Abstracts
3427238
(#40) Characterization of Patients With Mild Tardive Dyskinesia Taking Deutetrabenazine in the IMPACT-TD Registry
Abstract: Background: Individuals with tardive dyskinesia (TD) with mild symptom severity were not included in clinical trials of vesicular monoamine transporter 2 (VMAT2) inhibitors. This interim analysis of the IMPACT-TD Registry evaluates real-world changes among individuals with mild TD symptoms newly initiating treatment with the VMAT2 inhibitor deutetrabenazine (DTBZ).
Methods: IMPACT-TD Registry participants with baseline total motor Abnormal Involuntary Movement Scale (AIMS) scores ≤6, who were naïve to VMAT2 inhibitor treatment or for whom ≥3 months had elapsed since VMAT2 inhibitor exposure, and who then completed 3 months of DTBZ treatment, prescribed per routine clinical care, were included in this analysis. At baseline and at monthly follow-up, participants completed the IMPACT-TD PRO, a TD-specific 30-item questionnaire assessing 5 functional areas of impact. AIMS, psychiatric-specific Clinical Global Impression of Severity (CGIS-Psych), and psychiatric-specific Patient Global Impression of Severity (PGIS-Psych) were also assessed.
Results: At Month 3 of DTBZ treatment, all 8 participants had reductions in total motor AIMS score from baseline (n/N=6/8 [75%] with a ≥2-point reduction) and showed stability/improvement from baseline in psychiatric symptoms via PGIS-Psych and CGIS-Psych. Participants with meaningful baseline burden in specific areas reported improvements at Month 3 in activities of daily living (3/4), psychosocial impact (5/5), eating (5/7), speech/communication (4/5), and sleep/pain (4/6).
Conclusions: In this small cohort of 8 IMPACT-TD Registry participants who had mild TD symptoms at baseline, all had improvements in movement severity and most reported improvements in quality of life in areas most impacted by TD after 3 months of treatment with DTBZ.
Short Description: Among 8 IMPACT-TD Registry participants with mild tardive dyskinesia symptoms who initiated deutetrabenazine, all had reductions in movement severity from baseline (6 of 8 with ≥2-point reduction in total motor Abnormal Involuntary Movement Scale score) after 3 months of treatment. Most participants with meaningful baseline burden in specific areas of impact (activities of daily living, psychosocial impact, eating, speech/communication, and sleep/pain) reported improvement in the affected area after 3 months of deutetrabenazine treatment.
Name of Sponsoring Organization(s): Teva Branded Pharmaceutical Products R&D LLC
Methods: IMPACT-TD Registry participants with baseline total motor Abnormal Involuntary Movement Scale (AIMS) scores ≤6, who were naïve to VMAT2 inhibitor treatment or for whom ≥3 months had elapsed since VMAT2 inhibitor exposure, and who then completed 3 months of DTBZ treatment, prescribed per routine clinical care, were included in this analysis. At baseline and at monthly follow-up, participants completed the IMPACT-TD PRO, a TD-specific 30-item questionnaire assessing 5 functional areas of impact. AIMS, psychiatric-specific Clinical Global Impression of Severity (CGIS-Psych), and psychiatric-specific Patient Global Impression of Severity (PGIS-Psych) were also assessed.
Results: At Month 3 of DTBZ treatment, all 8 participants had reductions in total motor AIMS score from baseline (n/N=6/8 [75%] with a ≥2-point reduction) and showed stability/improvement from baseline in psychiatric symptoms via PGIS-Psych and CGIS-Psych. Participants with meaningful baseline burden in specific areas reported improvements at Month 3 in activities of daily living (3/4), psychosocial impact (5/5), eating (5/7), speech/communication (4/5), and sleep/pain (4/6).
Conclusions: In this small cohort of 8 IMPACT-TD Registry participants who had mild TD symptoms at baseline, all had improvements in movement severity and most reported improvements in quality of life in areas most impacted by TD after 3 months of treatment with DTBZ.
Short Description: Among 8 IMPACT-TD Registry participants with mild tardive dyskinesia symptoms who initiated deutetrabenazine, all had reductions in movement severity from baseline (6 of 8 with ≥2-point reduction in total motor Abnormal Involuntary Movement Scale score) after 3 months of treatment. Most participants with meaningful baseline burden in specific areas of impact (activities of daily living, psychosocial impact, eating, speech/communication, and sleep/pain) reported improvement in the affected area after 3 months of deutetrabenazine treatment.
Name of Sponsoring Organization(s): Teva Branded Pharmaceutical Products R&D LLC
