Interim data from a real-world study suggest that adjunctive treatment with brivaracetam is well-tolerated and may improve quality of life over 12 months for those with focal seizures.
New interim data from BASE, a real-world, prospective observational study conducted in Europe suggest that treatment with adjunctive brivaracetam (Briviact; UCB Pharma) is safe and well-tolerated, and may improve quality of life over time for patients with focal seizures aged 4 years and older.
At 6 months (n = 120), 44.2% of patients reported improvement in quality of life, while 39.2% reported no change and 16.7% reporting a worsening. At 12 months (n = 81), those percentages were 46.9%, 37%, and 16%, respectively. Importantly, the investigators did note that the improvement in quality-of-life scores, as measured by the Patient-Weighted Quality of Life in Epilepsy Inventory-31 (QOLIE-31-P), may be due to those with poor response discontinuing over time.
The data were presented virtually at the 2020 American Epilepsy Society (AES) Annual Meeting, December 4–8, 2020, by study author Bernhard J. Steinhoff, MD, PhD, professor of neurology and clinical neurophysiology, University of Freiburg, and medical director, Kork Epilepsy Center.
There were 535 patients enrolled in the study, 534 of which received ≥1 dose. In total, by the November 28, 2019, cutoff date, the study included 360 patients who completed 6 months of brivaracetam treatment, of which 233 completed 12 months. There were 196 discontinuations, with the most common reported reasons being adverse events (AEs; 13.1%) and lack of efficacy (11.6%).
The analysis included a safety set (n = 534), consisting of all patients receiving a dose; a full analysis set, including those who did not received the therapy prior to study entry; and a modified full analysis set (n = 299), consisting of those treated according to the recommended use the therapy, per the EU Summary of Product Characteristics.
In the full analysis and modified full analysis sets, the largest percentages of improvement on the QOLIE-31-P were observed with social functioning at 12 months (60.2%; 6 months, 55.4%), medication effects at 12 months (57.6%; 6 months, 54%), and seizure worry at 12 months (57%; 6 months, 44%).
In the modified full analysis set, the largest improvements on the QOLIE-31-P at 6 months were observed with social functioning (53.6%; 12 months, 55.8%), cognitive function (53.5%; 12 months, 52.8%), and medication effects (51.4%; 12 months, 54.7%). At 12 months, the top improvements were observed in seizure worry (60.4%; 6 months, 49.3%), social functioning, and medication effects.
“More patients had a clinically meaningful improvement than worsening in QOLIE-31-P total score and individual subdomains from baseline to 6 and 12 months,” Steinhoff et al wrote.
With regard to Clinical Global Impression of Change (CGIC) and Patient Global Impression of Change (PGIC), the therapy showed similar results. At 6 months on CGIC (n = 175), 61.1% of patients reported an overall improvement compared to just 13.7% who reported worsening. At 12 months (n = 122), those percentages were 67.2% and 4.9%, respectively. For PGIC, at 6 months (n = 173), 60.1% reported an overall improvement, and at 12 months (n = 129), 62% reported improvement. At 6 months, 14.5% had reported worsening, while 9.3% reported worsening at 12 months.
Treatment-emergent AEs were reported by 50.7% (n = 271) of patients in the safety set, with 12.7% (n = 68) reporting a serious AE. Discontinuation due to treatment-emergent AEs were observed in 26.2% (n = 140) of patients, and drug-related treatment-emergent AEs were reported in 34.3% (n = 183). In the modified full analysis set, treatment-emergent AEs were reported by 34.1% (n = 102), while serious treatment-emergent AEswere reported by 9.7% (n = 20). There were discontinuations due to a drug-related AE for 19.1% (n = 57) of those in the modified full analysis set.
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