Objective: To assess global improvement and patient satisfaction in participants with tardive dyskinesia (TD) who received long-term treatment with once-daily valbenazine (VBZ).

Background: VBZ, approved for treating TD in adults, has been evaluated in 2 prior long-term studies (KINECT 3, KINECT 4) in which participants received VBZ (40 or 80mg) for up to 48 weeks. The current rollover study (NCT02736955) is the first to include a Patient Satisfaction Questionnaire (PSQ) that evaluates VBZ as a TD treatment.

Methods: Key eligibility criteria: age 18 to 85 years; completion of KINECT 3 or KINECT 4; maintenance medications (for schizophrenia, schizoaffective disorder, or mood disorder) at stable doses; Brief Psychiatric Rating Scale score <50; without high risk of active suicidal ideation or behavior. Following washout of prior VBZ treatment, participants were re-initiated at 40mg (4 weeks) and escalated to 80mg based on tolerability and clinical assessment of TD; dose was reduced to 40mg if 80mg was not tolerated (80/40mg group). Participants received open-label VBZ for up to 72 weeks or until commercial availability. Assessments included the Clinical Global Impression of Severity-TD (CGIS-TD: range, 1 [normal/not ill] to 7 [extremely ill]) and PSQ (range, 1 [very satisfied] to 5 [very dissatisfied]).

Results: Preliminary results are available for 160 participants (40mg=35; 80mg=117; 80/40mg=8). 138 (85.7%) participants were ongoing in the study when VBZ became commercially available. The percentages of participants who completed Wks 12, 24, 36, and 48 were 96.3%, 80.6%, 56.9% and 35.6%, respectively. Few participants reached Wk60 (n=4) or Wk72 (n=0) due to study termination. The percentage of participants with CGIS-TD score ≤2 (normal/not ill or borderline ill) increased from baseline (before restarting VBZ) (40mg, 5.7%; 80mg, 18.1%) to Wk48 (40mg, 46.2%; 80mg, 74.4%). At baseline, 100% of 40mg participants and 99.1% taking 80mg rated their prior VBZ experience with a PSQ score ≤2 (very satisfied or somewhat satisfied). At Wk48, most of these participants continued to express satisfaction with VBZ (40mg, 100%; 80mg, 97.4%).

Conclusions: A clinician-based global assessment indicated ongoing, meaningful TD improvements in adults who received once-daily VBZ in the current study. Patient satisfaction rates with VBZ remained high, even in patients treated for up to 2 years.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/global-improvement-and-patient-satisfaction-results-from-a-long-term-open-label-rollover-study-of-valbenazine-in-tardive-dyskinesia/