Predictors of Clinically Meaningful Improvements in Health-Related Quality of Life Among Adults With Partial-Onset Epilepsy: A Pooled Analysis From Two Eslicarbazepine Acetate Monotherapy Trials (P6.283)

Objective: To evaluate potential predictors of achieving minimal clinically important differences (MCID) in health-related quality of life (HRQoL) among adults with partial-onset seizures (POS) receiving eslicarbazepine acetate (ESL) monotherapy. Background: Adults with POS who experience frequent seizures report poor HRQoL. HRQoL and MCID achievement were assessed using Quality of Life in Epilepsy-31 Inventory (QOLIE-31) administered in two phase 3 dose-blind, ESL conversion-to-monotherapy trials of adults with POS at baseline (beginning of 2-week titration/6-week taper/conversion period) and week 18 (end of 10-week monotherapy period). Design/Methods: QOLIE-31 change from baseline to week 18 and the percentage of patients with change ≥MCIDs were calculated for patients who entered the titration/conversion period (efficacy; N=332), completed the titration/conversion period (per-protocol; n=268), and remained in the study through the last visit (completer; n=226). Logistic regression was used to examine possible predictors (i.e., baseline seizure frequency, baseline QOLIE-31 score, ESL dose, age, body mass index, sex, ethnicity, race, region) of MCID achievement at week 18, based on published MCIDs for QOLIE-31 total score (TS) and 7 subscale scores. Results: Half (n=126) of the efficacy population with QOLIE-31 scores (n=252) achieved the QOLIE-31 TS MCID. Energy/fatigue subscale had the lowest percentage achieving MCID (41.3%) while social functioning had the highest (53.2%). The best predictor of MCID achievement was baseline score. A 5.4% increased odds of TS MCID achievement per unit decrease in baseline TS was observed (p Conclusions: These results suggest that half of patients who initiated, converted to, or completed ESL monotherapy realized clinically meaningful QOLIE-31 improvements. Additionally, patients with poorer baseline QOLIE-31 had a greater likelihood of achieving MCIDs. Study Supported by: Sunovion Pharmaceuticals Inc. Disclosure: Dr. Cramer has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with UCB, Sunovion, Supernus, Sun, Liva-Nova. Dr. Anastassopoulos has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Covance Market Access Services. Dr. Rajagopalan has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Sunovion Pharmaceuticals Inc. Dr. Blum has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employment: Sunovion Pharmaceuticals Inc.