2315 12-month effectiveness and tolerability of brivaracetam in the real-world: interim analysis of the international, multicenter non-interventional EXPERIENCE study

• Published in: BMJ neurology open Vol. 4; no. Suppl 1; pp. A36 - A37
• Main Authors: Villanueva, Vicente, D’Souza, Wendyl J, Faught, Edward, Klein, Pavel, Reuber, Markus, Rosenow, Felix, Salas-Puig, Javier, Adam, Strzelczyk, Szaflarski, Jerzy, Kristen, Ricchetti-Masterson, Cédric, Laloyaux, Veronica, Sendersky, Sophia, Zhou, Florin, Floricel, Daniels, Tony, Bernhard, Steinhoff J
• Format: Journal Article
• Language: English
• Published: London BMJ Publishing Group Ltd 01-08-2022; BMJ Publishing Group LTD
• Subjects: Abstracts; Australia
• ISSN: 2632-6140
• DOI: 10.1136/bmjno-2022-ANZAN.96

ObjectivesTo evaluate effectiveness and tolerability of brivaracetam (BRV) in routine clinical practice in a large, multicenter, international patient population (North America/Europe/Australia).MethodsRetrospective, pooled cohort study (EPD332/EXPERIENCE) of patients initiating BRV. Seizure-freedom and incidence of treatment-emergent adverse events (TEAEs) assessed at 3/6/12 months.ResultsInterim analysis including 1,910 patients from Spain/Germany/Australia/United Kingdom/United States (851/503/301/130/125); 52% female; median 17 years since diagnosis (N=1,819); 89.5%/10.6% had focal-onset/generalized-onset seizures at baseline (N=1,855). Most common known etiology (≥10%) was malformation of cortical development (283/1,883 [15.0%]). Most common comorbid conditions (≥10%) were psychiatric (680/1,843 [36.9%]), cognitive/learning disability (451/1,828 [24.7%]), and neurological (357/1,266 [28.2%]). At baseline, patients reported previous use of mean 5.4/2.1 historical/concomitant antiseizure medications (N=1,716/N=931). Patients were treated with BRV for a median of 343.0 days (Q1-Q3: 147.0–410.9 days; N=1,894). Seizure-freedom was reported in 241/886 (27.2%), 242/1,020 (23.7%), and 191/804 (23.8%) patients at 3/6/12 months. TEAEs (since prior visit) were reported in 464/1,733 (26.8%), 230/1,537 (15.0%), and 128/1,346 (9.5%) patients at 3/6/12 months. Most frequently reported TEAEs (≥15% patients with specified TEAEs) were fatigue (87/433 [20.1%])/dizziness (72/433 [16.6%])/irritability (72/433 [16.6%]) at 3 months, somnolence (36/176 [20.5%])/irritability (31/176 [17.6%]) at 6 months, and somnolence (28/108 [25.9%]) at 12 months. 609/1,904 (32.0%) patients discontinued BRV, mostly due to insufficient effectiveness and tolerability.ConclusionsIn this interim pooled analysis in a large real-world setting, BRV appears both effective and well tolerated in this highly drug-resistant cohort. Limitations: mixed populations, variables, and time-points across centers present data harmonization challenges, adding analytic complexity.FundingUCB Pharma-sponsored