Key Takeaways

From the Authors As published in the article
  1.  Older patients who take antipsychotics or other dopamine receptor blocking agents have a higher risk of developing tardive dyskinesia (TD), but treatment-related data in more elderly patients (≥65 years) had been lacking. This article reports on data indicating that once-daily valbenazine is effective and well-tolerated in the ≥65-year age group.
  2. Valbenazine is the only approved TD medication with sufficient clinical trial data indicating that no dose reduction is needed in patients who are ≥65 years of age. Valbenazine has a sprinkle formulation that can be added to soft foods, and there is no prohibition on crushing the compacted powder formulation.
Extended Takeaways
  1. In adults aged ≥65 years, AIMS improvement exceeded the estimated minimal clinically important difference of −2 points by Week 8 and continued to deepen over time, with mean changes of −4.5 ± 0.7 at Week 8, −8.6 ± 0.9 at Week 24, and −8.8 ± 0.9 at Week 48.
  2. Responder rates in the elderly subgroup increased steadily with continued treatment: the proportion achieving ≥30% AIMS improvement rose from 58.0% at Week 8 to 88.5% at Week 24 and 89.3% at Week 48, while ≥50% response increased from 40.0% to 65.4% to 82.1% over the same timepoints.
  3. Week 48 outcomes favored the 80 mg group numerically in both age strata, with mean AIMS changes of −9.8 in elderly participants on 80 mg versus −6.4 on 40 mg; the authors note, however, that no conclusions can be drawn regarding dose effects because dosing in KINECT 4 was based on investigator judgment of tolerability and response.
  4. Clinician-rated global improvement at Week 48 was high in older adults, with 92.9% of elderly participants rated much improved or very much improved on CGI-TD; this was significantly higher than the 76.5% observed in younger participants, whereas PGIC response in the elderly subgroup was 85.7% and not statistically different from younger adults.
  5. Tolerability in the elderly subgroup was broadly comparable to younger adults for overall TEAEs and serious TEAEs, but discontinuations due to TEAEs were more frequent in older patients (25.5% vs 13.3%, P =.023), which is important when monitoring persistence in long-term treatment.
  6. Psychiatric and motor safety signals remained stable during long-term treatment in elderly participants, with minimal mean changes on PANSS, CDSS, YMRS, MADRS, BARS, and SAS and no significant Week 48 differences versus younger adults.
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