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.

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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/