Long-term efficacy and safety of eslicarbazepine acetate (ESL) monotherapy: results from BIA-2093-311/EXT study -the 2-year open-label extension of the ESL study (BIA-2093-311)

Objective: Evaluate efficacy and safety of Eslicarbazepine acetate (ESL) monotherapy during long-term treatment. Background: Eslicarbazepine acetate (ESL) is a once-daily antiepileptic drug (AED) approved for the treatment of focal (partial-onset) seizures, including as monotherapy for newly diagnosed adults with focal seizures. Design/Methods: Patients who completed the double-blind Phase III trial and remained seizure free for ≥6 months at the last evaluated dose, were eligible to enter a 2-year open-label extension (OLE) study (311-EXT), in which all patients received open-label treatment with flexibly-dosed ESL monotherapy. Efficacy: seizure freedom rate and overall treatment satisfaction. Safety: treatment-emergent adverse events (TEAEs), treatment-related TEAEs, serious TEAEs, TEAEs by severity, and TEAEs leading to discontinuation. Results: 206 patients entered the OLE study (ESL/ESL, n=109; CBZ-CR/ESL, n=97). The majority of patients, (89.3%; n= 184), remained under ESL monotherapy throughout the OLE study (ESL/ESL, n=96; CBZ-CR/ESL, n=88), and maintained the same ESL dose (ESL/ESL, 95.8%; CBZ/ESL, 89.8%). 158/184 (85.9%) of patients maintained seizure freedom during the 2-year. Treatment satisfaction was rated as ‘very good’ or ‘good’ by 100% of patients and investigators. 109/184 (59.2%) patients reported TEAEs (ESL/ESL, 53.1%; CBZ-CR/ESL, 65.9%). The majority of TEAEs were of mild or moderate intensity (77.7% overall; ESL/ESL, 69.8%; CBZ-CR/ESL, 86.4%). Serious TEAEs were reported for 12/184 (6.5%) patients overall (ESL/ESL, 7.3%; CBZ-CR/ESL, 5.7%). No serious TEAE was reported for more than one patient. Withdrawal due to TEAEs was low and similar between groups (ESL/ESL, 3.1%; CBZ-CR/ESL, 4.5%). Conclusions: Efficacy of ESL monotherapy was largely sustained during this 2-year OLE study in patients initially treated with ESL monotherapy and in those who transitioned from controlled-release carbamazepine (CBZ-CR) monotherapy. Long-term safety/tolerability of ESL monotherapy was consistent with what has been previously reported. These findings support the use of ESL as long-term monotherapy in newly diagnosed patients with focal epilepsy, including those previously treated with CBZ-CR. Disclosure: Dr. Trinka has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with a. Consultation fees from Bial, Biogen, Idec, Eisai, Ever Pharma, LivaNova, Medtronics, Novartis, Sanofi, Genzyme, and UCB Pharma; speaker’s honoraria from Bial, Boehringer Ingelheim, Eisai, GL Pharma, LivaNova, Newbridge, and UCB Pharma. Dr. Trinka has received research support from a. Research funding from Bayer, Biogen Idec, Bundesministerium fur Wissenschaft und Forschung, the European Union, FWF Osterreichischer Fond zur Wissenschaftsforderung, Merck, Novartis, Red Bull, and UCB Pharma.. Dr. Pereira has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with BIAL -PORTELA. Dr. Moreira has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employment: BIAL – Portela & Ca, S.A.. Dr. Magalhaes has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employment: BIAL – Portela & Ca, S.A.. Dr. Ikedo has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with BIAL – Portela.Dr. Gama has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with BIAL – Portela & Co S.A.