Abstract Details

Title Brivaracetam Adjunctive Therapy in Earlier Treatment Lines in Adults with Focal-onset Seizures in Europe and Canada: Interim Results of 12-month Real-world Data From BRITOBA

Topic Epilepsy/Clinical Neurophysiology (EEG)

Presentation(s) P8 - Poster Session 8 (5:30 PM-6:30 PM)

Poster/Presentation
Number 1-008

Objective Evaluate effectiveness of adjunctive brivaracetam (BRV) in earlier treatment lines in adults with focal-onset seizures (FOS) for ≤12months(m).

Background Planned interim analysis of BRITOBA/EP0103, an ongoing, prospective, postmarketing, noninterventional study at 81 sites in Europe/Canada prescribing BRV per standard practice.

Design/Methods

Selection criteria: age ≥18years(y), history of FOS (with/without focal to bilateral tonic-clonic seizures [FBTCS]), no BRV treatment before study entry, ≥1 antiseizure medication (ASM) at BRV initiation, ≤3 lifetime (prior/at BRV initiation) ASMs. Observation: ≤~12m. Endpoints: seizure freedom for ≥6m consecutively, ≥50% reduction in FOS (all types), Clinical and Patient’s Global Impression of Change (CGIC; PGIC), treatment-emergent adverse events (TEAEs).

Results At data snapshot (06/03/2022), 252 patients received ≥1 BRV dose (Safety Set; SS), 176 followed SmPC and were included in Per Protocol Set (PPS). At baseline, mean age in SS/PPS was 45.4/46.4y (n=252/176), mean time since epilepsy diagnosis was 13.24/13.59y (n=249/176), mean 28-day FOS frequency was 4.07/4.74 (n=245/175), 35.1%/40.9% had FBTCS (n=251/176), mean number of lifetime ASMs was 1.9/2.0 (n=247/176). Mean/median BRV dose (SS) was 81.8/100.0 mg/day (n=249) at visit 1 (PPS: 88.6/100.0 mg/day [n=175]), 128.7/100.0 mg/day (n=41) at 12m (PPS: 137.1/125.0 mg/day [n=31]). In SS/PPS, 174/126 (69.0%/71.6%) patients completed the 3m visit, 97/65 (38.5%/36.9%) the 6m visit, 42/31 (16.7%/17.6%) the 12m visit. For SS/PPS patients who completed the 12m period and had data, 51.4%/51.9% (n=35/27) were seizure-free for ≥6m consecutively; ≥50% reduction in FOS frequency at 6/9/12m was 74.7%/70.9%/73.2% in SS (n=91/55/41), 71.4%/65.8%/67.7% in PPS (n=63/38/31). In SS/PPS, median percent reduction in FOS frequency was ≥89.9%/≥83.3% at 6/9/12m. In SS, patients with improvement (very much/much improved) at 3/6/12m was 42.0%/48.4%/51.2% (n=169/91/41) for CGIC, 36.4%/37.3%/55.0% (n=129/59/20) for PGIC. In SS/PPS, 35/19 (13.9%/10.8%) patients reported TEAEs, 24/12 (9.5%/6.8%) reported drug-related TEAEs, 12/6 (4.8%/3.4%) discontinued due to TEAEs.

Conclusions

Adjunctive BRV was effective and well tolerated in adults with FOS in earlier treatment lines.

Authors/Disclosures
Alyssa Jameson, PA (UCB) PRESENTER	Ms. Jameson has nothing to disclose.
Susanne Knake	No disclosure on file
Marco De Curtis	No disclosure on file
Eliane Kobayashi, MD, PhD (University of Texas Southwestern)	Dr. Kobayashi has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Knight pharmaceuticals. Dr. Kobayashi has received personal compensation in the range of $0-$499 for serving as a Consultant for Creative Research Designs. Dr. Kobayashi has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Jazz Pharmacuticals. Dr. Kobayashi has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Paladin Laboratories. Dr. Kobayashi has received personal compensation in the range of $0-$499 for serving as a author with Medlink .
Teresa Lema Facal	No disclosure on file
Louis Maillard	No disclosure on file
Bonita Rehel (UCB)	No disclosure on file
Sylvain Rheims	No disclosure on file
Anne-Liv Schulz	No disclosure on file
Iryna Leunikava	No disclosure on file

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