Once-daily eslicarbazepine acetate (ESL), an oral anti-epileptic drug for focal seizures, was found to be effective and well-tolerated, and was associated with numerical improvements in health-related quality of life, according to 3 abstracts presented at the American Epilepsy Society 2019 Annual Meeting, held in Baltimore, Maryland from December 6 to 10.

One study focused on the safety and tolerability of ESL when used in a real-world setting, as a first adjunctive therapy with levetiracetam or lamotrigine monotherapy (Arm 1), or as later adjunctive therapy (Arm 2) in treatment-resistant patients with focal seizures.1 A separate abstract reported the efficacy2 of ESL in these populations and a third explored the effect of ESL on health-related quality of life (HRQoL).3

All three abstracts incorporated data from a multicenter, phase 4, open-label, non-randomized study that included adult patients (≥18 years) with focal seizures, treated in the USA and Canada. Of the 102 patients included in the study (median age 40.5 years, 59% female), 42 were treated with ESL as first adjunctive therapy (Arm 1), either in combination with levetiracetam (n=28) or with lamotrigine (n=14); 59 patients received ESL as a later adjunctive therapy (Arm 2).

Median standardized seizure frequency (seizures per 28 days) was 2.0 in Arm 1, and 2.4 in Arm 2.  At 24 weeks, the median reductions in standardized seizure frequency were higher in Arm 1 than in Arm 2 (74.0% vs 23.7%, respectively). Similarly, the proportion of patients with ≥50% reduction in standardized seizure frequency was also higher in Arm 1 than in Arm 2 (63.2% vs 37.7%, respectively). During the 24-week maintenance period, a higher proportion of patients in Arm 1 than patients in Arm 2 remained seizure-free (26.3% vs 9.4%, respectively).


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Quality of Life in Epilepsy (QOLIE-31), a patient-reported survey that includes 7 subscales, was used to measure HRQoL at baseline and after 11 and 27 weeks. Baseline mean QOLIE-31 overall score was 69.59 in Arm 1 and 60.66 in Arm 2. At week 11, mean QOLIE-31 overall scores were 70.47 in Arm 1 and 61.55 in Arm 2. At week 27, the respective mean scores were 70.49 and 60.46. The greatest improvement in HRQoL was evident for seizure worry and social functioning subscales, and the changes in scores from baseline to week 27 exceeded clinically meaningful thresholds in Arm 1.

Treatment-emergent adverse events (TEAEs) were more common when ESL was used as a later adjunctive therapy (48 patients, 81.4%) than when ESL was given as first adjunctive therapy (30 patients, 69.8%). The most common TEAEs were dizziness, nausea, headache, somnolence, fatigue, nasopharyngitis, vomiting, and anxiety.

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When ESL was given as first adjunctive, TEAEs were more common with combination of ESL and lamotrigine than combination of ESL with levetiracetam (92.9% vs 57.1%, respectively). When ESL was used as a later adjunctive therapy, the incidence of TEAEs was comparable when given in combination with either lamotrigine or levetiracetam (76.2% vs 75.0%, respectively).

The researchers concluded that treatment with ESL was effective for treatment of focal seizures and was generally well tolerated when taken as a first adjunctive therapy, or as a later adjunctive therapy for focal seizures. The incidence of TEAEs was greater in the latter group.

Reference

1. Cantu D, Gidal BE, Tosiello R, Blum D, Pikalov A, Grinnell T. Safety and tolerability of eslicarbazepine acetate as first adjunctive therapy with levetiracetam or lamotrigine, or as later adjunctive therapy in patients with focal seizures Presented at The American Epilepsy Society 2019 Annual Meeting; December 6-10, 2019; Baltimore, MD. Abstract 1.427.

2. Pikalov A, Grinnell T, Hixson J, Tosiello R, Blum D, Cantu D. Efficacy of eslicarbazepine acetate as first adjunctive therapy with levetiracetam or lamotrigine, or as later adjunctive therapy in patients with focal seizures. Presented at The American Epilepsy Society 2019 Annual Meeting; December 6-10, 2019; Baltimore, MD. Abstract 1.45.

3. Sosa A, Mehta D, Lee A, Cantu D, Grinnell T. Health-related quality of life in patients with focal seizure taking eslicarbazepine acetate as first adjunctive agent to levetiracetam/lamotrigine or as later adjunctive agent: Phase 4 study results. Presented at The American Epilepsy Society 2019 Annual Meeting; December 6-10, 2019; Baltimore, MD. Abstract 1.456.