Abstract

BackgroundTo compare clinical and health-related quality of life (HRQoL) outcomes between children and adolescents with ADHD treated with OROS® MPH, using data from two large similarly-designed multicenter, prospective, open-label, single-arm, non-interventional studies.MethodsPooled analysis (42603ATT4037, 42603 - ATT - 4001) including patients (6 to 18 years) with a confirmed diagnosis of ADHD. Patients were treated with OROS® MPH for 12 weeks; ADHD symptoms, functioning, HRQoL, safety and tolerability parameters were assessed.Results822 patients (583 children [6-12 years], 239 adolescents [13-18 years]) were included in the pooled analysis. Mean daily OROS® MPH starting doses in the child and adolescent subgroups were 29.0 ± 11.7 and 37.6 ± 15.6 mg, respectively (p < 0.001). At study end (week 12), the overall mean daily dose was 35.5 ± 14.0 mg, with children and adolescents receiving 32.8 ± 12.7 and 42.0 ± 15.1 mg/day, respectively (p < 0.001). Significant (p < 0.0001: overall population, children, adolescents) symptomatic, functional and HRQoL improvements were observed from baseline to study end using the Conners' Parents Rating Scale (overall: 29.2 ± 10.7 [baseline] to 19.3 ± 11.3 [endpoint]), Children's Global Assessment Scale (overall: 58.5 ± 14.5 [baseline] to 69.6 ± 16.1 [endpoint]), and ILC-LQ0-28. At week 12, between-age group differences were seen in the individual ILC-LQ0-28 parameters: school performance (p = 0.001 [parents' assessment], p = 0.032 [childrens' assessment]), global QoL (p = 0.012 [parents']) and interests and hobbies (p = 0.023 [childrens']). Treating physician's planned continued use of OROS® MPH in 76.9%, 86.0% and 79.3% of children, adolescents and the total population, respectively, at study end (p = 0.029 between-age subgroups). 195 of 822 patients (23.7%) experienced at least one treatment-emergent adverse event; most commonly reported AEs in the total group (≥4%) were insomnia (7.2%), anorexia (4.3%) and involuntary muscle contractions (4.1%). No clinically relevant changes in body weight or vital signs were observed.ConclusionsClinically relevant differences between children and adolescents with ADHD are present. Adolescents appeared to have a lower health related quality of life and functioning compared to children at baseline, however, they were able to reach comparable ratings at endpoint for most items. Similarly, burden of disease decreased in patients and their carers. OROS MPH was generally safe and well tolerated.

Highlights

  • To compare clinical and health-related quality of life (HRQoL) outcomes between children and adolescents with ADHD treated with OROS® MPH, using data from two large -designed multicenter, prospective, open-label, single-arm, non-interventional studies

  • Study design and participants This pooled analysis combines data from two similarlydesigned large multicenter, prospective, open-label, single-arm, non-interventional studies which explored the efficacy, safety, tolerability and HRQoL outcomes of children and adolescents with ADHD treated with individualised dosing of OROS® MPH (Concerta®; Janssen Cilag GmbH, Germany) over a 12-week treatment period

  • Patients had been treated with either atomoxetine, extended-release (ER) methylphenidate (GER-CON-2), or any ADHDrelevant psychostimulant (LeCO), before they started on OROS MPH

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Summary

Introduction

To compare clinical and health-related quality of life (HRQoL) outcomes between children and adolescents with ADHD treated with OROS® MPH, using data from two large -designed multicenter, prospective, open-label, single-arm, non-interventional studies. The effects of ADHD in children are well-documented, impacting negatively on the child, peer group interaction, immediate family and home life as well as on the child’s educational performance at school [1,2]. Numerous follow-up studies of children with ADHD show that the disorder persists during adolescence and adulthood in around twothirds of individuals with persistence of symptoms associated with continued clinical and psychosocial impairments [5]. Combined with continued learning disabilities, adolescents with ADHD demonstrate impaired interpersonal relationships at school/college and at home, have significantly fewer close friends, more problems maintaining friendships, increased antisocial behavioural problems, greater parent-child conflict and parental hostility, and considerable overall negative impact as they progress into adulthood [1,2]

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