scholarly journals Using Item 8 of the Abnormal Involuntary Movement Scale (AIMS) to Assess Improvement in Patients with Tardive Dyskinesia

CNS Spectrums ◽  
2021 ◽  
Vol 26 (2) ◽  
pp. 152-152
Author(s):  
Leslie Citrome ◽  
Leslie Lundt ◽  
Chirag Shah ◽  
Tara Carmack
Keyword(s):  
Tardive Dyskinesia ◽  
Involuntary Movement ◽  
Real Life ◽  
Meaningful Improvement ◽  
Once Daily ◽  
Abnormal Involuntary Movement Scale ◽  
Clinical Measure ◽  
Long Term Study ◽  
Using Data ◽  
Post Hoc

AbstractObjectiveThe Abnormal Involuntary Movement Scale (AIMS) total score (sum of items 1–7) is usually the primary efficacy measure in tardive dyskinesia (TD) clinical trials. However, item 8 of the AIMS (clinician’s global impression of severity) might also be an appropriate assessment in real-life healthcare settings. To explore the potential of item 8 as a clinical measure, post hoc analyses were conducted using data from a long-term study of valbenazine, an approved TD medication.MethodsIn KINECT 4 (NCT02405091), adults with TD received once-daily valbenazine (40 or 80 mg) for 48 weeks. Analyses included two sets of AIMS item 8 scores: based on investigators ratings of item 8 using protocol-defined descriptors; and based on investigators highest scores from items 1–7 (analyzed post hoc). Shift analyses included an improvement from score =3 at baseline (moderate or severe) to score =2 at Week 48 (none to mild).ResultsAt baseline in all participants (N=163), AIMS item 8 mean scores were 3.2 (protocol) and 3.3 (post hoc). In participants with a score =3 at baseline per investigators ratings using protocol-defined descriptors, 95.9% [94/98] shifted to a score =2 by Week 48. A similar result (93.9% [93/99]) was found when item 8 was based on investigators highest scores from items 1–7.ConclusionShift analyses using AIMS item 8 scores indicated that most participants in KINECT 4 had a clinically meaningful improvement after 48 weeks of once-daily treatment with valbenazine. AIMS item 8 may be an appropriate clinical measure for assessing changes in TD severity.FundingNeurocrine Biosciences, Inc.

scholarly journals 149 Deutetrabenazine for the Treatment of Tardive Dyskinesia: Results From an Open-Label, Long-Term Study

CNS Spectrums ◽  
2018 ◽  
Vol 23 (1) ◽  
pp. 92-93
Author(s):  
Karen E. Anderson ◽  
Mat D. Davis ◽  
Stewart A. Factor ◽  
Robert A. Hauser ◽  
L. Fredrik Jarskog ◽  
...  
Keyword(s):  
Tardive Dyskinesia ◽  
Involuntary Movement ◽  
Treatment Success ◽  
Open Label ◽  
Dopamine Receptor Antagonists ◽  
Long Term Study ◽  
Patient Global Impression ◽  
Pharmaceutical Industries ◽  
Global Impression Of Change

AbstractIntroductionTardive dyskinesia (TD) is an involuntary movement disorder resulting from exposure to dopamine-receptor antagonists. In the 12-week ARM-TD and AIM-TD studies, deutetrabenazine demonstrated significant improvements in Abnormal Involuntary Movement Scale (AIMS) scores at Week 12 compared with placebo, and was generally well tolerated.ObjectiveTo evaluate the efficacy and safety of long-term deutetrabenazine therapy in patients with TD.MethodsPatients with TD who completed the ARM-TD or AIM-TD studies were eligible to enter this open-label, single-arm, long-term safety study after they completed the 1-week washout period and final evaluation in the blinded portion of the trial. Efficacy endpoints included the change in AIMS score from baseline, and treatment success (defined as “much improved” or “very much improved”) on the Clinical Global Impression of Change (CGIC) and Patient Global Impression of Change (PGIC). This analysis reports results up to Week 54.Results304 patients enrolled in the extension study. At Week 54, the mean (standard error) change in AIMS score was –5.1 (0.52). After 6 weeks of deutetrabenazine treatment, the proportion of patients who achieved treatment success was 58% per the CGIC and 53% per the PGIC, and by Week 54 was 72% per the CGIC and 59% per the PGIC, thus demonstrating maintenance or enhancement of benefit over time. Deutetrabenazine was well tolerated for up to 54 weeks, and compared with the ARM-TD and AIM-TD studies, no new safety signals were detected.Conclusions54 weeks of deutetrabenazine treatment was generally efficacious, safe, and well tolerated in patients with TD.Presented at: The American Psychiatric Association 2017 Annual Meeting; May 20–24, 2017; San Diego, California, USA.Funding AcknowledgementsThis study was funded by Teva Pharmaceutical Industries, Petach Tikva, Israel.

