Aripiprazole in the real-world treatment for irritability associated with autism spectrum disorder in children and adolescents in Japan: 52-week post-marketing surveillance

• Published in: BMC psychiatry Vol. 21; no. 1; pp. 204 - 12
• Main Authors: Sugimoto, Yuna, Yamamura, Kayo, Takayama, Tomoyo, Fukuta, Yasuhiko, Aoki, Kazuo, Mikami, Katsunaka, Tomoda, Akemi
• Format: Journal Article
• Language: English
• Published: England BioMed Central 22-04-2021; BMC
• Subjects: Adolescent; Antipsychotic Agents - adverse effects; Aripiprazole; Aripiprazole - adverse effects; Autism; Autism spectrum disorder; Autism Spectrum Disorder - drug therapy; Behavior; Caregivers; Child; Child & adolescent psychiatry; Children and adolescents; Clinical trials; Drug dosages; Humans; Hyperactivity; Irritability; Irritable Mood; Japan; Marketing; Mental disorders; Mental health; Multiple regression analysis; Patients; Pediatrics; Post-marketing surveillance; Product Surveillance, Postmarketing; Prospective Studies; Psychiatry; Psychotropic drugs; Schizophrenia; Sleep; Social interaction; Surveillance; Teenagers; Treatment Outcome; Japan; United States > US; Irritability; Children and adolescents; Aripiprazole; Autism spectrum disorder; Post-marketing surveillance
• ISSN: 1471-244X; 1471-244X
• DOI: 10.1186/s12888-021-03201-6

The purpose of this study was to evaluate the post-marketing safety and effectiveness of aripiprazole in treating irritability in pediatric patients (6-17 years) with autism spectrum disorder (ASD) in actual clinical sites of Japan.
In this post-marketing surveillance, patients were enrolled into the multicenter, prospective, non-interventional, observational study for 52 weeks, and were dosed with aripiprazole (1-15 mg/day) under daily clinical settings in Japan.
In 510 patients, the continuation rate of aripiprazole treatment was 84.6% at day 168 (week 24) and 78.1% at day 364 (week 52). Adverse drug reactions (ADRs) occurred in 22.7% of patients (n = 116), and the most common ADRs were somnolence (9.4%), followed by weight increased (3.3%). At week 4, the mean change from baseline in the irritability subscale score for the Aberrant Behavior Checklist Japanese version (ABC-J) was - 5.7 ± 6.8 (n = 288). Based on multiple regression analysis, comorbid attention deficit and hyperactivity did not affect the ABC-J irritability subscale score at endpoint. At week 24, the mean change from baseline for the Strengths and Difficulties Questionnaire was - 3.3 ± 4.9 (n = 215) for the total difficulties score and 0.6 ± 1.7 (n = 217) for the prosocial behavior subscale score.
Aripiprazole was well tolerated and effective in the long-term treatment of irritability associated with ASD in Japanese pediatric patients in the real-world clinical practice.
This surveillance was registered with Clinical Trial.gov (no. NCT03179787 ) on June 7, 2017 (retrospectively registered).