Effectiveness of lacosamide monotherapy in clinical practice: a retrospective chart review in patients with focal seizures (P5.230)

Objective: To assess effectiveness and tolerability of lacosamide monotherapy in patients with focal seizures (FS). Background: Lacosamide is approved as monotherapy for FS in the USA; there is a lack of published data from daily clinical practice. Design/Methods: Retrospective assessment of lacosamide monotherapy (first line or conversion to monotherapy) patients in Europe who were aged ≥16 years with an observational point (OP) of 12 (±3) months. Outcomes included retention rate at OP 3 (12±3 months), seizure freedom rates at OP2 (6±3 months) and OP3 and treatment emergent adverse drug reactions (TEADRs). Results: Overall, 439 patients were included (98 first-line and 341 conversion to monotherapy; aged ≥65 years n=128 [25 first-line monotherapy and 103 conversion to monotherapy]). Retention rates in first-line and conversion to monotherapy subgroups were 60.2% (59/98; 95% confidence interval 50.5–69.9%) and 62.5% (213/341; 57.3–67.6%), respectively. Kaplan-Meier estimates of 12-month retention rates were 81.2%, and 91.4% for first-line and conversion to monotherapy, respectively. Retention rates in patients aged ≥65 years were 60.0% (40.8–79.2%) and 68.9% (60.0–77.9%) for first line versus conversion to monotherapy, respectively. At OP2, 66.3% of first line and 63.0% of conversion to monotherapy patients were seizure free (odds-ratio 1.15 [95% CI 0.713–1.839]). At OP3, 60.2% of first-line and 52.5% of conversion to monotherapy patients were seizure free (odds-ratio 1.80 [95% CI 1.080–3.001]). In patients aged ≥65 years, seizure freedom rates at OP2 were 72.0% and 68.0% for first-line and conversion to monotherapy, respectively, and at OP3, 68.0% and 56.3%, respectively. Overall, 52/439 (11.8%) patients reported TEADRs (16.4% in patients aged ≥65 years), most commonly (≥1%) dizziness (5.0%), headache (2.1%) and somnolence (1.6%). Conclusions: Lacosamide was effective and well tolerated as first-line or conversion to monotherapy for FS in a real-world clinical setting, including the subset of patients aged ≥65 years. Study Supported by: UCB Pharma Disclosure: Dr. Villanueva has received personal compensation for activities with Eisai, UCB, Bial, Novartis and Estevefor participating in advisory boards or industry-sponsored symposia. Dr Giraldez received personal compensation for activities with UCB Pharma for speaking. Dr. Toledo has received personal compensation for activities with UCB Pharma, BIAL, EISAI, Esteve, and Shire as a consultant. Dr. Toledo has received research support from EISAI and BIAL. Dr. de Haan received personal compensation for activities with UCB Pharma as as speaker and/or consultant. Dr. Cumbo has nothing to disclose. Dr. Gambardella received personal compensation from EISA and UCB for consulting, serving on a scientific advisory board, or speaking at scientific meeting,,,,,, Dr. De Backer has received personal compensation for activities with UCB Pharma as an employee. Dr. Joeres has received personal compensation for activities with UCB Pharma. Dr. Brunnert has received personal compensation for activities with UCB Biosciences GmbH as an employee. Dr. Dedeken has received personal compensation for activities with UCB Pharma as an employee. Dr Serratosa has received personal compensation for activities with UCB, Esteve, Eisai Ltd, Bial, and Cyberonics.