Abstract Details

Title Time Course of Efficacy and Tolerability Outcomes With Adjunctive Brivaracetam in Adults: A Post Hoc Analysis

Topic Epilepsy/Clinical Neurophysiology (EEG)

Presentation(s) P5 - Poster Session 5 (5:30 PM-6:30 PM)

Poster/Presentation
Number 6-011

Objective To assess the time course of efficacy and tolerability outcomes during adjunctive brivaracetam (BRV) initiated without titration in adults with focal seizures.

Background Most antiepileptic drugs require titration, which can last several weeks. BRV can be initiated at therapeutic dose as was done in clinical trials.

Design/Methods Post hoc analysis of pooled data from three pivotal Phase III trials (N01252, N01253, N01358; NCT00490035, NCT00464269, NCT01261325) of adjunctive BRV in adults with focal seizures. Safety population included patients taking ≥1 dose of study drug; efficacy analysis excluded those on concomitant levetiracetam. Outcomes were assessed weekly over the 12-week evaluation period and included 50% and 75% responder rates (based on focal-onset seizure frequency/week) and treatment-emergent adverse events (TEAEs).

Results In the efficacy population (n=1160), 50% responder rates during Week 1 of treatment were 30.8% placebo (PBO), and 52.8%, 54.1%, and 55.4% for BRV 50, 100, and 200 mg/day; 75% responder rates were 22.8% PBO, and 41.6%, 40.5%, and 45.4% for BRV 50, 100, and 200 mg/day; efficacy was maintained through Week 12. In the safety population (n=1262), drug-related TEAEs during Week 1 were reported by 12.0% PBO, and 25.5%, 25.8%, and 34.0% for BRV 50, 100, and 200 mg/day groups, and decreased thereafter. Discontinuations due to TEAEs were 1.5% PBO, and 2.0%, 2.5%, and 2.0% for BRV 50, 100, and 200 mg/day during Week 1, and decreased thereafter. For the overall BRV population, the most common TEAEs (reported in ≥5% of patients) over the 12-week evaluation period were somnolence (15.2%), dizziness (10.8%), headache (9.1%) and fatigue (8.7%); most had onset during Week 1 (22.4%) vs the entire evaluation period (34.0%).

Conclusions A clear efficacy response was observed from the first week of BRV treatment and generally maintained over 12 weeks, while the incidence of TEAEs was highest at Week 1 and decreased thereafter.

Authors/Disclosures
Kimford J. Meador, MD, FAAN (Stanford University School of Medicine) PRESENTER	The institution of Dr. Meador has received research support from NIH. The institution of Dr. Meador has received research support from The Epilepsy Consortium.
Cedric Laloyaux, PhD (UCBMedical Affairs Center of Expertise)	Dr. Laloyaux has received personal compensation for serving as an employee of UCB.
	No disclosure on file
Teresa D. Gasalla, MD (UCB Biosciences Inc)	Dr. Gasalla has received personal compensation for serving as an employee of UCB Biosciences Inc. Dr. Gasalla has stock in UCB Pharma.
Jesse Fishman, PharmD	No disclosure on file
Melinda S. Martin, PhD	Dr. Martin has received personal compensation for serving as an employee of UCB. Dr. Martin has received stock or an ownership interest from UCB.
Pavel Klein, MD, FAAN (Mid-atlantic Epilepsy and Sleep Center)	The institution of Dr. Klein has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Aquestive. The institution of Dr. Klein has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Neurelis. The institution of Dr. Klein has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for UCB Pharma. The institution of Dr. Klein has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for SK Life Sience. The institution of Dr. Klein has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Eisai. The institution of Dr. Klein has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. The institution of Dr. Klein has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Alliance. The institution of Dr. Klein has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Arvelle Therapeutics. Dr. Klein has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Aquestive. Dr. Klein has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Eisai. Dr. Klein has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for UCB Pharma. Dr. Klein has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for SK Life Sciences. Dr. Klein has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Sunovion. Dr. Klein has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for PrevEp. Dr. Klein has received personal compensation in the range of $500-$4,999 for serving as an Expert Witness for Fenwick . Dr. Klein has received research support from DOD/CURE.

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