12-month Effectiveness and Tolerability of Brivaracetam in Pediatric Patients in the Real-world: Subgroup Data from the EXPERIENCE Analysis
Abstract number :
1.301
Submission category :
7. Anti-seizure Medications / 7C. Cohort Studies
Year :
2022
Submission ID :
2203965
Source :
www.aesnet.org
Presentation date :
12/3/2022 12:00:00 PM
Published date :
Nov 22, 2022, 05:22 AM
Authors :
Tony Daniels, – UCB Pharma; Victor Soto Insuga, MD – Pediatric Hospital, Hospital Universitario Infantil Nino Jesus, Madrid, Spain; Wendyl D'Souza, MBChB – Department of Medicine – St Vincent’s Hospital Melbourne, The University of Melbourne, Melbourne, Australia; Edward Faught, MD – Emory Epilepsy Center, Atlanta, Georgia, US; Pavel Klein, MD – Mid-Atlantic Epilepsy and Sleep Center, Atlanta, Georgia, US; Markus Reuber, MD, PhD – The University of Sheffield, Sheffield, UK; Felix Rosenow, MD – Epilepsy Center Frankfurt Rhine-Main, Center of Neurology and Neurosurgery, Frankfurt, Germany; Javier Salas-Puig, MD – Universitari Vall d’Hebron, Barcelona, Spain; Bernhard Steinhoff, MD, PhD – Kork Epilepsy Center, Kehl-Kork, Germany; Adam Strzelczyk, MD, MHBA – Epilepsy Center Frankfurt Rhine-Main, Center of Neurology and Neurosurgery, Frankfurt, Germany; Jerzy Szaflarski, MD, PhD – UAB Epilepsy Center, Birmingham, Alabama, US; Herve Besson, PhD – UCB Pharma, Breda, Netherlands; Florin Floricel, MD, PhD – UCB Pharma, Monheim am Rhein, Germany; Cedric Laloyaux, PhD – UCB Pharma, Brussels, Belgium; Veronica Sendersky, PharmD – UCB Pharma, Brussels, Belgium; Sophia Zhou, MS – UCB Pharma, Morrisville, North Carolina, US; Vicente Villanueva, MD, PhD – Hospital Universitario y Politécnico La Fe, Valencia, Spain
Rationale: This analysis evaluated effectiveness and tolerability of brivaracetam (BRV) in pediatric patients (< 16 years of age) in routine clinical practice.
Methods: Subgroup analysis from EXPERIENCE/EPD332, a pooled analysis of retrospective cohorts that included patients with epilepsy initiating BRV in clinical practice. 50% responder rate (≥50% seizure reduction from baseline), seizure freedom (SF; no seizures within 3 months prior to timepoint), continuous seizure freedom after baseline (CSF; no seizures within 3 months prior to the timepoint and previous follow-up timepoints), and treatment-emergent adverse events (TEAEs) since prior visit were assessed at 3, 6, and 12 months. Patients with less than 6 months of follow-up were excluded. Patients with missing data after BRV discontinuation were assigned nonresponse for 50% responder rate, and no SF for SF and CSF.
Results: This analysis included 66 pediatric patients; 65.2% were male, 18.2% were aged 0–5 years, 45.5% aged 6–11 years, and 36.4% aged 12–15 years. Median time since epilepsy diagnosis was 6 years; 63.6% and 37.9% of patients had focal-onset and generalized-onset seizures, respectively (Table 1). The most common known epilepsy etiology was genetic (27.3%). The most common comorbid conditions (≥15% of patients) were cognitive/learning disability (90.9%), neurological (72.7%), and psychiatric (68.2%). At baseline, patients had a mean of 7.2 prior antiseizure medications (ASMs; any ASM used and stopped before BRV initiation); 2 (3.0%) patients, 6 (9.1%) patients, 21 (31.8%) patients, and 37 (56.1%) patients had 0–1, 2–3, 4–6, and ≥7 prior ASMs, respectively. The mean number of concomitant maintenance ASMs at index was 2.1. The median BRV dose at index was 38.0 mg/day (Q1–Q3, 25.0–63.0 mg/day; n=61). Patients were exposed to BRV for a median of 375.0 days (Q1–Q3, 200.0–730.0 days; n=66). 50% responder rate was 32.8% at 3 months, and 31.3% at 6 and 12 months (Figure 1). 15.2% of patients were seizure-free at 3, 6, and 12 months. CSF was experienced by 15.2% of patients at 3 and 6 months, and 12.1% of patients at 12 months. TEAEs (since prior visit) were reported in 12/66 (18.2%) patients at 3 months, 10/66 (15.2%) patients at 6 months, and 3/62 (4.8%) patients at 12 months. Most TEAEs in patients with reported severity were mild or moderate (3 months [n=10]: mild 2 [20.0%], moderate 8 [80.0%]; 6 months [n=9]: mild 2 [22.2%], moderate 6 [66.7%], severe 1 [11.1%]; 12 months [n=1]: mild 1 [100%]). Among patients who reported TEAEs at 3 months (n=12), 5 (41.7%) had somnolence, 5 (41.7%) had irritability, 3 (25.0%) had insomnia, and 1 (8.3%) had dizziness. No patients discontinued BRV at or before 6 months, 27/66 (40.9%) discontinued at 12 months, and 16/66 (24.2%) discontinued after 12 months.
Conclusions: In this analysis in a real-world setting, BRV appears both effective and well tolerated in a highly drug-resistant pediatric patient cohort (87.9% had ≥4 prior ASMs at baseline).
Funding: Sponsored by UCB Pharma
Anti-seizure Medications