Abstract Details

Title 12-month effectiveness and tolerability of brivaracetam in the real-world: interim analysis of the international, non-interventional EXPERIENCE study

Topic Epilepsy/Clinical Neurophysiology (EEG)

Presentation(s) P13 - Poster Session 13 (8:00 AM-9:00 AM)

Poster/Presentation
Number 10-002

Objective To evaluate effectiveness and tolerability of brivaracetam (BRV) in routine clinical practice in a large multicenter international patient population (North America/Europe/Australia).

Background This is the first study of sufficient size to describe and assess BRV outcomes among subpopulations of interest.

Design/Methods Retrospective, pooled cohort study (EPD332/EXPERIENCE) of patients initiating BRV in clinical practice. Seizure-freedom and incidence of treatment-emergent adverse events (TEAEs) assessed at 3, 6, and 12 months.

Results Interim analysis including 1,910 patients from Spain/Germany/Australia/United Kingdom/United States (851/503/301/130/125); 52% female; median time since diagnosis: 17 years (N=1,819); 89.5% had focal-onset seizures, 10.6% had generalized-onset seizures at baseline (N=1,855). Most common known etiology (≥10% of patients) was malformation of cortical development (283/1,883 [15.0%]). Most common comorbid conditions (≥10% of patients) were psychiatric (680/1,843 [36.9%]), cognitive/learning disability (451/1,828 [24.7%]), and neurological (357/1,266 [28.2%]). At baseline, patients reported previous use of mean 5.4 historical antiseizure medications (ASMs) (N=1,716) and 2.1 concomitant ASMs (N=931). Patients were treated with BRV for a median of 343.0 days (Q1–Q3, 147.0–410.9 days; N=1,894). Seizure-freedom was reported in 241/886 (27.2%) patients at 3 months, 242/1,020 (23.7%) at 6 months, and 191/804 (23.8%) at 12 months. TEAEs (since prior visit) were reported in 464/1,733 (26.8%) patients at 3 months, 230/1,537 (15.0%) at 6 months, and 128/1,346 (9.5%) at 12 months. Most frequently reported TEAEs (≥15% of patients with specified TEAEs) were fatigue (87/433 [20.1%]), dizziness (72/433 [16.6%]), and irritability (72/433 [16.6%]) at 3 months, somnolence (36/176 [20.5%]) and irritability (31/176 [17.6%]) at 6 months, and somnolence (28/108 [25.9%]) at 12 months. 609/1,904 (32.0%) patients discontinued BRV, mostly due to insufficient effectiveness and tolerability.

Conclusions In this interim pooled analysis in a large real-world setting, BRV appears both effective and well tolerated in this highly drug-resistant cohort. Limitations: mixed populations, variables, and time-points across centers present data harmonization challenges, adding analytic complexity.

Authors/Disclosures
Rajbir Sandhar, PharmD (UCB) PRESENTER	Dr. Sandhar has received personal compensation for serving as an employee of UCB inc. Dr. Sandhar has stock in UCB inc.
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
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.
	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
Florin Floricel (UCB Biosciences GmbH)	No disclosure on file
Tony Daniels	Tony Daniels has received personal compensation for serving as an employee of UCB. Tony Daniels has stock in UCB.
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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