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Published on: October 14, 2021
Abnormal involuntary movement scale in tardive dyskinesia: Minimal clinically important difference
Mark Stacy1, Martha Sajatovic2,3, John M Kane4,5
1Brody School of Medicine, East Carolina University, Greenville, North Carolina, USA.
A 2-point reduction in the Abnormal Involuntary Movement Scale may signify a clinically important improvement for tardive dyskinesia patients treated with valbenazine. This finding helps establish a meaningful outcome measure for treatment efficacy.
Area of Science:
- Movement Disorders
- Clinical Neuroscience
- Pharmacology
Background:
- The Abnormal Involuntary Movement Scale (AIMS) is used to assess tardive dyskinesia (TD).
- A minimal clinically important difference (MCID) for AIMS in TD has not been established.
- Valbenazine, a VMAT2 inhibitor, is approved for treating TD in adults.
Purpose of the Study:
- To estimate the MCID for the AIMS using data from valbenazine clinical trials.
- To employ an anchor-based method for determining the AIMS MCID in TD patients.
Main Methods:
- Pooled data from three 6-week, double-blind, placebo-controlled trials of valbenazine (KINECT, KINECT 2, KINECT 3).
- Valbenazine doses were categorized as low (40-50 mg/day) or high (75-80 mg/day).
- Anchor-based analysis used Clinical Global Impression of Change-TD or Patient Global Impression of Change scores (1-3, very much to minimally improved) at week 6.
Main Results:
- Valbenazine significantly improved AIMS total score compared to placebo (low dose: -2.4, high dose: -3.2 vs. -0.7; P<0.001).
- The estimated MCID for AIMS was 2 points, based on mean changes in participants reporting improvement (CGIC ≤3: -2.2; PGIC ≤3: -2.0).
- Median AIMS change for improved participants was -2 points for both anchors.
Conclusions:
- An anchor-based method suggests a 2-point decrease in AIMS total score is clinically important for TD.
- This finding provides a benchmark for assessing meaningful treatment effects of valbenazine in TD.
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