Brivaracetam linked to significant seizure reduction, freedom at 12 months

Key takeaways:

• A total of 37% of study participants were seizure-free for at least 6 months.
• The researchers noted the positive safety profile of the drug, with adverse events recorded in 35 of 252 participants.

ORLANDO — Adjunctive treatment with brivaracetam led to significant seizure reduction and seizure freedom in a cohort of adults with focal onset epilepsy, according to interim results of a study.

“This is quite early in the patient’s journey, where the patients could have received no more than three previous antiseizure medications,” Louis Maillard, MD, PhD, professor of neurology at the University of Lorraine in France, told Healio during a poster presentation at the American Epilepsy Society annual meeting. “The unmet need was to get medication with higher efficiency.”

Maillard and colleagues sought to examine the benefits of brivaracetam as an adjunctive therapy to adults with focal onset seizures through the BRITOBA study, which evaluated the drug’s safety, efficacy, tolerability and quality of life. Brivaracetam had been indicated for both monotherapy and adjunctive therapy for patients aged 1 month and older in the United States, for adjunctive therapy in patients aged 4 years and older in Canada, and as adjunctive therapy for patients aged 2 years and older in the European Union.

Their study was a prospective, non-interventional trial at 81 sites in France, Germany, Italy and Spain that included 252 adults (mean age 45.4 years; 52.4% male), with a history of focal onset seizures, no prior treatment with brivaracetam. prescribed at least one antiseizure medication (ASM), and a history of at least three ASMs. Participants, who were observed for roughly 12 months, had the option of self-reporting seizure frequency and additional questionnaires through an online app instead of conventional data collection.

Primary outcomes for the study were seizure freedom for 6 consecutive months over the 12-month observation interval, a reduction of at least 50% in all types of focal seizures, improvements on the Clinical Global Impression of Change (CGIC), Patient’s Global Impression of Change (PGIC) scores and paucity of treatment-emergent adverse events. Also included for analysis were 176 individuals in the per-protocol set (PPS), who were treated according to on-label use of the drug in Europe and Canada.

According to interim results, 29 of 78 participants experienced seizure freedom for at least 6 consecutive months, 30 of 41 participants experienced a seizure reduction of at least 50% by the 12-month mark and data showed a 100% median reduction in seizure frequency at 12 months.

Additionally, 71 of 91 enrollees showed improvement in CGIC at 6 months and 29 of 41 showed improvement at 12 months, while 34 of 59 individuals recorded PGIC improvement at 6 months and 11 of 20 did so at 12 months.

TEAEs were recorded in 35 of 252 study participants, with 24 being drug-related. Only one TEAE was considered to be “serious” in nature and 12 TEAEs resulted in treatment discontinuation.

“The safety profile is very nice, especially with respect to psychiatric side effects,” Maillard told Healio. “There is a rate of seizure freedom over 6 consecutive months, which is much higher than expected.”