Abstract：
OBJECTIVE: Using data from KINECT® 4, a phase 3, 48-week study of valbenazine, post hoc analyses were conducted to assess long-term outcomes that are relevant to the real-world management of tardive dyskinesia (TD).
METHODS: Post hoc analyses of the participants of the KINECT 4 study who completed 48 weeks of open-label valbenazine (40 or 80 mg) treatment were conducted. Valbenazine effects on TD were evaluated using the Abnormal Involuntary Movement Scale (AIMS), Clinical Global Impression of Change-TD (CGI-TD), and Patient Global Impression of Change (PGIC).
RESULTS: Of 103 participants completing 48 weeks of treatment, 55% experienced clinically meaningful improvement (defined as ≥2-point reduction in AIMS total score [sum of items 1 - 7, evaluated by site raters]) by week 4; at week 48, 97% met this threshold. The percentage of completers who achieved AIMS total score response thresholds of ≥10% to ≥90% increased over time, with 86% of completers reaching ≥50% improvement. Of the 40 (39%) completers with AIMS ≥50% response at week 8, 38 (95%) sustained this response at week 48; 81% of those who did not meet this threshold at week 8 had achieved it by week 48. At week 48, more than 85% of completers achieved CGI-TD and PGIC ratings of \"much improved\" or \"very much improved.\"
CONCLUSIONS: The majority of participants who completed 48 weeks of treatment with once-daily valbenazine experienced substantial clinically meaningful and sustained TD improvements. These findings indicate that valbenazine can be a highly effective long-term treatment in patients with TD.
METHODS: Post hoc analyses of the participants of the KINECT 4 study who completed 48 weeks of open-label valbenazine (40 or 80 mg) treatment were conducted. Valbenazine effects on TD were evaluated using the Abnormal Involuntary Movement Scale (AIMS), Clinical Global Impression of Change-TD (CGI-TD), and Patient Global Impression of Change (PGIC).
RESULTS: Of 103 participants completing 48 weeks of treatment, 55% experienced clinically meaningful improvement (defined as ≥2-point reduction in AIMS total score [sum of items 1 - 7, evaluated by site raters]) by week 4; at week 48, 97% met this threshold. The percentage of completers who achieved AIMS total score response thresholds of ≥10% to ≥90% increased over time, with 86% of completers reaching ≥50% improvement. Of the 40 (39%) completers with AIMS ≥50% response at week 8, 38 (95%) sustained this response at week 48; 81% of those who did not meet this threshold at week 8 had achieved it by week 48. At week 48, more than 85% of completers achieved CGI-TD and PGIC ratings of \"much improved\" or \"very much improved.\"
CONCLUSIONS: The majority of participants who completed 48 weeks of treatment with once-daily valbenazine experienced substantial clinically meaningful and sustained TD improvements. These findings indicate that valbenazine can be a highly effective long-term treatment in patients with TD.
摘要：
目的：使用来自KINECT®4的数据，这是一项为期48周的缬草那嗪3期研究，我们进行了事后分析,以评估与真实世界的迟发性运动障碍(TD)管理相关的长期结局.
方法：对KINECT4研究中完成了48周开放标记缬草那嗪（40或80mg）治疗的参与者进行了事后分析。使用异常非自愿运动量表（AIMS）评估了缬草嗪对TD的影响，临床总体变化印象-TD（CGI-TD），和患者的全球变化印象(PGIC)。
结果：在完成48周治疗的103名参与者中，到第4周，55％的患者经历了有临床意义的改善（定义为AIMS总分[项目1-7的总和，由站点评估者评估]降低≥2分）；在第48周时，97％达到了该阈值。完成者达到AIMS总分反应阈值≥10%至≥90%的百分比随着时间的推移而增加，86%的完井者达到≥50%的改善。在第8周AIMS反应≥50％的40名（39％）完成者中，有38名（95％）在第48周保持了这种反应；在第8周未达到该阈值的人中有81％在第48周达到了该阈值。在第48周，超过85％的完成者获得了CGI-TD和PGIC评级“大大改善”或“大大改善”。
结论：完成每日一次缬草嗪治疗48周的大多数参与者经历了实质性的临床意义和持续的TD改善。这些发现表明缬草嗪可以是TD患者的高效长期治疗。
方法：对KINECT4研究中完成了48周开放标记缬草那嗪（40或80mg）治疗的参与者进行了事后分析。使用异常非自愿运动量表（AIMS）评估了缬草嗪对TD的影响，临床总体变化印象-TD（CGI-TD），和患者的全球变化印象(PGIC)。
结果：在完成48周治疗的103名参与者中，到第4周，55％的患者经历了有临床意义的改善（定义为AIMS总分[项目1-7的总和，由站点评估者评估]降低≥2分）；在第48周时，97％达到了该阈值。完成者达到AIMS总分反应阈值≥10%至≥90%的百分比随着时间的推移而增加，86%的完井者达到≥50%的改善。在第8周AIMS反应≥50％的40名（39％）完成者中，有38名（95％）在第48周保持了这种反应；在第8周未达到该阈值的人中有81％在第48周达到了该阈值。在第48周，超过85％的完成者获得了CGI-TD和PGIC评级“大大改善”或“大大改善”。
结论：完成每日一次缬草嗪治疗48周的大多数参与者经历了实质性的临床意义和持续的TD改善。这些发现表明缬草嗪可以是TD患者的高效长期治疗。
