New clinical practice data confirms clinical effectiveness of Zebinix® (eslicarbazepine acetate) monotherapy for focal-onset epilepsy in adults
Posted in Industry News on 8th Oct 2018
Bial and Eisai have today (8th October 2018) announced new sub-analysis data from the Euro-Esli study, that confirms that the effectiveness of eslicarbazepine acetate monotherapy is significantly greater compared with eslicarbazepine acetate as adjunctive therapy in adults with focal-onset epilepsy based on clinical practice.1 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 today in Acta Neurologica Scandinavica.1
The Euro-Esli study presents the largest clinical practice study of eslicarbazepine acetate to date, with over 2,000 patients included.2 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.
“We are very encouraged by these results which demonstrate efficacy and tolerability of eslicarbazepine acetate monotherapy in patients with focal-onset seizures,” comments Professor Martin Holtkamp, Medical Director, Epilepsy Center Berlin-Brandenburg, Berlin, Germany, and author of this sub-analysis of the Euro-Esli study. “These findings complement those found in the Phase III clinical trials, providing further evidence to confirm its effectiveness in a clinical practice setting.”
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); p<0.001; seizure freedom rates, 77.4% (n=190) versus 25.9% (n=598); p<0.001).1
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) p=0.259).1 The most commonly reported adverse events were dizziness, somnolence, instability/ataxia and fatigue.1
“Euro-Esli is the largest study into the effectiveness of eslicarbazepine acetate to date and included a large number of patients with a broad inclusion and exclusion criteria. This means that the patients assessed in this study were truly representative of the variety of patients encountered in clinical practice,” comments Dr Vicente Villanueva, Neurologist and Epileptologist, Hospital Universitario y Politécnico La Fe, Valencia, Spain. “This evidence provides a significant insight into how eslicarbazepine acetate performs in a routine medical setting.”
Eslicarbazepine acetate is indicated in the European Union (EU) as a monotherapy in the treatment of partial-onset seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy.3 Eslicarbazepine acetate is also indicated in the EU as adjunctive therapy in adults, adolescents and children aged above 6 years, with partial-onset seizures with or without secondary generalisation.3
1 Holtkamp M, et al. (2018) Eslicarbazepine acetate as monotherapy in clinical practice: Outcomes from Euro-Esli. Acta Neurol Scand. doi: 10.1111/ane.13023
2 Villanueva V, et al. (2017) Euro-Esli: a European audit of real-world use of eslicarbazepine acetate as a treatment for partial-onset seizures. Journal of Neurology. 264(11),2232-2248
3 European Medicines Agency (2017) Zebinix® (eslicarbazepine acetate) Summary of Product Characteristics.
Available at: www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000988/WC500047225.pdf. Last accessed September 2018
4 Hebeisen S, et al. (2015) Eslicarbazepine and the enhancement of slow inactivation of voltage-gated sodium channels: A comparison with carbamazepine, oxcarbazepine and lacosamide. Neuropharmacology. 89, 122-135.
5 Trinka E, et al. (2018) Efficacy and safety of eslicarbazepine acetate versus controlled-release carbamazepine
monotherapy in newly diagnosed epilepsy: A phase III double-blind, randomized, parallel group, multicenter study. Epilepsia. 59(2):479-491.
6 Jóźwiak S, et al. (2018) Effects of adjunctive eslicarbazepine acetate on neurocognitive functioning in children with refractory focal-onset seizures. Epilepsy & Behavior. 81:1-11.
7 Kirkham F, et al. (2017) A placebo-controlled trial of eslicarbazepine acetate add-on therapy for focal seizures in children. Presented at European Paediatric Neurology Society Congress (EPNS) 2017; Lyon, France. Poster presentation.