BackgroundTardive dyskinesia (TD) is an involuntary movement disorder that is more prevalent in older patients. However, there is limited information on TD treatment for this population. In two 12-week pivotal trials (ARM-TD and AIM-TD), TD patients demonstrated significant improvements in Abnormal Involuntary Movement Scale (AIMS) score with deutetrabenazine versus placebo.MethodsPatients who completed ARM-TD or AIM-TD enrolled in an open-label extension (OLE) study. This post hoc analysis assessed change and percent change from baseline in AIMS score, response rates for ≥50% AIMS improvement, Patient Global Impression of Change (PGIC), Clinical Global Impression of Change (CGIC), and safety in younger (<55 years) and older (≥55 years) patients.ResultsThis analysis included 119 younger and 218 older patients enrolled in the OLE. Data presented at Week 145 (mean±SE): total deutetrabenazine dose was 39.4±1.39mg/day and 39.5±1.04mg/day in younger and older patients, respectively. Changes from baseline in AIMS score were –6.7±0.62 and –6.5±0.47, respectively (percent changes of –61.4%±4.10% and –54.6%±3.01%). The majority of younger and older patients achieved treatment success per CGIC (67% and 76%) and PGIC (64% and 63%) and achieved ≥50% AIMS response (76% and 62%). Deutetrabenazine was generally well tolerated in both groups. Exposure-adjusted incidence rates (incidence/patient-years) were <0.01 and 0.02 for akathisia, 0.07 (both) for somnolence and sedation, 0.04 and 0.11 for parkinson-like events, and 0.06 and 0.09 for depression in younger and older patients, respectively.ConclusionsDeutetrabenazine treatment was associated with sustained improvements in AIMS score and was well tolerated in both younger and older TD patients.FundingTeva Pharmaceutical Industries Ltd., Petach Tikva, Israel

中文翻译：

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Deutetrabenazine 在年轻和老年迟发性运动障碍患者中的​​长期安全性和有效性

背景迟发性运动障碍（TD）是一种不自主运动障碍，在老年患者中更为普遍。然而，关于这一人群的 TD 治疗的信息有限。在两项为期 12 周的关键试验（ARM-TD 和 AIM-TD）中，TD 患者在异常不自主运动量表（AIMS）评分方面表现出显着改善，使用 deutetrabenazine 与安慰剂相比。方法完成 ARM-TD 或 AIM-TD 的患者参加了一项公开-标签扩展（OLE）研究。这项事后分析评估了 AIMS 评分的变化和相对于基线的百分比变化、≥50% AIMS 改善的反应率、患者总体变化印象 (PGIC)、临床总体变化印象 (CGIC) 和年轻患者（<55 岁）的安全性) 和老年（≥55 岁）患者。结果该分析包括 119 名年轻患者和 218 名老年患者参加 OLE。第 145 周提供的数据（平均值±标准差）：年轻和老年患者的总去丁苯那嗪剂量分别为 39.4±1.39mg/天和 39.5±1.04mg/天。AIMS 评分相对于基线的变化分别为 –6.7±0.62 和 –6.5±0.47（百分比变化为 –61.4%±4.10% 和 –54.6%±3.01%）。大多数年轻和年长的患者通过 CGIC（67% 和 76%）和 PGIC（64% 和 63%）获得了治疗成功，并实现了 ≥50% 的 AIMS 反应（76% 和 62%）。Deutetrabenazine 在两组中的耐受性一般都很好。暴露调整的发生率（发生率/患者-年）对于静坐不能分别为 <0.01 和 0.02，对于嗜睡和镇静剂分别为 0.07（两者），对于帕金森样事件分别为 0.04 和 0.11，对于年轻和老年患者的抑郁症分别为 0.06 和 0.09，分别。