Abstracts

Rationale: Generic-brittle (GB) epilepsy patients considered at risk for worsened seizures or drug side effects from generic antiepileptic drug (AED) formulation switching demonstrated no significant difference in their drug levels when switched between a brand and generic AED (Ting 2015). An alternative basis for being GB may relate to having a personality or mindset that predisposes to poor outcomes from a formulation switch. The objective of this study was to explore whether GB epilepsy patients could be differentiated from non-GB patients based on standardized measures of personality, mood, outlook, and beliefs. Methods: Eight neuropsychological tests were administered to adult patients recruited from the University of Maryland Medical Center outpatient epilepsy clinic. GB status was characterized based on three factors: 1) history of intractable seizures or AED adverse event(s); 2) opinion about generic medications in general or by personal experience; 3) whether taking brand or generic AED. Of n=127 subjects, 50 were GB and 77 were non-GB. Tests included Neuroticism Extraversion Openness Personality Inventory 3 (NEO-PI 3), Life Orientation Test-Revised (LOT-R), Quality of Life in Epilepsy Inventory-89 (QOLIE-89), Adverse Childhood Experiences Score (ACE), Physical Symptoms Questionnaire or Patient Health Questionnaire-15 (PHQ-15), Beck Depression Inventory II (BDI II), Beck Anxiety Inventory (BAI), and the Belief’s About Medicine’s Questionnaire Epilepsy (BMQ-Epilepsy). All patients completed LOT-R, QOLIE-89, ACE, PHQ-15, BDI II, and BAI. N=115 and n=123 patients completed NEO-PI 3 and BMQ-Epilepsy surveys, respectively. A total of 23 Chi-square analyses were performed to assess which test or test sub-components discriminate between GB and non-GB status. Chi-square analyses were corrected using Bonferroni adjustment.  Results: No neuropsychological test or test-subcomponent discriminated between GB and non-GB subjects. None even yielded p < 0.05. Only five assessments yielded p < 0.3, and were BMQ-Epilepsy specific necessity, BMQ-Epilepsy general overuse, BMQ-Epilepsy general harm, QOLIE-89 medication effects, and BDI II severity (with respective p-values of 0.10, 0.086, 0.14, 0.17, and 0.28).Subgroup analyses were performed within 30 GB subjects who opined against generics and had previously experienced a switch problem. The results were similar as the overall population, with no assessment differentiating GB from non-GB subjects. Eight assessments yielded p < 0.3, and were NEO-PI 3 conscientiousness and depression, BMQ-Epilepsy specific necessity and general harm, QOLIE-89 health perceptions, ACE, and BAI total score and severity distribution (with respective p-values of 0.23, 0.21, 0.039, 0.083, 0.198, 0.17, 0.15, and 0.199).  Conclusions: No neuropsychological test or test-subcomponent differentiated GB from non-GB subjects in this cohort of epilepsy patients. Funding: BEEP2 study funded by FDA HHSF223201400188C