Top line results from the retrospective EXPERIENCE study of brivaracetam are expected to read out in early 2021.
Kristen Ricchetti-Masterson, MSPH, PhD
The launch of the EXPERIENCE study to assess real world experience (RWE) of brivaracetam (BRV) has been announced at the American Epilepsy Society (AES) Annual Meeting, December 4–8, 2020. The study is funded by UCB Pharma, which developed the agent with the brand name Briviact.1
EXPERIENCE is a retrospective, pooled study that will assess data from a cohort of more than 3000 patients newly treated with BRV from over 30 sites around the world. Patients that are receiving BRV 6–12 months prior to database closure and with reliable follow-up data after starting BRV are eligible to participate in the study.
BRV is currently indicated for monotherapy and adjunctive therapy of focal seizures in the United States, and for adjunctive therapy in the European Union and Australia, in patients aged 4 years and older.
The study was presented by Kristen Ricchetti-Masterson, MSPH, PhD, epidemiologist, UCB Pharma, and colleagues, who wrote that “this is the first study with the statistical power to assess patient subgroups across a wide geography, to produce the first RWE BRV for each key subgroup that will help to identify the subgroups that may benefit the most from BRV.”
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The primary objective is to assess 12-month effectiveness and tolerability of BRV overall and stratified by country and region. Ricchetti-Masterson and colleagues will also assess the effect of epilepsy history, baseline characteristics, and subpopulations on BRV’s efficacy through multivariate regression. Subpopulations include idiopathic generalized epilepsy, early versus late BRV add-on, elderly patients, those post-stroke, those with brain tumor-related epilepsy, and those with post-traumatic brain injury.
The secondary objective will investigate 12-month responses in specific patient subgroups by multivariate regression. In terms of outcomes, Ricchetti-Masterson and colleagues are looking for responders to achieve ≥50% seizure reduction from baseline at 12 months and will additionally observe BRV discontinuation due to treatment emergent adverse events (TEAEs).
“EXPERIENCE is a unique opportunity to collaborate across North America, Europe, and Australia and identify clinical data from a wide range of practices and is the first study of BRV use in routine practice across these regions. The results will be more informative about BRV effectiveness and tolerability than results from clinical trials and will provide additional outcomes for key patient subgroups that are often excluded from clinical trials,” Ricchetti-Masterson and colleagues concluded.
Ricchetti-Masterson and colleagues anticipate the first results to read out in early 2021.
NeurologyLive previously covered an analysis of long-term BRV use by Terrence J. O’Brien, MBBS, MD, head, Departments of Neuroscience and Medicine, and deputy head of school, Central Clinical School, Monash University; program director, Alfred Brain; and director of neurology, and deputy director of research, Alfred Health, and colleagues. Based on up to 11 years of follow-data on brivaracetam clinical development trials (NCT00175825, NCT00490035, NCT00464269, or NCT00504881), over half of those with focal seizures in the assessment experienced ≥50% reduction in focal seizure frequency, while 30% experienced continuous seizure freedom for ≥6 months.2
That study from O’Brien et al. included a safety dataset of 667 patients (focal seizures, 97.8% [n = 652]; primary generalized seizures [PGS], 2.2% [n = 15]) and an efficacy set with 648 patients with focal seizures and 15 patients with PGS. Overall, 49.2% (n = 328) of patients had ≥48 months of exposure. With regard to efficacy, those with focal seizures experienced a median reduction in 28-day seizure frequency of 57.3%, with 55.6% (n = 360) of patients reporting a ≥50% reduction in seizures. The 6-month and 12-month seizure freedom rates were 30.3% (n = 170) and 20.3% (n = 114), respectively. Throughout the 108-week assessment of efficacy, the mean (standard deviation [SD]) reduction in seizures ranged from 47.3% (SD, 57.9) in months 1—12 (n = 485) to 67% (SD, 33.2) in months 1–108 (n = 83).2
For more coverage of AES 2020, click here.