Real-world efficacy of cenobamate in focal-onset seizures

Cenobamate has been recently approved as adjunctive treatment of uncontrolled, focal-onset seizures (FOS). Two case series shed light on the efficacy and safety of cenobamate in clinical practice. Results were positive and even in patients with superrefractory focal epilepsy, cenobamate was highly efficacious.

Although in the past years there has been an increase in available anti-seizure medications, drug-resistance in epilepsy patients has not decreased. An Italian study, presented by Dr Giovanni Falcicchio (University Hospital of Bari "A. Moro", Italy), investigated cenobamate as adjunctive treatment for patients with uncontrolled FOS [1]. Included were 20 adult patients who were enrolled in an Italian Expanded Access Program (EAP) with uncontrolled FOS and no treatment alternatives. Collected were efficacy and safety data 3, 6, and 12 months after administration of cenobamate, along with plasma concentrations of concomitant anti-seizure medication. Primary efficacy outcomes were median percentage change in monthly seizure frequency and responder rate (≥50% monthly seizure frequency reduction).

After 3 months, participants taking cenobamate reported a significant reduction (mean 63%) in seizure frequency compared with baseline, with a responder rate of 11/20 (58%). At month 6 and 12, decrease in seizure frequency was sustained. Adverse events were reported in 16 patients (80%), mainly mild and transient, and generally disappeared after reducing the posology of other anti-seizure medication the patient was taking.

Safety and efficacy of cenobamate as adjunctive therapy in an early-access programme was also assessed in a Spanish case series [2]. This prospective, longitudinal, multicentre study, presented by Dr Ariadna Gifreu (Bellvitge University Hospital, Spain), included 58 adult patients with drug-resistant epilepsy (mean age 40 [range 19–70]; 31 women). Median number of previous and concomitant anti-seizure medications were 9 and 3, respectively. Median monthly seizure frequency at baseline was 8.5 (range 5–30). Responder rates (≥50% monthly seizure frequency reduction), seizure free rates, and retention rates were measured at 6 months; adverse events (AE) at 3 and 6 months.

Median dose at 6 months was 200 mg/day (range 75–400 mg/day). At 6 months, median seizure frequency per month decreased significantly from 8.5 to 4 (P<0.001). Of 44 participants, 26 (59%) were responders (see Figure for all responder rates). Retention rate was 41 out of 47 participants (87%). Of 58 patients, 36 (62%) experienced AEs during the titration period and 25 out of 44 (57%) after 6 months.

The most common AEs were somnolence, unsteadiness, and dizziness. There were no serious AEs.

Figure: Responder rates at 6 months for seizure frequency reduction >50%, >90%, and seizure-free [2]

1. Falcicchio G, et al. Cenobamate: preliminary results of efficacy and safety in a real-life setting. OPR-077, EAN 2022, 25–28 April, Vienna, Austria.
2. Gifreu A, et al. Short term efficacy and safety of adjunctive cenobamate in patients with super-refractory focal epilepsy. OPR-082, EAN 2022, 25–28 April, Vienna, Austria.

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Posted on 22 August 202217 May 2024