scholarly journals Deutetrabenazine Reduces Severe Tardive Dyskinesia Movements in a 3-year Open-Label Extension Trial

CNS Spectrums ◽  
2021 ◽  
Vol 26 (2) ◽  
pp. 156-156
Author(s):  
Nayla Chaijale ◽  
Joseph Bona ◽  
Hadas Barkay ◽  
Amanda Wilhelm ◽  
Mark Forrest Gordon
Keyword(s):  
Tardive Dyskinesia ◽  
Treatment Guidelines ◽  
Involuntary Movement ◽  
Open Label ◽  
Percent Change ◽  
Open Label Extension ◽  
Pharmaceutical Industries ◽  
Clinically Significant ◽  
Post Hoc ◽  
Lost To Follow Up

AbstractBackgroundThere are no established treatment guidelines for tardive dyskinesia (TD) based on movement severity. The 12-week ARM-TD and AIM-TD studies in TD patients with baseline Abnormal Involuntary Movement Scale (AIMS) total score (items 1–7) ≥6 showed clinically significant improvements in AIMS score with deutetrabenazine versus placebo. Patients who completed these studies were eligible for the open-label extension (OLE) trial. This post-hoc analysis evaluated deutetrabenazine in TD patients with severe movements.MethodsSubgroups were defined by upper quartile of baseline total AIMS score (local rating). Endpoints were: change and percent change from baseline in AIMS score, and percent of patients achieving ≥50% AIMS reduction from baseline.Results337 patients were analyzed. The upper quartile of baseline total AIMS score was 14. Subgroups were defined as >14 and ≤14 at baseline, respectively (n=64 vs 273); data are presented at Week 145 (n=40 vs 120). Mean treatment duration was 880.5 and 760.8 days. Mean±SE daily doses were 41.1±1.6mg and 38.9±1.0mg. Mean±SE change from baseline in AIMS score was –11.0±0.8 versus –5.1±0.3; percent change from baseline was –60.1%±3.6% versus –55.9%±3.0%. More patients with AIMS score >14 had ≥50% AIMS reduction (73% vs 65%). Less patients discontinued (38% vs 51%); reasons included withdrawal by subject (16% vs 25%), adverse event (3% vs 11%), and lost to follow-up (6% vs 7%). Withdrawal due to lack of efficacy was uncommon (5% vs 2%).ConclusionsPatients with baseline total AIMS score >14 had clinically meaningful reductions in AIMS score, suggesting deutetrabenazine has long-term benefit in these patients.FundingTeva Pharmaceutical Industries Ltd., Petach Tikva, Israel

scholarly journals Genome wide study of tardive dyskinesia in schizophrenia

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Keane Lim ◽  
Max Lam ◽  
Clement Zai ◽  
Jenny Tay ◽  
Nina Karlsson ◽  
...  
Keyword(s):  
Tardive Dyskinesia ◽  
Age Of Onset ◽  
Involuntary Movement ◽  
Fold Increase ◽  
Severe Condition ◽  
Duration Of Illness ◽  
Genome Wide ◽  
Causal Variants ◽  
Post Hoc ◽  
Genome Wide Study

AbstractTardive dyskinesia (TD) is a severe condition characterized by repetitive involuntary movement of orofacial regions and extremities. Patients treated with antipsychotics typically present with TD symptomatology. Here, we conducted the largest GWAS of TD to date, by meta-analyzing samples of East-Asian, European, and African American ancestry, followed by analyses of biological pathways and polygenic risk with related phenotypes. We identified a novel locus and three suggestive loci, implicating immune-related pathways. Through integrating trans-ethnic fine mapping, we identified putative credible causal variants for three of the loci. Post-hoc analysis revealed that SNPs harbored in TNFRSF1B and CALCOCO1 independently conferred three-fold increase in TD risk, beyond clinical risk factors like Age of onset and Duration of illness to schizophrenia. Further work is necessary to replicate loci that are reported in the study and evaluate the polygenic architecture underlying TD.

