Category: Other
Objective: To evaluate the effectiveness, dosing patterns, and patient treatment satisfaction in patients with tardive dyskinesia treated with deutetrabenazine using a 4-week titration kit.
Background: Deutetrabenazine is a vesicular monoamine transporter type 2 inhibitor for treatment of adults with tardive dyskinesia (TD) and Huntington disease (HD)–related chorea. A 4-week titration kit was launched in July 2021 to assist patients in titrating to optimal deutetrabenazine dosages.
Method: START was a noninterventional, 2-cohort (TD/HD) study evaluating deutetrabenazine effectiveness, dosing patterns, and treatment satisfaction using a 4‑week patient titration kit, with further titration allowed based on effectiveness and tolerability. The final results from the patients enrolled in the TD cohort are presented in this analysis.
Results: Of the 53 TD patients (mean age, 58.1 years; mean baseline Abnormal Involuntary Movement Scale [AIMS] total motor score, 13.6), 72% successfully completed the kit within 5 weeks or reached minimal therapeutic dose of ≥24 mg/day within 4 weeks. The mean (SE) adherence rate with the kit was 96% (1.27%). At weeks 4, 8, 12 (primary endpoint), and 24, 15/52 (29%), 17/50 (34%), 25/52 (48%), and 25/51 (49%) patients, respectively, achieved treatment success (“much”/“very much” improved) per Clinical Global Impression of Change and 17/52 (33%), 18/50 (36%), 23/52 (44%), and 26/51 (51%) per Patient Global Impression of Change. Total motor AIMS scores decreased by a mean of 6.3 (45%) from baseline to week 24. Mean (SE) deutetrabenazine doses were 28.1 (0.83) mg/day at week 4, 33.0 (1.03) mg/day at week 8, 32.6 (1.15) mg/day at week 12, and 33.5 (1.13) at week 24. Of the 40 patients reaching week 24, 39 (98%) had a maintenance dose ≥24 mg/day. 28/41 (68%) patients found it easy to understand when to take which dose, 32/41 (78%) to use the kit overall, and 31/41 (76%) found it easy to change doses weekly and found the kit helpful to remember taking medication. There were 11/53 (21%) patients who had an adverse event (AE), leading to dose reduction for 1, drug interruption for 1, and study discontinuation for 2 patients.
Conclusion: The 4-week titration kit enabled patients to titrate to minimal therapeutic deutetrabenazine dosages with effectiveness similar to that of pivotal clinical trials and with high adherence rates and patient satisfaction.
To cite this abstract in AMA style:
K. Anderson, M. Konings, S. Finkbeiner, J. Bennett, M. Asim Nisar, G. Alva, A. Cutler. Effectiveness of Deutetrabenazine for Tardive Dyskinesia When Initiated Using a 4-Week Patient Titration Kit: Final Results of the START Study [abstract]. Mov Disord. 2024; 39 (suppl 1). https://www.mdsabstracts.org/abstract/effectiveness-of-deutetrabenazine-for-tardive-dyskinesia-when-initiated-using-a-4-week-patient-titration-kit-final-results-of-the-start-study/. Accessed October 9, 2024.« Back to 2024 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/effectiveness-of-deutetrabenazine-for-tardive-dyskinesia-when-initiated-using-a-4-week-patient-titration-kit-final-results-of-the-start-study/