Health-related quality of life in patients treated with eslicarbazepine acetate monotherapy: Pooled analysis from two registered clinical trials.

PURPOSE: While antiepileptic drug (AED) treatment effectiveness is traditionally assessed based on seizure frequency reduction (SFR), the overall value of AEDs in managing epilepsy and associated sequelae may be best assessed by how patients feel and function in terms of overall health-related quality of life (HRQoL). We conducted a pooled analysis of the Quality of Life in Epilepsy-31 (QOLIE-31) questionnaire from two phase 3 trials to explore the effect of response to conversion to eslicarbazepine acetate (ESL) monotherapy on HRQoL. METHODS: Data were pooled from two multicenter, randomized, double-blind, historical control phase 3 trials examining conversion to ESL monotherapy in adults with inadequately controlled partial-onset seizures (POS). The relationship between HRQoL and ESL treatment response was examined through the analysis of week 18 QOLIE-31 scores between patients who met the SFR ≥50% threshold (responders) and patients with SFR <50% (nonresponders). The analysis was conducted in the efficacy population (intent-to-treat (ITT) patients who entered the AED taper/conversion period) and completer population (efficacy patients who completed the ESL monotherapy period) and was repeated using an SFR ≥75% threshold. RESULTS: In the efficacy population, week 18 QOLIE-31 total score least squares mean (LSM) was significantly higher for responders with ≥50% SFR (LSM difference: 3.0; 95% confidence interval (CI): 0.2-5.8; p = 0.037) and with ≥75% SFR (LSM difference: 7.0; 95% CI: 3.6-10.3; p < 0.001) than nonresponders. In the completer population, overall quality of life (QoL) (LSM difference: 5.1; 95% CI: 1.5-8.6; p = 0.006) and social functioning (LSM difference: 5.4; 95% CI: 0.1-10.7; p = 0.046) were significantly higher for responders with ≥50% SFR than nonresponders, and all domain LSMs were higher for responders with ≥75% SFR (all p < 0.05) than nonresponders. CONCLUSIONS: This analysis of data from the phase 3 trials demonstrated significantly higher HRQoL among ESL responders with SFR of ≥75% and also at the lower SFR threshold of ≥50% compared with nonresponders.