Effectiveness and Tolerability of Brivaracetam by Reason for Initiation in Adults with Focal Seizures: Post-hoc Analysis of a Real-world, US Study (P15-8.003)

Objective: Assess long-term real-world effectiveness and tolerability of brivaracetam (BRV) in adults with focal seizures by reason for BRV initiation.

Background: BRV is an effective antiseizure medication (ASM) for the treatment of focal seizures.

Design/Methods: Post-marketing, prospective, observational study at 33 US sites (EP0088). Patients aged ≥16 years with focal seizures and lifetime history or concomitant use of ≥1 of four predefined ASMs (levetiracetam/lamotrigine/oxcarbazepine/carbamazepine) initiating BRV were followed for up to 12 months; visits occurred at 1.5/3/6/12 months. Post-hoc analysis was performed by reason for initiating BRV: lack of efficacy (LoE), any adverse effects (AEs), or behavioral AEs (BAEs) with current ASMs (before BRV initiation).

Results: Of 254 patients who initiated BRV, 156 (61.4%) initiated due to LoE, 118 (46.5%) due to any AEs, and 82 (32.3%) due to BAEs. 12-month BRV retention was achieved by 54.5%/62.7%/59.8% patients who initiated BRV due to LoE/any AEs/BAEs. Seizure-freedom between 6- and 12-month visits was 22.3%/30.8%/32.1% in patients initiating BRV due to LoE/any AEs/BAEs. Treatment-emergent adverse events (TEAEs) were reported in 55.1%/54.9% patients initiating BRV due to any AEs/BAEs, and 46.2% patients initiating due to LoE. Discontinuation rates due to TEAEs (13.6–19.2%) and common TEAEs leading to BRV discontinuation (e.g., fatigue/headache/dizziness) were similar in all subgroups. Irritability (3.4–3.8%) was the most common behavioral TEAE across all subgroups. BRV was discontinued in more patients who initiated BRV due to LoE (27.6%) than any AEs/BAEs (17.8%/18.3%). Of 82 patients who initiated BRV due to BAEs with current ASMs, only one (1.2%) discontinued due to behavioral TEAEs.

Conclusions: There were no substantial differences in 12-month BRV retention (measure of effectiveness) and tolerability among subgroups of patients who initiated BRV due to lack of efficacy/adverse events (including BAEs) on current treatment. BRV was well tolerated, with a low incidence of behavioral TEAEs in patients who had BAEs with current ASMs.

Disclosure: 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. 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 . 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. Dr. Dave has nothing to disclose. 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. Dr. Porter has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Otsuka. Dr. Porter has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Cadent. Dr. Porter has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Xenon. Dr. Porter has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Aeterna. Dr. Porter has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Passage Bio. Dr. Porter has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Xenon. Dr. Porter has received publishing royalties from a publication relating to health care. Dr. Porter has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant with Epilepsy Study Consortium. Dr. Martin has received personal compensation for serving as an employee of UCB. Dr. Martin has received stock or an ownership interest from UCB. Sami Elmoufti has nothing to disclose. Anne-Liv Schulz has received personal compensation for serving as an employee of UCB. Anne-Liv Schulz has received stock or an ownership interest from UCB. Prashant Dongre has received personal compensation for serving as an employee of UCB Inc. Prashant Dongre has received stock or an ownership interest from UCB Inc. The institution of Dr. French has received research support from Epilepsy Research Foundation. The institution of Dr. French has received research support from Epilepsy Study Consortium (Funded by: Andrews Foundation, Eisai, Engage, Lundbeck, Pfizer, SK Life Science, Sunovion, UCB, Vogelstein 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.