ObjectiveThe Abnormal Involuntary Movement Scale (AIMS) total score (sum of items 1–7) is usually the primary efficacy measure in tardive dyskinesia (TD) clinical trials. However, item 8 of the AIMS (clinician’s global impression of severity) might also be an appropriate assessment in real-life healthcare settings. To explore the potential of item 8 as a clinical measure, post hoc analyses were conducted using data from a long-term study of valbenazine, an approved TD medication.MethodsIn 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).ResultsAt 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.ConclusionShift analyses using AIMS item 8 scores indicated that most participants in KINECT 4 had a clinically meaningful improvement after 48 weeks of once-daily treatment with valbenazine. AIMS item 8 may be an appropriate clinical measure for assessing changes in TD severity.FundingNeurocrine Biosciences, Inc.

中文翻译：

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使用异常不自主运动量表 (AIMS) 第 8 项评估迟发性运动障碍患者的改善情况

目的异常不自主运动量表（AIMS）总分（1-7项总和）通常是迟发性运动障碍（TD）临床试验中的主要疗效指标。然而，AIMS 的第 8 项（临床医生对严重程度的全球印象）也可能是现实医疗保健环境中的适当评估。为了探索第 8 项作为临床措施的潜力，使用来自批准的 TD 药物缬苯那嗪长期研究的数据进行事后分析。方法在 KINECT 4 (NCT02405091) 中，患有 TD 的成年人每天接受一次缬苯那嗪 (40或 80 毫克）持续 48 周。分析包括两组 AIMS 第 8 项评分：基于调查人员使用协议定义的描述符对第 8 项的评分；并基于调查人员在项目 1-7 中的最高分（事后分析）。转变分析包括从基线得分 = 3（中度或重度）到第 48 周得分 = 2（无到轻度）。结果在所有参与者的基线（N = 163）中，AIMS 项目 8 平均得分为 3.2（协议）和 3.3（事后）。在使用协议定义的描述符的每个研究者评分的基线得分 = 3 的参与者中，到第 48 周时，95.9% [94/98] 的得分变为 = 2。类似的结果 (93.9% [93/99]) 被发现时第 8 项基于调查人员在第 1-7 项中的最高分。结论 使用 AIMS 第 8 项分数进行的 Shift 分析表明，大多数 KINECT 4 参与者在每天一次使用缬苯那嗪治疗 48 周后有临床意义的改善。AIMS 项目 8 可能是评估 TD 严重程度变化的适当临床措施。FundingNeurocrine Biosciences, Inc.