Abstracts
3427236
(#39) Deutetrabenazine Long-Term Treatment Response in Adults With Tardive Dyskinesia in the RIM-TD Open-Label Extension Study: Analysis of Treatment Response Patterns
Abstract: Background: In the pivotal Phase 3 AIM-TD and ARM-TD studies, deutetrabenazine demonstrated significant improvement in tardive dyskinesia (TD), with reductions in Abnormal Involuntary Movement Scale (AIMS) scores observed by Week 2 and clinically meaningful mean improvements of ≈2-3 points (≈30%) by Week 12. Long-term benefit of deutetrabenazine was supported by the 3-year RIM-TD open-label extension study, which showed a sustained improvement, including a mean 6.6-point reduction in AIMS score from baseline to Week 145. However, not all patients achieve clinically meaningful improvement early in treatment. This analysis evaluated the timing of delayed response during long-term deutetrabenazine treatment.
Methods: Adults who completed AIM-TD or ARM-TD entered RIM-TD and received deutetrabenazine for up to 145 weeks following dose titration and optimization. Symptom improvement was assessed using AIMS score. Here, AIMS scores were analyzed to determine the earliest timepoint at which each patient achieved a ≥30% improvement from baseline.
Results: Of 337 patients, 172 (51%) showed a ≥30% improvement in AIMS score from baseline at Week 15. An additional 79 (23%) patients achieved this response after Week 15, most of whom (65/79; 82%) achieved the response within the first 54 weeks. Thirty-one (9%) patients had no data at/after Week 15, 12 (4%) had no response at Week 15 and no subsequent data, and 42 (12%) did not show a response during the study.
Conclusions: Results suggest that early lack of a clinically meaningful response does not uniformly predict long-term nonresponse, supporting the importance of sustained treatment before concluding an insufficient response.
Short Description: In AIM-TD and ARM-TD, adults with TD achieved clinically significant AIMS score improvements, which were sustained in the RIM-TD open-label extension. Because some patients responded after 15 weeks, delayed responses in RIM-TD were evaluated. Of 337 patients, ≥30% improvement was achieved by 51% within 15 weeks and by another 23% after 15 weeks. Most delayed responses (82%) occurred within the first year. Results suggest early lack of a response does not uniformly predict long-term nonresponse.
Name of Sponsoring Organization(s): Teva Branded Pharmaceutical Products R&D LLC
Methods: Adults who completed AIM-TD or ARM-TD entered RIM-TD and received deutetrabenazine for up to 145 weeks following dose titration and optimization. Symptom improvement was assessed using AIMS score. Here, AIMS scores were analyzed to determine the earliest timepoint at which each patient achieved a ≥30% improvement from baseline.
Results: Of 337 patients, 172 (51%) showed a ≥30% improvement in AIMS score from baseline at Week 15. An additional 79 (23%) patients achieved this response after Week 15, most of whom (65/79; 82%) achieved the response within the first 54 weeks. Thirty-one (9%) patients had no data at/after Week 15, 12 (4%) had no response at Week 15 and no subsequent data, and 42 (12%) did not show a response during the study.
Conclusions: Results suggest that early lack of a clinically meaningful response does not uniformly predict long-term nonresponse, supporting the importance of sustained treatment before concluding an insufficient response.
Short Description: In AIM-TD and ARM-TD, adults with TD achieved clinically significant AIMS score improvements, which were sustained in the RIM-TD open-label extension. Because some patients responded after 15 weeks, delayed responses in RIM-TD were evaluated. Of 337 patients, ≥30% improvement was achieved by 51% within 15 weeks and by another 23% after 15 weeks. Most delayed responses (82%) occurred within the first year. Results suggest early lack of a response does not uniformly predict long-term nonresponse.
Name of Sponsoring Organization(s): Teva Branded Pharmaceutical Products R&D LLC
