Abstracts

Rationale: To assess the effectiveness and tolerability of brivaracetam (BRV) in combination with one specific antiseizure medication (ASM) in earlier treatment lines in daily clinical practice.

Methods: Post hoc of second interim analysis from BRITOBA/EP0103, a prospective, postmarketing, noninterventional study of adjunctive BRV in Europe/Canada. Study selection criteria: age ≥ 18 years, history of focal-onset seizures (FOS), no prior BRV, ≥ 1 ASM at BRV initiation, failure of ≤ 3 lifetime ASMs (prior and at BRV initiation). This post hoc subgroup analysis was performed on the four most common concomitant ASMs combined with BRV at initiation, in patients (pts) in the Safety Set (SS; pts who took ≥ 1 BRV dose) on a single specific ASM at BRV initiation who had the opportunity to complete ≥ 9 months (mos) on BRV.


Results: At data cutoff, 208 pts in the SS were on one concomitant ASM at BRV initiation and had the opportunity to complete ≥ 9 mos on BRV therapy (“total population”). In this group, 50 pts were on concomitant lacosamide (LCM), 50 on lamotrigine (LTG), 29 on carbamazepine (CBZ), and 28 on levetiracetam (LEV) (Table). Demographics and baseline (BL) epilepsy characteristics were similar across ASM subgroups, except LTG and CBZ pts were numerically younger. The most common reason for starting BRV was lack of efficacy of current therapy in all subgroups (LCM 98.0%, LTG 94.0%, CBZ 82.8%, LEV 78.6%, total population 89.4%). BRV retention at 3/6/9 mos was numerically higher in the LCM and LEV subgroups vs CBZ and LTG subgroups (Fig). In pts completing 9-mo BRV therapy, ≥ 50% response at 9 mos was numerically higher in patients on concomitant LEV (79.2% [19/24]) or CBZ (78.9% [15/19]) vs LCM (67.6% [25/37]) or LTG (62.9% [22/35]) (total population 73.3% [110/150]). BRV discontinuation due to TEAEs was numerically lower in patients on concomitant LEV or LCM vs LTG or CBZ (Fig). Per Clinical Global Impression of Change (CGIC) assessment, a numerically higher percentage of pts improved vs BL at 9 mos (very much/much/minimally improved) in the LCM, LEV, and CBZ subgroups (82.1% [32/39], 75.0% [18/24], 72.2% [13/18]) vs the LTG subgroup (60.6% [20/33]) (total population 71.3% [107/150]). Per Patient’s Global Impression of Change (PGIC), a numerically higher percentage of pts improved vs BL at 9 mos in the CBZ and LCM subgroups (100% [9/9], 81.5% [22/27]) vs the LTG and LEV subgroups (55.6% [15/27], 45.0% [9/20]) (total population 63.2% [67/106]).


Conclusions: This post hoc analysis of BRITOBA study data suggests BRV was effective and well-tolerated in patients on one concomitant ASM regardless of the ASM it was added to. At 9 mos, BRV added to LCM or LEV offered numerically higher retention and fewer TEAE-related discontinuations; BRV added to LCM, LEV, or CBZ offered numerically greater CGIC improvement; numerically higher ≥ 50% response was achieved in patients on concomitant CBZ or LEV and numerically greater PGIC improvement in patients on concomitant CBZ or LCM.

Funding: UCB Pharma-sponsored