Effectiveness and Tolerability of Brivaracetam by Reason for Initiation in Adults with Focal Seizures: Post-hoc Analysis of a Real-world, US Study
Abstract number :
3.277
Submission category :
7. Anti-seizure Medications / 7B. Clinical Trials
Year :
2021
Submission ID :
1825642
Source :
www.aesnet.org
Presentation date :
12/6/2021 12:00:00 PM
Published date :
Nov 22, 2021, 06:44 AM
Authors :
Heidi Henninger, MD - Maine Medical Center; Michael Sperling, MD – Thomas Jefferson University; Hamada Hamid Altalib, DO, MPH – Yale University; Hina Dave, MD – University of Texas Southwestern Medical Center; Michael Gelfand, MD, PhD – University of Pennsylvania; Roger Porter, MD - University of Pennsylvania; Melinda Martin, PhD – UCB Pharma, Smyrna; Sami Elmoufti, MS – UCB Pharma, Raleigh; Anne-Liv Schulz, MD – UCB Pharma, Monheim am Rhein; Prashant Dongre, MD – UCB Pharma, Smyrna; Jacqueline French, MD – NYU Comprehensive Epilepsy Center
Rationale: Brivaracetam (BRV) provides long-term effectiveness in adults with focal seizures who have suboptimal results with commonly used antiseizure medications (ASMs). This analysis assessed effectiveness and tolerability of BRV in adults with focal seizures by reason for BRV initiation in real-world clinical practice.
Methods: EP0088 was a post-marketing, prospective, multicenter, observational study at 33 US sites. Patients ≥ 16 years of age with focal seizures received BRV as prescribed by their physician and were followed for up to 12 months. Patients must have had lifetime history or current concomitant use of ≥ 1 of four predefined ASMs (levetiracetam [LEV], lamotrigine, oxcarbazepine, carbamazepine). Visits occurred at 1.5, 3, 6, and 12 months. Post-hoc analysis was performed on the Safety Set, by reason for initiating BRV (lack of efficacy, any adverse effects [AEs] including behavioral adverse effects [BAEs], or BAEs [per investigator’s assessment] with current ASMs).
Results: Of 254 patients initiating BRV, 156 (61.4%) initiated BRV due to lack of efficacy of current ASMs, 118 (46.5%) due to any AEs with current ASMs, and 82 (32.3%) due to BAEs with current ASMs. BRV retention at 12 months was achieved by 54.5%, 62.7%, and 59.8% of patients initiating BRV due to lack of efficacy with current ASMs, any AEs with current ASMs, and BAEs with current ASMs, respectively (Table 1). Retention rates were consistent when patients with off-label BRV use or patients lost to follow-up were excluded. Seizure freedom between 6- and 12-month visits was numerically higher in patients initiating BRV due to any AEs (30.8%) or BAEs (32.1%) with current ASMs versus those initiating BRV due to lack of efficacy with current ASMs (22.3%). Treatment-emergent adverse events (TEAEs) were reported in 55.1% and 54.9% of patients initiating BRV due to any AEs or BAEs with current ASMs, respectively, and in 46.2% of those initiating BRV due to lack of efficacy with current ASMs (Table 2). BRV discontinuation rates due to TEAEs and common TEAEs leading to BRV discontinuation (such as fatigue, headache, dizziness) were similar in all subgroups. Irritability (3.4–3.8%) was the most common BAE across all subgroups. Fewer patients discontinued BRV in the group initiating BRV due to any AEs (17.8%) or BAEs (18.3%) with current ASMs versus the group initiating BRV due to lack of efficacy (27.6%) with current ASMs. From the patients who initiated BRV due to BAEs with current ASMs, only one (1.2%) discontinued due to behavioral TEAEs.
Conclusions: Overall, there were no substantial differences in retention on BRV (a measure of effectiveness) at 12 months among patients who initiated BRV due to any AEs, BAEs, or lack of efficacy with current ASMs. BRV was well tolerated, with a generally similar tolerability profile in all subgroups by reason for BRV initiation. The discontinuation of BRV treatment because of behavioral TEAEs in patients initiating BRV due to BAEs with current ASMs was low.
Funding: Please list any funding that was received in support of this abstract.: UCB Pharma-funded.
Anti-seizure Medications