Abstract Details

Title Real-world Adverse Event Profile and Comorbidity Index in Children and Adolescents with Tourette Syndrome (TS) Treated with Dopamine D2 Receptor Antagonists

Topic Child Neurology and Developmental Neurology

Presentation(s) P11 - Poster Session 11 (11:45 AM-12:45 PM)

Poster/Presentation
Number 8-011

Objective This study explored real-world adverse events (AEs) in children and adolescents with TS treated with dopamine D2 receptor antagonists/partial agonists (D2RAs).

Background Psychiatric comorbidities are prevalent in TS populations. D2RAs reduce tic severity but pose a substantial risk of AEs.

Design/Methods This was a retrospective health records database (TriNetX Dataworks-USA Network) analysis. A D2RA-exposed cohort was indexed at first D2RA medication record (2011-2021) with prior TS diagnosis (ICD-9-CM:307.23/ICD-10-CM:F952). A nonexposed cohort was indexed at a randomly selected record with TS diagnosis (2011-2021). Individuals (6-17 years) had ≥1 provider encounter during baseline/follow-up (18 months before/after index). Cohorts were exact-matched (age group/index year/region/sex). Baseline comorbidity index was calculated using a validated pediatric comorbidity index (higher scores represented increased hospitalization risk). Incident AEs (per diagnosis codes/anthropometric data/laboratory results) were identified during follow-up and cohorts compared using standardized mean difference (SMD; ≥|0.10| indicated meaningful imbalance).

Results 1684 matched individuals were included in each cohort. Mean (SD) baseline comorbidity index was higher for D2RA-exposed versus nonexposed cohort (3.4 [3.5] vs 2.1 [2.5]; SMD=0.44). During follow-up, the D2RA-exposed cohort was more likely to experience sleep disorders (7.7% vs 2.4%; SMD=0.24), obsessive-compulsive disorder (6.2% vs 2.6%; SMD=0.18), mild (15.0% vs 3.9%; SMD=0.39) and moderate (6.9% vs 1.1%; SMD=0.30) metabolic AEs, depression (6.3% vs 2.7%; SMD=0.18), and suicidal ideation/behavior/attempt (5.8% vs 2.1%; SMD=0.19). Dystonia, akathisia, and tardive dyskinesia were reported in 0.5% (n=8), 0.2% (n=3), and 0.1% (n=1) of patients, respectively, in the D2RA-exposed cohort; none were reported in the nonexposed cohort.

Conclusions In this real-world study of children and adolescents with TS, metabolic and neuropsychiatric AEs were more common among those treated with D2RAs. Alternative treatment strategies and pharmacologic interventions are needed that can provide sustained relief of symptoms with minimal risk of AEs.

Authors/Disclosures
David A. Isaacs, MD (Vanderbilt University Med Center) PRESENTER	The institution of Dr. Isaacs has received research support from NIH NINDS. The institution of Dr. Isaacs has received research support from Teva Branded Pharmaceutical Products, R&D, Inc.. The institution of Dr. Isaacs has received research support from Emalex Biosciences, Inc. Dr. Isaacs has received personal compensation in the range of $0-$499 for serving as a attendee at the annual meeting for Center of Excellence Directors with Tourette Association of America. Dr. Isaacs has a non-compensated relationship as a research collaborator with Emalex Biosciences, Inc that is relevant to AAN interests or activities.
Jason P. Swindle, PhD	Mr. Swindle has nothing to disclose.
Firas Dabbous, PhD	Dr. Dabbous has received personal compensation for serving as an employee of Thermofisher Scientific.
Donald Gilbert, MD, FAAN (Cincinnati Children's Hospital Med. Ctr.)	Dr. Gilbert has received personal compensation in the range of $500-$4,999 for serving as a Consultant for PTC Therapeutics. Dr. Gilbert has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Illumina. Dr. Gilbert has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Emalex Biosciences. The institution of Dr. Gilbert has received research support from NIMH. The institution of Dr. Gilbert has received research support from Emalex Biosciences. The institution of Dr. Gilbert has received research support from PTC Therapeutics. The institution of Dr. Gilbert has received research support from Department of Defense. The institution of Dr. Gilbert has received research support from Quince Therapeutics. Dr. Gilbert has received publishing royalties from a publication relating to health care. Dr. Gilbert has received publishing royalties from a publication relating to health care. Dr. Gilbert has received personal compensation in the range of $500-$4,999 for serving as a Medical Second Opinion Expert with Teldoc/Advanced Medical. Dr. Gilbert has received personal compensation in the range of $10,000-$49,999 for serving as a Medical Expert with Department of Health and Human Services/Vaccine Injury Compensation Program.
George Karkanias, PhD (Emalex Biosciences, Inc.)	Dr. Karkanias has received personal compensation for serving as an employee of Emalex Biosciences, Inc.
Sarah Atkinson (Emalex Biosciences)	Sarah Atkinson has received personal compensation for serving as an employee of Emalex Biosciences. Sarah Atkinson has received personal compensation for serving as an employee of World Wide Clinical Trials.
Frederick E. Munschauer III, MD, FAAN (FEMC)	Dr. Munschauer has received personal compensation for serving as an employee of Emalex Biosciences. Dr. Munschauer has stock in Emalex Biosciences.
Safa Mazhar, MBBS	Miss Mazhar has nothing to disclose.
Charlotte A. Pettersson, MSc	Ms. Pettersson has received personal compensation for serving as an employee of PPD Scandinavia AB, part of Thermo Fisher Scientific.
Stephen Wanaski, PhD (Paragon Biosciences)	Dr. Wanaski has received personal compensation for serving as an employee of Paragon Biosciences. Dr. Wanaski has or had stock in Paragon Biosciences.Dr. Wanaski has or had stock in Emalex Biosciences.
Timothy Cunniff, PharmD	Dr. Cunniff has received personal compensation for serving as an employee of Paragon Biosciences. Dr. Cunniff has stock in Harmony Biosciences. Dr. Cunniff has stock in Emalex Biosciences.
Kinga Tomczak, MD, PhD (Boston Children's Hospital Tic Disorders and Tourette Syndrome Program)	The institution of Dr. Tomczak has received research support from Emalex Biosciences, Inc.. Dr. Tomczak has a non-compensated relationship as a collabolator with Emalex Biosciences, Inc. that is relevant to AAN interests or activities.

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