Abstracts

Rationale: Lacosamide (LCM) is an antiepileptic drug for the adjunctive treatment of adults with partial-onset seizures.To evaluate the effects of long-term LCM treatment on patients self-reported seizure severity, health-related quality of life (HRQoL), and health status, pooled data from three Phase III open-label extension trials (SP756, SP774, SP615) were analyzed.Methods: All trials included the Quality of Life In Epilepsy scale (QOLIE-31), an epilepsy-specific HRQoL assessment with a 100-point range. The Seizure Severity Questionnaire (SSQ), measuring seizure severity on a 7-point scale, and Patient Global Impression of Change (PGIC), a 7-category scale assessing change in health state, were included as secondary endpoints in trials SP756 and SP774. SP615 assessed health outcomes at different visits and at a different frequency; the common time point across trials was every 48 weeks. SSQ and QOLIE-31 scores at week 48 were compared with baseline scores in the double-blind trial that led into the open-label trial. Data were analyzed using t-tests for observed cases (scores at each visit for patients with data at that visit), as well as a last observation carried forward (LOCF) approach. The percentage of patients with improvement on QOLIE-31, as well as on PGIC, was described at week 48. Results: At week 48, patients (LOCF, SP756 and SP774, n=607) showed a statistically significant mean improvement on all SSQ subscales, including cognitive, emotional and physical effects during and after seizures. Patients also showed an average improvement of -0.74 on the Overall SSQ score, a rating combining overall seizure severity and bother. On average, improvement on all QOLIE-31 subscales was shown with the exception of Medication Effects (-1.77, NS). Statistically significant improvements were found for Seizure Worry (+7.36), Social Functioning (+2.84), and the Total score (+1.66; LOCF, all 3 trials, n=867). For all QOLIE-31 subscales, at least one-third of patients showed clinically meaningful improvement (based on thresholds previously defined by the authors using Phase III LCM trial data) at week 48. The largest percentages of patients with clinically meaningful improvement were seen for the subscales of Seizure Worry (47.7%) and Social Functioning (47.7%). Mean improvements on both the QOLIE-31 and SSQ remained stable for up to 5 years of treatment. On the PGIC, 67.7% of patients (SP756 and SP774, n=614), reported overall improvement, with 46.9% of patients in the very much or much improved categories.Conclusions: After one year of LCM treatment, the SSQ revealed significant improvements in all aspects of seizure severity. The QOLIE-31 showed improvements in some aspects of HRQoL, with nearly half of patients reporting clinically meaningful improvement on seizure worry and social functioning. A total of 67.7% of patients reported their overall health state to be improved. These data indicate the effectiveness of LCM on both seizures and health-related outcomes. Study funded by UCB