Austedo does not improve tics in pediatric patients with Tourette syndrome

06 October 2021

2 minutes reading

Source/Revelations

disclosures:
Jankovic reports that he has received research and/or training funding from Allergan Inc., the CHDI Foundation, Civitas/Acorda Therapeutics, Dystonia Coalition, Dystonia Medical Research Foundation, F. Hoffmann-La Roche, Huntington Study Group, Medtronic Neuromodulation, Merz Pharmaceuticals , Michael J Fox Foundation for Parkinson’s Research, NIH, Neurocrine Biosciences, Parkinson’s Foundation, Nuvelution, Parkinson Study Group, Pfizer, Prothena Biosciences, Psyadon Pharmaceuticals, Revance Therapeutics, Teva Pharmaceuticals and US WorldMeds, as well as an advisor and member of the advisory board for Teva Pharmaceuticals outside the submitted work. See the study for the relevant financial disclosures from Jankovic and all other authors.

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According to the results of a randomized clinical trial published in JAMA Network Open, Austedo has not effectively treated the tics associated with Tourette syndrome in children and adolescents.

The study revealed no new safety signals for Austedo (deutetrabenazine; Teva Pharmaceuticals), a vesicular monoamine transporter 2 inhibitor approved by the FDA for the treatment of chorea associated with Huntington’s disease and tardive dyskinesia in adults.

“In a pilot study in adolescents with [Tourette syndrome (TS)], deutetrabenazine was generally well tolerated and significantly reduced the severity of the tic,” Joseph Jankovic, MNS, from Baylor College of Medicine in Texas, and colleagues wrote. “Based on these results, clinical development of deutetrabenazine was continued in the Alternatives for Reducing Tics in TS (ARTISTS) program.

“Here we report results from the ARTISTS 1 study, which evaluated the efficacy, safety, and tolerability of flexible, response-driven doses of deutetrabenazine in children and adolescents with TS,” she added.

According to the Yale Global Tic Severity Scale-Total Tic Score (YGTSS-TTS), the researchers analyzed data from children and adolescents ages 6 to 16 with TS and active tics that caused anxiety or disability. They randomly assigned 59 participants to deutetrabenazine (mean age 11.5 years; 90% boys) and 60 participants to placebo (mean age 11.5 years; 85% boys), titrated over 7 weeks to an optimal level. They followed this up with a 5-week maintenance period. A total of 48 mg per day represented the maximum daily dose of deutetrabenazine.

Change from baseline to week 12 in YGTSS-TTS served as the primary efficacy endpoint. Changes in Gilles de la Tourette syndrome Gilles de la Tourette quality of life activities of daily living subscale score served as important secondary endpoints.

Jankovic and colleagues evaluated safety based on treatment-emergent adverse events, vital signs, questionnaires, and laboratory parameters.

The results showed no significant difference in YGTSS-TTS score at week 12 between the two groups, with a least squares mean of –0.7 (95% CI, –4.1 to 2.8). Researchers reported that the groups had no nominally significant differences for key secondary endpoints. A total of 38 (66%) patients who received deutetrabenazine and 33 (56%) who received placebo had treatment-emergent adverse events that were generally mild or moderate.

“The reason for the decreased improvement with deutetrabenazine from weeks 9 to 12, while the placebo effect increased, is unknown,” Jankovic and colleagues wrote. “This is consistent with the findings of the phase 3 ARTISTS 2 study, which at the end of the study found that fixed doses of deutetrabenazine showed favorable numerical differences, but did not significantly reduce tics in TS compared to placebo.

“Future review of pharmacokinetic data collected during these studies may provide insight into whether responses to deutetrabenazine differ based on drug exposure and active drug metabolites,” she added.

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