Lacosamide as Add-On to Monotherapy in Patients with Partial-Onset Seizures: Interim Results of the Post-Marketing VITOBA Study (VImpaT Added to One Baseline AED) (P06.126)

Abstract

Objective: To evaluate the efficacy and safety of lacosamide when added to a single antiepileptic drug (AED) in patients with partial-onset seizures (POS). Background Lacosamide was approved as adjunctive treatment for adults with POS based on results from three pivotal Phase II/III trials in which highly refractory patients (45.2% had >7 lifetime AEDs) were treated according to strict dosing regimens and titration schedules. Design/Methods: VITOBA is a 6-month prospective, non-interventional study with a planned enrollment of 500 evaluable adult patients. Efficacy measures include seizure freedom and Clinical Global Impression of Change score. Safety and tolerability are also being evaluated. Results: Efficacy data are available for 99 patients (FAS) and safety data for 109 (SS). Patients were less refractory than those in the pivotal trials with 73.4% (SS) having a history of 1–3 lifetime AEDs, and only 6.4% (SS) having >6. Over the final three months of the study period, 77.8% and 64.6% of patients experienced a ≥50% and ≥75% reduction in seizure frequency and 43.4% were seizure free at study endpoint. Patients with a history of one lifetime AED experienced greater benefit with lacosamide than the overall population: 86.7% and 80.0% showed a ≥50% and ≥75% reduction in seizure frequency, and 66.7% experienced seizure freedom. Overall, treating physicians judged symptoms in 23.2% and 40.4% of patients as “very much improved” or “much improved.” The incidence of TEAEs (50.5%) was lower than in the pooled pivotal Phase II/III trials (81.0% for all doses). The most common TEAEs (≥5%) were fatigue (11.9%), dizziness (10.1%) and convulsion (5.5%). The mean lacosamide maintenance dose was 250mg/day and the median was 200mg/day. Conclusions: In this interim analysis, patients with less refractory POS treated with lacosamide as add-on to monotherapy derived therapeutic benefits that exceed those observed in the pivotal controlled trials of lacosamide for POS. Supported by: UCB Pharma. Disclosure: Dr. Noack-Rink has received personal compensation for activities with UCB Pharma. Dr. Mayer has nothing to disclose. Dr. Arnold has received personal compensation for activities with DESITIN, Eisai, Inc., and UCB Pharma. Dr. Kumke has received personal compensation for activities with UCB Pharma as an employee. Dr. Runge has received personal compensation for activities with Eisai and UCB.Dr. Runge has received research support from UCB.