Abnormal Involuntary Movement Scale (AIMS) and Extrapyramidal Symptom Rating Scale (ESRS): Cross-scale comparison in assessing tardive dyskinesia

2005 ◽  
Vol 77 (2-3) ◽  
pp. 119-128 ◽  
Author(s):  
Georges M. Gharabawi ◽  
Cynthia A. Bossie ◽  
Robert A. Lasser ◽  
Ibrahim Turkoz ◽  
Stephen Rodriguez ◽  
...  
Keyword(s):  
Tardive Dyskinesia ◽  
Rating Scale ◽  
Extrapyramidal Symptom ◽  
Involuntary Movement ◽  
Abnormal Involuntary Movement Scale ◽  
Symptom Rating

scholarly journals 140 Effects of Long-Term Valbenazine on Tardive Dyskinesia in KINECT 4: Post Hoc Response and Shift Analyses

CNS Spectrums ◽  
2020 ◽  
Vol 25 (2) ◽  
pp. 289-289
Author(s):  
Stephen R. Marder ◽  
Cynthia L. Comella ◽  
Carlos Singer ◽  
Khodayar Farahmand ◽  
Roland Jimenez
Keyword(s):  
Tardive Dyskinesia ◽  
Dose Reduction ◽  
Open Label ◽  
Item Score ◽  
Once Daily ◽  
Medical Disorders ◽  
Score Improvement ◽  
Long Term Treatment ◽  
Post Hoc

Abstract:Study Objective:Valbenazine (VBZ) is a highly selective vesicular monoamine transporter 2 (VMAT2) inhibitor approved for the treatment of tardive dyskinesia (TD), a persistent and potentially disabling movement disorder associated with prolonged antipsychotic exposure. Post hoc response and shift analyses were conducted using Abnormal Involuntary Movement Scale (AIMS) data from KINECT 4 (NCT02405091), a long-term open-label study in which participants received up to 48 weeks of open-label treatment with once-daily VBZ (40 or 80 mg).Methods:KINECT 4 included participants who met the following criteria: ages 18 to 85 years; DSM-IV diagnosis of schizophrenia, schizoaffective disorder, or mood disorder; neuroleptic-induced TD for ≥3 months prior to screening; stable psychiatric status (Brief Psychiatric Rating Scale score <50); no high risk of active suicidal ideation or behavior. Stable doses of concomitant medications to treat psychiatric and medical disorders were allowed. VBZ dosing was initiated at 40 mg, with escalation to 80 mg at Week 4 based on clinical assessment of TD and tolerability; a dose reduction to 40 mg was allowed if 80 mg was not tolerated. AIMS responses, ranging from ≥10% to 100% improvement from baseline in AIMS total score (sum of items 1-7), were analyzed at Week 48 based on scoring by site investigators. AIMS shift, conducted for each item (representing 7 different body regions), was defined as an improvement from a score ≥3 (moderate/severe) at baseline to a score ≤2 (none/minimal/mild) at Week 48.Results:103 participants had an available AIMS assessment at Week 48 (40 mg, n=20; 80 mg, n=83 [including 9 with a dose reduction]). At Week 48, 94.2% of participants had ≥30% total AIMS score improvement (40 mg, 90.0%; 80 mg, 95.2%) and 86.4% had ≥50% improvement (40 mg, 90.0%; 80 mg, 85.5%). The percentage of participants meeting the remaining AIMS response thresholds ranged from 9.7% (for 100% response) to 97.1% (for ≥10% response). In participants who had an AIMS item score ≥3 at baseline, shifts to a score ≤2 at Week 48 were as follows: 100% for lips, upper extremities, and lower extremities (VBZ 40 mg and 80 mg). Shift rates for the remaining regions were as follows (40 mg, 80 mg): face (100% [9/9], 96.9% [31/32]), jaw (100% [10/10], 97.6% [40/41]), tongue (100% [11/11], 97.9% [47/48]), trunk (87.5% [7/8], 88.9% [16/18]).Conclusions:After 48 weeks of treatment with once-daily VBZ (40 or 80 mg), >85% of KINECT 4 participants had a clinically meaningful AIMS response (≥30% total score improvement), a robust AIMS response (≥50% total score improvement), or an AIMS shift (from item score ≥3 at baseline to score ≤2 at Week 48). These results suggest that VBZ is an appropriate long-term treatment for many adults with TD.Funding Acknowledgements:This study was sponsored by Neurocrine Biosciences, Inc.

