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Abstract Details

Using Item 8 of the Abnormal Involuntary Movement Scale (AIMS) to Assess Improvement in Patients with Tardive Dyskinesia
Movement Disorders
Movement Disorders Posters (7:00 AM-5:00 PM)
030
To analyze Abnormal Involuntary Movement Scale (AIMS) item 8 using data from a long-term study of valbenazine, an approved tardive dyskinesia (TD) medication.
AIMS total score (sum of items 1-7) is usually the primary efficacy measure in TD clinical trials. However, item 8 of the AIMS might also be an appropriate assessment in real-life healthcare settings. Item 8 measures “severity of abnormal movements” per the clinician’s global judgement and is scored from 0 (“none, normal”) to 4 (“severe”). 
In KINECT 4 (NCT02405091), adults with TD received once-daily valbenazine (40 or 80 mg) for 48 weeks. Analyses included two sets of AIMS item 8 scores: based on investigators’ ratings of item 8 using protocol-defined descriptors; and based on investigators’ highest scores from items 1-7 (analyzed post hoc). Shift analyses included an improvement from score ≥3 at baseline (moderate or severe) to score ≤2 at Week 48 (none to mild).
At baseline in all participants (N=163), AIMS item 8 mean scores were 3.2 (protocol) and 3.3 (post hoc). In participants with a score ≥3 at baseline per investigators’ ratings using protocol-defined descriptors, 95.9% [94/98] shifted to a score ≤2 by Week 48. A similar result (93.9% [93/99]) was found when item 8 was based on investigators’ highest scores from items 1-7.
Once-daily valbenazine treatment resulted in improved AIMS item 8 scores (clinician’s global impression of severity) in patients with TD. Shift analyses indicated that most participants had a clinically meaningful improvement at Week 48 (end of treatment). These results demonstrate that AIMS item 8 scores may be an appropriate clinical measure for assessing changes in TD severity.
Authors/Disclosures
Leslie Citrome
PRESENTER 		Leslie Citrome has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for AbbVie, Acadia, Alkermes, Allergan, Avanir, BioXcel, Cadent Therapeutics, Eisai, Impel, Intra-Cellular Therapies, Janssen, Lundbeck, Luye, Merck, Neurocrine, Noven, Osmotica, Otsuka, Sage, Shire, Sunovion, Takeda, Teva. Leslie Citrome has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for AbbVie, Acadia, Alkermes, Allergan, Eisai, Intra-Cellular Therapies, Janssen, Lundbeck, Merck, Neurocrine, Noven, Otsuka, Sage, Shire, Sunovion, Takeda, Teva. Leslie Citrome has received personal compensation in the range of $10,000-$49,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Wiley, Elsevier. Leslie Citrome has stock in Bristol-Myers Squibb, Eli Lilly, J & J, Merck, Pfizer . Leslie Citrome has received publishing royalties from a publication relating to health care.
No disclosure on file
No disclosure on file
No disclosure on file