Patient Case: 15-Year-Old ADHD Patient Treated With a Nonstimulant

PATIENT CASE

Review the clinical considerations, therapeutic history, and need for symptom improvement that led to nonstimulant ADHD treatment for 15-year-old Jeff.

INDICATION

Qelbree is indicated for the treatment of ADHD in adults and pediatric patients 6 years and older.

Please see full Important Safety Information to the top left.

 JEFF, 15 YEARS OLD  

❯ Current ADHD treatment: none, recently discontinued low-dose stimulant treatment

❯ Ongoing struggles with attention in school and extracurricular activities: parents talked to his doctor about an adjustment to his ADHD treatment plan

Based on a real patient story. Patient participated in Study 2 (P302) and the open-label extension (OLE/P310).¹ Patient name and images have been changed. Individual results may vary.
 

 CLINICAL CONSIDERATIONS:  

• Inattention and hyperactivity were causing significant impairment in school and at home
• Evaluation scheduled due to decreased appetite and moodiness on prior therapy. Caregiver also wanted symptom coverage for homework after soccer practice
   

 JEFF'S THERAPEUTIC HISTORY:  

• Diagnosed with ADHD at age 10; pediatrician tried multiple stimulants
• The first treatment was stopped due to decreased appetite and weight loss, despite a dose decrease
• Switched to another long-acting stimulant but became blunted in the morning and then moody when it wore off in the afternoon
• Behavior counseling and dietary interventions (without medication) were tried 
• Eventually referred to a psychiatrist and started on a nonstimulant; treatment was only partially effective and Jeff had some nausea
• Switched to another nonstimulant but could not tolerate treatment due to sedation
• Managed with low doses of stimulant, with some residual symptoms; side effects prevented dose increase
   

 JEFF'S NEED FOR ADDITIONAL SYMPTOM IMPROVEMENT:  

• Inattentive symptoms made it hard to pay attention in class and to focus on his homework; Jeff’s grades suffered
• ADHD-RS-5 score prior to enrolling in Study 2 (P302) was 40 (Moderately ill)
  • Moderate impairment on CGI-S
• Despite being the best player on his soccer team, Jeff had trouble listening to his coach and often was out of position or doing the wrong drill during practice
   

 CLINICAL TRIALS^1,2:  

STUDY 2 (P302)^1,2 Randomized, double-blind, placebo-controlled, fixed-dose, parallel-group, multicenter study of children 12 to 17 years of age with ADHD, with a baseline ADHD-RS-5 total score ≥28 and CGI-S ≥4. The primary endpoint was CFB in the ADHD-RS-5 total score at EOS. Results: Total score at EOS was significantly reduced with Qelbree vs placebo. The CFB in ADHD-RS-5 total score at EOS (LS mean ± SE) was -16.0 ± 1.45 for Qelbree 200 mg/day, -16.5 ± 1.38 for Qelbree 400 mg/day, and -11.4 ± 1.37 for placebo.

OLE (P310)¹ Patients who completed a previous double-blind study of Qelbree for the treatment of ADHD were eligible to enroll in an open-label safety trial. Patients 12 to 17 years of age were initially treated at 200 mg/day, and dose could be adjusted by 200 mg/week to a range of 100 mg to 400 mg/day, based on clinical response.

STUDY 2²: Primary analysis is based on mITT population; EOS=Week 8.
OLE 310¹: Analysis populations: All subjects who have documented informed consent and have taken at least 1 dose of Qelbree during the OLE were in the safety population.

Qelbree treatment results may be found below.

Abbreviations: ADHD-RS-5, Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition; CFB, change from baseline; CGI-S, Clinical Global Impression-Severity of Illness; EOS, end of study; LS mean, least-squares mean; mITT, modified intent to treat; SE, standard error.

IMPORTANT SAFETY INFORMATION

• Suicidal thoughts and behaviors: Closely monitor all Qelbree-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy, and at times of dosage changes
   

Please see full Important Safety Information to the top left.

 TREATMENT WITH QELBREE¹:  

• Jeff completed the 8-week double-blind study (Study P302) where he received Qelbree 200 mg/day*
  • Jeff’s ADHD-RS-5 total score at EOS was 23
• Jeff then entered the open-label treatment study (OLE/P310) where he was started on Qelbree 200 mg/day for 1 week, then increased to Qelbree 400 mg/day
• Jeff experienced some mild sedation, so the dose was decreased to Qelbree 300 mg/day
• After 2 weeks, both Jeff and his mother continued to see improvement in his ADHD symptoms  

*During the clinical trial, Jeff, his parents, and his treatment team were blinded to dose.
 

IMPORTANT SAFETY INFORMATION

• Heart rate, blood pressure increases: Qelbree can cause an increase in diastolic blood pressure and heart rate. Assess these measures prior to starting therapy, following increases in dosage, and periodically during therapy
   

Please see full Important Safety Information to the top left.

Please see full Prescribing Information, including Boxed Warning.

Learn more about Qelbree at QelbreeHCP.com.

References:

1. Data on file, Supernus Pharmaceuticals, Inc.
2. Qelbree [package insert]; Rockville, MD; Supernus Pharmaceuticals, Inc.

QBE.2023-0201