Euro-Esli study of Aptiom confirms effectiveness in focal-onset epilepsy.- Bial + Eisai.

Bial and Eisai have announced new sub-analysis data from the Euro-Esli study, that confirms that the effectiveness of Aptiom (eslicarbazepine acetate) monotherapy is significantly greater compared with eslicarbazepine acetate as adjunctive therapy in adults with focal-onset epilepsy based on clinical practice. Whilst this may be expected, given that patients managed on monotherapy will tend to be less refractory to treatment, it provides real-world substantiation for the value of eslicarbazpine acetate as monotherapy in newly diagnosed patients. The data, which add to the body of evidence on eslicarbazepine acetate as monotherapy were published in Acta Neurologica Scandinavica.

The data from the Euro-Esli study sub-analysis shows that at 12 months, responder and seizure freedom rates were significantly higher in patients treated at the last visit with eslicarbazepine acetate monotherapy versus adjunctive therapy (responder rates, 93.2% (n=190) versus 70.4%(n=598); seizure freedom rates, 77.4% (n=190) versus 25.9% (n=598). The overall incidence of adverse events was similar in patients treated with eslicarbazepine acetate monotherapy at the last visit and those treated with adjunctive therapy at the last visit (27.1% (62/229) versus 30.8% (342/1109)). The most commonly reported adverse events were dizziness, somnolence, instability/ataxia and fatigue.

Comment: The Euro-Esli study presents the largest clinical practice study of eslicarbazepine acetate to date, with over 2,000 patients included. This is similar to the total number of patients recruited into the Phase III trials assessing eslicarbazepine acetate. The Euro-Esli data allows for a wide breadth of patients to be studied, including those who are routinely excluded from clinical studies, and thereby provides strong evidence for how eslicarbazepine acetate performs in the clinical practice setting.