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150 Estimation of an MCID for AIMS Total Score Change in Tardive Dyskinesia

Published online by Cambridge University Press:  15 June 2018

Martha Sajatovic
Affiliation:
Neurological and Behavioral Outcomes Center, University Hospitals Cleveland Medical Center, Cleveland, OH
Andrew J. Cutler
Affiliation:
Meridien Research, Tampa, FL
Khodayar Farahmand
Affiliation:
Director, Head of Medical Communications, Neurocrine Biosciences, Inc., San Diego, CA
Joshua Burke
Affiliation:
Director, Head of Medical Communications, Neurocrine Biosciences, Inc., San Diego, CA
Scott Siegert
Affiliation:
Executive Director, Head of Medical Affairs, Neurocrine Biosciences, Inc., San Diego, CA
Grace S. Liang
Affiliation:
Medical Director, Clinical, Neurocrine Biosciences, Inc., San Diego, CA
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Abstract

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Background

The efficacy of valbenazine (INGREZZA) in tardive dyskinesia (TD) was demonstrated in placebo-controlled clinical trials, based on the Abnormal Involuntary Movement Scale (AIMS) total score (sum of items 1-7). In these trials, mean changes in the AIMS total score were significantly greater with valbenazine 80 mg than with placebo. Currently, no minimal clinically important difference (MCID) has been established for the AIMS total score in patients with TD. Using valbenazine trial data, analyses were conducted to establish a MCID for AIMS total score in TD.

Methods

Data were pooled from three 6-week trials: KINECT (NCT01688037), KINECT 2 (NCT01733121), KINECT 3 (NCT02274558). Using the Clinical Global Impression ofChange (CGI-TD) as an anchor comparison, AIMS total score changes from baseline to Week 6 were summarized for all study participants (pooled valbenazine and placebo groups) with a “minimal” CGI-TD score of ≤3 (minimally improved or better) or “robust” ≤2 (much improved or better) at Week 6.

Results

In the pooled population (N=373), 72% and 29% of all participants had CGI-TD scores of ≤3 and ≤2, respectively. The median (maximum, minimum) change from baseline in AIMS total score at Week 6 was -2 (-13, 8) in participants with CGI-TD score ≤3 and -3 ( 13, 8) in participants with a score ≤2.

Conclusion

Pooled data from 3 randomized, double-blind, placebo-controlled trials suggest that a 2 point decrease in AIMS total score may represent the minimal clinically meaningful improvement. Larger AIMS score improvements were associated with “much improved” or “very much improved” CGI TD assessments.

Funding Acknowledgements

This study was funded by Neurocrine Biosciences, Inc.

Type
Abstracts
Copyright
© Cambridge University Press 2018 
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