Log In

Forgot Password?
Create New Account

Loading... please wait

Abstract Details

Real-world Safety and Effectiveness of Cannabidiol (CBD) in Adults with Treatment-resistant Epilepsies (TREs): Long-term Results from the United States Expanded Access Program (EAP)
Epilepsy/Clinical Neurophysiology (EEG)
P8 - Poster Session 8 (5:30 PM-6:30 PM)
1-002

Four-year results from the overall EAP population (mean age, 13.5 years) reported seizure reduction associated with long-term CBD use.

To present the effectiveness and safety results of CBD in adult patients with TREs from the EAP.

Patients received plant-derived highly purified CBD (Epidiolex®; 100 mg/mL oral solution) increasing from 2–10 mg/kg/d to tolerance or maximum of 25–50 mg/kg/d. Percentage change from baseline in median monthly frequency of convulsive and total seizures and responder rates (RRs) across 12-week intervals through 144 treatment weeks were evaluated.

Within the overall safety population (n=892), 193 (22%) patients were adults (mean age [range]: 27.3 [18.0–74.5] years). Median (range) of ASMs at baseline: 3 (1–7). Most common ASMs: clobazam (37%), levetiracetam (34%), lamotrigine (33%). Median (range) CBD exposure: 733 (15–1742) days. Median (IQR) top CBD dose: 25 (21–35) mg/kg/d. In the efficacy analysis set (n=182), baseline median (IQR) monthly frequency of convulsive and total seizures was 22 (6–60) and 40 (15–100), respectively. CBD treatment was associated with median reductions from baseline of 45%–64% (convulsive seizures) and 41%–63% (total seizures). Convulsive seizure RRs (≥50%, ≥75%, and 100% reduction) were maintained through 144 weeks, ranging from 49%–64%, 27%–39%, and 7%–16% across visit intervals, respectively. Total seizure RRs showed sustained/profound reductions of ≥75% among 25%–38% of patients across visit intervals. AEs occurred in 92% of patients and serious AEs in 39%; 8% withdrew because of AEs. Two deaths occurred, both deemed unrelated to treatment. Most common treatment-related AEs (≥20%) were diarrhea (49%) and somnolence (24%). Liver-related AEs (>1%) were increased ALT, increased AST, and abnormal liver function test (5% each).

Add-on CBD was associated with seizure reduction through 144 weeks with an acceptable safety profile in adult patients with TRE, supporting its long-term use in a real-world setting.
Authors/Disclosures
Timothy B. Saurer, PhD
PRESENTER
Dr. Saurer has received personal compensation for serving as an employee of Jazz Pharmaceuticals. Dr. Saurer has stock in Jazz Pharmaceuticals.
Jerzy P. Szaflarski, MD, PhD, FAAN (University of Alabama At Birmingham) Dr. Szaflarski has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for UCB Pharma. Dr. Szaflarski has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for LivaNova Inc. Dr. Szaflarski has received personal compensation in the range of $500-$4,999 for serving as a Consultant for PureTech Health. Dr. Szaflarski has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Gidley, Sarli & Marusak, LLP. Dr. Szaflarski has received personal compensation in the range of $5,000-$9,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Elsevier. Dr. Szaflarski has received personal compensation in the range of $5,000-$9,999 for serving as an Expert Witness for Law Firm. Dr. Szaflarski has stock in AdCel Biopharma, LLC. Dr. Szaflarski has stock in iFovea.
No disclosure on file
Farhad Sahebkar-Moghaddam, MD (Amgen) Dr. Sahebkar-Moghaddam has received personal compensation for serving as an employee of Jazz pharmaceuticals. Dr. Sahebkar-Moghaddam has stock in Jazz pharmaceuticals.
Sheryl R. Haut, MD (Albert Einstein College of Medicine) Dr. Haut has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Nile AI. Dr. Haut has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for UCB. Dr. Haut has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Jazz. Dr. Haut has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Ventus. Dr. Haut has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for AbbieVe.