Abstract Details

Title Real-world Study of Brivaracetam in the United States

Topic Epilepsy/Clinical Neurophysiology (EEG)

Presentation(s) S13 - Epilepsy/Clinical Neurophysiology (EEG): Antiseizure Medications (1:00 PM-1:12 PM)

Poster/Presentation
Number 001

Background Multicenter, prospective, observational study (EP0088) of patients initiating BRV in the United States (US).

Objective To assess effectiveness of adjunctive brivaracetam (BRV) in adults with focal seizures as measured by retention.

Design/Methods Patients were enrolled if BRV initiation was planned. Main eligibility criteria included a history of focal seizures, age ≥16 years, and lifetime history or concomitant use of ≥1 of four specific antiseizure medications (ASMs): levetiracetam/lamotrigine/oxcarbazepine/carbamazepine. Information on BRV dose, concomitant ASMs, retrospective seizure data, BRV discontinuation, and adverse events was collected at 1.5/3/6/12 months. Retention rates were calculated at 3/6/12 months.

Results

304 patients enrolled at 33 sites; of whom 254 initiated BRV (median time since diagnosis: 17.3 years; 83.6% had ≥1 seizure during 6-month retrospective baseline). Prior ASMs were reported by 98.8% patients (mean: 5.3); concomitant ASMs by 94.5% (mean: 2.3). 162/254 patients completed the study (139 on BRV); 59 discontinued BRV, mainly because of side effects. Most frequent BRV starting doses were ≥100–<150mg/day (48.4%) and ≥50–<100mg/day (34.3%). BRV modal daily doses were ≥100–<150mg/day in 31.5% and 200mg/day in 27.6% patients. Retention of patients on BRV was 183/254 (72.0%; 95% confidence interval: 66.1–77.5) for ≥90 days (3 months), 164/254 (64.6%; 58.3–70.4) for ≥180 days (6 months), and 145/254 (57.1%; 50.8–63.3) for ≥311 days (12 months). Excluding patients who dropped out without a BRV discontinuation visit, 12-month retention on BRV was 145/201 (72.1%; 65.4–78.2). 92 patients (36.2%) dropped out (primary reasons: “consent withdrawn” [42.4%], “lost to follow-up” [35.9%], “other [21.7%]”). 44/157 (28.0%) patients on BRV were seizure-free for 6 months at Month 12 compared with 41/250 (16.4%) during retrospective baseline. Treatment-emergent adverse events (TEAEs) were reported in 126/254 (49.6%) patients (drug-related: 97 [38.2%]; serious: 52 [20.5%]). 41 (16.1%) patients discontinued BRV due to TEAEs.

Conclusions BRV demonstrated long-term effectiveness in this US observational study.