Correlates of the Abnormal Involuntary Movement Scale in Veterans With Tardive Dyskinesia

2020 ◽  
Vol 40 (4) ◽  
pp. 373-380 ◽  
Author(s):  
Stanley N. Caroff ◽  
Shirley H. Leong ◽  
Christopher B. Roberts ◽  
Rosalind M. Berkowitz ◽  
E. Cabrina Campbell
Keyword(s):  
Tardive Dyskinesia ◽  
Involuntary Movement ◽  
Abnormal Involuntary Movement Scale

Orofacial Dyskinesia, Cognitive Function and Medication

1986 ◽  
Vol 149 (2) ◽  
pp. 216-220 ◽  
Author(s):  
Philip Thomas ◽  
Ralph McGuire
Keyword(s):  
Regression Analysis ◽  
Cognitive Function ◽  
Tardive Dyskinesia ◽  
Involuntary Movement ◽  
The Other ◽  
Orofacial Dyskinesia ◽  
Duration Of Treatment ◽  
Delayed Recall ◽  
Abnormal Involuntary Movement Scale ◽  
Abnormal Movements

The presence of tardive dyskinesia in a sample of 43 patients with schizophrenia and 37 psychopaths who had been hospitalised for many years and exposed to large amounts of medication was assessed while testing their cognitive function. Subjects who showed no evidence of abnormal movements performed significantly better on the test of delayed recall, but there were no differences in performance on any of the other tests of cognitive function used. Multiple regression analysis revealed that age and the total lifetime dose of neuroleptic medication received (in chlorpromazine equivalents) were the only variables to predict the Abnormal Involuntary Movement Scale score, although a large amount of variance in this variable was unaccounted for. The duration of treatment with neuroleptics did not predict AIMS score.

scholarly journals 150 Estimation of an MCID for AIMS Total Score Change in Tardive Dyskinesia

CNS Spectrums ◽  
2018 ◽  
Vol 23 (1) ◽  
pp. 93-93
Author(s):  
Martha Sajatovic ◽  
Andrew J. Cutler ◽  
Khodayar Farahmand ◽  
Joshua Burke ◽  
Scott Siegert ◽  
...  
Keyword(s):  
Tardive Dyskinesia ◽  
Involuntary Movement ◽  
Controlled Clinical Trials ◽  
Double Blind ◽  
Meaningful Improvement ◽  
Pooled Data ◽  
Study Participants ◽  
Median Maximum ◽  
Maximum Minimum ◽  
Funding Acknowledgements

AbstractBackgroundThe efficacy of valbenazine (INGREZZA) in tardive dyskinesia (TD) was demonstrated in placebo-controlled clinical trials, based on the Abnormal Involuntary Movement Scale (AIMS) total score (sum of items 1-7). In these trials, mean changes in the AIMS total score were significantly greater with valbenazine 80 mg than with placebo. Currently, no minimal clinically important difference (MCID) has been established for the AIMS total score in patients with TD. Using valbenazine trial data, analyses were conducted to establish a MCID for AIMS total score in TD.MethodsData were pooled from three 6-week trials: KINECT (NCT01688037), KINECT 2 (NCT01733121), KINECT 3 (NCT02274558). Using the Clinical Global Impression ofChange (CGI-TD) as an anchor comparison, AIMS total score changes from baseline to Week 6 were summarized for all study participants (pooled valbenazine and placebo groups) with a “minimal” CGI-TD score of ≤3 (minimally improved or better) or “robust” ≤2 (much improved or better) at Week 6.ResultsIn the pooled population (N=373), 72% and 29% of all participants had CGI-TD scores of ≤3 and ≤2, respectively. The median (maximum, minimum) change from baseline in AIMS total score at Week 6 was -2 (-13, 8) in participants with CGI-TD score ≤3 and -3 ( 13, 8) in participants with a score ≤2.ConclusionPooled data from 3 randomized, double-blind, placebo-controlled trials suggest that a 2 point decrease in AIMS total score may represent the minimal clinically meaningful improvement. Larger AIMS score improvements were associated with “much improved” or “very much improved” CGI TD assessments.Funding AcknowledgementsThis study was funded by Neurocrine Biosciences, Inc.

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