PORTO, Portugal and HATFIELD, England, December 12, 2017 /PRNewswire/ --
- Results from the pooled analysis presented at the American Epilepsy Society Annual Meeting 2017 in Washington DC, US.[1],[2],[3]
Bial and Eisai have announced new real-world audit data presented at the American Epilepsy Society (AES) Annual Meeting 2017, which add to the existing clinical trials examining the effectiveness and tolerability of Zebinix(R) (eslicarbazepine acetate). These data assess the real-world effectiveness, safety and tolerability of eslicarbazepine acetate when used as monotherapy in patients with partial-onset seizures, following conversion from previous treatment with carbamazepine or oxcarbazepine and when treated with less than or equal to1200 or >1200 mg/day eslicarbazepine acetate.[1],[2],[3]
Euro-Esli, an exploratory pooled analysis of data from 14 European clinical practice studies including 2,058 patients aged 14-88 years old with partial-onset seizures (POS), with or without secondary generalization, examined the real world use of eslicarbazepine acetate as monotherapy, as well as adjunctive therapy, for POS in clinical practice.
"Euro-Esli study offered data of >200 patients with eslicarbazepine acetate in monotherapy, where it proved to be an effective and tolerable option," says Dr Vicente Villanueva, Neurologist and Epileptologist, Hospital Universitario y Politécnico La Fe, Valencia, Spain.
The Euro-Esli study also showed that eslicarbazepine acetate was efficacious and generally well tolerated in patients switching from carbamazepine or oxcarbazepine in clinical practice.[1] A further abstract, examining a different Euro-Esli data set, explored the effectiveness, safety and tolerability of eslicarbazepine acetate in patients with partial-onset seizures treated with less than or equal to1200 or >1200 mg/day.[2]
Epilepsy is one of the most common neurological conditions in the world, affecting approximately fifty million people in Europe. [4] It is defined as either: (1) the occurrence of two or more unprovoked seizures >24 hours apart; (2) one unprovoked (or reflex) seizure and a probability of further seizures occurring over the next 10 years that is similar to the general recurrence risk (at least 60%) after two unprovoked seizures; (3) diagnosis of an epilepsy syndrome.[5] Depending on the type, seizures may involve one part of the body or the whole body, and may affect consciousness. Epilepsy has many possible causes but sometimes the cause is unknown.[6]
"Real-world data explores the impact of a treatment in a real-life environment and these data improve our knowledge and understanding around the use of eslicarbazepine acetate, reinforcing BIAL's commitment to developing and delivering beneficial treatment options for people living with epilepsy." comments António Portela, CEO of BIAL.
"We are committed to the development of our anti-epileptic drug product portfolio, and Eisai continues to invest in real world evidence which will help us ensure we are addressing the diversity of epilepsy patients, which may help improve their quality of life," comments Neil West, Vice President EMEA, Global Neurology Business Unit at Eisai.
In Europe eslicarbazepine acetate is indicated as:
- monotherapy in the treatment of partial-onset seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy; - adjunctive therapy in adults, adolescents and children aged above 6 years, with partial-onset seizures with or without secondary generalisation.[7]
Notes to Editors
About the Euro-Esli study[1],[2],[3]
Euro-Esli was a pooled analysis of 14 European clinical practice studies. Effectiveness assessments included responder rate (greater than or equal to50% seizure frequency reduction) and seizure freedom rate (seizure freedom at least since prior visit), assessed after 3, 6 and 12 months of ESL treatment, and at last visit. Safety and tolerability were assessed throughout follow-up by evaluating adverse events (AEs) and ESL discontinuation due to AEs, respectively.
Monotherapy in clinical practice[3]
Data were compared for patients treated initially with ESL monotherapy versus adjunctive therapy, and for patients treated at last visit with ESL monotherapy versus adjunctive therapy.
Of the 2058 patients included in Euro-Esli (mean age 44.0 years; 52.1% male), the number of concomitant AEDs used at baseline and last visit was known for 2045 and 1340 patients, respectively. ESL was used as monotherapy in 88/2045 (4.3%) patients initially and in 229/1340 (17.1%) patients at last visit. At 12 months, responder and seizure freedom rates were significantly higher in patients treated initially with ESL monotherapy versus adjunctive therapy, and in patients treated at last visit with ESL monotherapy versus adjunctive therapy. The overall incidence of AEs was similar in patients treated initially with ESL monotherapy and adjunctive therapy, and in patients treated at last visit with ESL monotherapy and adjunctive therapy. The rate of discontinuation due to AEs was not significantly different in patients treated initially with ESL monotherapy versus adjunctive therapy, but the rate was significantly lower in patients treated at last visit with ESL monotherapy versus adjunctive therapy.
Transitioning from carbamazepine or oxcarbazepine in everyday clinical practice[1]
Data were analysed for cohorts of patients who transitioned from carbamazepine or oxcarbazepine to ESL either due to, in most of the cases, lack of efficacy or poor tolerability.
Euro-Esli included 2058 patients (52.1% male; mean age, 44 years; mean duration of epilepsy, 20.9 years), of whom 233 (11.3%) transitioned from carbamazepine to ESL and 134 (6.5%) transitioned from oxcarbazepine to ESL. After 12 months of ESL treatment, responder and seizure freedom rates for patients transitioning from carbamazepine due to lack of efficacy (n=163) were 70.0% and 30.9%, respectively. Corresponding values for patients transitioning from oxcarbazepine due to lack of efficacy (n=90) were 57.1% and 25.0%, respectively. Among patients who transitioned from carbamazepine and oxcarbazepine to ESL due to lack of efficacy, 11.6% and 10.5% discontinued ESL due to lack of efficacy, respectively. Among patients who transitioned from carbamazepine and oxcarbazepine to ESL due to poor tolerability (n=64 and n=61, respectively), 26.6% and 39.5% experienced AEs, and 8.3% and 6.8% discontinued ESL due to AEs, respectively.
Doses >1200 mg/day versus less than or equal to1200 mg/day[2]
Data were compared for patients who were treated at any time during follow-up with ESL at a dose >1200 mg/day vs those who were only treated with ESL at doses less than or equal to1200 mg/day.
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