Abstracts
3427212
(#51) Clinically Meaningful Improvements and Symptomatic Remission With Once-Daily Valbenazine in Adults With Tardive Dyskinesia
Abstract: Introduction: In KINECT® 4 (NCT02405091), a long-term open-label study of once-daily valbenazine for tardive dyskinesia (TD), participants who received 48 weeks of treatment had a substantial mean improvement from baseline (-10.5 points) in the Abnormal Involuntary Movement Scale (AIMS) total dyskinesia score (sum of items 1-7). AIMS data from this trial were analyzed post hoc to explore clinically relevant outcomes with long-term valbenazine, including a rigorous threshold of TD symptomatic remission.
Methods: AIMS data from participants who completed 48 weeks of treatment were analyzed post hoc. The percentages of participants who met the following AIMS thresholds were analyzed: ≥2-point total score improvement from baseline, per the minimal clinically important difference (MCID) threshold (-2 points); ≥30% and ≥50% improvement from baseline, reflecting clinically meaningful and protocol-defined response thresholds, respectively; and TD symptomatic remission, defined as a score of ≤1 ("none" or "minimal" movement severity) in each of the 7 body regions (AIMS items 1-7).
Results: At Week 48 (N=103), 100 (97%) participants met the AIMS MCID threshold, and 97 (94%) met the clinically meaningful ≥30% response threshold. The more stringent protocol-defined response threshold of ≥50% total score improvement was met by 89 (86%) participants at Week 48. The most rigorous outcome of TD symptomatic remission was met by 61 (59%) participants.
Conclusions: Almost all KINECT 4 study participants who received 48 weeks of once-daily valbenazine experienced clinically meaningful improvements in TD movement severity. A substantial majority met more rigorous thresholds for improvement, including TD symptomatic remission.
Short Description: Once-daily valbenazine is a highly selective vesicular monoamine transporter 2 (VMAT2) inhibitor approved for the treatment of tardive dyskinesia (TD). Long-term trials of valbenazine for TD have been conducted, including the 48-week KINECT® 4 study. Post hoc analyses of KINECT 4 data indicate that almost all participants experienced clinically meaningful improvements in TD movement severity at Week 48. Moreover, a substantial majority of participants met more rigorous thresholds for improvement, including TD symptomatic remission.
Name of Sponsoring Organization(s): Neurocrine Biosciences, Inc.
Methods: AIMS data from participants who completed 48 weeks of treatment were analyzed post hoc. The percentages of participants who met the following AIMS thresholds were analyzed: ≥2-point total score improvement from baseline, per the minimal clinically important difference (MCID) threshold (-2 points); ≥30% and ≥50% improvement from baseline, reflecting clinically meaningful and protocol-defined response thresholds, respectively; and TD symptomatic remission, defined as a score of ≤1 ("none" or "minimal" movement severity) in each of the 7 body regions (AIMS items 1-7).
Results: At Week 48 (N=103), 100 (97%) participants met the AIMS MCID threshold, and 97 (94%) met the clinically meaningful ≥30% response threshold. The more stringent protocol-defined response threshold of ≥50% total score improvement was met by 89 (86%) participants at Week 48. The most rigorous outcome of TD symptomatic remission was met by 61 (59%) participants.
Conclusions: Almost all KINECT 4 study participants who received 48 weeks of once-daily valbenazine experienced clinically meaningful improvements in TD movement severity. A substantial majority met more rigorous thresholds for improvement, including TD symptomatic remission.
Short Description: Once-daily valbenazine is a highly selective vesicular monoamine transporter 2 (VMAT2) inhibitor approved for the treatment of tardive dyskinesia (TD). Long-term trials of valbenazine for TD have been conducted, including the 48-week KINECT® 4 study. Post hoc analyses of KINECT 4 data indicate that almost all participants experienced clinically meaningful improvements in TD movement severity at Week 48. Moreover, a substantial majority of participants met more rigorous thresholds for improvement, including TD symptomatic remission.
Name of Sponsoring Organization(s): Neurocrine Biosciences, Inc.
