QUALITY-OF-LIFE PREDICTORS OF TREATMENT CONTINUATION ON ESLICARBAZEPINE ACETATE MONOTHERAPY AMONG SUBJECTS WITH REFRACTORY PARTIAL-ONSET SEIZURES
Author(s)
Bond TC1, Velez FF2, Cramer JA3, Anastassopoulos KP1, Wang X1, Sousa R4, Rocha F4, Blum D2
1Covance Market Access, Gaithersburg, MD, USA, 2Sunovion Pharmaceuticals Inc., Marlborough, MA, USA, 3Yale University, Houston, TX, USA, 4BIAL, S. Mamede do Coronado, Portugal
OBJECTIVES: To examine quality-of-life (QOL) predictors of treatment continuation on eslicarbazepine acetate (ESL) monotherapy (1200 or 1600 mg/day) among subjects with partial epilepsy not well-controlled by current anti-epileptic drugs (AEDs). METHODS: Analysis of efficacy and QOL data from the pooled per-protocol population (n=200) of two 18-week randomized clinical trials of ESL (045 and 046), both with an 8-week taper/conversion period and a 10-week efficacy period. The primary efficacy endpoint for these trials was study exit due to: worsening seizure type, increased seizure frequency (SF), or investigator judgment. Predictors of monotherapy treatment continuation after 10 weeks were examined using stepwise logistic regression. Covariates included ESL dose, demographics, disease duration, baseline SF, baseline AEDs, number of AEDs, change in SF, and changes in the QOLIE-31 subscale scores (Cognitive Functioning, Emotional Well-being, Energy/Fatigue, Medication Effects, Overall QOL, Seizure Worry [SW], and Social Functioning) during the taper/conversion period. A separate model included change in SF to test whether predictors were independent of efficacy during taper/conversion. RESULTS: Change in SW during the 8-week taper/conversion period was the only predictor of remaining on ESL monotherapy. Mean change was 9.6 (SD: 20.98) for 181 subjects remaining on monotherapy, indicating a reduction in worry. Mean change for 19 subjects who exited was ‑4.8 (SD: 20.79). Each point improvement in SW was associated with a 4% increase in the odds of remaining on monotherapy (odds ratio [OR]: 1.04; 95% CI: 1.01, 1.06). Results were similar with inclusion of SF change in this model (OR: 1.03; 95% CI: 1.01, 1.06). CONCLUSIONS: In this pooled, per-protocol population analysis, change in a subject’s level of seizure worry was moderately predictive of remaining on ESL monotherapy. This may be a surrogate for severity of epilepsy and the value of such predictors needs additional research and assessment.
Conference/Value in Health Info
2015-05, ISPOR 2015, Philadelphia, PA, USA
Value in Health, Vol. 18, No. 3 (May 2015)
Code
PND55
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Neurological Disorders