Using Item 8 of the Abnormal Involuntary Movement Scale (AIMS) to Assess Improvement in Patients with Tardive Dyskinesia (1235)

Objective: To analyze Abnormal Involuntary Movement Scale (AIMS) item 8 using data from a long-term study of valbenazine, an approved tardive dyskinesia (TD) medication. Background: 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”). Design/Methods: 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). Results: 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. Conclusions: 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. Disclosure: 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 received stock or an ownership interest from Bristol-Myers Squibb, Eli Lilly, J & J, Merck, Pfizer . Leslie Citrome has received publishing royalties from a publication relating to health care. Leslie Lundt has received personal compensation for serving as an employee of Neurocrine Biosciences, Inc. Chirag Shah has received personal compensation for serving as an employee of Neurocrine Biosciences, Inc. Tara Carmack has received personal compensation for serving as an employee of Neurocrine Biosciences, Inc.