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(Abst. 1.297), 2019

Baseline Seizure Related Disability Assessment Scale (SERDAS) Scores in an Observational Study of Brivaracetam
Authors: Dale C. Hesdorffer, Mailman School of Public Health, Columbia University, New York, NY, USA; Melinda Martin, UCB Pharma, Smyrna, GA, USA; Roger J. Porter, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA and Department of Pharmacology, Uniformed Services University of the Health Sciences, Bethesda, MD, USA.; Julie Varner, UCB Pharma, Raleigh NC, USA; Anne-Liv Schulz, UCB Pharma, Monheim am Rhein, Germany; Ying Zhang, UCB Pharma, Raleigh NC, USA; Jacqueline A. French, NYU Comprehensive Epilepsy Center
Content: Rationale: Although seizure severity has been recognized as one of the principal aspects of clinical and investigational epilepsy assessment, the available tools for measuring this important outcome have limitations. We wished to test SERDAS (Seizure Related Disability Assessment Scale), a novel scale that assesses disability related to seizures or medication side effects, in patients enrolled in an observational study. The SERDAS is based on the MIDAS (Migraine Disability Assessment Scale). MIDAS has demonstrated test-retest reliability and treatment change sensitivity. SERDAS asks 5 questions to assess the disability of patients with epilepsy related to days lost as a result of seizures/seizure-related problems or medication side effects. There is also one overall assessment of disability. Methods: EP0088 is a post-marketing, multicenter prospective noninterventional study of brivaracetam (BRV) conducted in 33 sites in the US. Enrolled patients had received adjunctive BRV treatment; entry criteria included history of focal seizures in patients ≥16 years. At enrollment, a retrospective calculation of seizure frequency was determined. We also administered a novel disability assessment scale, the SERDAS. The relationship of SERDAS score to seizure frequency was evaluated in 218 patients enrolled with reported baseline SERDAS scores and baseline seizure frequency. Lower scores mean fewer disabled days. 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 by seizure frequency category.  Results: Patients who reported recent seizures had a higher baseline SERDAS score on seizure-related questions (Questions 1, 3, and 4) than patients who reported no seizures (Table 1). There was no clear relationship between seizure frequency and days lost due to side effects (Questions 2 and 5) (Table 2). 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. Conclusions: Sites did not report significant difficulty completing the SERDAS scale. 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. SERDAS scores will be obtained at subsequent study visits, and will be compared to reported seizure and side effect outcomes. Funding: This study was a partnership between UCB Pharma, PRA, and the Epilepsy Study Consortium, and funded by UCB Pharma.
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