Improvements in tardive dyskinesia with treatment are consistent across two outcomes scales
Presenter: Maria Mercedes Perez-Rodriguez, MD, PhD, Icahn School of Medicine at Mount Sinai, New York, NY.
Trajectories of tardive dyskinesia impact scale (TDIS) and abnormal involuntary movement Scale (AIMS) over time with valbenazine treatment. Abstract 657. Presented August 27, 2023.
Among patients with tardive dyskinesia (TD) treated for 48 weeks with valbenazine, patterns of improvement are similar on both the Abnormal Involuntary Movement Scale (AIMS) and the Tardive Dyskinesia Impact Scale (TDIS). The finding suggests that both clinician-related TD severity and patient-reported TD impact decrease with treatment.
Using data from the KINECT4 trial,1 an open-label 52-week trial assessing valbenazine in TD, researchers led by Maria Mercedes Perez-Rodriguez, MD, PhD, Icahn School of Medicine at Mount Sinai, New York City, found that the improvement in TDIS was comparable to the improvement in the total AIMS score, TD severity, and TD awareness and distress over 48 weeks of treatment.
The AIMS and TDIS scales have been developed to assess the signs, symptoms, and impact of TD. The AIMS is a clinician-rated outcome measure that evaluates signs of TD severity of involuntary body movements in seven body regions (facial muscles, lips, jaw, tongue, upper and lower extremities, and trunk). Other items of the 12-item AIMS scale consider global judgment (overall TD severity, TD incapacitation, and TD awareness and distress). Higher scores on AIMS indicate greater severity and awareness/distress, with a low score of 0 and a maximum score of 4.
The TDIS is a TD-specific, patient-reported outcome measure that assesses the daily physical, social, and emotional impact of TD symptoms over the previous 7 days. The TDIS is an 11-item-scale, and a higher score indicates greater impairment/disability, with a total score range of 0 to 44.
“As both of these measures are designed to assess different aspects of TD, it is useful to understand how the patient’s perceived TD-related measures [assessed with the TDIS] correlate with clinician-rated TD severity [assessed with the AIMS] if TDIS is responsive to change with treatment,” the investigators wrote in their poster presentation.
They used data from KINECT4, which that assessed the effect of valbenazine (40 mg or 80 mg) treatment on the relationship between TDIS and AIMS total score, AIMS item 8 (overall TD severity), and AIMS item 10 (TD incapacitation), and the change trajectories of TDIS, AIMS items 1 through 7, and global AIMS item 8 and AIMS item 10 measures. In KINECT4, 163 patients who completed a 48-week treatment period plus a 4-week washout period were analyzed. For this analysis, data from all 167 patients enrolled in KINECT4 were analyzed. A total of 121 patients (73%) had a diagnosis of schizophrenia/schizoaffective disorder and 46 (27%) were diagnosed with mood disorder.
At baseline, the mean AIMS total score was 14.6 and TD severity was moderate (AIMS item 8 mean: 3.2). A low/moderate (weakly significant) correlation was observed between AIMS and TDIS total scores at baseline, indicating little overlap between the two measures (Pearson correlation coefficient r = 0.31). Most (98%) patients were aware of TD with an average rating of moderate distress (mean AIMS item 10 score: 2.7).
The AIMS total score decreased over 48 weeks, with a mean decline from baseline of 10.2 for the 40 mg valbenazine cohort and a decline of 11.2 for the 80 mg valbenazine cohort. The severity and distress associated with TD decreased, with most patients scored with minimal severity and as aware/no distress at 48 weeks. The mean TDIS scores decreased from 16.5 at baseline to 6.0 at week 48, “indicating TD had little impact on activity by the end of the treatment period, which was seen for schizophrenia and mood disorder groups,” according to the investigators. A weak significant correlation was seen between total AIMS and TDIS scores (r = 0.26). Correlations between AIMS item 8 (TD severity) and AIMS item 10 (awareness/distress) and TDIS were also low/moderate (r = 0.22-0.31).
A regression analysis showed that TDIS total score was significantly related to TD severity, controlling for awareness/distress. A stronger correlation was observed for TDIS total score and incapacitation (P = 0.003) while controlling for TD awareness/distress, indicating that awareness/distress has a greater effect on TDIS compared with TD severity.
During the washout period, the mean AIMS item 8 and AIMS item 10 scores increased, indicating worsening severity and awareness/distress.
Reference
- 1. Marder SR, Singer C, Lindenmayer JP, et al. A phase 3, 1-year, open-label trial of valbenazine in adults with tardive dyskinesia. J Clin Psychopharmacol 2019; 39(6):620-627. doi: 10.1097/JCP.0000000000001111.