Abstracts

Rationale: The burden of seizure clusters affects patient quality of life (QoL), but few studies have examined this impact. Diazepam nasal spray is approved for acute treatment of seizure clusters in patients with epilepsy aged ≥6 years. The present analysis of a long-term safety study of diazepam nasal spray examines results of the patient-reported Quality of Life in Epilepsy (QOLIE) questionnaire among adults with seizure clusters.

Methods: Patients aged 6–65 years in a long-term, open-label safety study of diazepam nasal spray (Valtoco®) used 5-, 10-, 15- or 20-mg doses (based on age and weight) to treat seizure clusters. QOLIE-31-P is an epilepsy-specific instrument to assess health-related QoL in adult patients. The total score, on a 100-point scale, is a weighted composite of 7 separate 100-point subscales: Seizure Worry, Overall QoL, Emotional Well-Being, Energy/Fatigue, Cognitive Functioning, Medication Effects, and Social Functioning. Higher scores indicate better QoL. Patients ≥18 years old completed the QOLIE-31-P at baseline (day 0) and days 30, 150, 270, and 365, recording responses covering the prior 4 weeks. Descriptive statistics for total score and unweighted subscale scores were calculated across time points using all available data from each patient (All Data) and data from the subset of patients who completed QOLIE-31-P at all 5 time points (Completers).

Results: Among 163 treated patients, 74 adults (59.5% female) provided data and had a mean age of 35.6 years. Exposure was ≥12 months for 60 patients (range, 3.1–40.4 months), with a mean of 2.4 doses per month. Mean QOLIE-31-P scores tended to be similar or increase slightly across time points, with maximum at day 365 in both the All Data (n=53-71; Figure 1) and Completer (n=48; Figure 2) analyses. Total scores increased from day 0 to day 365 by 5.20 (All Data) and 2.21 (Completers). Subscore means for Seizure Worry and Social Functioning showed the greatest numeric increase from baseline. The mean change from day 0 to day 365 for Seizure Worry was 8.75 (All Data) and 5.88 (Completers); and for Social Functioning was 8.10 (All Data) and 6.29 (Completers).

Tolerability was similar to that seen in the full study cohort with 23.0% reporting treatment-related treatment-emergent adverse events; none of which ere serious or led to discontinuation.

Conclusions: In this analysis, adults with highly refractory epilepsy treated with diazepam nasal spray for seizure clusters maintained QOLIE scores across the 12-month study period, generally with small numeric improvement. Seizure Worry and Social Functioning subscale scores showed apparent improvements over time. Differences in results for individual subscales may suggest variations in sensitivity to use of an intermittent treatment. Availability of diazepam nasal spray for out-of-hospital seizure treatment has potential to improve patients’ sense of empowerment to treat seizure clusters. Further study of QoL and the most appropriate tools for patients treated for seizure clusters is needed.

Funding: Please list any funding that was received in support of this abstract.: Neurelis, Inc.