Symptomatic and Functional Response and Remission From the Open-Label Treatment-Optimization Phase of a Study With DR/ER-MPH in Children With ADHD

Abstract

Objective: Delayed-release and extended-release methylphenidate (DR/ER-MPH), the first stimulant predicted to be absorbed primarily in the colon, demonstrated significant improvements in attentiondeficit/hyperactivity disorder (ADHD) symptoms and functional impairment from awakening until evening versus placebo in clinical trials. The clinical significance of these improvements was explored post hoc by examining response and remission thresholds as well as safety in the context of dose optimization. Methods: Data from the open-label, treatment-optimization phase of a phase 3 study of DR/ER-MPH in children (aged 6-12 years) with ADHD, as diagnosed by DSM-5 criteria and enrolled between July 2015 and March 2016, were analyzed. Thresholds for response (anchored to Clinical Global Impressions-Improvement scale [CGI-I] score of 1 or 2) and remission were applied to ADHD Rating Scale-IV (ADHD-RS-IV), Before School Functioning Questionnaire (BSFQ), and Parent Rating of Evening and Morning Behavior, Revised, Morning Subscale (PREMB-R AM) and Evening Subscale (PREMB-R PM) scores. Rates of response, remission, and treatment-emergent adverse events by starting dose were examined. Results: Mean DR/ER-MPH dose increased from 29.7 mg/d at baseline (51% on 20 mg/d; 49% on 40 mg/d) to 66.2 mg/d at week 6. At week 6, most participants achieved response/remission thresholds

Moderators and Other Predictors of Methylphenidate Response in Children and Adolescents with ADHD

“…There is evidence that when MPH dosage was optimized the majority of patients with ADHD achieved a remission of symptoms and demonstrated functional improvement attaining to the level of non-ADHD peers [18]. However, there is also evidence that the severity of ADHD and comorbid symptoms, such as conduct problems, oppositional and defiant behavior, depression, and substance use may interfere with MPH effect [19][20][21][22].…”

Real-World Efficacy and Safety of Extended-Release Methylphenidate (PRC-063) in the Treatment of ADHD in Pediatric and Adult Subjects: Results of a Phase IV Multicenter Comparison With Lisdexamfetamine Dimesylate

“…A 3-point decrease in the AM scale and a 5-point decrease in the PM scale have been correlated to a Clinical Global Impressions (CGI)-Improvement Score of ≤2 (much or very much improved) ( Wilens et al, 2022 ). Remission has been defined as ≤4 in the AM scale and ≤10 in the PM scale for children 8 years old or younger and ≤3 in the AM scale and ≤8 in the PM scale for children aged 9 years old or older ( A. C. Childress et al, 2021 ). The AAQoL-R assesses the impact of the subject’s ADHD symptomatology on everyday activities and QoL over the past 2 weeks ( Brod et al, 2006 ).…”