Abstract Details

Title 12-Month Effectiveness and Tolerability of Brivaracetam in the Real-World: The International EXPERIENCE Pooled Analysis

Topic Epilepsy/Clinical Neurophysiology (EEG)

Presentation(s) P11 - Poster Session 11 (11:45 AM-12:45 PM)

Poster/Presentation
Number 9-003

Objective Effectiveness and tolerability of brivaracetam (BRV) in routine practice were assessed in a large international population (United States/Europe/Australia).

Background To date, real-world evidence studies of BRV have been restricted in scope, location, and numbers, limiting identification of trends in BRV response and tolerability.

Design/Methods EXPERIENCE/EPD332 is a meta-analysis of patient-level data from patients with epilepsy initiating BRV in clinical practice. Effectiveness and tolerability outcomes were assessed at 3/6/12 months. Patients with missing data after BRV discontinuation were considered non-responders/not seizure free. Subgroup analyses were performed by number of prior antiseizure medications (ASMs).

Results Analyses included 1644 adults; 92.2%/7.7% had focal-onset/generalized-onset seizures at baseline (mean: 5.5 prior ASMs at baseline [n=1620], 2.1 concomitant ASMs at index [n=1644]). Median BRV duration: 345.5 days (Q1–Q3, 131.5–410.9; n=1629); median dose at index: 100 mg/day (Q1–Q3, 50.0–100.0; n=1615). ≥50% seizure reduction from baseline at 3/6/12 months: 32.1%/36.7%/36.9% (n=619/867/822); seizure freedom (SF; no seizures within 3 months before timepoint): 22.4%/17.9%/14.9% (n=923/1165/1111); continuous SF after baseline (CSF; no seizures reported for any timepoint after baseline): 22.4%/15.7%/11.7% (n=923/1165/1111). Treatment-emergent adverse events (TEAEs) since prior visit: 25.6%/14.2%/9.3% of patients at 3/6/12 months (n=1542/1376/1232). At 12 months, somnolence was the most common TEAE (2.2%). Of patients with TEAEs at 3/6/12 months, 6.4%/2.6%/2.6% had psychiatric TEAEs and 1.6%/0.8%/0.6% had behavioral TEAEs. During follow-up, 551/1639 (33.6%) patients discontinued BRV. In analyses by number of prior ASMs (n=1620; 0–1/2–3/4–6/≥7 ASMs: 15.4%/21.9%/28.8%/34.0%), ≥50% seizure reduction from baseline generally declined with increasing number of prior ASMs at 3 (48.3%–23.1%), 6 (48.0%–26.5%), and 12 months (45.9%–29.9%), as did SF/CSF. In 0–1/ 2–3/4–6/≥7 ASMs subgroups, TEAE incidences at 12 months were 7.0%/7.4%/11.5%/10.0% (n=214/282/356/359).

Conclusions These analyses suggest BRV was effective and well tolerated in highly drug-resistant cohorts. Limitations: challenging to harmonize variables from different studies with mixed populations.

Authors/Disclosures
Herbert Peeples II, Other (UCB) PRESENTER	Mr. Peeples has received personal compensation for serving as an employee of UCB.
Vicente Villanueva	Vicente Villanueva has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UCB. Vicente Villanueva has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Angelini. Vicente Villanueva has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Xenon. Vicente Villanueva has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Rapport. Vicente Villanueva has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for UCB. Vicente Villanueva has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Angelini. Vicente Villanueva has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for EISAI. Vicente Villanueva has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Paladin. Vicente Villanueva has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Jazz pharmaceutical.
Wendyl J. D'Souza, MD, MBChB	Dr. D'Souza has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for LivaNova, Eisai, UCB, Tilray. Dr. D'Souza has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for UCB Pharma, Eisai Pharmaceutical. Dr. D'Souza has stock in Epiminder. The institution of Dr. D'Souza has received research support from UCB Pharma. The institution of Dr. D'Souza has received research support from Eisai Pharmaceutical.
R E. Faught, Jr., MD, FAAN (Emory University)	Dr. Faught has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Neurelis. Dr. Faught has received personal compensation in the range of $500-$4,999 for serving as a Consultant for LivaNova. Dr. Faught has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for SK Life Science. Dr. Faught has received personal compensation in the range of $500-$4,999 for serving as an Expert Witness for Gideon, Essary, Tardio and Carter PLC, Nashville TN TN law firm. Dr. Faught has received personal compensation in the range of $5,000-$9,999 for serving as an Expert Witness for Friedman Dazio and Zulanas Law Firm Birmingham AL. The institution of Dr. Faught has received research support from UCB Pharma. The institution of Dr. Faught has received research support from Cognizance.
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.
Markus Reuber (Sheffield Teaching Hospitals NHS Trust)	No disclosure on file
Felix Rosenow	No disclosure on file
Javier Salas-Puig	No disclosure on file
Victor Soto Insuga	No disclosure on file
Adam Strzelczyk	Adam Strzelczyk has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Angelini. Adam Strzelczyk has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bicodex. Adam Strzelczyk has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Desitin. Adam Strzelczyk has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Jazz. Adam Strzelczyk has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Takeda. Adam Strzelczyk has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for UCB. Adam Strzelczyk has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for UNEEG.
Jerzy P. Szaflarski, MD, PhD, FAAN (University of Alabama At Birmingham)	Dr. Szaflarski has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UCB Pharma. Dr. Szaflarski has received personal compensation in the range of $500-$4,999 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.
Herve Besson (UCB)	Herve Besson has received personal compensation for serving as an employee of UCB.
Tony Daniels	Tony Daniels has received personal compensation for serving as an employee of UCB. Tony Daniels has stock in UCB.
Florin Floricel (UCB Biosciences GmbH)	No disclosure on file
Cedric Laloyaux, PhD (UCBMedical Affairs Center of Expertise)	Dr. Laloyaux has received personal compensation for serving as an employee of UCB.
Veronica Sendersky (ucb)	No disclosure on file
	No disclosure on file
Bernhard Steinhoff	Bernhard Steinhoff has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Arvelle. Bernhard Steinhoff has received personal compensation in the range of $0-$499 for serving as a Consultant for B.Braun Melsungen. Bernhard Steinhoff has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eisai. Bernhard Steinhoff has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UCB. Bernhard Steinhoff has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neuraxpharm. Bernhard Steinhoff has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Precisis. Bernhard Steinhoff has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Arvelle. Bernhard Steinhoff has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for UCB. The institution of Bernhard Steinhoff has received research support from UCB. The institution of Bernhard Steinhoff has received research support from Eisai. The institution of Bernhard Steinhoff has received research support from SK LIfe Science.

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