Abstract Details

Title Long-term Tolerability and Efficacy of Adjunctive Brivaracetam in Pediatric Patients with Primary Generalized Seizures: Subgroup Analysis of an Open-label, Follow-up Trial

Topic Epilepsy/Clinical Neurophysiology (EEG)

Presentation(s) P8 - Poster Session 8 (8:00 AM-9:00 AM)

Poster/Presentation
Number 9-009

Objective Assess long-term safety/tolerability/efficacy of adjunctive brivaracetam in children with primary generalized seizures (PGS).

Background Safety/tolerability/efficacy of brivaracetam in children with epilepsy have been demonstrated for up to 9.5 years of exposure.

Design/Methods Subgroup analysis of phase 3, open-label, long-term trial (N01266/NCT01364597; patients aged <17 years at core trial entry; ≤5 mg/kg/day brivaracetam tablet/oral solution [≤200 mg/day]). Pre-specified seizure-related outcomes were assessed for patients aged <2/≥2 years at core trial entry using daily record-card data. Kaplan-Meier-estimated brivaracetam retention and change in Achenbach Child Behavior Checklist (CBCL) 1.5-5/6-18 scores were assessed post-hoc.

Results 68 patients had PGS at baseline (50.0% male; mean age: 6.7 years; median modal brivaracetam dose 3.63 mg/kg/day). 14 (20.6%)/54 (79.4%) patients were aged <2/≥2 years. 28 (41.2%) patients completed the trial; most common reasons for discontinuation (≥10% of patients): adverse event (22.1%), lack of efficacy (17.6%), withdrawn consent (11.8%). Kaplan-Meier-estimated retention at 12/36/60 months: 61.8%/47.7%/43.3%; similar proportions of patients discontinued due to treatment-emergent adverse events (TEAEs) or lack of efficacy. 61 (89.7%) patients had TEAEs (drug-related 19 [27.9%]; serious 25 [36.8%]; discontinuations 15 [22.1%]). In patients aged <2/≥2 years, median percent reduction in 28-day-adjusted total seizure frequency from baseline to end of evaluation period was 66.7%/56.9% (n=12/n=36); 50.0%/60.6% had ≥50% response in all seizures (n=12/n=33). 2/54 (3.7%) patients aged ≥2 years were seizure-free (entire evaluation period). Mean changes from baseline to last evaluation in Achenbach CBCL 1.5-5 raw syndrome scores (n=18) fluctuated around 0 and were of minimal/small amplitude, suggesting stability. Mean changes from baseline in Achenbach CBCL 6-18 raw syndrome scores (n=20) showed small numerical improvements for most syndromes. At last evaluation, most patients remained in baseline T-score categories (range: 61.1%-100%).

Conclusions Long-term adjunctive brivaracetam was well-tolerated and efficacious in children with PGS at baseline. Behavior/emotional function were generally stable (CBCL 1.5-5) or slightly improved (CBCL 6-18) during brivaracetam treatment.

Authors/Disclosures
Brian D. Moseley, MD PRESENTER	Dr. Moseley has received personal compensation for serving as an employee of UCB. Dr. Moseley has received personal compensation for serving as an employee of Neurocrine Biosciences Inc. Dr. Moseley has or had stock in UCB.
Lieven G. Lagae, PhD (University Hospital Gasthuisberg)	Dr. Lagae has nothing to disclose.
Christine de la Loge	The institution of Mrs. de la Loge has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for UCB.
Sami Elmoufti, MBBS	Dr. Elmoufti has nothing to disclose.
Jan-Peer Elshoff, PhD (Schwarz Biosciences GmbH)	Dr. Elshoff has nothing to disclose.
Kristy L. Pucylowski, PharmD (UCB, Inc.)	Dr. Pucylowski has received personal compensation for serving as an employee of UCB, Inc.. Dr. Pucylowski has stock in UCB, Inc..
Dimitrios Bourikas (UCB)	Dr. Bourikas has nothing to disclose.

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