Time course of 75%–100% efficacy response of adjunctive brivaracetam

Abstract

A common primary measure of antiepileptic drug (AED) efficacy is the 50% responder rate (RR), reflecting the proportion of patients with ≥50% seizure frequency reduction during a given treatment period. However, RR does not capture seizure frequency distribution, the timing, or persistence of the seizure reduction response, and includes patients who discontinue treatment. We previously proposed the concept of "sustained ≥50% response," 1 which is a response that is maintained without interruption or treatment discontinuation from the day it is first achieved and continues for the remainder of the treatment period. It allows

Brivaracetam as Early Add-On Treatment in Patients with Focal Seizures: A Retrospective, Multicenter, Real-World Study

“…In the current subgroup analysis of BRIVAFIRST, the SSR and SSF were observed in around 60% and 32% of patients when BRV was given as the first- or second add-on treatment; the corresponding figures in patients who received BRV as a later therapeutic option were 35% and 11%. Of note, sustained seizure frequency reduction was obtained on the first day of treatment in most cases, supporting the evidence that BRV can have an early, sustained onset of action, with potential utility when rapid onset of action is necessary [ 26 , 27 ]. The lack of need for titration with initiation at target dose and the fast entry of BRV into the central nervous system may contribute to explain the early onset of action.…”

Long-term safety, efficacy, and quality of life during adjunctive brivaracetam treatment in patients with uncontrolled epilepsy: An open-label follow-up trial

“…Brivaracetam (BRV) is an AED that displays a high and selective affinity for the synaptic vesicle 2A protein [2,3]. Brivaracetam may allow seizure control from the first day of treatment [4,5], and has a low potential for clinically relevant pharmacokinetic drug-drug interactions with other AEDs [6,7]. Brivaracetam is indicated in patients 4 years of age and older with focal (partial-onset) seizures with or without secondary generalization as adjunctive treatment in the European Union [8] and as monotherapy and adjunctive treatment in the United States (oral formulations only; BRV injection is currently only indicated for patients 16 years of age) [9].…”

Sustained seizure freedom with adjunctive brivaracetam in patients with focal onset seizures

“…8,9 In the pooled efficacy population of 1160 patients, the 100% sustained response rates on Day 1 of treatment were 5.1% and 4.0% for BRV 100 and 200 mg/ day and remained substantially unchanged by Day 84. 8 Sustained ≥50% responder status was achieved on Day 1 by 15.5%, 18.1%, and 19.4% of patients taking BRV at 50, 100, and 200 mg/day, and corresponding values on Day 84 were 34.8%, 35.8%, and 35.2%. 9 In a longitudinal, multicenter study, the 50% or greater seizure reduction at 12 months was observed in 33.1% of 262 included patients, including 10.9% reporting seizure freedom.…”

“…A similar approach has been utilized to examine the time course of add‐on BRV efficacy and assess sustained ≥50% and 100% response in three RCTs with a 12‐week treatment period 8,9 . In the pooled efficacy population of 1160 patients, the 100% sustained response rates on Day 1 of treatment were 5.1% and 4.0% for BRV 100 and 200 mg/day and remained substantially unchanged by Day 84 8 . Sustained ≥50% responder status was achieved on Day 1 by 15.5%, 18.1%, and 19.4% of patients taking BRV at 50, 100, and 200 mg/day, and corresponding values on Day 84 were 34.8%, 35.8%, and 35.2% 9 .…”

“…So far, only limited evidence exists about the long‐term sustained seizure frequency improvement with BRV treatment. A similar approach has been utilized to examine the time course of add‐on BRV efficacy and assess sustained ≥50% and 100% response in three RCTs with a 12‐week treatment period 8,9 . In the pooled efficacy population of 1160 patients, the 100% sustained response rates on Day 1 of treatment were 5.1% and 4.0% for BRV 100 and 200 mg/day and remained substantially unchanged by Day 84 8 .…”