Objective:

To evaluate the real-world effectiveness of deutetrabenazine (DTBZ) treatment on the multidimensional impact of tardive dyskinesia (TD), as assessed by patient-reported outcome (PRO) scales.

Background:

TD can substantially impair quality of life, highlighting the need to assess the effect of treatment on PROs. 

Design/Methods:

The IMPACT-TD Registry is an ongoing phase 4 study including 611 adults with a score of ≥2 on ≥1 item of the Abnormal Involuntary Movement Scale (AIMS) and probable TD or, alternatively, who were receiving vesicular monoamine transporter 2 (VMAT2) inhibitor therapy for TD at enrollment. Part B included participants who were naïve to VMAT2 inhibitor treatment or for whom ≥3 months had elapsed since VMAT2 inhibitor exposure and for whom DTBZ was prescribed per routine clinical care. At baseline and at monthly visits, participants completed the IMPACT-TD PRO scale and rated the severity of their TD and underlying psychiatric conditions with the Patient Global Impression of Severity (PGIS) scales (TD-specific, PGIS-TD and psychiatric-specific, PGIS-Psych). 

Results:

Among 27 adults who initiated and completed 3 months of DTBZ treatment at this interim analysis (age range 26–80 years, 67% female, 63% White), all had ≥1 comorbid psychiatric disorder. At month 3, total motor AIMS score mean (SE) change from baseline was −2.9 (1.1). Participants with baseline impact reported meaningful improvements at month 3 in activities of daily living (59%), psychosocial impact (65%), eating (75%), speech/communication (77%), and sleep/pain (50%). At month 3, PGIS-TD was improved in 63% of participants and PGIS-Psych was improved/remained stable in 85% of participants. 

Conclusions:

In this real-world study, IMPACT-TD Registry participants newly treated with DTBZ for TD had meaningful reductions in abnormal movement severity, similar to those seen in the pivotal randomized controlled trials. Up to 77% of participants experienced meaningful improvements in specific aspects of their lives impacted by TD.