Abstracts

Rationale: Patient perception of treatment change in clinical studies needs to be better evaluated. Beyond quality of life scales, patient-reported outcomes (PROs) are underused in trials of antiseizure medicines to date, leaving a unique outcome gap. In this real-world study of brivaracetam (BRV), we measured patient perception of change in mood, fatigue, sleep disturbance, and disability during treatment using PROs: the validated PRO Measurement Information System (PROMIS) forms and a new Seizure-Related Disability Assessment Scale (SERDAS).

Methods: EP0088 was a prospective, observational study. Patients ≥ 16 years with focal seizures were enrolled upon prescription of adjunctive BRV and followed for ≤ 12 months. Changes in PROMIS anger, anxiety, depression, fatigue, and sleep disturbance domains and SERDAS (overall disability, days lost to seizure-related problems or medication side effects) were evaluated from baseline to 1.5, 3, 6, and 12 months on BRV and in subgroups of patients completing or not completing 12 months of BRV. For non-completers, PROs from visits before stopping BRV and data at last evaluation were analyzed.

Results: 252 patients were evaluated, and 161 completed the study. Across all patients improvements were seen at 1.5 months and were maintained over 12 months for all PROMIS domains (Fig. 1). Improvements on BRV in all domains, except fatigue, were considered meaningful at 12 months. In completers, BRV substantially improved patient-reported anger, anxiety, depression, fatigue, and sleep disturbance from baseline to 12 months (mean T-score change from baseline: −3.18, −3.76, −4.00, −1.95, −2.84, respectively). At last evaluation, non-completers (n=91) had no meaningful improvement in anxiety, depression, fatigue, and sleep disturbance (mean T-score change: −0.36, −1.57, −0.93, −0.28, respectively), but a meaningful improvement in anger was observed (mean T-score change: −3.65). BRV improved total SERDAS disability score, disability due to seizures, and disability due to medication side effects at each timepoint (mean change at 12 months compared with baseline [days]: −7.8, −5.0, −2.8), and overall perception of disability (mean change: −1.2). At last evaluation, non-completers reported no improvement in disability due to seizures (mean change: 0.5 days) or side effects (mean change: 0.7 days).

Conclusions: BRV treatment substantially improved patient anger, anxiety, fatigue, sleep disturbance, and disability within the first 1.5 months, and this was maintained for 12 months among those remaining on BRV. Patients who did not complete 12 months of BRV showed less improvement in anxiety, fatigue, and sleep disturbance symptoms versus completers. BRV improved patient overall disability, as well as disability due to seizures and medication side effects according to the new SERDAS scale. PROMIS short forms and SERDAS are efficient PRO scales that can be incorporated into real-world studies to measure patient symptoms and disability.

Funding: Please list any funding that was received in support of this abstract.: UCB Pharma-funded; partnership between UCB Pharma, Epilepsy Study Consortium, and PRA.