Authors/Disclosures
Hina N. Dave, MD (Debakey VA hospital) PRESENTER	Dr. Dave has nothing to disclose.
Jacqueline French, MD, FAAN (NYU Comprehensive Epilepsy Ctr)	Dr. French has received personal compensation in the range of $50,000-$99,999 for serving as an officer or member of the Board of Directors for Epilepsy Foundation. The institution of Dr. French has received research support from Epilepsy Study Consortium/ Epilepsy Foundation (Funded by UCB). The institution of Dr. French has received research support from GW/One8 Foundation/FACES. The institution of Dr. French has received research support from NINDS. The institution of Dr. French has received research support from Xenon. The institution of Dr. French has received research support from Cerevel. The institution of Dr. French has received research support from FACES. The institution of Dr. French has received research support from UCB. The institution of Dr. French has received research support from Epilepsy Study Consortium. The institution of Dr. French has received research support from UCB. Dr. French has received personal compensation in the range of $100,000-$499,999 for serving as a Chief Medical/Innovation Officer with Epilepsy Foundation. Dr. French has a non-compensated relationship as a Consultant with Angelini that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consultant with Alterity Therapeutics Limited that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consultant with Bright minds Biosciences that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Cerecin Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Cognizance Biomarkers that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Arvelle that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consultant with Beacon biosignals that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, Advisory Board with Biohaven Pharmaceuticals that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Bloom Science Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with BridgeBio Pharma Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consultant, scientific advisory board with Camp4 Therapeutics Corporation that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, Scientific Advisory Board with Cerebral Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Cerevel that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a SAB with Coda Biotherapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Genentech Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Crossject that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Eisai, that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Eliem Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Encoded Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with iQure Pharma that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, SAB with Engrail that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a SAB with Epihunter that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a SAB with Epiminder that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Epitel Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Equilibre BioPharmaceuticals that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consultant with Greenwich Biosciences that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Grin Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with GW Pharma that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Janssen Pharmaceutica that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consultant with Jazz Pharmaceuticals that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Knopp Biosciences that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Lipocine that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with LivaNova that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Longboard Pharmaceuticals that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, SAB with Lundbeck that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, SAB with Marinus that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consultant with Modulight Bio that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Leal therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Neumirna Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant,SAB with Neurocrine that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Neuroelectrics USA Corporation that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Neuronetics Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Ono Pharmaceutical Co that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, SAB with Otsuka Pharmaceutical Development that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, SAB with Ovid Therapeutics Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Paladin Labs Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Rapport Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Praxis that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with PureTech LTY Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consultant with SK Life Sciences that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Stoke that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Supernus that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consultant with Takeda that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, SAB with UCB Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Ventus Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consulting, steering committee with Xenon that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consultant with Korro Bio Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with NeuroPro Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Advisory board with Receptor that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Advisory board with Sage Therpeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Advisory Board with Third Rock Ventures that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Vida Ventures Management that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consulting with Pfizer that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consulting with Agrithera, Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consulting with Autifony therapeutics, Unlimited that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consulting with Baergic Bio that is relevant to AAN interests or activities.
Hamada H. Altalib, DO (VA Connecticut Healthcare System)	The institution of Dr. Altalib has received research support from UCB. The institution of Dr. Altalib has received research support from Eisai. The institution of Dr. Altalib has received research support from Sunovian. The institution of Dr. Altalib has received research support from DEPARTMENT OF DEFENSE - CONGRESSIONALLY DIRECTED MEDICAL RESEARCH PROGRAMS.
Heidi L. Henninger, MD, FAAN (Maine Medical Partners Neurology)	Dr. Henninger has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Guidepoint. Dr. Henninger has received research support from UCB.
Roger J. Porter, MD, FAAN	Dr. Porter has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Xenon. Dr. Porter has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neurocrine. Dr. Porter has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Longboard. Dr. Porter has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Engrail. Dr. Porter has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Axonis. Dr. Porter has received publishing royalties from a publication relating to health care.
Michael Gelfand, MD, PhD (University of Pennsylvania)	Dr. Gelfand has received personal compensation in the range of $0-$499 for serving as a Consultant for Aquestive. Dr. Gelfand has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Livanova. The institution of Dr. Gelfand has received research support from Aquestive. The institution of Dr. Gelfand has received research support from Xenon. The institution of Dr. Gelfand has received research support from Cerevel. The institution of Dr. Gelfand has received research support from UNEEG. The institution of Dr. Gelfand has received research support from Livanova. The institution of Dr. Gelfand has received research support from UCB. The institution of Dr. Gelfand has received research support from SK Pharma. The institution of Dr. Gelfand has received research support from Otsuka.
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.
Prashant Dongre, MD, MBBS (UCB Inc)	Dr. Dongre has received personal compensation for serving as an employee of UCB Inc. Dr. Dongre has stock in UCB Inc.
	No disclosure on file
Anne-Liv Schulz	No disclosure on file
Michael R. Sperling, MD, FAAN (Thomas Jefferson University)	Dr. Sperling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neurelis. The institution of Dr. Sperling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medtronic. Dr. Sperling has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for UCB Pharma. Dr. Sperling has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Medscape. Dr. Sperling has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for International Medical Press. Dr. Sperling has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Projects for Knowledge. The institution of Dr. Sperling has received research support from SK Life Science. The institution of Dr. Sperling has received research support from UCB Pharma . The institution of Dr. Sperling has received research support from Takeda. The institution of Dr. Sperling has received research support from Neurelis. The institution of Dr. Sperling has received research support from Engage Therapeutics . The institution of Dr. Sperling has received research support from Medtronic. The institution of Dr. Sperling has received research support from Cavion. The institution of Dr. Sperling has received research support from Xenon Pharma. The institution of Dr. Sperling has received research support from Cerevel. The institution of Dr. Sperling has received research support from National Institutes of Health . The institution of Dr. Sperling has received research support from DARPA. Dr. Sperling has received publishing royalties from a publication relating to health care. Dr. Sperling has received publishing royalties from a publication relating to health care. Dr. Sperling has received personal compensation in the range of $500-$4,999 for serving as a Vice President with Epilepsy Consortium .