD [n=35]), 52 (88%) completed the Wk24 visit; 45 were included for efficacy analyses. TDIS, SDS, and EQ-VAS improvements were observed by Wk4 after initial treatment with VBZ 40 mg. Mean changes at Wk24 were as follows: TDIS (-6.8, -8.9, -8.0 [mild, mod/sev, overall]); SDS social life (-1.8, -2.8, -2.3) and family life (-1.3, -1.8, -1.6); EQ-VAS (+12.8, +13.3, +13.1). At Wk24, mean changes in AIMS total score were -5.6 (mild), -7.8 (mod/sev), and -6.8 (overall). Adverse events were consistent with the known safety and tolerability profile for VBZ.

Conclusion: This is the first study to report the effects of a VMAT2 inhibitor on the physical, social, and emotional impacts of TD using multiple PROs, including the validated and disease-specific TDIS. Results present a comprehensive assessment of the impact of TD on patients’ lives and the broad range of improvements that occurred following VBZ treatment.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/valbenazine-improves-the-burden-and-symptoms-of-tardive-dyskinesia-topline-results-from-the-phase-4-kinect-pro-study/