Baseline Seizure Related Disability Assessment Scale (SERDAS) Scores in an Observational Study of Brivaracetam

Objective: Assess the real-world effectiveness of brivaracetam (BRV) and explore seizure disability using a novel patient reported scale that assesses seizure-related disability or medication side effects. Background: The available tools measuring seizure-related disability have limitations. SERDAS measures time lost to seizures and side effects. Design/Methods: EP0088 is a post-marketing, multicenter, prospective, noninterventional, open-label study of BRV conducted in 33 US sites. Enrolled patients received adjunctive BRV treatment; entry criteria included history of focal seizures in patients ≥16 years. We administered a novel disability assessment scale, the SERDAS. The change in SERDAS score with BRV treatment and the relationship of SERDAS score to seizure frequency was evaluated in 218 patients enrolled with baseline SERDAS scores and baseline seizure frequency. Patients were divided into those with 0 (n=34), >0–5 (n=158), >5–10 (n=7), and >10 (n=19) seizures per 28 days for retrospective SERDAS score calculation. Results: Patients reporting recent seizures had higher baseline SERDAS scores on seizure-related questions (Questions 1, 3, and 4) than patients who reported no seizures (0 seizures: mean 2.7; >0–5: 12.4; >5–10: 10.6; >10: 11.5 seizures/28 days). There was no clear relationship between baseline seizure frequency and days lost due to side effects (Questions 2 and 5). Overall mean SERDAS disability score (2.9) (Question 6) was also lower in seizure free patients than in patients with >0–5 (4.1), >5–10 (4.7) or >10 (4.4) seizures per 28 days during baseline. In an interim analysis (3 month and 6 month cohorts) BRV treatment resulted in reduced patient-reported disability as measured by SERDAS, with the greatest reduction observed in seizure-related disability. Conclusions: Baseline scores suggest many more days lost to seizures/seizure-related problems compared to medication side effects, except in seizure free patients, who lost more days to side effects. BRV treatment was associated with the largest reduction in seizure-related disability on this novel scale. Disclosure: Dr. French has received research support from Adamas, Addex, Anavex, Arvelle Therapeutics, Axovant, Biogen, BioMotiv/Koutif, Blackfynn, Bloom Science, BridgeValley, Cavion, Cerebral Therapeutics, Cerevel, Clinilabs, Crossject, Eisai, Encoded, Engage Therapeutics, Epitel, Fortress Biotech, and GW Pharma.Dr. Porter has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Consulting: Otsuka, Praxis, Crossject, NeuroPace, UCB, Astellas, Ovid, SFA, Xenon, Novartis, Epilepsy Study Consortium. Dr. Varner has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with employee of UCB Pharma. Dr. Schulz has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with employee of UCB Pharma. Dr. Zhang has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with employee of UCB Pharma. Dr. Zhang holds stock and/or stock options in UCB stock >$10,000. Dr. Martin has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with employee of UCB Pharma. Dr. Martin holds stock and/or stock options in UCB stock >$10,000.