First real-world study finds brivaracetam extended-release (SR) safe and effective for focal epileptic seizures

The recently publishedBEAM study shows that Brivaracetam(BRIVIACT)(BRV) extended-release (SR) tablets are safe and effective for the treatment of focal epileptic attacks in real-life settings in India. This study provides the first real-world evidence in India of the efficacy and safety of BRV-SR, highlighting its feasibility in the treatment of focal epilepsy with good retention rates and improved quality of life (QoL).

According to statistics from the World Health Organization (WHO), epilepsy is the fourth most common neurological disease in the world, affecting 50 million people. Antiepileptic drugs (ASMs) are key to treatment, and sustained-release (SR) formulations improve compliance and convenience. Brivaracetam (BRV) is a third-generation antiepileptic drug (ASM) with a short half-life, making it an ideal drug for SR.

In this observational study, researchers analyzeddata from 1989 patients (mean age 42.33±12.33 years) who received BRV-SR at 181 centers. The primary endpoint was efficacy, measured by change in seizure frequency. Secondary endpoints include response rate (≥50% reduction in focal seizure frequency (FoS) or focal bilateral tonic-clonic seizure frequency (FBTC)), usage pattern, Clinical Global Impression Efficacy Index (CGI-EI) and safety outcomes, providing a comprehensive real-world assessment of the BRV-SR drug.

Among the 1989 patients, 44.7% had epileptic seizures for 0 to 1 year, 34.64% for 1 to 3 years, 15.69% for 3 to 5 years, and 4.97% for more than 5 years. Psychiatric comorbidities included depression (21.97%), sleep disorders (15.54%), and anxiety disorders (9.6%), while 58.27% of patients had no psychiatric problems. Previously prescribed ASMs include levetiracetam (21.62%), sodium valproate (20.01%), lacosamide (14.08%), oxcarbazepine (12.57%), carbamazepine (9.05%), lamotrigine (6.28%), palampanib (2.82%) and brivaracetam IR (0.25%).

1. Secondary endpoint:

1. Response rate and seizure freedom: 72.1% of patients had a 50% or greater reduction in seizure frequency (response rate). Overall, 1268 (63.75%) patients reported complete seizure freedom, with similar incidence rates at BRV-SR doses of 50 mg (63.16%), 100 mg (64.01%), and 200 mg (63.57%).

2. Clinical Global Impression Efficacy Index (CGI-EI score): Among 1,895 patients with available CGI-EI score data, BRV-SR showed "significant improvement" in 1,310 cases (69.14%), "moderate improvement" in 452 cases (23.85%), "minimal improvement" in 131 cases (6.91%), and "unchanged" in 2 cases (0.1%). Improvements were consistent at BRV-SR doses of 50 mg, 100 mg and 200 mg/day.

2. Subgroup analysis of clinical importance:

1. Effectiveness of seizure types: The effective rate for patients with focal seizures (FoS) is 71.44% (seizure reduction ≥50%), and the degree of seizure freedom is 63.34%, while the effective rate for patients with focal to bilateral tonic-clonic seizures (FBTC) is 73.42%, and the degree of seizure freedom is 64.79%. There is no significant difference between the two groups.

2. Effectiveness over the duration of epilepsy: Patients with epilepsy duration >1 year have a better prognosis, with an effective rate of 77.64%.

3. The degree of freedom from epileptic seizures was 66%, while the rates for patients with duration ≤ 1 year were 65.24% and 60.96% respectively.

4. Monotherapy and adjuvant therapy: Compared with monotherapy, BRV-SR as adjuvant therapy resulted in higher response rate (80.58% vs. 57.87%) and seizure freedom (68.22% vs. 56.26%).

5. Correlation between ASM-induced BAEs and BRV-SR initiation: Patients with ASM-induced behavioral adverse events (BAEs) are more likely to take BRV-SR, suggesting that it is the preferred method of treatment for otherwise intolerable side effects of ASM.

6. Psychiatric comorbidities: BRV-SR was significantly associated with use in patients with psychiatric comorbidities.

7. Drug-resistant epilepsy: BRV-SR has also been found to be effective in cases of drug-resistant epilepsy.

3. Security analysis:

Mild and transient adverse events (AEs) were reported by 52 patients (2.61%), including drowsiness/sedation (0.9%), dizziness (0.8%), fatigue (0.5%), and nausea/vomiting (0.4%). No serious AEs requiring discontinuation were observed with BRV-SR tablets.

The BEAM study highlights that brivaracetam extended-release (BRV-SR) is a well-tolerated, effective and easy-to-use treatment for focal epilepsy, showing significant reductions in seizures, high response rates and improved quality of life.

References:https://medicaldialogues.in/neurology-neurosurgery/first-real-world-study-finds-brivaracetam-sustained-release-sr-safe-and-effective-for-focal-seizures-in-indian-population-142304