Session Time: 1:45pm-3:15pm
Location: Agora 2 West, Level 2
Objective: To assess clinically relevant reductions with treatment of deutetrabenazine in abnormal involuntary movements in patients with tardive dyskinesia (TD), as evidenced by correlation between centrally read Abnormal Involuntary Movement Scale (AIMS) score with investigator’s Clinical Global Impression of Change (CGIC) and Patient Global Impression of Change (PGIC).
Background: Deutetrabenazine (DBTZ) was FDA approved for treatment of TD based on the Phase 3 studies in patients with baseline (BL) AIMS scores ≥6. In ARM-TD, DBTZ reduced overall AIMS scores compared with placebo (–3.0 vs –1.6, P=0.019). In AIM-TD, DBTZ reduced overall AIMS scores compared with placebo, with comparable outcomes in patients treated with 24 mg/day (–3.2 vs –1.4 in placebo, P=0.003) or 36 mg/day (–3.3 vs –1.4, P=0.001).
Method: ARM-TD and AIM-TD were 12-week, randomized, double-blind, placebo-controlled studies evaluating the safety and efficacy of DTBZ for treating TD. The AIMS score was assessed by blinded central rating. AIMS response was defined as ≥50% reduction in AIMS score; treatment success was defined as ‘much improved’ or ‘very much improved’ in the CGIC or PGIC.
Results: 295 patients were included in the analysis. At Week 12, 41% of patients achieved CGI success; AIMS score mean (±SE) change from BL in this group was –4.2±0.31, and 44% of patients had AIMS response. Patients who did not meet CGIC treatment success had AIMS score mean change from BL of –1.3±0.20, and 90% of them did not meet AIMS response. Patients who met AIMS response were more likely to show CGIC treatment success (OR 7.3 [95% CI, 3.9–13.5]). 38% of patients met PGIC treatment success; their AIMS score mean change from BL was –4.0±0.31, and 42% of them achieved AIMS response. In patients not meeting PGIC treatment success, the AIMS score mean change from BL was –1.6±0.22, and 87% did not achieve AIMS response. Patients who achieved AIMS response were more likely to meet PGIC treatment success (OR 4.8 [95% CI, 2.7–8.5]).
Conclusion: DTBZ treatment provides clinically relevant reductions in abnormal involuntary movements in TD patients, based on AIMS improvement correlated with CGIC or PGIC treatment success. Based on this analysis, both clinicians and patients can recognize the benefit of DTBZ in treating TD symptoms.
To cite this abstract in AMA style:H. Barkay, A. Wilhelm, M. Wieman, M. Gordon, R. Hauser, JM. Savola. Clinically Relevant Changes in AIMS Based on Clinical and Patient Global Impression of Change in Patients With Tardive Dyskinesia Treated with Deutetrabenazine [abstract]. Mov Disord. 2019; 34 (suppl 2). https://www.mdsabstracts.org/abstract/clinically-relevant-changes-in-aims-based-on-clinical-and-patient-global-impression-of-change-in-patients-with-tardive-dyskinesia-treated-with-deutetrabenazine/. Accessed December 5, 2023.
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MDS Abstracts - https://www.mdsabstracts.org/abstract/clinically-relevant-changes-in-aims-based-on-clinical-and-patient-global-impression-of-change-in-patients-with-tardive-dyskinesia-treated-with-deutetrabenazine/