Abstract Details

Title Efficacy and Tolerability of Adjunctive Brivaracetam in Adults With Focal Seizures by Antiepileptic Drug Treatment History: Post Hoc Analysis

Topic Epilepsy/Clinical Neurophysiology (EEG)

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

Poster/Presentation
Number 6-006

Objective To evaluate the efficacy and tolerability of adjunctive brivaracetam (BRV) in adults with focal seizures by the number of lifetime antiepileptic drugs (AEDs).

Background Evidence suggests that the clinical response to a newly administered AED is highly dependent on the past AED treatment history (Schiller and Najjar, Neurology 2008;70(1):54-65).

Design/Methods

Post hoc analysis of a randomized, double-blind, placebo-controlled, phase 3 trial (N01358; NCT01261325) of adjunctive BRV in patients (≥16 years) with focal seizures. Efficacy and tolerability outcomes during 12-week BRV (100 and 200 mg/day combined) or placebo (PBO) treatment were assessed in subgroups of patients based on number of lifetime AEDs (stopped before trial drug initiation and ongoing at trial drug initiation).

Results Among patients randomized to BRV, numerically higher 75% responder rates (≥75% seizure reduction) were observed in subgroups with fewer lifetime AEDs (36.0%, 21.2%, 22.2%, 12.3% in the 1-2 [n=75], 3-4 [n=99], 5-6 [n=108], 7+ [n=219] lifetime AEDs subgroups). In PBO patients, 75% responder rates were 26.5%, 6.9%, 3.7%, 4.4% in the subgroups with 1-2 (n=34), 3-4 (n=58), 5-6 (n=54), 7+ (n=113) lifetime AEDs. The Kaplan-Meier estimated proportion of patients who achieved a ≥75% decrease in seizure frequency from the first day of BRV treatment, which was sustained through the entire 12-week evaluation period, was 21.3% (PBO 11.8%), 10.1% (PBO 1.7%), 13.9% (PBO 0%), 4.6% (PBO 1.8%) in the 1-2, 3-4, 5-6, 7+ lifetime AEDs subgroups. The proportion of patients who discontinued BRV due to treatment-emergent adverse events increased with the number of lifetime AEDs (1.3%, 3.0%, 8.3%, 10.5% in the 1-2, 3-4, 5-6, 7+ lifetime AEDs subgroups); corresponding proportions for PBO were 8.8%, 6.8%, 0%, 1.8%.

Conclusions

In adults with focal seizures exposed to fewer AEDs before adjunctive BRV initiation, this post hoc analysis showed numerically higher 75% responder rates and lower discontinuation rates due to adverse events.

Authors/Disclosures
Pavel Klein, MD, FAAN (Mid-atlantic Epilepsy and Sleep Center) PRESENTER	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.
Kathy Foris, MD (UCB Canada Inc)	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file
Christian Brandt, MD (Bethel Epilepsy Center, Mara Hospital)	Dr. Brandt has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Idorsia. Dr. Brandt has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for GW. Dr. Brandt has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Desitin. Dr. Brandt has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Arvelle. Dr. Brandt has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for UCB. Dr. Brandt has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Eisai. Dr. Brandt has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Zogenix. Dr. Brandt has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for GW. Dr. Brandt has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Arvelle. The institution of Dr. Brandt has received research support from Rubin-Stiftung. Dr. Brandt has received publishing royalties from a publication relating to health care.

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