12-month Effectiveness and Tolerability of Brivaracetam in the Real-world: The International EXPERIENCE Pooled Analysis
Abstract number :
1.298
Submission category :
7. Anti-seizure Medications / 7C. Cohort Studies
Year :
2022
Submission ID :
2203957
Source :
www.aesnet.org
Presentation date :
12/3/2022 12:00:00 PM
Published date :
Nov 22, 2022, 05:22 AM
Authors :
Vicente Villanueva, MD, PhD – Hospital Universitario y Politecnico La Fe; Wendyl D'Souza, MBChB – Department of Medicine – St Vincent's Hospital Melbourne, The University of Melbourne; Edward Faught, MD – Emory Epilepsy Center; Pavel Klein, MD – Mid-Atlantic Epilepsy and Sleep Centre; Markus Reuber, MD, PhD – The University of Sheffield; Felix Rosenow, MD – Center of Neurology and Neurosurgery – Epilepsy Center Frankfurt Rhine-Main; Javier Salas-Puig, MD – Universitari Vall d'Hebron; Victor Soto Insuga, MD, PhD – Pediatric Neurology – Hospital Universitario Infantil Nino Jesus; Adam Strzelczyk, MD, MHBA – Center of Neurology and Neurosurgery – Epilepsy Center Frankfurt Rhine-Main; Jerzy Szaflarski, MD, PhD – UAB Epilepsy Center; Herve Besson, PhD – UCB Pharma; Tony Daniels, BS – UCB Pharma; florin Floricel, MD, PhD – UCB Pharma; cedric Laloyaux, PhD – UCB Pharma; veronica Sendersky, PharmD – UCB Pharma; sophia Zhou, MS – UCB Pharma; bernhard Steinhoff, MD, PhD – Kork Epilepsy Center
Rationale: Effectiveness and tolerability of brivaracetam (BRV) in routine practice were assessed in a large international population (North America/Europe/Australia).
Methods: EXPERIENCE/EPD332 is a pooled analysis of retrospective cohorts that included patients with epilepsy initiating BRV in clinical practice. 50% responder rate (RR; ≥50% seizure reduction from baseline [BL]), seizure freedom (SF; no seizures within 3 months [m] prior to timepoint), continuous SF after BL (CSF; no seizures within 3 m prior to timepoint and previous follow-up timepoints) and treatment-emergent adverse events (TEAEs) were assessed at 3, 6, and 12 m. Patients with missing data after BRV discontinuation were assigned nonresponse for 50% RR, and no SF for SF and CSF.
Results: Analyses included 1644 adults from Spain/Germany/Australia/United States (n=740/488/291/125); 72.0%, 19.1%, 6.1%, and 2.8% were aged 16–49, 50–64, 65–74, ≥75 years; 51.9% were female; median time since diagnosis: 18.0 years. At BL, 92.2% had focal-onset seizures and 7.7% had generalized-onset seizures. 675/1150 (58.7%) patients with focal-onset seizures and seizure subtype data had focal to bilateral tonic-clonic seizures (FBTCS). The most common known epilepsy etiology (≥10% of patients) was malformation of cortical development (16.2%). The most common comorbid conditions (≥20% of patients) were psychiatric (37.4%; n=1616), neurological (27.5%; n=1100), and cognitive/learning disability (24.6%; n=1635). Patients had mean of 5.5 prior antiseizure medications (ASMs) at BL (n=1620) and 2.1 concomitant maintenance ASMs at index (n=1644). Patients took BRV for a median of 345.5 days (Q1–Q3, 131.5–410.9; n=1629); median dose at index was 100.0 mg/day (Q1–Q3, 50.0–100.0; n=1615). 50% RRs were 32.1%, 36.7%, and 36.9%, and SF rates were 22.4%, 17.9%, and 14.9% at 3, 6, and 12 m (Figure). CSF rates were 15.7% and 11.7% at 6 and 12 m. 50% RRs were similar in the focal seizures only and FBTCS subgroups at 3 m (31.7% vs. 31.3%) and 6 m (38.2% vs. 34.6%), and numerically higher in the focal seizures only subgroup at 12 m (40.4% vs. 34.0%). CSF rates at 6 and 12 m were numerically higher in patients with FBTCS (21.3% and 16.7%) vs. focal seizures only (11.0% and 7.5%). TEAEs (since prior visit) were reported in 25.6%, 14.2%, and 9.3% of patients at 3, 6, 12 m (Table). Most TEAEs (in patients with reported severity) were mild or moderate. At 12 m, somnolence was the most common TEAE (27.6% of patients with TEAEs). Of patients who reported TEAEs, 26.9%, 23.2%, and 32.7% had psychiatric TEAEs, and 6.6%, 7.1%, and 8.2% had behavioral TEAEs at 3, 6, and 12 m. During the whole study follow-up, 551/1639 (33.6%) patients discontinued BRV, mostly due to insufficient effectiveness and/or tolerability.
Conclusions: This pooled analysis in a variety of real-world settings suggests BRV was effective and well tolerated in highly drug-resistant cohorts. Limitations: challenging to harmonize variables from different studies with mixed populations.
Funding: Sponsored by UCB Pharma
Anti-seizure Medications